(State Emblem)

MINISTRY 
OF HEALTH 
OF THE REPUBLIC OF BELARUS

(Unofficial translation)

RESOLUTION

November 6, 2020, No. 94
Minsk

On Clinical Trials of Medicinal Products

In accordance with parts two and five of Article 17 of Law No. 161-3 of the Republic of Belarus On Circulation of Medicinal Products dated July 20, 2006, the Ministry of Health of the Republic of Belarus RESOLVES:
1.	To approve:
Provisions on the Procedure and Terms and Conditions of Clinical Trials of Medicinal Products (as attached); Provisions on Independent Ethical Committee (as attached).
2.	Recognize void:
Resolution No. 55 of the Ministry of Health of the Republic of Belarus On Approval of the Provisions on Ethics Committee dated March 28, 2008;
Resolution No. 72 of the Ministry of Health of the Republic of Belarus On Amendments and Supplements to Resolution No. 55 of the Ministry of Health of the Republic of Belarus dated March 28, 2008, as of June 25, 2009;
Resolution No. 40 of the Ministry of Health of the Republic of Belarus On Amendments and Supplements to Resolution No. 55 of the Ministry of Health of the Republic of Belarus dated March 28, 2008, as of April 17, 2015.
3.	This Resolution shall enter into force upon its official publication.

Deputy 
Minister of Health 
of the Republic of Belarus	B.N. Andorsiuk	
		
APPROVED 
 by the Ministry of Foreign Affairs 
of the Republic of Belarus		

APPROVED
Resolution No. 94
 of the Ministry of health
 of the Republic of Belarus
 dated 06.11.2020

PROVISIONS
on the Procedure of Clinical Trials of Medicinal Products

CHAPTER 1	
GENERAL PROVISIONS

1.  	This Provisions establish the procedure and terms and conditions of conducting clinical trials of medicinal products (unless specified otherwise hereinafter, clinical trials) on trial subjects at state healthcare institutions (unless specified otherwise hereinafter, healthcare institutions).
2.  	Terms and their respective definitions are used in this Provisions as established in the Law of the Republic of Belarus On Circulation of Medicinal Products, Rules of Good Clinical Practice of the Eurasian Economic Union approved by Resolution No. 79 of the Board of the Eurasian Economic Commission dated November 3, 2016 (hereinafter, the Rules of Good Clinical Practice).
3.  	Grounds to conduct clinical trials shall be: resolution of the Ministry of Health on assignment of a clinical trial and issue of a clinical trial authorisation;
approval by the Ministry of Health of a clinical trial programme (protocol) approved by an independent ethics committee at a healthcare institution (hereinafter, the ethics committee at a healthcare institution);
compliance of the investigators’ qualification with the requirements of the Rules of Good Clinical Practice;
compliance of the setting for clinical trial at healthcare institutions with the requirements of the Rules of Good Clinical Practice.

CHAPTER 2	
CLINICAL TRIAL ASSIGNMENT AND ISSUE OF A CLINICAL TRIAL AUTHORISATION

4.  	A clinical trial shall be assigned by resolution of the Ministry of Health preceded with:
a complex of preliminary technical works (unless specified otherwise, hereinafter, the complex of preliminary works) including expert examinations, approbation of the medicinal product quality control methods and quality control of the medicinal product with the use of such methods (unless specified otherwise, hereinafter, testing and quality control) performed at Centre for Examinations and Tests in Health Service Republican Unitary Enterprise (unless specified otherwise, hereinafter, the Centre);
approval of a clinical trial by the independent ethics committee at a healthcare institution which is planned to be a clinical base of the clinical trial.
5.  	The complex of preliminary works shall be subject to a contract between the Centre and the sponsor of a clinical trial or a contract research organisation authorised to submit documents to obtain a clinical trial authorisation (unless specified otherwise, hereinafter, the applicant).
The total duration of the complex of preliminary works shall not exceed 290 calendar days. The specified period may be extended up to 360 calendar days by a contract between the Parties.
6.  	To perform the complex of preliminary works, the applicant shall submit to the Centre:
an application in any format with attachment of information on the complex of preliminary works preceding the issue of a clinical trial authorisation under Annex 1;
documents for the complex of preliminary works preceding the issue of a clinical trial authorisation according to the list under Annex 2 in Russian and in Belarusian in three paper copies and one electronic copies.
7.  	The complex of preliminary works shall include:
a primary examination of the documents as specified in clause 6 hereof (hereinafter, the primary examination);
specialised examination of the documents specified in clause 6 hereof including a clinical pharmacological and pharmaceutical examination of the documents (hereinafter, the specialised examination);
approbation and quality control in cases when the Republic of Belarus is the first country on which territory the procedure of issuing a clinical trial authorisation is implemented, except for the cases specified in part two of this clause.
Approbation and quality control shall not be performed for:
narcotic drugs or psychotropic substances;
radiopharmaceutical medicinal products;
orphan (rare) medicinal products.
8.  	The primary expert examination shall be carried out by the experts on staff of the Centre.
9.  	The specialised expert examination shall be carried out:
by the experts on staff of the Centre;
by the expert(s) included in the group of experts approved by the Ministry of Health;
by the expert(s) having special knowledge in the field of application of the medicinal products within the disease area specified in the clinical trial programme (protocol) assigned by the Ministry of Health (if necessary).
10.  	Approbation and quality control shall be performed:
by the Laboratory of Pharmacopoeial and Pharmaceutical Analysis of the Centre (hereinafter, the Laboratory of the Centre);
by testing laboratories accredited in the National Accreditation System of the Republic of Belarus for testing of medicinal products, provided the lack of technical possibilities with the Laboratory of the Centre to conduct such based on the contracts with the Centre.
11.  	The primary expert examination shall include examination of document completeness and correctness of document filling. The term of the primary expert examination shall not exceed 15 calendar days of the date of receipt of money at the Centre’s settlement account in accordance with the contract between the Centre and the applicant.
If the primary expert examination results are positive, the documents shall be submitted for the specialised expert examination.
12.  	If any comments are present as a result of the primary expert examination, they shall be submitted to the applicant in writing and (or) in electronic form within 5 working days of the date of signing.
The applicant shall address all comments within 30 calendar days of their receipt. The period specified shall not be included in the period of the complex of preliminary works.
Upon elimination of all deficiencies, an expert examination shall be conducted of the documents and materials provided confirming the elimination of deficiencies, within 5 working days of the date of their submission. Should the deficiencies be recognized eliminated, the documents shall be forwarded to the specialised expert examination.
Should the deficiencies be not eliminated, the Centre shall within 5 working days of the date of expiration of the terms established for elimination notify the applicant in writing about termination of the complex of preliminary works.
13.  	The specialised expert examination shall include evaluation of the documents confirming:
results of pre-clinical (non-clinical) medicinal product efficacy and safety studies;
compliance of the medicinal product quality with the established regulatory requirements;
possibility to obtain reliable data during the clinical trial;
expected benefit of a medicinal product for the trial subject exceeding the foreseeable (predictable) risk and (or) discomfort during the clinical trial;
respect of the rights, safety and well-being of the trial subjects.
The specialised expert examination shall be conducted within 45 calendar days of the date of receipt of the documents, except for the cases specified in part three hereof.
specialised expert examination of bioequivalent, biological, biotechnological medicinal products shall be conducted within 60 calendar days of the date of receipt of the documents.
14.  	Based on the results of the specialised expert examination, each expert shall issue an expert opinion.
In case of comments in the expert opinions, the Centre shall forward them to the applicant in writing and (or) in electronic form (without specifying the experts) within 5 working days of signing of them.
15.  	The term for elimination of deficiencies shall not exceed 30 calendar days since the date of receipt by the applicant. The period specified may be extended for up to 60 calendar days on the grounds of a reasonable written request from the applicant. The period specified shall not be included in the period of the complex of preliminary works.
Upon elimination of all deficiencies by the applicant, the specialised expert examination shall be conducted again within 15 calendar days of the submission of documents confirming elimination of deficiencies. Subsequent comments are sent to the applicant only in case of additional questions regarding the documents submitted by the applicant in response to the previous comments.
Should the deficiencies after the specialised expert examination be not eliminated, the complex of preliminary works shall be terminated and the Centre shall draft a conclusion on the grounds (absence of the grounds) for the issue of authorisation by the Ministry of Health for a clinical trial under the form presented in Annex 3, containing conclusions on the impossibility to issue a clinical trial authorisation and the impossibility to approve the clinical trial programme (protocol). One counterpart of the conclusion shall be sent to the applicant within 5 working days from the date it was signed and the second counterpart is kept at the Centre.
16.  	In the event that the results of the specialised expert examination are positive, approbation and quality control shall be performed.
To perform the approbation and quality control, an employee of the Laboratory of the Centre shall in the presence of the applicant’s representative collect samples of the medicinal product in accordance with the requirements of the monograph of the State Pharmacopoeia of the Republic of Belarus in the amount required for the approbation and quality control.
The approbation and quality control shall be performed within 60 calendar days of the date of receipt by the Laboratory of the Centre of the medicinal product samples, standard drug substances and related substances, microorganism test strains, cell culture, diagnostic test systems, specific disposables and reagents from the medicinal product manufacturer.
17.  	Upon completion of approbation and quality control, the Centre draws up an approbation statement and a test protocol for the medicinal product, which are sent to the applicant in writing and (or) electronic form within a period not exceeding 5 working days from the date they were signed.
If there are any comments in the approbation statement, the applicant eliminates the inconsistencies noted therein within a period not exceeding 30 calendar days from the date the applicant received the approbation statement and the test report for the medicinal product. The period specified may be extended for up to 60 calendar days on the grounds of a reasonable written request from the applicant. The period specified shall not be included in the period of the complex of preliminary works.
The laboratory of the Centre shall confirm the applicant’s elimination of inconsistencies noted in the comments specified in the approbation statement, which do not require re-approbation, and draws up an approbation statement within a period not exceeding 15 calendar days from the date the documents and materials confirming the elimination of inconsistencies were submitted.
To confirm elimination of deficiencies requiring re-approbation by the applicant, the Laboratory of the Centre shall repeat the approbation and quality control within 60 calendar days of the date of receipt of the documents and materials required for the confirmation of the elimination of deficiencies. The results shall be documented by an approbation statement and a test report for a medicinal product.
Subsequent comments shall be sent to the applicant only in case of additional questions regarding the information (materials) submitted to them by the applicant in response to the previous comments.
18.  	Based on the results of the complex of preliminary works the Centre shall draft a conclusive statement on the grounds (absence of grounds) for the issue by the Ministry of Health of a clinical trial authorisation by the form presented in Annex 3, containing conclusions on:
the possibility (impossibility) to issue a clinical trial authorisation;
the possibility (impossibility) to approve a clinical trial programme (protocol).
The conclusive statement specified in part one of this clause shall be drawn up in two counterparts, signed by the authorised officer of the Centre and sealed with the Centre’s seal. One counterpart of the conclusion shall be sent to the applicant within 5 working days from the date it was signed and the second counterpart shall be kept at the Centre. The conclusion shall be valid for 6 months from the date of its issue.
19.  	To obtain the conclusive statement of the Ethic Committee of a healthcare institution on approval (denial of approval) of a clinical trial including the conclusion on approval (denial of approval) of a clinical trial programme (protocol), an applicant shall submit documents, materials and information in accordance with Annex 4.
The Ethics Committee of a healthcare institution shall conduct an expert examination of the documents, materials and information submitted, as well as the investigators’ qualification and the availability of the setting at a healthcare institution required for a clinical trial in accordance with the requirements of the Rules of Good Clinical Practice Rules of Good Clinical Practice (hereinafter, the Expert Examination) based on the agreement between the applicant and the healthcare institution.
The Expert Examination and the issue of the conclusive statement on approval (denial of approval) of a clinical trial by the Ethics Committee of a healthcare institution shall be in the manner and within the term stipulated by the Provisions on Independent Ethics Committee as approved by the decree approving this Provision.
As a result of the Expert Examination the Ethics Committee of a healthcare institution shall adopt a decision on the approval (denial of approval) of a clinical trial executed in any format as a conclusive statement signed by the Chairman.
The conclusive statement if the Ethics Committee of a healthcare institution shall reflect the results of the Expert Examination on the issues of ensuring the trial subjects’ rights, safety and health protection, conformity of the investigators’ qualification and availability of the setting required for the clinical trial at a healthcare institution in accordance with the Rules of Good Clinical Practice, and a conclusion shall be drawn:
on approval (denial of approval) of a clinical trial;
on approval (denial of approval) of a clinical trial programme (protocol).
20.  	To obtain a clinical trial authorisation, the applicant, after completion of the preliminary works and the Expert Examination, shall submit to the Ministry of Health documents stipulated by clause 10.17 of the Unified List of Administrative Procedures Performed by the State Institutions and other Organisations for Legal Entities and Individual entrepreneurs, approved by Resolution No. 156 of the Council of Ministers of the Republic of Belarus dated February 17, 2012.
With the applicant’s written consent the Centre shall provide the Ministry of Health with access to the documents earlier submitted by the applicant to the Centre for the performance of preliminary works.
21.  	Upon consideration of the documents specified in clause 20 hereof the Ministry of Health shall adopt one of the decisions as follows:
about assigning a clinical trial, issue a clinical trial authorisation and approval of the clinical trial programme (protocol);
about denial of assigning a clinical trial and denial of the issue of a clinical trial authorisation with indication of reasons for denial.
The decision adopted by the Ministry of Health shall be executed in the form of an order which copy shall be sent to the Centre in the written and (or) electronic form.
22.  	The Ministry of Health shall issue a clinical trial authorisation to the applicant by the form presented in Annex 5 within the term stipulated in clause 10.17 of the Unified List of Administrative Procedures Performed by the State Institutions and other Organisations for Legal Entities and Individual entrepreneurs, or shall send the applicant a written notification of denial of the issue of a clinical trial authorisation with indication of reasons for denial.
23.  	Based on the order of the Ministry of Health on the issue of a clinical trial authorisation the Centre shall include the information about the clinical trial in the register of authorisations for clinical trials of medicinal products (hereinafter, the Register). 
The Register is an information resource containing the information about clinical trials for which an authorisation has been issued by the Ministry of Health.
The Register is kept by the Centre.
24.  	Information about __________ shall be included in the Register:
number and date of a clinical trial authorisation;
name (code) of a medicinal product;
the dosage form and medicinal product’s dose;
medicinal product manufacturer;
applicant;
number and date of a clinical trial programme (protocol) (number and date of the clinical trial programme (protocol) with consideration of amendment made);
name of a clinical trial programme (protocol);
code of a clinical trial programme (protocol);
type (phase) of a clinical trial;
purpose of a clinical trial;
healthcare institutions conducting a clinical trial;
number of trial subjects approved for enrolment in a clinical trial;
clinical trial status. 

