GENERAL RULES
OF PROGRAMMES OF THE MINISTRY OF
HEALTH TO SUPPORT APPLIED MEDICAL
RESEARCH
V. 250203
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Table of Contents
I. TITLE I - INTRODUCTION3
1. BASIC INFORMATION3
2. GLOSSARY OF TERMS3
II. BEFORE SIGNING THE CONTRACT7
3. DEFINITION OF DATA TO BE DISCLOSED7
4. PUBLICITY8
5. DIVISION OF THE PROGRAMME INTO AREAS8
5.1. AREA 1 - PUBLIC HEALTH8
5.2. AREA 2 - PATHOGENESIS AND DEVELOPMENT OF DISEASES9
5.3. AREA 3 - INNOVATIVE SOLUTIONS FOR MEDICINE10
6. PROOF OF ELIGIBILITY12
7. OPINIONS ON THE PROJECT PROPOSAL16
7.1. OPINION OF THE ETHICS COMMITTEE OF THE APPLICANT/OTHER PARTICIPANT16
7.2. STATEMENT OF THE EXPERT COMMITTEE - PROTECTION OF EXPERIMENTAL ANIMALS16
8. EVALUATION PANELS ANDTHEIR PROFESSIONAL FOCUS17
9. METHODOLOGY FOR RECEIVING AND EVALUATING PROJECT PROPOSALS20
9.1. ACCEPTANCE OF PROJECT PROPOSALS20
9.2. EVALUATION OF THE TRUTHFULNESS AND ACCURACY OF DATA IN THE PROJECT PROPOSAL22
9.3. ECONOMIC EVALUATION OF PROJECT PROPOSALS23
9.4. REASONS FOR ELIMINATING A PROJECT PROPOSAL FROM THE PUBLIC TENDER24
III. TITLE III - AFTER SIGNING THE CONTRACT24
10. CONDITIONS FOR PROJECT SOLUTIONS24
10.1. PROCEDURE FOR CONCLUDING A CONTRACT FOR THE PROVISION OF SPECIAL PURPOSE SUPPORT
OR FOR ISSUING A DECISION ON A BUDGET INCREASE24
10.2. CONDITIONS, TIME LIMIT AND METHODS OF GRANTING TARGETED SUPPORT25
10.3. CONDITIONS FOR THE USE OF TARGETED SUPPORT26
10.4. PRINCIPLES FOR PROJECT DESIGN29
10.5. PARTIAL REPORT ON THE PROJECT30
10.6. FINAL PROJECT REPORT31
10.7. EVALUATION OF THE PROGRESS OF THE PROJECT31
10.8. EVALUATION OF THE COMPLETED PROJECT32
10.9. CHANGES IN THE COURSE OF THE PROJECT33
10.10. PROJECT CHANGE PROCEDURE34
10.11. PROCEDURE FOR CHANGING ANOTHER PARTICIPANT, INVESTIGATOR OR CO-INVESTIGATOR35
10.12. PROCEDURE FOR CHANGE OF BENEFICIARY36
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I. Introduction
1. Basic information
(1) These General Rules are issued by the Provider, which is the Ministry of Health of the Czech
Republic, with its registered office at Palackého náměstí 375/4, 128 00 Prague 2, ID No.
00024341 (hereinafter referred to as the "Provider or the Ministry of Health") as an
accompanying document for the announced public tenders.
(2) The Czech Health Research Council (hereinafter referred to as "AZV") is an organizational
unit of the state under the direct management of the Ministry of Health of the Czech
Republic. AZV is entrusted by the Ministry with the support of applied research in the health
sector in accordance with the law, in particular by ensuring the evaluation of project
proposals and the preparation of documents for the provision of special-purpose support, as
well as the subsequent control of implementation.
(3) Public tenders are announced in accordance with Act No. 130/2002 Coll., on support for
research and development from public funds and on amendments to certain related laws, as
amended (hereinafter referred to as "the Act") and in accordance with Commission
Regulation (EU) No 651/2014 of 17 June 2014, as amended by Commission Regulation
(EU) No 2021/1237 of 23 June 2014. of 19 July 2021 declaring certain categories of support
compatible with the internal market in accordance with Articles 107 and 108 of the Treaty
on the Functioning of the EU1
("Commission Regulation") and in accordance with the
Framework for State support for Research, Development and Innovation - Official Journal
of the European Union of 19 October 2022 (2022/C 414/01) ("the Framework").
2. Glossary of terms
(1) Application
An online web application created for the ISVP application process at
http://eregpublic.ksrzis.cz
(2) Applied research
According to the law, applied research means industrial research, experimental development
or a combination thereof. The OECD Frascati Manual further defines applied research as
original research carried out with the aim of obtaining new knowledge. However, it is
primarily directed towards a specific practical purpose or objective. Applied research may
be subdivided into basic research which is necessary to obtain the results of applied research.
(3) Another participant
Another project participant is an organisational unit of the State or an organisational unit of
the Ministry engaged in research and development, as well as a legal entity or natural person
1
Published in the Official Journal of the European Union on 26 June 2014, 2014/L 187/01.
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whose participation in the project is defined in the project proposal and with whom the
beneficiary has concluded a contract on participation in the project.
(4) Intensity of support
The support intensity is the proportion of the total eligible costs represented by the public
support granted by the provider. The support intensity is set by the provider in accordance
with the law, the Commission Regulation and the Framework.
(5) Project proposal
The project proposal is an application by the applicant for the provision of special-purpose
support in the form of a grant or an increase in expenditure by an organisational unit of the
State or a local self-government unit or an organisational unit of the Ministry engaged in
research and development, in accordance with the budgetary rules. It must contain the
information required by the DB and comply with the relevant legal provisions necessary for
the granting of the support.
(6) Proposer
The proposer (or co-proposer) is the natural person who is responsible to the applicant (or
co-proposer) for the professional level of the project proposal, must be in an employment
relationship with the applicant (or co-proposer) (employment relationships based on
agreements on work performed outside the employment relationship are not admissible), or
such a relationship must have been established at the latest on the date of the start of the
project and must last for the entire duration of the project. The only exception is if the
applicant is a natural person, in which case the applicant is also the proposer. Each project
proposal must include the name of the proposer (or co-proposer, as appropriate). The same
natural person may act as proposer and co-proposer for only one project proposal in this call
for proposals. The proposer (or co-proposer, as the case may be) becomes the principal
investigator (or co-investigator, as the case may be) after the conclusion of the contract or
the decision. Two types of project proposals can be submitted to this call for proposals:
a) Standard projects - only natural persons engaged in research who, at the time of submitting
a project proposal to the call for proposals, hold an academic degree of Ph.D., its equivalent
or higher (e.g. CSc., Dr., DrSc., DSc., etc.) may be a proposer;
(b) Junior Researcher Projects - only natural persons engaged in research who, in the year of
submission of the project proposal to the call for proposals, meet the condition that no more
than 8 years have elapsed since the award of the academic degree of Ph.D. or equivalent,
which must have been obtained by the date of conclusion of the contract/issuance of the
project decision.
(7) Enterprise
Under the Commission Regulation, an enterprise is any entity engaged in an economic
activity, regardless of its legal form. These entities include, in particular, self-employed
persons and family businesses engaged in craft or other activities and companies or
associations regularly engaged in economic activities. The decisive factor in designating a
beneficiary as an enterprise is whether it carries out an economic activity consisting of
offering products or services on the market in question.
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(8) Provider
The provider is the Ministry of Health of the Czech Republic, see point 2.3.
(9) Research project
A research, development and innovation project (hereinafter referred to as 'project') means
activities falling under one or more categories of support, intended to fulfil an indivisible
task of a precise economic, scientific or technical nature with clearly defined objectives,
formulated by the tenderer in a research, development and innovation call for tenders or by
the provider in the context of a research, development and innovation contract award. The
provider shall support a project proposal whose stated outcome is clearly aimed at healthcare
applications.
(10) Beneficiary
The beneficiary is the applicant in whose favour the decision to grant support has been made
by the provider. The beneficiary is responsible to the provider for the entire project
(including the parts addressed by another project participant) in terms of its design,
compliance with the eligibility conditions announced in this call for proposals, financial
aspects, compliance with generally applicable regulations and provisions of the
contract/decision, the TD, the GR for projects under the general rules, including
responsibility for any changes during the duration of the special-purpose support.
(11) Investigation team
The project team are individuals involved in the project. The team members are:
1. The project Proposer is a natural person who is responsible to the beneficiary for the
project investigation from the labour law point of view and is responsible together with the
beneficiary for the professional part of the investigation towards the provider of the specialpurpose
support.
2. A co-applicant is a natural person who is responsible to the beneficiary for the
professional level of the part of the project provided by another project participant.
3. An expert collaborator is a natural person - an expert member of the researcher's or coinvestigator's
team, who is mentioned by name in the project proposal and participates in the
project investigation.
4. An additional staff member is a natural person who assists in the project (e.g. support
staff, technicians and administrative staff identified in the project proposal). Only the
activities they provide and the scope of these activities (not by name) shall be mentioned in
the project proposal.
(12) Co-applicant
A co-contestant in this public competition is a legal or natural person, an organisational unit
of the State or a local self-government unit, an organisational unit of the Ministry, engaged
in research and experimental development, which is responsible to the tenderer for a part of
the project proposal. The participation of the co-contestant in the project investigation must
be defined in the project proposal, and the amount of the part of the special-purpose support
that the co-contestant requires from the total state budget must be indicated. The co-applicant
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must be an entity distinct from the applicant (in the case of a legal entity with a different
registration number).
(13) Special-purpose support
The special-purpose support for the project is provided in the form of a subsidy to legal or
natural persons or an increase in the expenditure of organisational units of the State,
organisational units of local self-government units or organisational units of the Ministry
engaged in research and development, after a public competition has been held and evaluated
and after the conditions laid down by law have been met. The special-purpose support is
intended exclusively for the reimbursement of eligible costs.
(14) Applicant
The applicant is an organisational unit of the State or an organisational unit of the Ministry
engaged in research and development, as well as a legal entity or a natural person applying
for support.
(15) Eligible costs
Eligible costs are those eligible costs or expenditure in research, development and innovation
which are approved by the provider and which are justified.
(16) General rules
The General Rules (also referred to as 'GR') contain information relevant to the tender and
are publicly available on the Health Research Agency's website at the following link.
Tenderers are required to refer at all times to the current version of the GQ available on the
above-mentioned website.
