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RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS

of May 7, 2009 No. 50

About some questions of carrying out clinical testing of medicines

(as amended on 06-06-2012)

Based on parts one and the second article 40 of the Law of the Republic of Belarus of June 18, 1993 "About health care" in edition of the Law of the Republic of Belarus of June 20, 2008, "About medicines" in edition of the Law of the Republic of Belarus of August 5, 2008 the Ministry of Health of the Republic of Belarus DECIDES: parts three of article 15 of the Law of the Republic of Belarus of July 20, 2006

1. Approve enclosed:

1.1. technical code of common practice "Proper clinical practice" *;

1.2. The list of the documents submitted for purpose of clinical testing of medicines, and requirements to these documents.

______________________________

* It is not brought.

2. This resolution becomes effective since August 1, 2009.

Minister

V.I.Zharko

 

Approved by the Resolution of the Ministry of Health of the Republic of Belarus of May 7, 2009, No. 50

The list of the documents submitted for purpose of clinical testing of medicines, and requirements to these documents

1. For medicines of foreign production:

statement;

the draft of the program (protocol) of clinical testing of medicine with all available amendments to it (in case of their availability) on paper and electronic carriers;

the draft of the brochure of the researcher or the document replacing it on paper and electronic carriers;

the expert evaluation of documents on clinical testing executed by the independent expert, the specialist in profile of the studied pathology or scope of medicine (in the presence);

data on producer of medicine;

legalized or with putting down of apostille the copy of the document, about registration of medicine in the country in which it is made (in the presence);

legalized or with putting down of apostille the copy of the license for production or legalized or with putting down of apostille the document certifying production of medicine in the conditions of the Proper production practice;

the draft of the regulating documentation on quality control on acting and excipients as a part of medicine, and also on ready medicine;

the document confirming powers of the contractual and research organization (person) if the organization and carrying out clinical testing of medicines in the territory of the Republic of Belarus are performed by the contractual and research organization (person);

description of methods of receipt of medicine (short scheme of production);

high-quality and quantitative composition of medicine with indication of all entering ingredients, including excipients;

results of validation of techniques of quality control of medicine (detailed description of procedures and results);

the copy of quality certificates of ready medicine (the series provided for carrying out clinical testing) and all components entering it;

documentation on material of primary package of medicine;

the copy of the quality certificate on placebo and (or) the copy of the quality certificate of medicines of comparison in case of their use in clinical testing, according to the program (protocol) of clinical testing;

samples of the researched medicine (the series provided for carrying out clinical testing) in the quantity necessary for carrying out quality check in the territory of the Republic of Belarus and standard samples of medicine with appendix of the quality certificate (in case of its availability);

results of testing of stability of the researched medicine (at least two series, including series which is provided for carrying out clinical testing);

the reference of the producer of medicine containing data on risk assessment for the environment concerning medicines which contain genetically changed organisms;

model of marking of the researched medicine on Belarusian or Russian (in addition for medicines of foreign production information can be provided in original language);

reports on preclinical trials in the amount provided by the technical code "Proper laboratory practice" (if necessary);

data on prior clinical testing or clinical use of the researched medicine, including the data (information) on safety of medicine (in the presence);

sample of the individual registration card of the examinee;

form of the informed written consent;

written information which is planned to be represented to examinees;

information on insurance, payments and compensations by the examinee and doctors-researchers (if those are provided);

data on education, advanced training, academic degrees and ranks, practical work of doctors – researchers on date of clinical testing;

copies of documents on all doctors-researchers confirming passing of training by them to rules of carrying out clinical testing within the last five years for date of filing of application on carrying out clinical testing;

the list of authorized bodies of the countries to which requests concerning this clinical testing, and copies of the decisions made by them were also submitted (in the presence);

short data on all current testing which are carried out using this researched medicine (in the presence);

other documents on clinical testing (research of virus safety; researches of safety of medicines with special characteristics (the medicines received from genetically modified microorganisms, radio pharmaceutical drugs and others);

the copy of the veterinary certificate or the declaration of the producer on non-use in production of medicine of initial components of animal origin which can be potentially infected with causative agents of spongy encephalopathy of cattle.

2. For medicines of national production:

statement;

the draft of the program (protocol) of clinical testing with all available amendments to it (in case of their availability) on paper and electronic carriers;

the draft of the brochure of the researcher or the document replacing it on paper and electronic carriers;

the expert evaluation of documents on clinical testing executed by the independent expert, the specialist in profile of the studied pathology or scope of medicine (in the presence);

data on producer of the medicine provided for carrying out clinical testing;

the document confirming powers of the contractual and research organization (person) if the organization and carrying out clinical testing for the territories of the Republic of Belarus are performed by the contractual and research organization (person);

description of methods of receipt of medicine (short scheme of production);

high-quality and quantitative composition of medicine with indication of all entering ingredients, including excipients;

draft of pharmacopoeian Article;

results of validation of techniques of quality control of medicine (detailed description of procedures and results);

documentation on material of primary package of medicine;

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