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RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS

of April 17, 2015 No. 51

About approval of the Instruction about cases and procedure for inspection of pharmaceutical production of medicines regarding compliance to requirements of Proper pharmaceutical practice and to requirements of the State pharmacopeia of the Republic of Belarus

Based on part eight of article 10 of the Law of the Republic of Belarus of July 20, 2006 "About medicines", the paragraph of the seventh subitem 8.17 of Item 8, of 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:

1. Approve the enclosed Instruction about cases and procedure for inspection of pharmaceutical production of medicines regarding compliance to requirements of Proper pharmaceutical practice and to requirements of the State pharmacopeia of the Republic of Belarus.

2. This resolution becomes effective after its official publication.

First Deputy Minister

D.L.Pinevich

Approved by the Resolution of the Ministry of Health of the Republic of Belarus of April 17, 2015 No. 51

The instruction about cases and procedure for inspection of pharmaceutical production of medicines regarding compliance to requirements of Proper pharmaceutical practice and to requirements of the State pharmacopeia of the Republic of Belarus

1. This Instruction determines cases and procedure for inspection of pharmaceutical production of medicines regarding compliance to requirements of Proper pharmaceutical practice and to requirements of the State pharmacopeia of the Republic of Belarus (further - inspection).

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).

3. Inspection is performed in the following cases:

the medicine made in drugstore according to the recipe of the doctor, acknowledged test laboratory accredited in accreditation system of the Republic of Belarus for testing of medicines (further - test laboratory), low-quality can also pose itself hazard to life and health of the person;

the medicine made in drugstore according to requirements (requests) of the organizations of health care or medicine in the form of intra pharmaceutical procurement and packing either the waters purified or the water for injections made in drugstore which are medicines are acknowledged as test laboratory low-quality.

4. The decision on implementation of inspection is made by the Ministry of Health of the Republic of Belarus (further - the Ministry of Health) based on the test report of the medicine made in drugstore, which is drawn up by test laboratory in case of identification of the low-quality medicine made in drugstore.

5. Inspection is performed by the specialist or group of specialists of the system of the Ministry of Health (further - inspectors) headed by the leading inspector.

6. Inspectors when conducting inspection according to the purpose and the program of inspection:

perform survey of the rooms and the equipment relating to pharmaceutical production of medicine;

perform observation of activities of workers of drugstore on workplaces, and also study documentation and records connected with pharmaceutical production and quality control of medicine in drugstore;

conduct survey of workers of drugstore.

7. Upon completion of inspection the leading inspector acquaints the pharmacy manager with preliminary results of inspection and leads up information on the revealed discrepancies.

8. The report on results of inspection of pharmaceutical production of medicine (further - the inspection report) is constituted and signed by all inspectors in time, not exceeding 5 calendar days after conducting inspection, and shall contain:

short description of activities of drugstore for pharmaceutical production of medicines;

the list of the revealed discrepancies;

the established reasons of unsatisfactory production of medicine;

the offer on elimination of the revealed discrepancies and terms of their elimination.

The inspection report goes to the head of the legal entity or the individual entrepreneur in time, not exceeding 5 calendar days after its signing.

9. In the absence of the data testimonial of elimination of the revealed discrepancies and (or) about taken (planned to acceptance) the measures directed to elimination of discrepancies and also in case of their unauthenticity the Ministry of Health takes measures according to the legislation of the Republic of Belarus.

 

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