(17) Research organisation
"Research and knowledge dissemination organisation" according to Commission Regulation
(EU) No 651/2014, Article 2, point 83) means an entity (e.g. university or research institute,
technology transfer agency, research-oriented innovation intermediary), regardless of its
legal status (established under public or private law) or method of financing, whose main
objective is to carry out independently fundamental research, industrial research or
experimental development or to disseminate publicly the results of these activities
through teaching, publications or knowledge transfer. If the body also carries out
economic activities, separate accounts must be kept of the funding, costs and income relating
to those activities. Enterprises which may exercise decisive influence over such an entity,
for example as shareholders or members, must not have preferential access to the results
achieved by the entity.
Before concluding a contract with the successful Applicant from this public tender, the
provider will take into account the currently valid list of research organisations managed by
the Ministry of Education, Youth and Sports of the Czech Republic.
(18) Eligible costs
Eligible costs are those costs or expenditure in research, development and innovation which
may be incurred by the beneficiary for, or in connection with, research, development and
innovation activities and include in particular:
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1. personal costs or expenses, including scholarships for research, development and
innovation under the Higher Education Act,
2. the cost or expense of acquiring tangible and intangible assets,
3. other operating costs or expenses,
4. costs or expenses for services,
5. additional costs or expenses.
II. Before signing the contract
3. Definition of data to be disclosed
(1) For the purposes of the public tender and the fulfilment of other obligations, the provider is
authorised to collect the necessary data on project proposals and applicants (co-applicants),
including personal data, in accordance with the provisions of Section 17(6) of the Act and
to fulfil the obligations under Section 32 of the Act. Both written and electronic forms of
data collection are permitted. These data are not publicly available information.
(2) In collecting, processing and disclosing data, the provider is governed by specific legal
regulations2
. The scope of the data processed on project proposals and applicants is shown
in the project proposal data. The project proposal data is identical to the data that the
beneficiary of the grant is obliged to submit to the R & D & I - CEP.
(3) When the results of the public competition are announced, information about the projects is
published on the Provider's website or on the AZV website, in the following scope: name of
the beneficiary; name, surname, academic titles and scientific rank of the researcher; project
title; programme title; programme code; application number; project duration; amount of
special-purpose support granted.
(4) After the conclusion of the contract on the provision of special-purpose support or the
issuance of the decision on the increase of the budget for the project, the data are published
on the Provider's website or on the AZV.
(5) After the completion of the projects and their evaluation, the scientific parts of the projects
(extracts from the final reports) will be submitted to the National Library of Medicine for
electronic archiving. This information will then be publicly available.
2
Act No. 110/2019 Coll., Act on the processing of personal data, as amended, and Regulation (EU) 2016/679/EC of
the European Parliament and of the Council on the protection of natural persons with regard to the processing of
personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection
Regulation) (hereinafter referred to as "GDPR")
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4. Publicity
(1) The publicity rules are listed on the Provider's and the AZV's websites; when presenting
information about the project or its results, the Beneficiary is obliged to comply with the
binding publicity rules in the current version published on the AZV's website.
5. Programme division into areas
5.1. Area 1 - Public health
Sub-area 1.1: Socio-economic aspects of health
Sub-objective 1.1.1: Collection, quality and application of data on health care and
population behaviour
Sub-objective 1.1.2: Measure program impacts and analyze new programs or legislative
proposals by government and independent experts
Sub-objective 1.1.3: Development of new methodologies and interdisciplinary
collaboration in health care
Sub-objective 1.1.4: Social determinants of health and gender dimension
Sub-area 1.2: Digitisation of health care
Sub-objective 1.2.1: Digitalisation will improve population health and the quality of health
services
Sub-objective 1.2.2: Digitisation will lead to improved accessibility and efficiency of
health services and a higher level of data integration within the healthcare provider system
Sub-objective 1.2.3: Increased use of data sources in the Czech health system
Sub-area 1.3: Demographic change and care for the elderly
Sub-objective 1.3.1: Analysis of the structure of providers and social health care provided
to the elderly population
Sub-objective 1.3.2: Analyse and address the social and health care needs of the elderly
(especially the very elderly)
Sub-objective 1.3.3: Early prevention and mitigation of the impacts of invasive changes,
including the use of modern technologies
Sub-objective 1.3.4: Promote quality and safe patient care with regard to age-specific risks
and prevention of adverse events in the provision of long-term medical and nursing care
Sub-area 1.4: Health care
Sub-objective 1.4.1: Analysis of the need for and use of health care among people with
chronic diseases
Sub-objective 1.4.2: Measurability of health care outcomes
Sub-objective 1.4.3: Capacity, consumption and access to health care
Sub-objective 1.4.4: Human resources in the health sector
Sub-objective 1.4.5: Patients' participation rights and respect for their autonomy of will
Sub-objective 1.4.6: Means of protecting the rights of persons in health care malpractice
Sub-area 1.5: Promoting health literacy and patient orientation
Sub-objective 1.5.1: Monitoring the level of health literacy in the Czech Republic
Sub-objective 1.5.2: Research on the competences and needs of health literacy actors
Sub-objective 1.5.3: Research on specific target groups of the National Health Literacy
Programme
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Sub-objective 1.5.4: Research on specific areas of health literacy
Sub-objective 1.5.5: Competence of health professionals in health literacy
Sub-objective 1.5.6: Combat unscientific views in health care
Sub-objective 1.5.7: Strengthen health literacy unencumbered by gender stereotypes
Sub-area 1.6: Health promotion and prevention
Sub-objective 1.6.1 Metabolic and endocrine diseases
Sub-objective 1.6.2. Diseases of the circulatory system
Sub-objective 1.6.3.
Sub-objective 1.6.4. Chronic lung diseases
Sub-objective 1.6.5 Blood diseases
Sub-objective 1.6.6. Nervous and psychological diseases
Sub-objective 1.6.7 Musculoskeletal diseases and inflammatory and immunological
diseases
Sub-objective 1.6.8. Addictions
Sub-area 1.7: Global health
Sub-objective 1.7.1: Environmental and work environment impacts on health
Sub-objective 1.7.2: Impact of nutrition and diet on health
Sub-objective 1.7.3: Infectious diseases
Sub-objective 1.7.4: Toxicology and health safety
Sub-objective 1.7.5: Occupational medicine and occupational diseases
Sub-objective 1.7.6: Innovative approaches to health promotion and intervention
programmes in primary prevention
5.2. Area 2 - Pathogenesis and development of diseases
Sub-area 2.1: Metabolic and endocrine diseases
Sub-objective 2.1.1: Etiology and pathophysiology of metabolic syndrome
Sub-objective 2.1.2: Etiology and pathogenesis of immune-mediated endocrine diseases
Sub-objective 2.1.3: Pathogenesis and treatment of complications of diabetes
Sub-area 2.2: Diseases of the circulatory system
Sub-objective 2.2.1: To elucidate the aetiological factors and pathophysiological processes
influencing the development and progression of cardiovascular (CVD) and cerebrovascular
(CVO) diseases
Sub-objective 2.2.2: Developing early diagnosis of cardiovascular (CVD) and
cerebrovascular (CVO) diseases and finding therapeutic modalities and procedures in the
treatment of cardiovascular and cerebrovascular diseases with higher therapeutic efficacy
and greater patient friendliness
Sub-area 2.3: Cancer
Sub-objective 2.3.1: Increase knowledge of cancer pathogenesis and development and
identify new therapeutic targets
Sub-objective 2.3.2: Improve the diagnosis and treatment of cancer, especially through the
implementation of precision medicine, advanced therapeutics, targeted drugs and modern
radiotherapy
Sub-objective 2.3.3: Improve the quality of life of cancer patients through a better
understanding of the factors associated with cancer and its treatment
Sub-area 2.4: Chronic lung diseases
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Sub-objective 2.4.1: Influence previously untreatable and progressive chronic diseases in
terms of halting progression or finding ways to reverse the process
Sub-objective 2.4.2: Establish new therapies by repurposing or combining known targeted
drugs. Proposals for new treatment modalities based on phenotype-specific markers of
pathogenesis
Sub-area 2.5: Blood diseases
Sub-objective 2.5.1: Increase knowledge of the pathogenesis and development of blood
diseases and identify new therapeutic targets
Sub-objective 2.5.2: Improve the diagnosis and treatment of blood diseases, especially
through the implementation of precision medicine, advanced therapeutics, targeted drugs
and modern radiotherapy
Sub-objective 2.5.3: Improve the quality of life of patients with blood diseases by
understanding the factors that accompany cancer and its treatment
Sub-area 2.6: Nervous and psychological diseases
Sub-objective 2.6.1: Mental and neurological diseases
Sub-objective 2.6.2: Diagnosis of diseases of the nervous system
Sub-objective 2.6.3: Increased effectiveness of treatments for diseases of the nervous
system
Sub-objective 2.6.4: Ensure quality of life in patients with diseases of the nervous system
Sub-area 2.7: Musculoskeletal and inflammatory diseases
Sub-objective 2.7.1: Etiology and pathogenesis of degenerative and metabolic diseases of
the musculoskeletal system
Sub-objective 2.7.2: Research in the field of musculoskeletal traumatology
Sub-area 2.8: Immunopathological diseases
Sub-objective 2.8.1: Define the determinants of immunopathological diseases and identify
new targets for the diagnosis and targeted treatment of these diseases
Sub-area 2.9: Infectious diseases
Sub-objective 2.9.1: Etiology and therapy of major infectious diseases
Sub-objective 2.9:2: Epidemiology of antimicrobial resistance
Sub-objective 2.9.3: New diagnostic methods
Sub-objective 2.9.4: New anti-infectives
Sub-area 2.10: Diseases of the perinatal period and childhood
Sub-objective 2.10.1: Diseases arising prenatally, perinatally and in early childhood
Sub-objective 2.10.2: Rare diseases
Sub-objective 2.10.3: Chronic immunopathological diseases with an environmental
component
5.3. Area 3 - Innovative solutions for medicine
Sub-area 3.1: Personalised medicine and new diagnostic and theranostic procedures
Sub-objective 3.1.1: High-throughput molecular biology methods and bioinformatics tools
for personalised medicine
Sub-objective 3.1.2: Genome sequencing (WGS) of a selected sample of the Czech
population
Sub-objective 3.1.3: Research and development of innovative diagnostic and theranostic
tools
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Sub-objective 3.1.4: Personalised disease prevention
Sub-objective 3.1.5: Personalised treatment
Sub-area 3.2: Low molecular weight drugs
Sub-objective 3.2.1: New low molecular weight compounds
Sub-objective 3.2.2: Identify new therapeutic targets, new methods and procedures for
biological testing
Sub-area 3.3: Medicinal products for advanced therapies
Sub-objective 3.3.1: Research and development of medicinal products for gene therapy
Sub-objective 3.3.2: Research and development of medicinal products for somatic cell
therapies
Sub-objective 3.3.3: Research and development of tissue engineered medicines
Sub-objective 3.3.4: Precision genomics as a tool for optimization and stratification of
patients suitable for gene and somatic cell therapies
Sub-objective 3.3.5: Support proof-of-concept Phase I/II clinical trials to evaluate the
safety and efficacy of medicines for advanced therapies
Sub-objective 3.3.6: Ethical, legal, regulatory and socio-economic aspects of research,
development and treatment of patients using ATMP medicines
Sub-area 3.4: Biologicals, including prophylactic and therapeutic vaccines
Sub-objective 3.4.1: New biological medicines
Sub-objective 3.4.2: New vaccines for the prevention and treatment of diseases
Sub-area 3.5: New drug formulations
Sub-objective 3.5.1: Development of novel carriers for time- and site-specific drug release
Sub-objective 3.5.2: Systems for pharmacotherapy-resistant diseases and for overcoming
biological barriers
Sub-objective 3.5.3: Introduce new formulation technologies into research, development
and production of dosage forms
Sub-area 3.6: Research and development of new medical devices and equipment
Sub-objective 3.6.1: Development and research of medical imaging techniques
Sub-objective 3.6.2: Development of minimally invasive treatment techniques and their
comparison with conventional procedures
Sub-objective 3.6.3: Development in the field of navigation and robotic systems
Sub-objective 3.6.4: Research and development in the field of medical implants neurostimulators
and cardiac implants
Sub-area 3.7: Innovative research in surgery, including transplantation
Sub-objective 3.7.1: Non-invasive treatment
Sub-objective 3.7.2: Hybrid performance
Sub-objective 3.7.3: Tissue and organ replacement
Sub-objective 3.7.4: Treatment procedures
Sub-area 3.8: Telemedicine
Sub-objective 3.8.1: Establish a data environment that enables the main objective to be met
Sub-area 3.9: Innovative practices in palliative and supportive care
Sub-objective 3.9.1: Effective organisation of health services for patients in palliative care
Sub-objective 3.9.2: Competence of health professionals in communication and ethics
Sub-objective 3.9.3: Innovative approaches to symptom management in palliative care
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6. Proof of eligibility
(1) The following persons may be applicants for, or beneficiaries of, support from the
Programme for a project under the Act, the Commission Regulation and the Framework, as
well as co-applicants (or other participants) in the project:
• Research organisations
• Businesses
(2) As a natural person, only an entrepreneur who carries out an economic activity and at the
same time carries out a business activity pursuant to Act No. 455/1991 Coll., on Trade
Enterprise (Trade Licensing Act), as amended, may be an eligible applicant.