CHAPTER 3	
PROCEDURE OF CONDUCTING A CLINICAL TRIAL

25.  	Upon receipt of a clinical trial authorisation from the Ministry of Health, the applicant shall execute contracts with healthcare institution stipulated by the authorisation of the Ministry of Health and a clinical trial programme (protocol).
26.  	The applicant shall inform the Centre about the start of a clinical trial within 30 calendar days of the start of the clinical trial by sending a notification by the form presented in Annex 6.
Start of a clinical trial shall be the date of the first administration of the investigational medicinal product by the first trial subject, unless otherwise specified in a clinical trial programme (protocol).
27.  	The applicant shall present a report on the progress of a clinical trial with indication of the number of trial subjects that were enrolled in the clinical trial and completed it including prematurely as of December 31 of the running year.
28.  	A clinical trial can be suspended by the decision of the sponsor of the clinical trial or by the decision of the Ministry of Health.
29.  	Sponsor of a clinical trial can make a decision on suspension of a clinical trial not stipulated by a clinical trial programme (protocol) with subsequent intention to restore it, of which a written notification shall be sent to the Ministry of Health within 30 calendar days of the date of a clinical trial suspension by the form presented in Annex 7. Duration of suspension shall be determined by the sponsor of a clinical trial.
30.  	Decision of the Ministry of Health on a clinical trial suspension shall be adopted in case of: 
receipt of the information about potential violation of the Rules of Good Clinical Practice by the clinical trial sponsor or a healthcare institution during the clinical trial;
deterioration of the safety profile of the investigational medicinal product or identification of facts potentially affecting the reliability of the data obtained during the clinical trial;
change of the investigational medicinal product quality parameters;
unforeseeable circumstances preventing the conduct of a clinical trial (imposition of quarantine measures, act of God, emergency situations, change in diagnostic and treatment activities of a healthcare institution, etc.).
A clinical trial can be suspended in one or in several healthcare institutions.
Decision of the Ministry of Health on a clinical trial suspension shall be executed by an order of which the applicant and a healthcare institution shall be notified in writing within 5 working days of the date of signing.
31.  	In should the information specified in paragraph two of part one of clause 30 hereof or elimination by the applicant of a healthcare institution of other reasons leading to a clinical trial suspension, the Ministry of Health shall adopt a decision on the clinical trial restoration. Decision of the Ministry of Health on a clinical trial restoration shall be executed by an order of which the applicant and a healthcare institution shall be notified in writing within 5 working days of the date of signing.
32.  	A clinical trial shall be terminated in cases stipulated by part five of Article 18 of the Law of the Republic of Belarus On Circulation of Medicinal Products by the decision of the Ministry of Health.
Decision of the Ministry of Health on a clinical trial termination shall be executed by an order of which the applicant and a healthcare institution shall be notified in writing within 5 working days of the date of signing.
A clinical trial can be terminated prematurely (early termination) by decision of the sponsor of a the clinical trial due to the impossibility to fulfil the requirements and terms and conditions specified in the clinical trial programme (protocol).
33.  	In case of premature (early) termination or upon completion of a clinical trial the applicant shall send a written notification to the Ministry of Health and to the Centre within 30 calendar days of the date of premature (early) termination, completion of the clinical trial by the form presented in Annex 7.
34.  	A clinical trial shall be deemed completed upon the final visit of the last trial subject or later, if that is specified in a clinical trial programme (protocol).
35.  	In order to establish the compliance of the clinical trial conducted with the requirements of the Rules of Good Clinical Practice an inspection (pharmaceutical inspection) of the clinical trial shall be conducted.

