of April 17, 2015 No. 46
About approval of the Instruction about procedure and conditions of inspection of clinical testing of medicines regarding compliance to requirements of Proper clinical practice
Based on part two of article 15 of the Law of the Republic of Belarus of July 20, 2006 "About medicines", the paragraph of the sixth subitem 8.17 of Item 8 and subitem 9.1 of Item 9 of the Regulations on the Ministry of Health of the Republic of Belarus approved by the resolution of Council of Ministers of the Republic of Belarus of October 28, 2011 No. 1446 "About some questions of the Ministry of Health and measures for implementation of the Presidential decree of the Republic of Belarus of August 11, 2011 No. 360" the Ministry of Health of the Republic of Belarus DECIDES:
First Deputy Minister
Approved by the Resolution of the Ministry of Health of the Republic of Belarus of April 17, 2015 No. 46
1. This Instruction establishes procedure and conditions of inspection of clinical testing of medicines regarding compliance to requirements of Proper clinical practice.
2. For the purposes of this Instruction terms and their determinations in the values established by the Law of the Republic of Belarus of July 20, 2006 "About medicines" are used (The national register of legal acts of the Republic of Belarus, 2006, No. 122, 2/1258), the technical code of common practice "Proper clinical practice" approved by the 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" and also the following terms and their determinations:
inspection - actions (studying and assessment of documents, survey of the rooms relating to clinical testing of medicine and other) performed for the purpose of establishment of compliance of clinical testing of medicine to requirements of Proper clinical practice;
the inspected organization - the research center, the research organization, kliniko-diagnostic laboratory, analytical laboratory or other structural division of the organization in which clinical testing of medicine was carried out and can be carried out inspection;
variation - the criterion used for assessment of conformity of clinical testing of medicine to requirements of Proper clinical practice;
ratio advantage risk - assessment of positive therapeutic effects of medicine in relation to the risks connected with its medical application including any risk connected with quality, safety or efficiency of medicine in relation to health of the patient.
3. Inspection is performed under following conditions:
3.1. when carrying out by the republican unitary enterprise "The Center of Examinations and Testing in Health Care" complex of the preliminary technical works connected with conducting examinations, the inspections of industrial production of medicines and pharmaceutical substances, testing and other researches, preceding state registration (confirmation of state registration) of medicines and pharmaceutical substances, modification of the registration file on medicine, pharmaceutical substance which are earlier registered in the Republic of Belarus if:
medicine is not registered in other countries, including according to the new indication to medical application and (or) new method of application (introduction);
when conducting specialized examination of documents on medicine the facts testimonial of possible violation of requirements of Proper clinical practice in case of carrying out clinical testing are elicited;
when conducting specialized examination of documents on medicine discrepancies between the report and the program (protocol) of clinical testing are revealed;
3.2. when carrying out clinical testing of the original medicine in the territory of the Republic of Belarus which is not entering clinical protocols with high risk of damnification of life and to health of the patients participating in this clinical testing;
3.3. in the presence of information on deterioration during clinical testing of medicine in the territory of the Republic of Belarus and (or) in the territory of other member countries of ratio advantage risk;
3.4. in the presence of information on violations of requirements of Proper clinical practice during clinical testing of medicines in the territory of the Republic of Belarus.
4. The decision on conducting inspection is made by the Ministry of Health of the Republic of Belarus (further - the Ministry of Health) in case of approach of the conditions specified in Item 3 of this Instruction.
5. The Ministry of Health creates the inspection team consisting of specialists of system of the Ministry of Health and in need of other specialists having special knowledge in the field of carrying out clinical testing (further - inspectors).
The list of inspectors and the program of inspection affirm the order of the Ministry of Health. The program of inspection goes to the applicant and (or) to the inspected organization.
6. Inspection includes:
studying of the program (protocol) of clinical testing, the report of clinical testing of medicine, the interim statement on safety of medicine, documents on medicine and other documents depending on inspection conditions;
informing the applicant and (or) the inspected organization on the beginning of inspection, on its purposes, the notification under list of the authorized representative of the applicant and (or) the inspected organization on application when conducting inspection of technical means (including the equipment performing zvuko-and video film and photographing), and also in case of need photocopying and scannings of documents;
survey of the inspected organization, the laboratory and analytical equipment, poll of responsible persons, studying of documentation and records according to the program of inspection;
acquaintance of the applicant and (or) the inspected organization with preliminary results of inspection.
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