(3) The assessment of whether the applicant or coapplicant fulfils the defining characteristics of
a research organisation according to the Act, the Commission Regulation and the Framework
will be carried out by the provider for each applicant or coapplicant individually during the
evaluation of the project proposal, during the project and after its completion.
(4) In accordance with Section 18 (2) of the Act, the Proposer shall demonstrate its eligibility
for the proposed project by submitting a project proposal as follows:
a) the professional prerequisites for the project according to Section 18(2)(a) of the Act are
demonstrated by the applicant in the project proposal in the section dealing with the
justification of the proposal, and the provider will assess these prerequisites with regard
to the nature of the project proposal, taking into account the content of the project
proposal and its financial scope according to the criteria set out in the general conditions;
b) Authorization to operate under Section 18(2)(b) of the Act shall be submitted by those
applicants/co-applicants who are not a public university3
or public research institution4
or
for which the MoH is not the founder, with a copy of the business license or other required
authorization (e.g., certificate of incorporation or other similar document of establishment
or incorporation, extract from the Commercial Register or other statutory list);
c) Eligibility under Section 18(2)(c) to (i) of the Act is demonstrated by the original or
officially certified copy of the affidavit (as per the TD Annex), while eligibility under
Section 18(2)(e) and (f) of the Act is demonstrated in the case of legal entities by persons
who act as the statutory body of the tenderer or its member (resp. 218/2000 Coll., with
the exception of persons for whom conditions for the performance of the function of the
statutory body or its member are laid down by another legal regulation (e.g. in the case
of public universities and public research institutions); within the framework of the
affidavit, the applicant/co-applicant shall also demonstrate compliance with the
requirement pursuant to Section 14(3)(e) of Act No. 218/2000 Coll, on budgetary rules
and on amendments to certain related acts, as amended (hereinafter referred to as the "Act
on budgetary rules")
d) if the project requires authorisation under a specific legal regulation or other proof (i.e.
professional competence), all applicants (or coapplicants), regardless of legal form, must
3
public universities established pursuant to Act No. 111/1998 Coll., on Higher Education and on Amendments and
Supplements to Other Acts (Act on Higher Education), as amended
4
public research institutions established pursuant to Act No. 341/2005 Coll., on Public Research Institutions, as
amended
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submit such authorisation or proof (a copy of the document is required as a minimum),
by way of example:
• authorization according to Act No. 78/2004 Coll., on the handling of genetically
modified organisms and genetic products, as amended (hereinafter referred to as Act
No. 78/2004 Coll.), according to Act No. 285/2002 Coll., on the donation, procurement
and transplantation of tissues and organs and on the amendment of certain acts
(Transplantation Act), as amended (hereinafter referred to as Transplantation Act),
according to Act No. 227/2006 Coll, on human embryonic stem cell research and
related activities and on amendments to certain related acts, as amended (hereinafter
referred to as Act No. 227/2006 Coll.), all valid at least until the start of the project;
• authorization for the use of experimental animals - in the case of a proposed project
involving experimental work with animals, the applicant shall attach to the project
proposal an "authorization for the use of experimental animals" (former
accreditation of the user facility) pursuant to Section 15b of Act No. 246/1992 Coll.,
on the Protection of Animals against Cruelty, as amended (hereinafter referred to as
Act No. 246/1992 Coll.), valid at least until the start of the project;
• permission to provide health services if the project will provide health services by an
entity that is not a health care institution (e.g. University, Academy of Sciences of the
Czech Republic);
• informed consent of the patient - if there is an experimental subject, the text of the
informed consent of the patient/experimental subject who is aware of the risks and
benefits of participation in the project and the possibility to withdraw from
participation without consequences;
• the opinion of the ethics committee of the applicant/other participant on the currently
submitted project proposal - see Article 7 of the TD;
e) the applicant must provide a document regulating the relationship of the project to the
rules of SÚKL (original, certified copy or electronic conversion of the document):
• in the case of a project proposal that corresponds to a clinical trial of medicines, the
applicant shall attach the Decision on the authorisation of the clinical trial for the
Czech Republic within the meaning of the Medicines Act and the same documentation
that was approved in this Decision.
• in the case of a project proposal that corresponds to the conduct of a clinical trial of a
medical device with a CE marking that will be used in the clinical trial outside the
intended purpose of use and/or in the case of a project proposal that corresponds to the
conduct of a clinical trial of a medical device without a CE marking, the applicant shall
attach the Decision on Authorisation of the CP within the meaning of the Medical
Devices and MDR Act (if such a clinical trial requires a Decision on Authorisation) or
the Confirmation of Acceptance of the submitted notification (if the clinical trial
requires a notification of the intention to conduct a clinical trial) within the meaning
of the Act on Medical Devices and MDR Act. Medical Devices and MDR.
(5) The applicant with whom a contract is to be concluded for the provision of special-purpose
support or in whose favour a decision on the budget increase is to be issued shall demonstrate
14 / 37
the following before the conclusion of the contract or, in the case of an organisational
unit of the State, before the decision on the budget increase is issued:
a) It is obliged to provide a certified copy, not older than 90 calendar days, of the deed of
incorporation, charter of incorporation or other document of establishment or
incorporation upon the provider's request, if this information about the applicant cannot
be found in any public administration information system
b) For the purpose of proving the authorization for activities under Section 18 (2) (b) of
the Act, if the applicant intends to carry out such activities in the framework of the project,
the applicant shall provide a certified copy of the authorization for activities not older
than 90 calendar days. Only an entity established by the Ministry of Health or by a special
law (e.g. Act No 111/1998 Coll., on universities and on amendments and supplements to
other acts (Act on universities), as amended, Act No 341/2005 Coll., on public research
institutions, as amended, etc.) shall not submit the authorisation to operate.
c) The Provider shall also request the necessary cooperation from the Applicant in providing
the data necessary for the submission of the request for an extract from the Criminal
Records Register as required by law.
d) In accordance with the provisions of Section 14(3) of the Act on Budget Rules, the
applicant, which is a legal entity, shall submit the following in the form of an affidavit:
1. information on the identification of the persons acting on behalf of the applicant,
indicating whether they act as its statutory body or whether they act on the basis of a
power of attorney, 2. information on the beneficial owner of the legal person in
accordance with the law governing the registration of beneficial owners in the form of a
full statement of the valid data and data which have been deleted without replacement or
replaced by new data, if it is the person registering; where the applicant for a grant is a
foreign legal person, it shall provide evidence of its beneficial owner either by means of
an extract from a foreign register similar to the register of beneficial owners or, where no
such foreign register exists, by providing the identification details of all persons who are
the beneficial owner of the foreign legal person, and submit documents showing the
relationship of all persons to the foreign legal person, in particular an extract from a
foreign register similar to the commercial register, a list of shareholders, a decision of the
statutory body on the payment of a share of profits, the memorandum of association, the
articles of association or the articles of association, 3. information on the identification of
the persons in whom it has a shareholding and the amount of such shareholding. The
information referred to in points 1 and 3 is part of the affidavit attached to the SO.
e) If the nature of the project requires it, the applicant shall attach an officially certified copy
of a valid document/authorisation for certain handling of genetically modified organisms
and products (see Act No. 78/2004 Coll.), authorisation under the Transplantation Act,
authorisation under Act No. 227/2006 Coll. In the case of a proposed project involving
experimental work with animals, the applicant shall provide a valid and effective
'experimental design' relating specifically to this project, or an officially certified copy
thereof, with the opinions of the expert committee of the user facility and the departmental
committee of the competent state authority, in accordance with Act No 246/1992 Coll.
15 / 37
and Decree No 419/2012 Coll, on the protection of experimental animals, as amended see
general conditions.
f) If the nature of the project requires it, the tenderer shall attach a certified copy of the
opinion of the ethics committee of the tenderer/other participant relating to this project see
Article 7 of the TD.
(6) If one tenderer submits more than one project proposal in a single call for proposals, it shall
demonstrate its eligibility once, at the stage of submission of project proposals and at the
stage before the signing of the support contract or the issuance of the decision to increase
the budget under this TD.