CHAPTER 4	
PROCEDURE FOR INTRODUCTION OF AMENDMENTS TO A CLINICAL TRIAL PROGRAMME (PROTOCOL)

36.  	The applicant can initiate introduction of amendments to a clinical trial programme (protocol) during the clinical trial (unless otherwise specified, hereinafter, the Amendments) to be executed by the applicant in writing. The Amendments can be substantial and non-substantial.
A substantial amendment is an amendment potentially affecting a trial subject (physical or psychological well-being) and (or) a clinical trial scientific value. The list of substantial amendments shall be presented in Annex 10 to the Rules of Good Clinical Practice.
A decision on introduction (denial of introduction) of substantial amendments shall be adopted by the Ministry of Health upon document examination conducted by the Centre and an Expert Examination conducted by the Ethics Committee of a healthcare institution based on the agreement.
37.  	The document examination shall be conducted based on a contract between the Centre and the applicant and shall be in the form of assessment of documents in order to determine the possibility of the substantial amendments introduction. The document examination shall be conducted within 30 calendar days from the date of receipt of funds to the settlement account of the Centre.
The applicant shall submit to the Centre for the examination the following documents:
an application in any format with information for the substantial amendment to a clinical trial programme (protocol) attached, by the form presented in Annex 8;
document for the introduction of the substantial amendment to a clinical trial programme (protocol) according to the list presented in Annex 9 in Russian and Belarusian languages on paper media in three counterparts and on electronic media.
Upon completion of the document examination as specified in part two of this clause each expert shall draw up an expert opinion.
38.  	In case of comments in the expert opinions, the Centre shall forward them to the applicant (without specifying the experts) in writing and (or) in electronic form within 5 working days of signing of them.
The applicant shall address all comments within 30 calendar days of their receipt. The period specified may be extended for up to 60 calendar days on the grounds of a reasonable written request from the applicant.
Upon elimination of deficiencies a re-examination shall be conducted which terms shall be not more than 15 calendar days of the date of submission of the documents confirming the elimination of deficiencies. Should the deficiencies be not eliminated within the term established, the Centre shall notify the applicant in writing about the document examination termination within 5 working days.
39.  	Based on the document examination results the Centre shall draw up a conclusive statement about the grounds or the absence of the grounds for introduction (denial of introduction) of the substantial amendments to be sent to the Ministry of health and the applicant within 5 working days of the date of signing.
40.  	To obtain a conclusive statement of the Ethics Committee of a healthcare institution on approval of the substantial amendments introduction, the applicant shall submit to the Ethics Committee of a healthcare institution documents for the introduction of a substantial amendment to a clinical trial programme (protocol) according to the list presented in Annex 9.
Based on the results of the Expert Examination the Ethics Committee shall adopt a decision on approval (denial) of the substantial amendments introduction executed in the form of a conclusive statement in any format and signed by the Chairman of the ethics Committee of a healthcare institution. The said conclusive statement shall be sent to the applicant within 3 working days of the date of signing.
The Expert Examination by the Ethics Committee of a healthcare institution shall be performed within the term stipulated by the Provisions on the Ethics Committee of a Healthcare Institution.
41.  	The Ministry of health shall adopt one of the following decisions with consideration of the conclusive statements from the Centre and the Ethics Committee of a healthcare institution:
on introduction of a substantial amendment:
on denial of substantial amendment introduction.
Decision of the Ministry of Health shall be executed in the form of an order of which the applicant shall be notified in writing within 5 days of the date of signing the order. A copy of the order shall be sent to the Centre in writing and (or) in electronic form.
Based on the order on introduction of a substantial amendment the Centre shall within 5 working days of the date of signing include the information about such amendment in the Register.
42.  	The information for the introduction of a non-substantial amendment to a clinical trial programme (protocol) shall be submitted by the applicant to the Centre by the form presented in Annex 10. Upon receipt of the information on the introduction of the non-substantial amendment to the clinical trial programme (protocol) related to changing the Register information the Centre shall introduce those in the Register.

Annex 1
 to the Provisions
 on the Procedure of clinical trials of medicinal products

Form

INFORMATION FOR A COMPLEX OF PRELIMINARY WORKS PRECEDING THE ISSUE OF A CLINICAL TRIAL AUTHORISATION

Date of receipt:	Registration number assigned by Centre for Examinations and Tests in Health Service Republican Unitary Enterprise:	

A.	CLINICAL TRIAL IDENTIFICATION
Full name of a clinical trial:	
	
Coded number of a clinical trial programme (protocol) (assigned by the sponsor of a clinical trial), version and date:	
EudraCT number
Name or short name of a clinical trial (if used):	

B.	APPLICANT’S CONTACT INFORMATION
B.1.	Sponsor of a clinical trial	
Surname, first name, patronymic (if any) of a contact person:	
Location address:	
Telephone:	
Fax:	
Email:	

B.2.	Contract research organisation (official representative of the sponsor of a clinical trial in the Republic of Belarus for this clinical trial)	
Name of organisation:	
Surname, first name, patronymic (if any) of a contact person:	
Location address:	
Telephone:	
Fax:	
Email:	

C.	APPLICANT’S INFORMATION
 (check the relevant box)
C.1.		
-	Applicant		
-	Applicant’s official representative		
-	Organisation or individual authorised by the applicant to provide this information.
In this case, specify:
-	Organisation name:
-	Surname, first name, patronymic (if any) of a contact person:
-	Location address:
-	Telephone:
-	Fax:
-	Email:		

D.	INFORMATION ABOUT THE INVESTIGATION MEDICINAL PRODUCT(S)
This section requires information about each of the investigational medicinal  products to be presented prior to the procedures specifically related to a clinical trial (procedures for ensuring blinded trial, packaging and labelling of the investigational medicinal product, etc.). Section E should contain information related to placebo (if used in the clinical trial). If several investigational medicinal products are planned to be used in the clinical trial, use additional pages and assign each investigational medicinal product a sequence number. Information should be provided for each investigational medicinal product. If the investigational medicinal product is a combined one, information should be provided for each active ingredient in its composition

Indicate which of the listed is described below and, if necessary, repeat the information about each numbered investigational medicinal product to be used in a clinical trial (sequence number starting with 1):	
Information about the investigational medicinal product No.: (...)	
A medicinal product being an object of the study		
Medicinal product used as a comparator		

D.1.	STATUS OF THE INVESTIGATIONAL MEDICINAL PRODUCT IN A CLINICAL TRIAL
D.1.(a).	Is marketing authorisation available for the investigational medicinal product:	Yes	No	If yes, specify as follows	
			Trade name	Name of the Marketing authorisation holder	Registration number	
in the Republic of Belarus						
in another country. If yes, specify where:						

D.1.(b).	For situations when the investigational medicinal product is approved in the Republic of Belarus, but the clinical trial programme (protocol) allows administration to the trial subjects of any trade name of the investigational medicinal product approved in the Republic of Belarus:	Yes	No	
A clinical trial programme (protocol) contains information on pharmacotherapy of the active ingredient only?
-	if yes, proceed to D.2			
Medicinal products to be used as investigational products are specified by adherence to a group within the ATC classification
-	if yes, specify the ATC group (the third level or higher which may be established for a medicinal product) using the relevant field for the ATC code in section D.2 hereof			
Other:
-	if yes, specify:			

Have clinical trials with this medicinal product been approved in the Republic of Belarus?	Yes 	No 	

Has this medicinal product with its intended indications been classified as a medicinal product for the treatment of orphan (rare) diseases?
If yes, specify the name of a medicinal product for the treatment of orphan (rare) diseases:	Yes 	No 	

D.2.	DESCRIPTION OF THE INVESTIGATIONAL MEDICINAL PRODUCT
Name of the medicinal product:
Code of the medicinal product (if available):
Names of each active substance (the international non-proprietary name or the suggested international non-proprietary name, if available, indicate whether it is approved or suggested):
Indicate all the known other names for each of active substance (CAS number, code(s) assigned by the applicant):
ATC code if officially registered:
Drug formulation:
Method of administration:
Dosage (specify dosage (concentration) to be used in clinical trial):
-	concentration (numerical):
-	unit of concentration:
-	type of concentration (underline the necessary: precise numerical value, range, more than or not more than).	
Type of medicinal product	
The investigational medicinal product contains active ingredient:	
-	of chemical origin?	Yes 	No 	
-	biological, biotechnological origin?			
			
This medicinal product is:	
1)	a biological medicinal product?	Yes 	No 	
2)	a radiopharmaceutical medicinal product?	Yes 	No 	
3)	an immunological medicinal product?	Yes 	No 	
4)	a herbal medicinal product?	Yes 	No 	
5)	a homeopathic medicinal product?	Yes 	No 	
6)	a hybrid medicinal product?	Yes 	No 	
7)	a generic medicinal product?	Yes 	No 	
8)	a biosimilar medicinal product?	Yes 	No 	
9)	a medicinal product containing genetically modified organisms?	Yes 	No 	
If yes, then			
-	has authorisation been obtained for limited use or release of the product to the environment?	Yes 	No 	
-	is issue of such authorisation at the stage of consideration?	Yes 	No 	
10)	other type of medicinal product?	Yes 	No 	
If yes, specify which:			

D.3.	INVESTIGATIONAL MEDICINAL PRODUCT OF BIOLOGICAL OR BIOTECHNOLOGICAL ORIGIN
Type of medicinal product	
-	extract	Yes 	No 	
-	recombinant	Yes 	No 	
-	containing genetically modified organisms	Yes 	No 	
-	blood or plasma product	Yes 	No 	
-	other	Yes 	No 	
If other, specify:			

D.4.	THE INVESTIGATIONAL MEDICINAL PRODUCT IS INTENDED FOR GENE THERAPY
Gene(s) involved:	

Gene therapy in vivo:	Gene therapy ex vivo:	

Type of medicinal product used for gene transfer	
-	Nucleic acid (for instance, of a plasmid):	Yes 	No 	
If yes, specify			
-	pure:	Yes 	No 	
-	within a complex:	Yes 	No 	
-	Viral transmitter	Yes 	No 	
If yes, specify type: adenovirus, retrovirus, adeno-associated virus, etc.			
-	Other:	Yes 	No 	
If yes, specify which:			

E.	INFORMATION ABOUT PLACEBO
(if more than one is used, repeat information for each)
Is placebo used:	Yes 	No 	
Information about placebo No.: (...)			
For which investigational medicinal product is placebo used?
(specify the investigational medicinal product number(s) from section D)
Drug formulation:
Method of administration:
Composition excluding active substance(s):			
-	identical to the investigational medicinal product?	Yes 	No 	
If no, specify main ingredients:			

F.	INFORMATION ABOUT MANUFACTURING FACILITY, PERSON RESPONSIBLE FOR THE INVESTIGATIONAL MEDICINAL PRODUCT RELEASE
This section concerns the investigational medicinal product and comparator used in a clinical trial (upon completion of the manufacturing process, assignment of randomization numbers, packaging, labelling). If several manufacturing facilities or several investigational medicinal products are used, use additional pages and indicate sequence numbers for each investigational medicinal product as specified in section D or in section E (for placebo) and indicate which medicinal product is manufactured at each manufacturing facility.
Person responsible for the investigational medicinal product release (specify the relevant):
This manufacturing facility is responsible for the investigational medicinal product release (specify number as assigned in section D for the investigational medicinal product and in section E for placebo):	
-	Medicinal product manufacturer			
			
-	Name of the manufacturer:			
-	Location address:			
			
-	Manufacturer’s licence registration number:			
If licence is not available, specify reasons:			
			
Was inspection of the manufacturing facility conducted by the authorised bodies?	Yes 	No 	
If yes, specify who conducted the inspection and date of the last inspection:			

G.	GENERAL INFORMATION ABOUT CLINICAL TRIAL
Pathological condition or disease studied			
Code under the International Classification of Diseases (ICD 10):			
MedDRA classification code:			
Is the disease an orphan (rare) one?	Yes 	No 	

Objective of a clinical trial	
Primary objective	
	
Secondary objectives:	

Main inclusion criteria (specify the most important)	

Main exclusion criteria (specify the most important)	

Primary endpoint(s):	

Clinical trial range – specify all the necessary	
Diagnostic		
Prophylaxis		
Therapy		
Safety		
Efficacy		
Pharmacokinetics		
Pharmacodynamics		
Bioequivalence (bioavailability)		
Dose-response relationship		
Pharmacogenomics		
Pharmacoeconomics		
Other		
If other, specify:		
Pharmacology clinical trial in humans (phase I)
Is the clinical trial:
The first administration to humans
Bioequivalence (bioavailability) study
Comparative pharmacodynamic study	Limited therapeutic clinical trial (phase II)	Expanded therapeutic clinical trial (phase III)	Therapeutic use study (phase IV)	
Comparative clinical trial (of a generic medicinal product)	
Other: specify which	
Clinical trial design	
Randomized	Yes 	No 		
Controlled	Yes 	No 	If yes, specify:	
			Open-labelled:	Yes 	No 	Double blind:	Yes 	No 	
			Single blind:	Yes 	No 				
			In parallel groups:	Yes 	No 	Cross-over:	Yes 	No 	
			Other:	Yes 	No 	If yes, specify:	
	
	Specify comparator:	
	-	other medicinal product(s)	Yes 	No 	
	-	placebo	Yes 	No 	
	-	other	Yes 	No 	
	If other, specify:	
	
Single-centered (see also Section I):	Yes 	No 	
Multi-centred (see also Section I):	Yes 	No 	
International clinical trial:	Yes 	No 	

Maximum duration of treatment of a trial subject in accordance with the clinical trial programme (protocol).	
	
Maximum permitted dose of the investigational medicinal product (specify: daily or total during the whole clinical trial):	

Determine the dates of clinical trial completion and justification in case it is not the last visit of the last trial subject enrolled in the clinical trial:	
Primary assessment of a clinical trial duration (years, months): 	
-	in the Republic of Belarus years, months	years	months	
-	in all countries where the clinical trial is conducted years months	years	months	

H.	GROUPS OF TRIAL SUBJECTS
Age range:	
Under 18 years
If yes, specify:
Prenatal
Premature infants (born at < 37 weeks of gestation)
Newborn (0 to 27 days of life)
Infants (28 days of life to 12 months)
Children (1 to 16 years)
Adolescents (16 to 18 years)	Adults (18 to 65 years)	Geriatric patients (> 65 years)	
Gender: Female	Male	
Groups of trial subjects	
Healthy subjects	Yes 	No 	
Patients	Yes 	No 	
Vulnerable groups of trial subjects			
-	underage	Yes 	No 	
-	pregnant	Yes 	No 	
-	military	Yes 	No 	
-	subjects in a critical state	Yes 	No 	
-	subjects unable to give informed consent for participation in a clinical trial	Yes 	No 	
	If yes, specify:	
-	other	If yes, specify:	
Planned number of trial subjects to be enrolled in a clinical trial:	
-	in the Republic of Belarus
-	for an international multi-centered clinical trial:
-	for the whole clinical trial	
Planned treatment or follow-up of the trial subjects that completed the clinical trial (if different from the suggested standard treatment for the given pathological condition):	
	
Specify:	

I.	SUGGESTED HEALTHCARE INSTITUTIONS FOR CONDUCTING A CLINICAL TRIAL (hereinafter, the Clinical Base)
I.1.	The Clinical Base, responsible investigator(for a single-centre clinical trial) and (or) coordinating investigator (for a multi-centre clinical trial)	
Clinical base name and address	Responsible investigator or coordinating investigator	
	surname, first name, patronymic (if any)	Qualification	
I.2.	Responsible investigators (for a multi-centre trial; if necessary, use other forms)	
Clinical base name and address	Responsible investigator	
	surname, first name, patronymic (if any)	Qualification	
I.3.	Centralised technical rooms to be used in a clinical trial (laboratory or other technical rooms) on the territory of the Republic of Belarus in which main evaluation criteria will be measured in a centralised manner (for several organisations, fill out for each one)	
Organisation:
Surname, first name, patronymic (if any) of a contact person:
Location address:
Telephone:
Subcontracted obligations:	
I.4.	Organisations subcontracted by the applicant or their official representative for the trial (for several organisations, fill out for each one)	
Has the applicant or their official representative re-assigned obligations and functions related to a clinical trial to another organisation or a third party?	
	Yes 	No 	
If yes, specify:
Organisation:
Surname, first name, patronymic (if any) of a contact person:
Location address:
Telephone:
Subcontracted obligations (function):	

J.	ETHICAL ISSUES OF PLANNING AND SECURING A CLINICAL TRIAL
Provide information about the independent Ethical Committee of a healthcare institution	
Independent Ethics Committee	
Name and location:	
Date of documents submission:	
Decision (approval):	to be requested	under consideration	
	issued		
If a decision (approval) has been obtained, specify:			
	Date of decision (approval):
allowed (approved):
denied:
If denied, specify:
-	reasons
-	possible date of documents re-submission for the complex of preliminary works	

K.	CONTROL LIST
Documents and information submitted for a clinical trial	
		Information submitted by the form established	
		Written confirmation of a EudraCT number (if any) receipt	
		Clinical trial programme (protocol) with all current amendments	
		Investigator’s brochure or equivalent	
		Non-clinical study reports in the scope according to the Rules of Good Laboratory Practice of the Eurasian Economic Union for Circulation of Medicinal Products, approved by Resolution No. 81 of the Board of the Eurasian Economic Commission dated November 3, 2016
	