(7) A tenderer with a seat outside the Czech Republic, who meets the conditions of Section 18
(11) of the Act, shall prove his/her eligibility according to Section 18 (2) (b) to (f) by means
of an affidavit (a specimen of the affidavit is given in the TD Annex. In accordance with
Article 1(5)(a) of the Regulation, the provider may require that the other participant,
established outside the Czech Republic, has an establishment or branch in the Czech
Republic at the time of payment of the support. At the same time, such a Proposer is obliged
to prove, at the latest before the conclusion of the contract for the provision of support, that
the establishment or branch of a legal person established in a Member State of the European
Union and located in the Czech Republic meets all eligibility requirements under the
provisions of Section 18 of the Act, similarly to a Proposer established in the Czech
Republic.
(8) Eligibility must be demonstrated in full, i.e. for all requirements and for all persons for whom
eligibility is demonstrated.
(9) Where a tenderer submits a project proposal with a co-tenderer, the obligation to demonstrate
eligibility shall apply to the co-tenderer to the same extent as to the tenderer.
(10) According to the Commission Regulation, an enterprise which has been the subject of a
recovery order (see Article 1(4)(A) of the Commission Regulation) and an enterprise in
difficulty (according to Article 1(4)(C) of the Commission Regulation) cannot be a
beneficiary or a participant.5
5
According to the Commission Regulation, Article 2(18), an 'enterprise in difficulty' is an enterprise where at least one of
the following circumstances applies:
(a) In the case of a limited liability company (which is not an SME that has been in existence for less than three years, or,
for the purposes of eligibility for risk finance support, which is not an SME within seven years of its first commercial sale, which
is eligible for risk finance investment on the basis of due diligence carried out by a selected financial intermediary) where, as a
result of the accumulation of losses, more than half of the subscribed share capital has been lost. This is the case when the result of
deducting the accumulated losses from the reserves (and all other elements generally considered to be the company's equity) is
negative and exceeds half of the subscribed capital. For the purposes of this provision, 'limited liability company' includes in
particular the forms of companies listed in Annex I to Directive 2013/34/EU and 'share capital' includes any share premium, where
applicable.
(b) In the case of a company in which at least some of the shareholders are fully liable for the obligations of the company
(which is not an SME that has been in existence for less than three years or, for the purposes of eligibility for risk finance support,
which is not an SME within seven years of its first commercial sale that is eligible for risk finance investment on the basis of due
diligence carried out by a selected financial intermediary), where the accumulation of losses has resulted in the loss of more than
half of its capital as recorded in the accounts of that company. For the purposes of this provision, 'a company in which at least some
of the shareholders are fully liable for the company's obligations' shall in particular be considered to be the forms of enterprises
listed in Annex II to Directive 2013/34/EU.
(c) where collective insolvency proceedings have been opened against the enterprise or the enterprise meets the criteria
under national law for opening collective insolvency proceedings at the request of its creditors.
(d) If the firm has received rescue support and has not yet repaid the loan or terminated the guarantee, or if it has received
restructuring support and is still subject to a restructuring plan.
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7. Opinions on the project proposal
The following representations shall be made, where appropriate, in the form of an annex to the
project proposal
7.1. Opinion of the ethics committee of the applicant/other participant
(1) The ethics committee's consent statement for a given project must always be submitted by
the applicant or coapplicant to whom the legal obligation applies, i.e. in the case of (i)
healthcare delivery, (ii) research with human subjects, and (iii) research with questionnaire
survey methodology and qualitative investigations with persons affected by or at risk of
disease in accordance with the International Ethics Committee for Biomedical Research with
Human Participants CIOMS/WHO, 2002. (2) The Ethics Committee herein expressly
confirms the accuracy of the attached "Informed Consent of the Patient/Investigator" and is
responsible for its compliance if Informed Consent is required under the relevant law. In
addition, in the case of anticipated work with human beings, a statement from the Ethics
Committee on the protection of human beings must be provided. The original of the consent
statement, a certified copy or an electronic conversion must be provided at the time of
conclusion of the Grant Agreement.
(2) If the applicant does not have an ethics committee, the ethics committee of the other
participant or the Ethics Committee for Multicentre Trials pursuant to the Medicinal
Products Act No. 378/2007 Coll.
7.2. Statement of the Expert Committee - Protection of Experimental Animals
(1) In the case of a proposed project that involves experimental work with animals, the applicant
shall provide a valid and effective "experimental project" relating specifically to the
project in question, with the opinions of the expert committee of the user facility and the
departmental committee of the relevant state authority pursuant to Act No. 246/1992 Coll.
on the Protection of Animals against Cruelty, as amended, and Decree No. 419/2012 Coll.
on the Protection of Experimental Animals, as amended. The experimental project shall be
documented by the applicant with whom a contract for the grant of support is to be concluded
or in whose favour a decision on the increase in the budget is to be issued before the contract
is concluded or the decision is issued. The experimental design enabling the relevant project
to be addressed shall be attached to each project, but nothing prevents one experimental
design from being attached to several projects supported by the Ministry of Health, provided
that this is in accordance with the relevant legal provisions.
(e) In the case of an enterprise which is not an SME, where in the last two years:
1) the company's book debt-to-equity ratio is greater than 7.5; and
2) the interest coverage ratio of the company's earnings before interest, taxes, depreciation and amortization (EBITDA) is
less than 1.0.
17 / 37
(2) The original, a certified copy or a document with electronic conversion must be presented
when concluding the Support Agreement. If the name of the experimental project does not
correspond to the name of the project, the Application for approval of the experimental
project (minimum copy) will also be attached.
8. Division of evaluation panels according to their professional
focus
(1) The Provider has established ten expert evaluation panels of the Czech Agency for Health
Research to which applicants will submit their project proposals (according to the
professional focus of the project):
• P01 Metabolic and endocrine diseases
• P02 Diseases of the circulatory system
• P03 Tumour diseases
• P04 Neuroscience and mental health
• P05 Immune disorders and infectious diseases
• P06 Organ dysfunction and critical care medicine
• P07 Age-specific groups
• P08 Biomedical technologies
• P09 Public health and nursing
• P10 Musculoskeletal medicine
(2) The focus of the individual expert review panels is as follows:
• P01 Metabolic and endocrine diseases
Panel 01 deals with metabolic aspects from the fields of: endocrinology and diabetology,
clinical biochemistry and clinical pharmacology, medical genetics, paediatrics,
gastroenterology, nephrology, rheumatology and other fields of internal medicine.
• P02 Diseases of the circulatory system
Panel 02 deals with clinical and experimental research of cardiovascular diseases ranging
from etiological and pathogenetic aspects to diagnostic, therapeutic and preventive issues
of cardiovascular diseases. Priority is given to the potential of the acquired knowledge to
be applied in clinical practice in order to improve the current diagnostic, therapeutic and
preventive measures of cardiovascular medicine.
• P03 Tumour diseases
Panel 03 deals with experimental, clinical, preventive and epidemiological issues in
cancer. In the field of research on carcinogenesis, molecular biology, genetics,
pharmacology and immunology of cancer, the panel prefers innovative projects with the
potential for real application in oncological practice. Research in this panel covers a
multidisciplinary spectrum of diagnostic, surgical, radiation, medical and other methods
used or potentially applicable in oncology. Research projects in personalised and
precision oncology and rare cancers are also supported.
• P04 Neuroscience and mental health
18 / 37
Panel 04 deals with applied research in the field of etiopathogenesis, prevention, early
and innovative diagnosis and treatment of psychiatric and neurological diseases in order
to prevent, cure or minimize difficulties, improve functional capacity and quality of life
of patients. These are mainly neurodevelopmental diseases, mental disorders in
adulthood, neurodegenerative, neurogenetic and neurometabolic diseases, vascular
diseases of the brain, epilepsy, infectious and autoimmune diseases of the nervous system,
as well as neurosurgical, neurotraumatological, neurooncological and neurorehabilitation
issues, clinical neurophysiology and neuropsychology. Topics include the social aspects
of nervous and psychiatric diseases and the organisation of the provision of health
services to the nervous and psychiatrically ill.
• P05 Immune disorders and infectious diseases
Panel 05 deals with the elucidation of the genetic basis, etiology, pathogenesis, diagnosis,
treatment and prevention of human immunopathological diseases. These include
inflammatory and autoimmune diseases, immunological hypersensitivity diseases and
immunodeficiency diseases. Attention is also paid to immunological diagnostics and
immunotherapy of other diseases. Communicable disease research focuses on the study
of the causative agents, etiopathogenesis, diagnosis, prevention and therapy of major
human infectious diseases threatening our population, including healthcare-associated
infections.
• P06 Organ dysfunction and critical care medicine
Panel 06 deals with organ failure and organ replacement, intensive care, resuscitation,
perioperative and transplantation medicine, especially epidemiology, prevention, early
detection, and the development of new therapies in these areas. Organ-specific research
includes diseases of the kidney and urogenital tract, liver and gastrointestinal tract,
respiratory system, ENT, eye and skin.
• P07 Age-specific disease groups
Panel 07 deals with diseases that are specific to newborns, children and adolescents, but
also to the senile period, and meet at least one of the following criteria: 1. their typical
course at this age is significantly different and therefore represents a general health
problem, 2. the medical approach to these diseases in childhood, adolescence or senile
period plays a leading role in the field, 3. they have a significantly higher incidence in the
mentioned age groups, including rare and ultra-rare diseases. To study the impact of
genetic and environmental factors on the etiopathogenesis and pathophysiology of major
diseases of childhood, adolescence and the elderly. Development of non-invasive
diagnostic methods for childhood, adolescent and elderly diseases and/or development of
preventive procedures and therapeutic methods to improve the quality of life of sick
children, adolescents and elderly. The panel also includes diseases of pregnancy and the
perinatal period if they may result in fetal and neonatal harm.
• P08 Biomedical technologies
Panel 08 focuses on the research and development of biomedical and pharmaceutical
technologies that directly contribute to innovation in diagnosis and treatment through
technological approaches. Key areas include: (i) advanced diagnostic and therapeutic
technologies (development of new imaging techniques, innovations in molecular
19 / 37
diagnostics, personalised and precision medicine and pharmacological approaches), (ii)
development of new biomaterials and technologies for tissue and organ replacement or
regeneration (design and testing of biomaterials with specific medical applications,
implementation of innovative (surgical) treatment techniques using these technologies),
(iii) pre-clinical research towards direct application in clinical practice (experimental
development and in vivo testing of innovative technologies in animal models, application
of new technological processes or materials with clear potential for clinical use), and (iv)
biomedical devices and software technologies including artificial intelligence tools
(development of new devices (hardware) and software solutions supporting diagnosis,
therapy or health monitoring, implementation of artificial intelligence and data-driven
technologies in biomedical research as well as in diagnosis and therapy). The scope of
Panel P08 does not include projects focused on pure basic research without a clear
technological overlap, projects focused on disease research (e.g. cardiovascular, cancer)
without the development of unique technologies or innovative diagnostic/therapeutic
tools, or projects that do not represent the actual development of a new technology or
therapy and that use existing methods outside their primary purpose (off-target
approaches). These projects fall under panels targeting specific disease groups.