		Information about the previous clinical trials or clinical use of the investigational medicinal product (for medicinal products approved in the Republic of Belarus)	
		Case report form (except for multi-centre clinical trials)	
		Document issued by a contract research organisation with clear reassigned authorities (in case it is the applicant)	
ADDITIONAL INFORMATION	
		Certificate from the medicinal product manufacturer containing environmental risk evaluation data for the medicinal products containing genetically modified organisms (if applicable and available)	
Information for trial subjects	
		Written information for a trial subject and informed consent form	
		Other written information for a trial subject (diaries, questionnaires, case report forms for the trial subjects, etc., list the relevant):	
Information about a clinical trial programme (protocol)	
		Summary of a clinical trial programme (protocol)	
		Expert evaluation of a clinical trial (if any)	
Information about the investigational medicinal product	
		Sample labelling with information about the medicinal product in Russian and in Belarusian languages	
		Relevant authorisations applicable to the clinical trials or medicinal products with special characteristics (if any), such as genetically modified organisms, radiopharmaceutical medicinal products	
		A copy of veterinary certificate (manufacturer’s declaration) about the absence in manufacturing of the starting materials of animal origin which can be potentially infected with spongiform encephalopathy (in necessary)	
		Quality certificates for the investigational medicinal product	
		A copy of the production e with indication of the scope of the licence;	
		Information about the investigational medicinal product manufacturer	
		Information about the production technology of the investigational medicinal product and documentation guiding the production control and investigational medicinal product quality control	
		Written confirmation of the works at the facility performed in accordance with the requirements of the Good Manufacturing Practice	
Information about funding	
		A document confirming life and health insurance for the trial subjects	
		Other documents	

L.	APPLICANT’S SIGNATURE
I, the undersigned, hereby confirm (confirm on behalf of the applicant) that	
(delete as appropriate):	
the above information is true; a clinical trial will be conducted in accordance with the clinical trial programme (protocol), legislative requirements and the Rules of Good Clinical Practice;
I hereby undertake to inform the Centre for Examinations and Tests in Health Service Republican Unitary Enterprise and the Independent Ethics Committee of a healthcare institution about the date of the start of a clinical trial.	
Applicant
Date:
Signature:
Surname, first name, patronymic (if any) in block letters:

Annex 2
 to the Provisions on the Procedure of clinical trials of medicinal products

LIST
 of documents for a complex of preliminary works preceding the issue of a clinical trial authorisation

1.	Documents to be submitted for the complex of preliminary works prior to the issue of a foreign medicinal product clinical trial authorisation:
1.1.	original and notarised copies of the document confirming the authorities of a contract research organisation in case it organises and conducts a clinical trial;
1.2.	certified by the applicant:
draft clinical trial programme (protocol) with amendments thereto (if any);
draft investigator’s brochure;
a copy of a clinical trial authorisation of a foreign authorised body including that for a substantial amendment introduction (if any);
a copy of manufacturing drug licence issued by an authorised body of the country of manufacturing of the investigational medicinal product;
a copy of the document certifying compliance of the investigational medicinal product production with the requirements of the Good Manufacturing Practice, issued by an authorised body of the country of manufacturing of the investigational medicinal product;
information about the medicinal product manufacturer (information about all the participants of the medicinal product manufacturing process and quality control);
information about the drug substance including general information, description of the manufacturing process and controls, brief manufacturing diagram, information about batch size, starting materials quality control, control of the critical production stages and intermediate products, information about changes in the production process (if any), methods of structure confirmation and justification of impurities, specifications and description of validation of the drug substance control methods and justification of specifications, information about the standards used, packaging information, drug substance stability data (including summary and conclusion, stress tests, photostability study, long-term and accelerated studies), drug substance batch quality control results.
the manufacturer’s document, comprising the data on the medicinal product’s composition, specifying the quantity of all ingredients, including all excipients for one dosed unit (for dosed medicinal products) or a unit of mass or volume (for non-dosed medicinal products) with reference to the documents on the quality control of the drug substance and excipients;
information about the medicinal product including: information about pharmaceutical development (including physico-chemical and biological testing data for confirmation of comparability with the original (reference) medicinal (for a bioequivalent medicinal product)); description of the medicinal product manufacturing process and controls, control of the critical production stages and intermediate products, brief manufacturing diagram, manufacturing formula and information about batch size; information about medicinal product production process validation (if any), critical stages for non-standard processes (products) validation results, information about changes in the manufacturing process (if any); specifications and, if necessary, description of excipients quality control procedures, information about new excipients (if any), quality control results for at least one batch of excipients; specifications and description of medicinal product quality control methods; information about quality control procedures validation, justification of specifications and impurities; information about standards used; packaging information, medicinal product stability study data (including summary, conclusion, plan, tabulated results);
copies of the documents confirming quality of the investigational medicinal products (batches provided for the clinical trial in accordance with the clinical trial programme (protocol));
information about (copies of reports of) a medicinal product pre-clinical (non-clinical) studies in accordance with the Rules of Good Laboratory Practice of the Eurasian Economic Union for Circulation of Medicinal Products, approved by Resolution No. 81 of the Board of the Eurasian Economic Commission dated November 3, 2016, within the scope determined by the international legal acts constituting the law of the Eurasian economic Union;
information about (copies of) all the previous clinical trials in accordance with the requirements of the Rules of Good Clinical Practice and the experience of medical use;
information about (copies of) the pre-clinical (non-clinical) studies and clinical trials conducted to confirm comparability with the original (reference) medicinal product – for a biosimilar medicinal product;
copies of biopharmaceutical study reports including validation of procedures – for generic medicinal products, hybrid medicinal products (not for herbal medicinal products);
copies of bioavailability (bioequivalence) study reports for generic medicinal products, hybrid medicinal products (not for herbal medicinal products);
copy of veterinary certificate or a manufacturer’s declaration about the absence in medicinal product manufacturing of the starting materials of animal origin which can be potentially infected with bovine spongiform encephalopathy;
draft informed consent form for a trial subject;
draft written information explaining aspects of a clinical trial to be provided for the trial subjects for them to make a decision on joining the clinical trial;
1.3.	expert opinion on assessment of a clinical trial documents, issued by an authorised body (organisation) of the country where the clinical trial was conducted (if any);
1.4.	draft instruction for medical use (package information leaflet) and summary of product characteristics (if any);
1.5.	draft sample case report form for a trial subject;
1.6.	sample labelling of the investigational medicinal product in Belarusian and Russian languages (additional information may be presented in original language);
1.7.	manufacturer’s declaration containing environmental risk assessment data for the medicinal products containing genetically modified organisms;
1.8.	information about trial subjects insurance, payments and compensation (if any);
1.9.	agreement of a healthcare institution to conduct a clinical trial in accordance with the requirements of the Rules of Good Clinical Practice;
1.10.	information about investigators’ education, further education, scientific degrees and knowledge, practical work and clinical trial experience;
1.11.	copies of documents confirming investigators’ training on the rules of conducting clinical trials in the last five years as of the date of contract with the Centre for the complex of preliminary works;
1.12.	summary information about all the current clinical trials of the investigational medicinal product (if any);
1.13.	other documents on:
medicinal product viral safety;
safety study of medicinal products with special properties (for medicinal products originating from genetically modified organisms, radiopharmaceutical products, etc.).
2.	Documents to be submitted for the complex of preliminary works prior to the issue of a domestic medicinal product clinical trial authorisation:
2.1.	original and notarised copies of the document confirming the authorities of a contract research organisation in case it organises and conducts a clinical trial;
2.2.	certified by the applicant:
draft clinical trial programme (protocol) with amendments thereto (if any);
draft investigator’s brochure;
a copy of manufacturing licence;
a copy of the document (certificate) confirming the compliance of the investigational medicinal product industrial manufacturing with the requirements of the Good Manufacturing Practice, issued by the Ministry of Health, or a document (certificate), confirming the compliance of the investigational medicinal product industrial manufacturing with the requirements of the Good Manufacturing Practice of the Eurasian Economic Union, issued by the authorised body of the Eurasian Economic Union member state;
information about the medicinal product manufacturer (information about all the participants of the medicinal product manufacturing process and quality control);
copies of manufacturer’s documents including the description of methods for obtaining the drug substance, brief diagram of manufacturing (synthesis). control of critical steps and intermediate products, information about batch size, methods of structure confirmation, justification of impurities, declaration of the production process validation or CEP certificate (if any), control procedure validation reports (in case the drug substance is not approved in the Republic of Belarus);
a copy of the document on the drug substance quality control;
a copy of the document on the excipients quality control;
a copy of the manufacturer’s document containing results of the drug substance stability study (plan, report, tabulated study results) (in case the drug substance is not approved in the Republic of Belarus);
copies of documents confirming the medicinal product, drug substance, excipients batch quality;
copies of the documents, confirming the quality of standards used for the investigational medicinal product and drug substance quality control;
copies of manufacturer’s documents including the description of methods for obtaining the medicinal product, control of critical steps and intermediate products, brief diagram of manufacturing, control of critical production stages, production formula, production process validation report (if any);
the manufacturer’s document containing data on the composition of a medicinal product with indication of the quantity of all ingredients including all excipients for one dose (for dosed medicinal products) or a unit of mass or volume (for non-dosed medicinal products) with reference to the documents on the quality control of the drug substance and excipients;
copies of the investigational medicinal product quality control procedures validation;
copies of documents on the investigational medicinal product pharmaceutical development;
a copy of the manufacturer’s document containing the medicinal product stability results (plan, report, tabulated study results);
copies of the physico-chemical and biological studies reports on confirmation of the comparability with an original (reference) medicinal product – for a biosimilar medicinal product;
copies of the quality control documents of the primary packaging materials of the drug substance (primary packaging components) and copies of the documents confirming that the primary packaging materials (primary packaging components) are suitable for the drug substance packaging (in case the drug substance is not approved in the Republic of Belarus);
copies of the quality control documents of the primary packaging materials (primary packaging components) and copies of the documents confirming that the primary packaging materials (primary packaging components) are suitable for the medicinal product packaging;
copies of the documents confirming the quality of one batch of the primary packaging materials (primary packaging components);
copies of the documents confirming quality of the investigational medicinal products (batches provided for the clinical trial in accordance with the clinical trial programme (protocol));
copies of biopharmaceutical study reports including validation of procedures – for generic medicinal products, hybrid medicinal products (not for herbal medicinal products);
copies of bioavailability (bioequivalence) study reports – for generic medicinal products, hybrid medicinal products (not for herbal medicinal products);
copies of the medicinal product pre-clinical (non-clinical) study reports (except for generic medicinal products);
copies of the pre-clinical (non-clinical) studies and clinical trials conducted to confirm comparability with the original (reference) medicinal product (for a biosimilar medicinal product);
copies of the medicinal product clinical trials conducted in accordance with the Good Clinical Practice (except for generic medicinal products in case the bioavailability (bioequivalence) study reports are provided and for herbal generic medicinal products);
copy of veterinary certificate or a manufacturer’s declaration about the absence in medicinal product manufacturing of the starting materials of animal origin which can be potentially infected with bovine spongiform encephalopathy;
draft informed consent form;
draft written information explaining aspects of a clinical trial to be provided for the trial subjects for them to make a decision on joining the clinical trial;
2.3.	draft instruction for medical use (package information leaflet) and summary of product characteristics (if any);
2.4.	draft normative document on medicinal product quality;
2.5.	sample labelling of the investigational medicinal product in Belarusian or Russian language;
2.6.	manufacturer’s declaration containing environmental risk assessment data for the medicinal products containing genetically modified organisms;
2.7.	draft sample case report form for a trial subject;
2.8.	information about trial subjects insurance, payments and compensation (if stipulated);
2.9.	agreement of a healthcare institution to conduct a clinical trial in accordance with the requirements of the Rules of Good Clinical Practice;
2.10.	information about investigators’ education, further education, scientific degrees and knowledge, practical work and clinical trial experience;
2.11.	2.11. copies of documents confirming investigators’ training on the rules of conducting clinical trials in the last five years as of the date of contract with the Centre for the complex of preliminary works;
2.12.	summary information about all the current clinical trials of the investigational medicinal product (if any);
2.13.	other documents on clinical trial of viral safety, safety of medicinal products with special properties (for medicinal products obtained from genetically modified organisms, radiopharmaceutical products, etc.).

Annex 3
 to the Provisions
 on the Procedure of clinical trials of medicinal products

Form

CENTRE FOR EXAMINATION AND TESTS IN HEALTH SERVICE REPUBLICAN UNITARY ENTERPRISE

CONCLUSIVE STATEMENT
 on the grounds (absence of grounds) for the issue by the Ministry of Health of a clinical trial authorisation

___________ ___, 20__	Minsk

This conclusive statement has been prepared based on the results of a complex of preliminary works,
	
(medicinal product name (code), dosage, dosage form, name, code, number (version) and date of a clinical trial programme (protocol)
	
name of the clinical trial sponsor, contract research organisation) 

prior to the issue of a clinical trial authorisation including:
1.	Results of the primary document expert examination 	
2.	Results of the specialised document expert examination including:
clinical and pharmacological 	
pharmaceutical examination 	
3.	Results of the medicinal product quality control methods approbation and quality control of the medicinal product using these methods
	
CONCLUSION:
clinical trial 	
(medicinal product name (code), dosage, dosage form)
under a clinical trial programme (protocol) 	
(name (code), version and date of a clinical trial programme (protocol))
	 with the requirements of the legislation on clinical trials.
(complies (does not comply))

Issue of a clinical trial authorisation 	
(possible (impossible))
Approval of a clinical trial programme (protocol) 	
(possible (impossible))
This conclusive statement is valid for 6 months from the date of issue.
					
(position of the authorised officer)		(Signature)		(initials (initial of a proper name), surname)	

L.S.

Annex 4
 to the Provisions
 on the Procedure of clinical trials of medicinal products

LIST
 of the documents, materials and information to obtain a conclusive statement of the Ethics Committee of a healthcare institution on approval (denial) of a clinical trial

1.	Draft clinical trial programme (protocol).
2.	Written informed consent form for a trial subject.
3.	The information intended for attraction of subjects for participation in a clinical trial (such as advertising announcements, leaflets, etc.).
4.	The written materials explaining aspects of a clinical trial to be provided for the trial subjects for them to make a decision on joining the clinical trial.
5.	Investigator’s brochure.
6.	Information (scientific publications) related to the trial subjects safety during medical use of the investigational medicinal product.
7.	Information about payments and compensations to the trial subjects (if such are stipulated by the clinical trial programme (protocol)).
8.	The investigators’ CVs and (or) other documents confirming their qualification.
9.	Other documents that the Ethics Committee of a healthcare institution may require to prepare the conclusive statement on approval of a clinical trial. 

Annex 5
 to the Provisions
 on the Procedure of clinical trials of medicinal products

Form

MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS

AUTHORISATION NO. _________
 for a clinical trial
dated _________________ 20__

A clinical trial is hereby authorised

(name (code) of a medicinal product)

(medicinal product dosage form and dose)

(code of a clinical trial programme (protocol) assigned by the sponsor of the clinical trial)

(number (version) and date of a clinical trial programme (protocol))

(name of a clinical trial programme (protocol))

(sponsor of a clinical trial)

(contract research organisation (if applicable))

Manufacturers of the investigational medicinal product:
Manufacturers of the finished dosage form: 	
Dispensing: 	
Packaging: 	
Release quality control: 	
Other stages of medicinal product manufacturing and quality control: 	
Clinical trial objectives: 	
Number of trial subjects approved for enrolment in a clinical trial (randomised) 	
State-owned healthcare institution selected for the clinical trial:
S. No.	Name of a state-owned healthcare institution	

Minister of Health 
(Deputy Minister)					
		(Signature)		(initials (initial of a proper name), surname)	
L.S.

Annex 6
 to the Provisions 
on the Procedure of clinical trials of medicinal products

Form

NOTIFICATION ABOUT THE START  OF A CLINICAL TRIAL
Date of receipt:	Registration number of Centre for Examinations and Tests in Health Service Republican Unitary Enterprise:	
CLINICAL TRIAL IDENTIFICATION

Code number of a clinical trial programme (protocol) assigned by the sponsor of the clinical trial:	
EudraCT number (if available):	
Full name of a clinical trial	
Authorisation of the Ministry of Health of the Republic of Belarus
Date ___/___/___ (dd/mm/yy)	
Approval of the Independent Ethics Committee of a healthcare institution:
Date ___/___/___ (dd/mm/yy)
Location address:	
IDENTIFICATION OF THE APPLICANT
(mark the relevant)
Information about the start of a clinical trial	
-	Sponsor of a clinical trial		
-	Contract research organisation		
-	Organisation or individual authorised by the applicant to submit this notification.		
In this case, specify:
-	Organisation name:
-	Surname, first name, patronymic (if any) (hereinafter, full name) of a contact person:
-	Location address:
-	Telephone:
-	Fax:
-	Email:		
Start of a clinical trial in the Republic of Belarus	(dd/mm/yy):	
Date of the first administration of an investigational medicinal product to the first trial subject in the Republic of Belarus	___/___/___	
Specify healthcare institution to be the first to enrol the first trial subject:
Name:
Responsible investigator:	
I, the undersigned (full name) hereby confirm that the above information is reliable.	
APPLICANT:
Date:
Signature:
Full name in block letters:	

Annex 7
 to the Provisions
 on the Procedure of clinical trials of medicinal products

Form

NOTIFICATION OF COMPLETION, SUSPENSION, PREMATURE (EARLY) TERMINATION OF A CLINICAL TRIAL

Date of receipt:	Registration number of Centre for Examinations and Tests in Health Service Republican Unitary Enterprise:	
Date of receipt:	By the independent ethics committee of a healthcare institution:	