• P09 Public health and nursing
Panel 09 deals with public health issues including preventive medicine, hygiene,
epidemiology and nursing. In the field of preventive medicine, the panel deals with
preventive health care leading to improved health and quality of life at the individual and
population level, specific and non-specific primary prevention including health risk
assessment, and in the field of hygiene, health protection and promotion and the
protection of healthy living conditions. In the field of epidemiology, the study of the
prevalence of diseases and health disorders affecting the whole population and the
monitoring of factors that condition or influence this prevalence at the population level,
in particular environmental, lifestyle, health predispositions, climatic and social factors.
Emphasis is placed on the prevention of the occurrence and spread of infectious diseases,
including the characterisation of the conditions of transmission, and spread of microorganisms,
as well as of mass-occurring non-infectious diseases. In the field of public
health, emphasis is placed on determinants of health, health policy objectives, strategies
and tools, macro and microeconomic approaches, management systems and their
application in the management of health system and health facility organization, health
care quality management, statistical and informatics projects. The P9 panel also includes
areas such as digitalization of health care, demographić changes, but alsó globaĺ health,
etc. Research on communication, combating misinformation and different types of
motivational campaigns are supported. In the field of nursing, the emphasis is on projects
focusing on active processes to meet the biological, psychological and social needs of the
sick and healthy person in their health care.
• P10 Musculoskeletal medicine
Panel 10 deals with: trauma in children and adults, congenital disorders and acquired
diseases in children and adults, musculoskeletal tumours, metabolic, degenerative and
inflammatory diseases of the musculoskeletal system, anatomy and biomechanics of the
20 / 37
musculoskeletal system. These topics include research in the following areas: etiology,
pathogenesis, clinical, laboratory, biomechanical, imaging, and therapeutics. The concept
of the panel is based on the need to elucidate some of the unresolved congenital and
acquired defects, as well as to address diseases associated with the aging population,
particularly in the increase of injuries and degenerative diseases and tumors, and
pathological fractures and traffic and sports injuries in the younger population.
9. Methodology for receiving and evaluating project proposals
The evaluation process meets the following conditions (specified in more detail below):
• the statutory assessment period;
• a three-tier evaluation system:
o the decision-making body is the provider, which, in accordance with the AZV Statutes,
acts on the proposal of the AZV Board;
o The Scientific Council of the AZV is a professional advisory body according to the
law;
o The expert panels are expert bodies of the Scientific Council of the AZV.
• the statutory number of at least two independent assessments for each project proposal
accepted for peer review;
• for projects advancing to the second stage of assessment, two additional external reviews by
foreign opponents;
participants in the evaluation process are bound by the obligation of confidentiality.
9.1. Acceptance of project proposals
(1) The evaluation of the project proposals will start at the earliest on the day following the last
day of the competition period.
(2) The evaluation of project proposals consists of (the evaluation process for project proposals
is described in the General Rules):
a) Acceptance of project proposals - is carried out in accordance with Section 21(2) of the
Act; it follows immediately after the end of the competition period and is concluded by
the decision of the provider on the acceptance of project proposals into the public
competition or their exclusion;
b) an evaluation of the truthfulness, completeness and accuracy of the data in the project
proposals, which includes a check on the inconsistency of the data contained in the project
proposals; it follows the provider's decision to accept or reject the project proposals and
is carried out throughout evaluation period;
c) evaluation of the professional level of project proposals - the professional evaluation of
project proposals is carried out in accordance with Section 21 (5) to (7) of the Act; it
follows the decision of the provider on the acceptance of project proposals into the public
21 / 37
tender or on their exclusion and ends with the preparation of project proposal evaluation
reports;
d) evaluation of the proposed eligible and eligible costs - a check is carried out on the
relevance and correctness of the proposed eligible and eligible costs included in the
project proposals, both in terms of the scope and definition of eligible and eligible costs
and the amount of the proposed eligible and eligible costs; it follows the decision of the
provider to accept the project proposals in the public tender or to exclude them and ends
with the preparation of the project proposal evaluation reports.
(3) The evaluation of the project proposals is completed with the announcement of the results
of the call for proposals.
(4) The decision to accept project proposals into the public competition or to exclude them, and
the decision of the provider to select projects for implementation, are not subject to Act No.
500/2004 Coll., the Administrative Code, as amended, within the meaning of Section 21(11)
of the Act.
(5) The reception of project proposals is carried out by the Commission for the Reception of
Project Proposals, which will evaluate the fulfilment of the conditions of the call for
proposals:
a) compliance with the competition deadline - it is assessed whether the project proposal
was submitted within the competition deadline;
b) method and place of submission of the project proposal - the assessment is whether the
method of submission of the project proposal specified in the TD, the name and originality
of the file, the name of the ISDS batch;6
c) completeness of the project proposal - it is assessed whether the project proposal contains
all the specified parts according to Article 4.2 of the TD;
d) requirements for the demonstration of eligibility - the assessment is whether all
supporting documents for the demonstration of eligibility have been submitted in the
prescribed manner and whether these documents confirm the eligibility of the tenderer or
co-tenderer;
e) compliance with the minimum amount of time of the researcher/co-researcher according
to Part 3 of the TD;
f) compliance with the condition that the same natural person may act as proposer and coproposer
for only one project proposal in this call for proposals.
(6) If at any time during the call for tenders it is proven that the tenderer or co-tenderer no longer
meets the eligibility conditions, this is a reason for the project proposal to be excluded from
the call for tenders.
(7) The Commission for the acceptance of project proposals prepares a summary report on the
evaluation of all received project proposals, in accordance with Act No. 130/2002 Coll., in
the case of non-compliant project proposals, it will indicate the reason for the exclusion from
the expert evaluation of project proposals.
6
information system for data boxes
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9.2. Evaluation of the truthfulness and accuracy of the data in the project
proposal
(1) The evaluation of the truthfulness and accuracy of the data in the project proposal is also
aimed at checking that the data are not contradictory. The evaluation is carried out
independently by the referees, the evaluation panels, the provider's expert advisory body,
which is the AZV Scientific Council, and the AZV office staff throughout the evaluation
period.
(2) In particular, the following are considered to be incorrect and false data:
a) The Proposal and Project Description section of Article 4.2(3) and (4) of the TD is in a
language other than the required language;
b) in Part A of the project proposal pursuant to Article 4.2(6) of the TD, an incorrect
indication of the tenderer's or co-tenderers' registration number, in Part B of the project
proposal pursuant to Article 4.2(8) to (11) of the TD:
A. numerical data which are not in the prescribed currency or in the prescribed units;
B. the proposed support intensity does not correspond to the actual proportion of the funds
requested from the provider in the total project cost;
C. the proposed funding is contrary to applicable law;
D. the proposed personnel costs do not correspond to the relevant staff capacities (fulltime
equivalents) or do not adequately respect the provisions in Part 3 of the TD;
E. the proposed costs are not specified in detail in Part B - Justification of financial items
as per Article 4.2.11 of the TD,
c) Part D of the project proposal under Article 4.2(14) of the TD does not provide full
information on other projects of the proponent and co-proponents,
d) in all parts of the project design:
1. adopted texts not supported by a bibliographic citation according to the TD;
2. information that is untrue or does not correspond to reality.
(3) In particular, the following is considered to be contradictory data:
a) the difference in meaning between the title, keywords and abstract of the project proposal
in Czech and English;
b) the difference between the investigation time in Part A of the project proposal and the
time resulting from Part B of the project proposal and the Project Description.
(4) The evaluation of the professional level of project proposals is carried out by the
provider's expert advisory body - the Scientific Council of the AZV and its expert bodies,
which are the AZV evaluation panels. The quality of the proposer, co-proposers and the
composition of the research team, the quality of the project and the history of cooperation
with the provider are assessed in the evaluation of proposals.
(5) For the quality of the proposer, co-proposers and the composition of the research team,
the following is assessed in particular: the ability and aptitude of the proposer, possible
co-proposers and their collaborators, to tackle the project, their professional skills, their
overall contribution to the field of science, with regard their track record in research and
experimental development, the extent of their active research activities over the last five
years (i.e. Their role as first or corresponding author); the expertise of the team needed to
23 / 37
address all project objectives; the involvement of junior researchers; the history of
international collaboration; the technical and institutional background of the applicant and
coapplicants; the integration of gender aspects of the research team (e.g. gender equality
plan, gender equality measures in the HR Award, etc.) shall also be taken into account.
(6) For the quality of the project, it is assessed primarily:
a) project focus and relevance - the project focus is assessed in terms of whether it is in
line with the support areas of the Programme, originality and topicality of the topic
addressed, expected benefits, their feasibility and potential impact,
b) quality of the project design - quality of the scientific hypothesis, definition of the
project's research objectives and their consistency with the hypothesis, quality of the pilot
data, their relevance to the thematic focus of the project and the formulated hypothesis;
quality of the experimental design, statistical justification of the composition and size of
the research population (exceptions may be projects focused on research on rare and ultrarare
diseases), definition and statistical justification of the number of experimental
animals, sufficient numbers of replicates in preclinical testing, etc. Adequacy and
timeliness of the planned methodological approaches, their suitability for meeting the
research objectives; gender considerations for project proposals where this is thematically
relevant; formal quality of the project proposal, precision of wording, quality of technical
language, number of typos, etc,
c) feasibility and other aspects of the project - feasibility of the study, feasibility of the
schedule; sophistication of the risk analysis; pure validation studies or projects whose
investigations are predominantly based on contracted research or paid services delivered
by partners outside the research team will not be preferred for support.
(7) Previous cooperation with the provider - the results and modalities of the applicant's (and
coapplicants') and proposer's (and co-proposers') projects with support from the provider (if
any); any breaches of the rules by the applicant (and co-applicants) or the proposer and coproposers)
in the management of the dedicated support provided, the fulfilment of all the
obligations defined in the contract for the provision of dedicated support/ decision on the
budget increase, the evaluation of projects already completed or currently under way.
9.3. Economic evaluation of project proposals
(1) The economic evaluation of project proposals is carried out objectively and impartially
throughout the evaluation.
(2) In assessing the proposed eligible costs, the following shall be considered:
a) the reasonableness of the proposed eligible costs in relation to the project design and
expected results;
b) the level of specification and justification of the individual items of recognised costs;
c) the proportion of the funding requested from the provider to the total proposed eligible
costs (i.e. the proposed support intensity);
d) meeting the requirements for the scope and definition of eligible costs.