CLINICAL TRIAL IDENTIFICATION
Code number of a clinical trial programme (protocol) assigned by the sponsor of the clinical trial:	
EudraCT number (if available):	
Full name of a clinical trial:	

IDENTIFICATION OF THE APPLICANT
(mark the relevant)
-	Sponsor of a clinical trial		
-	Contract research organisation		
-	Individual or organisation authorised by the applicant to submit this notification.		
In this case, specify:
-	Organisation name:
-	Surname, first name, patronymic (if any) (hereinafter, full name) of a contact person:
-	Location address:
-	Telephone:
-	Fax:
-	Email:		
Completion, suspension, premature (early) termination of a clinical trial	Date (dd/mm/yy):	
Does this completion of a clinical trial only apply to the Republic of Belarus?	Yes 	No 	___/___/___	
Does this completion of a clinical trial apply to all the countries where it was conducted?	Yes 	No 	___/___/___	
Does completion of a clinical trial mean premature (early) termination of a clinical trial?				
Is this a suspension of a clinical trial?				
If yes, fill out the following fields:				
What are the reasons for premature (early) termination of a clinical trial or its suspension?				
-	safety	Yes 	No 		
-	low efficacy	Yes 	No 		
-	the clinical trial has not started	Yes 	No 		
-	other
If yes, specify:
				
Number of trial subjects continuing therapy as of the date of clinical trial suspension:	
Describe briefly in appendix (in any format):
justification of the clinical trial suspension or its premature (early) termination;
supposed observation of the trial subjects receiving therapy by the date of the clinical trial suspension or its premature (early) termination;
impact of the clinical trial premature (early) termination on the assessment of the clinical trial results and overall risk assessment and expected benefit of administration of an investigational medicinal product.	

I, the undersigned, hereby confirm (confirm on behalf of the applicant) that the information provided is true.	
APPLICANT submitting the notification on completion, suspension or premature (early) termination of a clinical trial:
Date:
Signature:
Full name in block letters:	

Annex 8
 to the Provisions
 on the Procedure of clinical trials of medicinal products

Form

INFORMATION FOR SUBSTANTIAL CLINICAL TRIAL PROTOCOL AMENDMENT

Date of receipt:	Registration number assigned by Centre for Examinations and Tests in Health Service Republican Unitary Enterprise:	
A1. CLINICAL TRIAL IDENTIFICATION (if amendment applies to several clinical trials, please, fill out this form in as many copies at the number of clinical trials)
Full name of a clinical trial:	
Code number of a clinical trial programme (protocol) assigned by an applicant, revision and date:	
EudraCT number (if available):	
A2. SUBSTANTIAL AMENDMENT IDENTIFICATION
Amendments to a clinical trial programme (protocol)		If this position is checked, specify the amendment code number assigned by an applicant, revision and date:	
Changes to the information provided for the issue of authorisation		If this position is checked, specify the change code number assigned by an applicant, revision and date:	
B.	APPLICANT’S CONTACT INFORMATION
B.1.	Applicant	
Organisation:	
Surname, first name, patronymic (if any) (hereinafter, full name) of a contact person:	
Location address:	
Telephone:	
Fax:	
Email:	

B.2.	Official representative of an applicant in the Republic of Belarus for this clinical trial (if not the applicant themselves)	
Organisation:	
Full name of a contact person:	
Location address:	
Telephone:	
Fax:	
Email:	
C.	IDENTIFICATION OF THE APPLICANT
(check the relevant boxes)
C.1.			
-	Applicant		
-	Applicant’s official representative		
-	Individual or organisation authorised by an applicant to submit information and documents		
In this case, specify:		
-	Organisation name:		
-	Full name of a contact person:		
-	Location address:		
-	Telephone:		
-	Fax:		
-	Email:		
D.	TYPE OF AMENDMENTS (check the relevant box)
Changes to a clinical trial programme (protocol):	Yes 	No 	
purpose of a clinical trial;	Yes 	No 	
clinical trial design;	Yes 	No 	
informed consent;	Yes 	No 	
clinical trial subject selection procedure;	Yes 	No 	
efficacy parameters;	Yes 	No 	
biological sampling procedure;	Yes 	No 	
addition or elimination of tests or parameters;	Yes 	No 	
number of trial subjects;	Yes 	No 	
clinical trial subjects age range;	Yes 	No 	
inclusion criteria;	Yes 	No 	
exclusion criteria;	Yes 	No 	
safety monitoring;	Yes 	No 	
duration of administration of the study medicinal;	Yes 	No 	
changes in the study medicinal dosage;	Yes 	No 	
change of comparator;	Yes 	No 	
statistical analysis.	Yes 	No 	
Changes in the clinical trial organisation:	Yes 	No 	
replacement of the responsible investigator or involvement of new ones	Yes 	No 	
replacement of the coordinating investigator;	Yes 	No 	
replacement of a healthcare institution or addition of additional ones;	Yes 	No 	
replacement of the clinical trial sponsor of their official representative;	Yes 	No 	
replacement of the contract research organisation responsible for the conduct of a clinical trial;	Yes 	No 	
change of the terms and conditions of a clinical trial completion.	Yes 	No 	
Changes related to the investigational medicinal product:	Yes 	No 	
primary packaging material;	Yes 	No 	
active substance manufacturer;	Yes 	No 	
active substance production process;	Yes 	No 	
active substance specifications;	Yes 	No 	
investigational medicinal product manufacturing;	Yes 	No 	
investigational medicinal product specifications;	Yes 	No 	
specifications of excipients capable of affecting the action of the investigational medicinal product;	Yes 	No 	
shelf life including storage period after the first opening and (or) dilution;	Yes 	No 	
substantial change of the investigational medicinal product composition;	Yes 	No 	
storage conditions;	Yes 	No 	
active substance test methods;	Yes 	No 	
investigational medicinal product test methods;	Yes 	No 	
non-compendial excipients test methods.	Yes 	No 	
Changes related to pre-clinical (non-clinical) trials and accompanied by changes to the benefit-risk ratio assessment.  Corrections of pre-clinical pharmacological and toxicological trials of the on-going clinical trials connected with changes to the benefit-risk ratio assessment including in relation to:	Yes 	No 	
results of the new pharmacological trials;	Yes 	No 	
new interpretation of the existing pharmacological trials;	Yes 	No 	
results of the new toxicological trials;	Yes 	No 	
new interpretation of the existing toxicological trials;	Yes 	No 	
results of the new medicinal interaction trials.	Yes 	No 	
Changes related to clinical trials and accompanied by changes to the benefit-risk ratio assessment.  Corrections to a clinical trial, as well as corrections to data reflecting experience of medicinal product administration to humans, which are important for the on-going clinical trials and are connected with the change of the benefit-risk ratio assessment. Such as, in relation to:	Yes 	No 	
clinical trial safety or safety of medicinal product administration to humans; 	Yes 	No 	
results of the new clinical pharmacological trials;	Yes 	No 	
new interpretation of the existing clinical pharmacological trials;	Yes 	No 	
results of the new clinical trials;	Yes 	No 	
new interpretation of the existing clinical trial data;	Yes 	No 	
new data on medicinal product administration to humans;	Yes 	No 	
new interpretation of the existing data on the experience of medicinal product administration to humans.	Yes 	No 	
Other change:
If yes, specify
	Yes 	No 	
E.	REASONS FOR AMENDMENTS:

F.	BRIEF DESCRIPTION OF AMENDMENTS:

G.	LIST OF DOCUMENTS ATTACHED
Documents shall be presented related to this notification and (or) reference provided for the prior submitted documents. References to all changes in pagination shall be specified and both the old and the new revisions of texts shall be submitted.
Check the relevant boxes:
	Cover letter specifying the type of amendments and reason(s) for their introduction	
	Brief description of the essence of the amendment to be made	
	List of documents amended (identification, revision, date)	
	Numbers of pages with the old and the new wording (if applied)	
	Additional information	
	New file version in Word format and a copy of original information form with the changed data marked (if applicable)	
APPLICANT’S SIGNATURE
I, the undersigned, hereby confirm (confirm on behalf of the applicant) that (delete as appropriate):
-	the information provided is true;
-	a clinical trial will be conducted in accordance with the clinical trial programme (protocol), legislative requirements and the Rules of Good Clinical Practice.	
APPLICANT (as specified in section C1):

Date:

Signature:

Full name in block letters:

Annex 9
 to the Provisions
 on the Procedure of clinical trials of medicinal products
LIST 
of documents for substantial amendments to a clinical trials programme (protocol)

Form

1.	Description of a substantial amendment to a clinical trial programme (protocol) with indication of the previous and the new revision in tabular format.
2.	Clinical trial documents attached to the clinical trial programme (protocol) with account of the amendment made (the previous and the new revision).
3.	Justification of the substantial amendment with attachment of the justification documents (materials) (such as summary of the data obtained, updated benefit-risk ratio assessment, potential consequences for the trial subjects already enrolled in the clinical trial, potential consequences for the trial results assessment, documents related to the change of information submitted by the trial subjects, procedure of informed consent provision).
4.	Agreement of a healthcare institution to conduct a clinical trial with account of the substantial amendment made (if necessary).