(3) The provider's expert advisory body may suggest that the provider should disallow part of
the costs/expenses proposed by the applicant for the project and not include them among the
24 / 37
eligible costs of the project under the Act. In such a case, it shall propose to the provider a
reduction in the total amount of targeted support requested. The applicant will be informed
of this procedure by email and asked whether he/she will be able to carry out the project with
the reduced financial support. If the applicant refuses, the project is classified as
unsupported. If they agree, they will be asked to provide a corrected budget.
9.4. Reasons for eliminating a project proposal from the public tender
(1) Any violation or non-compliance with the conditions defined in the Terms of Reference shall
be grounds for elimination of the project proposal from the tender pursuant to Section 21 (3)
of the Act,
(2) Submission of a project proposal that has already received special-purpose support under the
Act, or that is submitted duplicatively or multiple times in a given calendar year to all
providers' public competitions, is grounds for elimination of the project proposal from the
public competition.
(3) The reason for the exclusion of a project proposal from the public tender pursuant to Section
21(3) of the Act is the fact that the beneficiary in previous projects has demonstrably failed
to comply with the obligations set out in the Budget Rules Act or has breached obligations
arising from the contract or the terms of the decision. In this case, the MoH may exclude the
beneficiary's project proposals from the public tender for a period of up to three years from
the date on which the beneficiary has been proven to have committed such a breach or has
acknowledged it in writing.
(4) The reason for the elimination of the project proposal is also the fact that the project is
submitted by a researcher whose project financed from the special-purpose support of the
Ministry of Health was prematurely terminated due to failure to fulfil the obligations set out
in the project agreement. These are projects that have been stopped in the last 3 years.
(5) The project Proposer whose final report has been evaluated in the "S" category is not
awarded the special-purpose support of the MoH for the following 3 years (from the date of
this evaluation, not from the end of the project) and is therefore excluded from participation
in further public competitions of the MoH during this period.
(6) The annexes to the project proposal cannot be documents that extend the annex "description
of the project" (see Article 4.2 (4) TD).
III. After the contract is signed
10. Conditions for project investigations
10.1. Procedure for concluding a contract for the granting of special purpose
support or for issuing a decision on a budget increase
(1) The time limit and method of concluding a contract on the provision of special-purpose
support or issuing a decision on the budget increase are laid down in Section 25 of the Act.
25 / 37
The provider shall notify the decision on the acceptance of the project proposal for the
project. A draft contract is drawn up or, for the beneficiary organisational unit of the State
or organisational unit of the Ministry, the provider issues a decision on the budget increase
and implements a budget measure in accordance with the budget rules; the contract or
decision sets out the binding conditions for the provision of the special-purpose support and
the obligations of the beneficiary and the researcher.
(2) Failure to comply with the deadline set by the provider for concluding the contract for the
provision of special-purpose support or for issuing a decision to increase the budget, due to
reasons on the part of the beneficiary, shall entitle the provider, within the meaning of
Section 25(2) of the Act, to conclude a contract for the provision of special-purpose support
with the next tenderer in the order resulting from the results of the public tender or to issue
a decision to increase the budget in favour of such tenderer.
(3) The beneficiary is entitled to accept or reject the draft contract in its entirety and to return it
without undue delay. The beneficiary shall not be entitled to make any amendments or
additions to the support contract, except for the addition of the beneficiary's identification
data required in the contract; the applicant shall, on the contrary, be obliged to add such
identification data to the contract in the manner and places provided for in the contract.
(4) The effectiveness of this Contract is subject to a condition precedent, which is that the
beneficiary has duly demonstrated to the Provider its eligibility for the Project within the
meaning of the relevant generally binding legal regulations and the TD. If this condition
precedent is fulfilled, the Contract shall become effective on the date of its publication in the
Register of Contracts in accordance with Act No. 340/2015 Coll., on Special Conditions of
Effectiveness of Certain Contracts, Publication of Such Contracts and on the Register of
Contracts (Act on the Register of Contracts), as amended.
(5) The decision is enforceable from the moment it is delivered to the beneficiary. It is a
condition of enforceability that the beneficiary has demonstrated its eligibility for the project
according to the TD. If the beneficiary and the other participant are organisational units of
the State under the competence of one administrator of the budget chapter, they do not
provide each other with cash benefits and the provider shall define their mutual relations in
the decision on the budget increase.
(6) If one or more additional participants will be involved in the project, the beneficiary shall be
obliged to conclude a contract with each such additional participant within 30 calendar days
of the entry into force of the grant agreement for the project part, in accordance with the
terms and conditions set out in the grant agreement, and to deliver such contract together
with all annexes to the provider within that period; the contract shall be concluded for the
entire period during which the additional participant is involved in the project.
10.2. Conditions, time limit and methods of granting special purpose support
(1) Unless the budget spending is regulated as a result of a budgetary provisional period under
the Budgetary Rules Act, the provider will start providing special-purpose support for newly
launched projects within 60 calendar days from the date of the contract's entry into force, or
from the date of the decision on the budget increase. If an additional participant is involved
26 / 37
in the project, special-purpose support may only be started in the first year of the project
once their mutual agreement has been concluded and submitted to the provider in accordance
with Article 1.1(5) of this Annex.
(2) In the second and subsequent year of the project, if the budget spending is not regulated as
a result of the budget proviso according to the Budget Rules Act, the provision of specialpurpose
support will start within 60 calendar days after the approval of the relevant partial
report on project by the provider, provided that the conditions set out in the contract or
decision are met. For ongoing projects, additional conditions must be met:
a) according to § 10 of the Act, the condition of inclusion of data in the information system
of research, experimental development and innovation must be fulfilled;
b) where an amendment to the contract or decision on the granting of the specific support is
to be concluded or issued for a given year, the amendment must take effect before the
start of the granting of the specific support
(3) According to Section 10 of the Act, the provider provides special-purpose support only to
the beneficiary by direct transfer to the beneficiary's bank account specified in the contract.
If another participant, which is not an organisational unit of the State or an organisational
unit of the Ministry, is involved in the project, the provider shall provide the beneficiary with
the special-purpose support, including the part of the special-purpose support specialpurpose
for the other participant, and the beneficiary shall transfer to the other participant
the part of the special-purpose support special-purpose for it on the basis of their mutual
agreement, which the beneficiary shall conclude with the other participant on the basis of a
contract with the provider.
(4) If another participant is involved in the project and its contribution to the project is clearly
specified in the project proposal, the provision of part of the special-purpose support to the
other participant is not subject to the Public Procurement Act.
(5) If the beneficiary or other participant is an organisational unit of the State or an
organisational unit of the Ministry, the provider shall request the Ministry of Finance to
implement the budget measure; the funds intended for this beneficiary or other participant
shall be provided through the budget chapter of the respective founder.
10.3. Terms and conditions for the use of targeted support
(1) The special-purpose support shall be managed by the beneficiary and the other participant
in accordance with the contract or the decision or any amendments thereto. The specialpurpose
support granted in accordance with the contract or decision for the relevant calendar
year must be accounted for in that calendar year. Any adjustments to the use of the specialpurpose
support for a given year may only be made in accordance with the conditions set
out in the TD, the contract and the TD. Actions contrary to these conditions constitute a
breach of budgetary discipline and are grounds for withdrawing from the contract or for
issuing a decision to terminate the support and other sanctions under the Financial
Regulation Act.
(2) The basic composition of the funds specified in the contract or decision must be respected
when using the special-purpose support. If the approved project budget differs in its
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composition or amount from the amounts requested in the project proposal (or specified in
the relevant sub-report), the provider will send an approved revised breakdown together with
the contract (or an amendment to the contract or a new decision), which is then binding on
the beneficiary and the other participant. Unless otherwise specified in the TA, the support
disbursement and its composition is binding to two decimal places (CZK 0,01), regardless
of the accuracy of the data presented in the sub-report or final report, in accordance with
Decree No 367/2015 Coll., on the principles and deadlines for financial settlement of
relations with the State budget, State financial assets and the National Fund (Decree on
financial settlement), as amended.
(3) The beneficiary is obliged to continuously control both the use of the special-purpose support
and the progress of the project. It shall be responsible for ensuring that the special-purpose
support is used in accordance with the dispositions of the researcher; however, if it finds that
these instructions are in breach of the regulations on the management of state property or
that the funds are used in an inefficient, ineffective and uneconomical manner, it shall
suspend the implementation of the disposition and inform the provider.
(4) In accordance with the provisions of Section 8(1) of the Act, the beneficiary and other
participants shall keep separate accounting records of the management of the allocated
special-purpose support in accordance with the composition of the eligible costs in order to
be able to provide credible data on the status of disbursement to the researcher for the
purposes of the provider and during the year without undue delay upon request. The method
of recording provided for in Act No 563/1991 Coll., on accounting, as amended, shall be
determined by the beneficiary.
(5) All accounting documents used by the beneficiary and the other participant to prove the use
of the special-purpose support must comply with the requirements of the Accounting Act
and be marked with the number of the separate special-purpose support register of the project
concerned. The separate accounting records must always show the registration number of
the project, all income and expenditure in that analytical account in the year, the date and
reason/purpose of each item (it must be clearly linked to the project), the amount in CZK
and the classification of the item according to the beneficiary's accounting schedule. If funds
other than the special-purpose support provided (support from other public sources, support
from non-public sources, own resources, etc.) are used for the project, the project statement
must indicate how these other funds were used. The beneficiary is also obliged to submit
accounting documents proving the use of these other funds when auditing (interim and expost)
the management of the special-purpose support during the project.
(6) The beneficiary shall submit to the provider in the partial or final reports a detailed overview
of the use of the eligible costs and the special-purpose support provided for the entire project,
including the amount of unspent special-purpose support and funds transferred to the specialpurpose
support fund created in accordance with Act No. 111/1998 Coll, 341/2005 Coll., on
Public Research Institutions, as amended, up to 5 % of the amount of special-purpose support
granted for the project, except for the last year of the project, when all funds allocated to the
project must be accounted for. Data on the use of funds by the beneficiary and the other
participant shall be provided. Unspent special-purpose support from a given calendar year
(unless transferred to the special-purpose fund by the eligible entities) may be used by the
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beneficiary or other participant in subsequent years of the project in accordance with the
approved Project Proposal, i.e. for the same purpose for which they were approved by the
provider. Any changes during the year must be justified in the periodic sub-reports.
(7) By 15 February of each subsequent year, each beneficiary is obliged to send the provider an
accounting of the subsidies provided to the beneficiary in the previous year (the beneficiary
shall indicate the amount allocated to the provider's individual projects and the amounts
spent on non-investment costs and on the costs of acquiring tangible and intangible fixed
assets for the entire accounting period of the previous year and information on the transfer
to the special-purpose fund, if the beneficiary can create an special-purpose fund) according
to the layout provided on the provider's website, to the electronic address veda@mzcr.cz.
This information is processed by the provider in accordance with specific legal provisions
and forwarded to the Ministry of Finance in the course of the financial settlement with the
State budget.
(8) The beneficiary manages the special-purpose support provided. If the beneficiary transfers
part of the special-purpose support to another participant, in accordance with the terms of
the contract or decision on the granting of the special-purpose support and on the basis of a
special agreement on the project part concluded between them, the part of the specialpurpose
support thus granted shall be managed by the other participant, who shall
shall be obliged to comply with all obligations under that contract. The beneficiary shall
in this case, the obligation to control also the management of the special-purpose support
transferred to the other participant.
(9) If the beneficiary or other participant discovers during a given year of project
implementation that there are facts requiring changes or transfers from the composition of
the eligible costs or the special-purpose support provided in the contract or in the decision
and its annexes, it is obliged to proceed in the manner set out in the DB and the general
conditions.
(10) If the beneficiary or another participant is entitled to create a special-purpose fund on the
basis of specific legal regulations and makes use of this right for a given project, it is obliged
to draw down and account for the fund created in the course of the project no later than the
last day of the last calendar year of the project.
(11) If the accounting has ended in the separate analytical records kept for the project
in a given calendar year with a surplus, i.e. if not all the funds provided to the beneficiary or
to another participant for the year in question have been used, the beneficiary shall inform
the provider. If the beneficiary (and for the other participant) is not interested in using the
unspent funds in subsequent years of the project, it shall inform the provider and return the
unspent funds to the State budget as instructed by the provider. At the end of the project, the
beneficiary is obliged to return all unspent funds for the project as a whole (including all
other participants) to the state budget as follows (at the same time, it is necessary to notify
the payment in writing according to the disposition indicated on the provider's website):
a) the beneficiary, which is an organisational unit of the state or a local self-government
unit, is obliged to return the unspent special-purpose support to the revenue account of its
founder;
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b) other beneficiarys return the unspent funds to the Ministry of Health's foreign funds
account No 6015-2528001/0710.
(12) Pursuant to Section 13 of the Act, the provider is obliged to carry out checks on the fulfilment
of the project objectives, including checks on the use and utilisation of the support and the
effectiveness of the recognised costs in accordance with the contract on the provision of
support or the decision on the provision of support, in the case of a beneficiary who also
submits documents on behalf of other participants, including financial checks pursuant to
Act No.320/2001 Coll., on financial control in public administration and on amendments to
certain acts (Act on financial control), as amended. The beneficiary and the other participant
are obliged to allow the provider to carry out the control and to provide the provider with all
the required cooperation.
(13) If during the audit deficiencies in the drawdown were found and in particular if there was an
unjustified drawdown of the special-purpose support from the state budget, the provider
proceeds in accordance with special legal regulations (in particular the Act on Budget Rules),
Act No. 320/2001 Coll., on financial control in public administration and on the amendment
of certain acts (Act on financial control), as amended, and Act No. 280/2009 Coll., Tax Code,
as amended) and notifies the results of the audit to the locally competent financial office.
(14) The beneficiary is obliged to notify the provider in writing of the proceeds from the results
of the project obtained in the course of the project, no later than 60 calendar days from the
date on which the claim to such income, stating the amount and the reason for it. In the subreport
or final report, the beneficiary must indicate the total amount of all the benefits from
the results of the project achieved during the project year and propose how they will be used
in the project. The proceeds of the project results obtained after the end of the project are:
a) revenue of the state budget if the beneficiary is an organisational unit of the state;
b) revenue of the budget of a local self-government unit if the beneficiary is an
organisational unit of that local self-government unit;
c) the beneficiary's yield for all other beneficiaries.
10.4. Principles for project design
(1) The beneficiary is obliged to initiate and implement the project in the manner and within the
timeframe specified in the contract or decision.
(2) The beneficiary is obliged to document or present the results of the project in a manner
appropriate to the nature of the relevant scientific field and the nature of the project. The
results of the investigation must be presented according to the types defined in the currently
applicable Methodology for the Evaluation of Results. A publication can only be recognised
as the result of a project if it explicitly states that the work was carried out with the financial
support of the funder and the registration number of the relevant project is also indicated,
and in the case of dedication of one publication to several projects, justification is required
in the sub- or final report. In documenting the results of the project, the beneficiary shall
proceed in accordance with the information contained in the project proposal. If the practices
in the field, the nature of the results and the conditions of the project allow it, it is appropriate
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to publish the results in Open Access form, or the publication outputs may be submitted to
open digital repositories, in accordance with the licensing conditions of the publisher.
(3) All rights to the results of the project belong to the beneficiary in accordance with the
provisions of Section 16 of the Act. The rights of the authors and originators of the results
and the owners of the protection rights to them are regulated by specific legal provisions.
The provisions of Section 16(4)(a) of the Act shall apply to the exploitation of the results.
(4) The beneficiary is obliged to deliver to the provider by the annually announced deadline data
on the results of all its projects carried out with the support of the provider, which are
intended for the information system of research, experimental development and innovation
(part of the Register of information on results) in accordance with Act No. 130/2002 Coll.
and Government Regulation No. 397/2009 Coll., on the information system of research,
experimental development and innovation.
(5) The Beneficiary is obliged to inform the Provider in writing of any changes that have
occurred during the course of the project which could have any effect on the project or which
affect in any way its legal personality or the data required to prove its eligibility, no later
than 7 calendar days from the date on which it became aware of such a fact.
(6) If it is found during or after the completion of the project that the terms of the contract for
the provision of special-purpose support or the decision to increase the budget have not been
complied with, or that there has been a breach of the conditions under the Act, the provisions
of Section 14 of the Act shall apply.
(7) The beneficiary and the other participant are obliged to keep all documentation relating
directly or indirectly to the project and its progress for at least 10 years after the end of the
project, in particular:
a) professional documentation for the project;
b) documentation on the management of the special-purpose support granted;
c) accounting documents relating to the separate accounting records of the management of
the special-purpose support granted;
d) contractual documents relating to the project and its investigation, including any
amendments or additions thereto;
e) the results of the project.
(8) The Provider shall keep the tender documents, including the project proposals submitted to
the tender, for a period of 10 years.
10.5. Partial project report
(1) The sub-report shall be drawn up annually and shall contain information on the management
of the special-purpose support granted for the period for which the sub-report is drawn up.
The sub-report shall be accompanied by annexes, which shall always be specified, as an
integral part of the sub-report. The provider is entitled to request additional documents
related to the project at any time. When completing the sub-report, the published instructions
at www.mzd.gov.cz or www.azvcr.cz and the instructions in the application shall be
followed.
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(2) After the second year of the project, a partial report is submitted, expanding on the progress
of the project so far and the results achieved, and the beneficiary is obliged to deliver it by
the date indicated on the websites www.mzd.gov.cz and www.azvcr.cz respectively. If, in
exceptional cases, the beneficiary is not able to prepare and submit the sub-report (or its
annexes) by the deadline for serious objective reasons, he/she must notify the provider in
writing before the deadline and state the reason why the sub-report cannot be submitted in
due time. The provider is entitled to decide to extend the deadline for delivery of the relevant
sub-report.
(3) An exception is the partial report after the first year of the project, where information
on the progress of the project is only provided if there is a deviation from the schedule
or the planned project investigation.
10.6. Final project report
(1) The final report contains information on the results of the project for the entire duration of
the project and on the results of the management of the special-purpose support for the last
year of the project.
(2) The beneficiary is obliged to deliver the final report to the provider no later than the date
indicated on www.mzd.gov.cz or www.azvcr.cz. The final report must be accompanied by
annexes, which will always be specified, as an integral part of the final report. The provider
is entitled to request further documents related to the project at any time. When completing
the final report, the published instructions on www.mzd.gov.cz or www.azvcr.cz and the
instructions in the application shall be followed.
(3) The beneficiary is entitled to request an extension of the deadline for submission of the final
report by completing the Part LO form and submitting it within the deadline referred to in
paragraph 2 of this Article together with those parts of the final report which can already be
processed and delivered in final form.
(4) If the support contract has been cancelled by withdrawal or has ceased to be effective for
any other reason, or if the decision to grant support has been revoked, the beneficiary must
draw up a final report and deliver it no later than 30 calendar days after the date on which
the support contract ceased to be effective or the date of the decision to revoke the decision
to increase the budget. The beneficiary's other obligations are not affected.
10.7. Evaluation of the project progress
(1) The evaluation of the progress of the project is carried out by the Scientific Council of the
AZV, based on the assessment of the evaluation panel, on the basis of the submitted partial
reports and the results of the monitoring activities of the provider.
(2) The provider evaluates the progress of the project according to the following main criteria:
a) the progress of the work and its consistency with the fulfilment of the set objectives;
b) providing solutions in terms of expertise and personnel;
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c) the use of technical and instrumental equipment acquired from the special-purpose
support provided;
d) achievement of the objectives of the solution in comparison with the plan set out in the
project proposal, assumptions of the overall time and material completion of the task;
e) evaluation of the current management of the special-purpose support provided, or the
proposed budget for the next period (the use of the allocated funds, the effectiveness of
their spending and compliance with their composition, proper justification of any
transfers or changes);
f) assessment of results according to the types defined in the currently valid Methodology
for the Evaluation of Research Results.
(3) If the prerequisites for the continuation of the project are fulfilled and the provider decides
to continue the project support, and if the conditions according to the TD and the GR are
fulfilled, the beneficiary is granted the special-purpose support for the next year of the
project.
(4) If the prerequisites for the continuation of the project are not fulfilled, the provider is entitled
to withdraw from the support contract or cancel the decision to grant support according to
the provisions set out in the contract or decision.
(5) The Provider is entitled to reduce the targeted support in view of the project's progress to
date or in view of the results of checks pursuant to Section 13 of the Act, in which case an
amendment to the contract on the provision of targeted support will be concluded or a
decision will be issued amending the original decision on the provision of targeted support.
When concluding an amendment or issuing a decision, the procedure shall be similar to that
set out in Article 1 of this Annex.
10.8. Evaluation of the completed project
(1) The evaluation of the completed project is carried out by the Scientific Council of the AZV
on the basis of the final report and the result of the audit activity on the management of the
special-purpose support provided. Each project is evaluated separately.
(2) The results of the evaluation of completed projects are published by the provider on its
website in a summary for the year.
(3) During the final evaluation of the projects after the completion of their investigation in
accordance with § 13 (4) of the Act, the provider shall evaluate the achievement of the
objectives set out in the contract on the provision of special-purpose support or in the
decision on the budget increase, the results achieved by the project according to the TD, their
relationship to the project objectives and provide information about them in the information
system of research, experimental development and innovation data according to Government
Regulation No.397/2009 Coll., on the information system of research, experimental
development and innovation. The basic evaluation categories are as follows:
• V = outstanding project results (of international importance, etc.), which means that the
project objectives and expected results as stated in the grant agreement/budget increase
decision have been met
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• U = succeeded according to the assignment, i.e. the project objectives and its expected
results as specified in the grant agreement/budget increase decision were met;
• O = assignment not fulfilled, but contract/decision conditions have been complied with
• S = assignment not fulfilled, the penalty provisions of the contract/decision have been
invoked.