Annex 10
 to the Provisions
 on the Procedure of clinical trials of medicinal products

Form

INFORMATION FOR NON-SUBSTANTIAL CLINICAL TRIAL PROTOCOL AMENDMENT

Date of receipt:	Registration number assigned by Centre for Examinations and Tests in Health Service Republican Unitary Enterprise:	

A.	CLINICAL TRIAL IDENTIFICATION
(if changes apply to several clinical trials, please, fill out as many copies of this form, as the number of clinical trials)

Full name of a clinical trial:	
Code number of a clinical trial programme (protocol) assigned by an applicant, revision and date:	
	
EudraCT number (if available):	
	
B.	APPLICANT’S CONTACT INFORMATION
B.1.	Applicant	
Organisation:	
Surname, first name, patronymic (if any) (hereinafter, full name) of a contact person:	
Location address:	
Telephone:	
Fax:	
Email:	

B.2.	Applicant’s official representative (if not the applicant itself)	
Organisation:	
Full name of a contact person:	
Location address:	
Telephone:	
Fax:	
Email:	
C.	IDENTIFICATION OF THE APPLICANT
(check the relevant boxes)
C.1.		
Applicant		
Applicant’s official representative		
Individual or organisation authorised to submit documents and information		
In this case, specify:		
-	Organisation name:		
-	Full name of a contact person:		
-	Location address:		
-	Telephone:		
-	Fax:		
-	Email:		

D.	BRIEF DESCRIPTION OF A NON-SUBSTANTIAL AMENDMENT:

G.	LIST OF DOCUMENTS ATTACHED,
Documents shall be presented related to this notification and (or) reference provided for the prior submitted documents. Provide reference to all pagination changes and both the old and the new versions of texts.
Check the relevant boxes:
	Cover letter	
	Brief description of the essence of the non-substantial amendment	
	List of documents amended (identification, revision, date)	
	Numbers of pages with the prior and the new text (if applicable)	
	Additional information	
	New file version in Word format and a copy of original information form with the changed data marked (if applicable)	
APPLICANT’S SIGNATURE
I, the undersigned, hereby confirm (confirm on behalf of the applicant) that (delete as appropriate):
-	the information provided is true;
-	a clinical trial will be conducted in accordance with the clinical trial programme (protocol), legislative requirements and the Rules of Good Clinical Practice.	
APPLICANT (as specified in section C.1):

Date:

Signature:

Full name in block letters:

APPROVED
Resolution No. 94
 of the Ministry of Health of the Republic of Belarus dated 06.11.2020

PROVISIONS 
on Independent Ethics Committee

1.	An independent ethics committee (hereinafter, the Committee) shall be established as an expert committee at the state-run healthcare institutions (hereinafter, healthcare institutions).
2.	Terms and their respective definitions are used in this Provisions as established in Law No. 2435-ХП of the Republic of Belarus On Healthcare dated June 18, 1993, the Law of the Republic of Belarus On Circulation of Medicinal Products, Rules of Good Clinical Practice of the Eurasian Economic Union approved by Resolution No. 79 of the Board of the Eurasian Economic Commission dated November 3, 2016 (hereinafter, the Rules of Good Clinical Practice).
3.	The Committee in its work shall be guided by ethical principles established by the Declaration of Helsinki adopted by the 18th Assembly of the World Medical Association (Finland, 1964), requirements of the Rules of the Good Clinical Practice, this Provisions and other legal acts.
4.	The main tasks of the Committee shall be:
to ensure respect of the rights, provision of safety and protection of health of the trial subjects (hereinafter, the subjects);
to approve clinical trials of medicinal products (unless specified otherwise, hereinafter, the clinical trials) and clinical trial programmes (protocols (unless specified otherwise, hereinafter, the protocol);
to approve substantial protocol amendments;
to assess compliance of the investigators’ qualification with the requirements of the Rules of Good Clinical Practice;
to assess the presence of the setting required for the clinical trials.
5.	In line with its tasks the Committee shall conduct expert examination of:
a protocol (substantial protocol amendments);
a written informed consent form for the subjects and subsequent revisions in case of changes;
the information intended for attraction of subjects for participation in a clinical trial (such as advertising announcements, leaflets, etc.);
the written materials explaining aspects of a clinical trial to be provided for the subjects for them to make a decision on joining the clinical trial;
the investigator’s brochure;
the information (scientific publications) related to the subjects’ safety with administration of the investigational medicinal product or medical device or biomedical cell product;
the information about payments and compensations to subjects (if such are stipulated by the protocol);
the investigator’s CV and (or) other documents confirming his/her qualification;
other documents as the Committee may require for fulfilling its task.
The Committee shall perform expert examination of the documents, materials and information related to a clinical trial (hereinafter, the Expert Evaluation) within 15 calendar days.
6.	The composition of the Committee shall be approved by the head of the healthcare institution serving as a base for a clinical trial. The composition of the Committee shall include not less than 5 persons including the chairman. At the same time, at least one of the members of the Committee shall not specialize in the field of the clinical trials and (or) scientific research and at least one shall not be the employee of that healthcare institution. Legal advisers and other specialists not healthcare workers shall be included in the composition of the Committee in order to evaluate the ethics aspects of a clinical trial to ensure rights, safety and protection of health of the subjects.
7.	Work of the Commission shall be led by the chairman and in his/her absence, by a deputy chairman.
The chairman, deputy chairman and secretary shall be elected from among the members of the Committee for a 5-year term.
8.	Chairman of the Committee shall:
organise the work of the Committee, as well as approve the agenda of the Committee’s meeting, establish the date, time and place for the meeting;
appoint tasks to the members of the Committee within the scope of its activities, supervise their fulfilment;
immediately take action to prevent conflict of interest or settle it after receipt of the information about the conflict of interest or the possibility of such due to performance of duties of a Committee member;
in necessary, invite persons with special knowledge and corresponding qualification required for the adoption of a decision related to a clinical trial (hereinafter, the Independent Experts) without the voting right provided confidentiality.
9.	Members of the Committee shall:
perform functions vested in the Committee and be present at its meetings in person;
maintain confidentiality of the information received during the Committee’s work;
timely notify the Chairman of the Committee about the conflict of interest or the possibility of such due to the performance of duties of a member of the Committee.
10.	Secretary of the Committee shall:
prepare materials for the Committee meetings; form a draft agenda for the Committee meeting; ensures the possibility for the members of the Committee to familiarize with the documents and materials submitted for review, prior to the meeting;
maintain the Committee’s documentation;
notify the members of the Committee and the Independent Experts about the date, time and place of the Committee’s meeting and its agenda;
ensure familiarisation of the members of the Committee with the minutes of the Committee meetings;
keep and format minutes of the Committee meetings, submit them for signing to the Chairman of the Committee;
keep record and store minutes of the Committee meetings and materials attached.
11.	The Committee’s works shall be organised in the form of meetings. Meeting of the Committee shall be held as required, but not less than once a year during the clinical trial.
The meeting shall be legally qualified, if at least two thirds of the members are present.
Should the required number of members of the Committee be absent for the adoption oh decision, the Chairman of the Committee shall establish a new date of the meeting.
12.	The Committee shall adopt one of the decisions as follows:
on approval of a clinical trial and its protocol; on denial of approval of a clinical trial and its protocol;
on approval of a substantial amendment to the protocol; on denial of substantial amendment to the protocol;
on other issues related to the clinical trial within the scope of the Committee’s competency.
13.	Decision of the Committee shall be adopted in each item of the agenda by simple majority of votes through open voting and recorded in the minutes.
14.	The minutes of the Committee meeting shall be approved by the members of the meeting and signed by the Chairman and the secretary of the Committee.
The minutes of the Committee meeting shall include: the date and place of the Committee meeting; information about the members of the Committee present at the meeting; information about the participants of the Committee meeting not being its members (with indication of the surname, name patronymic (if any), place of work and position of an officer);
agenda of the Committee meeting containing the issues for consideration and materials;
individual opinions of the members of the Committee on the issues in question;
voting results and decisions adopted by the Committee; information about the materials attached to the minutes of the Committee meeting. 
15.	The minutes of the Committee meeting shall be drawn up within five days from the date of the meeting, signed by the Chairman and the secretary of the Committee.
16.	When adopting decisions of the Committee specified in paragraphs two and three of clause 12 hereof, the secretary of the Committee shall draft a conclusive statement of the Ethics Committee of a healthcare institution on approval (denial of approval) of a clinical trial including the conclusion on approval (denial of approval) of a clinical trial programme (protocol). The said conclusive statement shall be drawn up in any format in three counterparts, signed by the Chairman of the Committee and sent in paper or electronic form to the applicant of a clinical trial, to the Ministry of Health and to the head of the healthcare institution within three days of the date of signing of the minutes of the Committee meeting. 
17.	The Committee shall keep the documents and materials related to its activities within at least three years upon completion of a clinical trial and shall present them at the request of an authorised bodies, sponsor of a clinical trial.