The project Proposer whose final report has been evaluated in the "S" category is not
awarded the special-purpose support of the MoH for the following 3 years (from the date of
this evaluation, not from the end of the project) and is therefore excluded from participation
in further public competitions of the MoH during this period.
10.9. Changes in the course of the project
(1) The beneficiary and the other participant shall not be entitled to deviate from the status
resulting from the concluded contract for the provision of special-purpose support/budget
increase decision, including the approved project proposal which is part of the contract or
decision. Any changes to the contract or decision must be supported by a valid and effective
amendment to the contract or a new decision.
(2) In the course of the project design, changes can be made from the originally approved project
design only in the following cases:
a) a change in the eligible costs or a change in the amount of support granted;
b) change of another participant, investigator or co-investigator of the project.
(3) Changing the aim and object of the project is not allowed.
(4) Transfers within the other operating costs or within the personnel costs of the funds allocated
under Article 10.3 of the TD, and changes in the research team, except for changes in the
beneficiary, researcher or co-investigator (including a reduction in the amount of their time)
or another participant, are possible without an application and do not require an amendment
to the contract or a new decision to grant support. The same applies if a member of the
research team who had the status of student leaves the research team. However, the
beneficiary must justify these changes in the following report (partial or final) in the DBReasoning
or ZB-Reasoning section. It must demonstrate that these changes or transfers
were efficient, cost-effective, effective and supported by approved activities and that they
meet the conditions for support set out in Act No 130/2002 Coll. and the tender
documentation. If the beneficiary does not duly demonstrate the justification of the changes
or transfers in accordance with the previous sentence, the provider has the right not to
recognise them and to apply the penalties provided for in the contract or decision.
(5) The procedure in paragraph (4) does not allow for a transfer or request for a transfer to the
additional (overhead) costs item listed in Section 10.3 of the TD. Personal expenses intended
for students must be used by the beneficiary or other participant for personal expenses
intended exclusively for students.
(6) Transfers between the items of the basic composition (other operating costs and personnel
costs) of the funds allocated under Article 10.3 of the TD are possible without an application
and do not require an amendment to the contract granting the support or a new decision to
increase the budget (i.e. CZK 100 000 per year per project for all participants). In the event
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of changes to generally binding legal provisions concerning personnel costs in the project
(e.g. changes to salary tariffs, changes to the mandatory allocation to the FKSP, etc.) and
their impact on economic indicators, transfers between individual items (from other
operating costs to personnel costs) can be made without an application and do not require an
amendment to the contract or a new decision. However, the beneficiary must describe and
justify these changes in the subsequent report (interim or final).
(7) In the event that the beneficiary and another participant are entitled to form a pool of specialpurpose
support, or in the case of unspent special-purpose support, the provisions of
paragraph (4) of this Article shall apply mutatis mutandis to their disbursement.
(8) The amount of the eligible costs and the related amount of support granted for the project
for the entire duration of the project may not be changed during the course of the project by
more than 50 % of the amount of eligible costs or the amount of public support specified in
the grant agreement or in the decision to increase the budget, as decided by the provider in
the evaluation of the call for proposals. Changes to the amount of eligible costs and the
related support amount must be justified, supported by the approved activities and the
amendment to the support contract or the issue of a new budget increase decision, and must
comply with the support conditions laid down in the law.
10.10. Project change procedure
(1) If there is a substantial change in the circumstances relating to the project which the provider
could not have foreseen and was not caused by the provider, the provider shall propose to
the beneficiary a change in the amount of eligible costs, a change in the amount of specialpurpose
support or an amendment to the grant agreement or a decision to increase the budget
in writing no later than 7 calendar days from the date on which it became aware of such a
fact. The beneficiary shall comment on the proposal in writing within 60 calendar days of
the date of receipt of the proposal.
(2) If there is a substantial change in the circumstances relating to the project which the
beneficiary could not have foreseen and which was not caused by the beneficiary, the
beneficiary shall request the provider to change the structure or amount of the eligible costs,
to change the amount of the special-purpose support or to amend the grant agreement or the
decision to increase the budget in writing no later than 7 calendar days from the date on
which it became aware of such a fact. This obligation is also fulfilled by sending an
information letter before the actual sending of the application form for approval of the
change in the project. In case the amendment concerns a change in the financial means of
the support provided in a given calendar year or an extension of the duration of the project
(only within the duration of the Programme), the beneficiary must apply for the amendment
no later than 60 calendar days before the end of the calendar year / before the end of the
project. However, the provider is not obliged to accept or agree to such a change in the
structure or amount of eligible costs or a change in the amount of special-purpose support.
(3) If the provider agrees with the beneficiary's request under paragraph (2) of this Article, it
shall conclude an amendment to the grant agreement or issue an amending decision to
increase the budget with the beneficiary within 60 calendar days from the date of receipt of
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the request. If the provider rejects the beneficiary's application under paragraph (2) of this
Article, it shall notify the beneficiary of this fact by written communication within 30
calendar days of the date of the examination of the application; no decision on the application
shall be issued.
(4) The request for changes to the project design must include the following:
a) identification details of the beneficiary, the investigator (or additional participant and coinvestigator
if there is a change concerning an additional participant) and the project
concerned, including the registration number;
b) specifications of the requested change;
c) a detailed description of the reason and justification for the requested change;
d) an indication of the time when the cause of the requested change occurred;
e) the signatures of the beneficiary, or the person authorised to act for the beneficiary, and
of the investigator (and, where appropriate, of the other participant and the co-investigator
if the change concerns another participant).
10.11. Procedure for changing another participant, investigator or co-
investigator
(1) If the researcher cannot continue the project at the beneficiary's workplace specified in the
contract for the provision of special-purpose support / decision on the budget increase for a
serious reason, the following procedure is followed:
• the beneficiary asks the provider, in accordance with the procedure similar to that set out
in Article 10.1 of the TD, for a change in the project design consisting in the appointment
of a new researcher; the professional qualifications of the new researcher must be
supported by a curriculum vitae as in the submission of the project proposal.
(2) If the Provider accepts the beneficiary's request under paragraph (1) of this Article, the
procedure under Article 10.1(3) of the TD shall continue, provided that if the beneficiary
rejects the draft amendment to the grant agreement, the Provider shall be entitled to withdraw
from the grant agreement. A similar procedure is followed in the event of a new decision to
increase the budget.
(3) If the co-principal investigator is unable to continue the project at the other participant's site
specified in the contract for the provision of special-purpose support or in the decision to
increase the budget for a serious reason, the following procedure is followed:
a) the beneficiary requests the provider to follow a procedure similar to the change in the
project design consisting in the appointment of a new co-leader; the qualifications of the
new co-leader must be supported by a CV as in the project proposal, or
b) the beneficiary shall request the provider in writing to transfer the rights and obligations
in the project to another additional participant, which is a new department of the coorganiser;
an integral part of this request must be a written consent of the original
beneficiary, the new proposed additional participant to such a procedure, bearing their
signatures, or the signatures of persons authorised to act for them in this matter, and the
eligibility of the proposed other additional participant must be demonstrated similarly
according to the GR and the TD.
36 / 37
(4) If the Provider accepts the beneficiary's request under paragraph (3)(a) of this Article, the
procedure under Article 10.1(3) of the TD shall continue, provided that if the beneficiary
rejects the draft amendment to the grant agreement, the Provider shall be entitled to withdraw
from the grant agreement. A similar procedure is followed in the event of a new decision to
increase the budget.
(5) If the provider accepts the beneficiary's request under paragraph (3)(b) of this Article, the
rights and obligations in the project shall be transferred from the existing additional
participant to the new additional participant by a separate tripartite contract between the
beneficiary, the existing additional participant and the new additional participant. At the
same time, an amendment to the support contract shall be concluded between the provider
and the beneficiary. If the beneficiary rejects the draft amendment to the support contract, or
if the original or new additional participant rejects the draft tripartite agreement on the
transfer of rights and obligations in the project, the provider is entitled to withdraw from the
support contract. A similar procedure shall be followed in the event of a new decision to
increase the budget. A contract between the beneficiary, the existing additional participant
and the new additional participant on the settlement of the assets acquired with the funds
during the course of the existing project, concluded between the existing additional
participant and the new additional participant, shall form an integral part of the tripartite
contract. If the existing and the new additional participant do not reach an agreement, the
provider is entitled to withdraw from the support contract.
(6) If the provider does not comply with the beneficiary's request under paragraph (3) of this
Article, it shall be entitled to withdraw from the support contract or to annul the decision to
grant support. The beneficiary shall then be obliged to reimburse any unused support after a
proper accounting.
10.12. Change of beneficiary procedure
(1) If, in exceptional cases, there is such a change in circumstances relating to the project that it
is not possible for the beneficiary to continue the project and to achieve the corresponding
project results, it is possible for the existing beneficiary, the new applicant and the project
Proposer to apply jointly for a change of beneficiary. In addition to the requirements set out
in the description of the project change procedure, the request for a change of beneficiary
must in particular include:
• an affirmative declaration and a detailed justification of all the relevant facts justifying
the application;
• a breakdown of the eligible costs of the project;
• the interim accounts of the project as at the date of the request for amendment;
• a description of the personnel, organisational and technical arrangements for the
execution and progress of the work on
• the workplace of the new applicant at the time of the change of beneficiary;
• a proposal for a mutual settlement between the existing beneficiary and the new
applicant, including both financial and property settlements and the settlement of the
project results and rights to the research results;
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• full proof of the new Proposer's full legal capacity;
• draft agreement on the assignment of the contract on the provision of special-purpose
support pursuant to Section 1895 et seq. of Act No. 89/2012 Coll., the Civil Code, as
amended
(2) The change of beneficiary must not change the content of the project according to the
contract or the decision on the provision of the project support grant.
(3) The application will then go through an approval process, during which the new applicant
must demonstrate that it meets all the legal requirements for eligibility under the public
tender and that it is also able to provide the researcher and members of his team with
adequate institutional and technical facilities for the project.
(4) If the provider accepts the application, the new applicant will enter into the legal status of
the existing beneficiary by virtue of the assignment of the grant agreement. A similar
procedure shall be followed in the event of a new grant decision.
(5) If the provider does not comply with the request, it is entitled to withdraw from the support
contract or cancel the decision to grant support. The beneficiary shall then be obliged to
reimburse any unused support after a proper accounting.