ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of July 5, 2011 No. 387

About introduction of amendments to the Order MZ of 30.10.2002 No. 391

According to the Law of Ukraine "About medicines", Regulations on the Ministry of Health of Ukraine, No. approved by the Presidential decree of Ukraine of 13.04.2011 467, resolutions of the Cabinet of Ministers of Ukraine of 28.10.2004 No. 1419 "Some measures for quality assurance of medicines "taking into account requirements of directives 2001/83/EC, 2003/94/EC of the European Parliament and EU Council, to recommendations to the international system of cooperation of pharmaceutical inspections (PIC/S) (the document RI 002) and the World Health Organization (WHO TRS No. 863, of 1996, to TRS No. 908, of 2003), I order:

1. Bring in the Procedure for carrying out certification of the production of medicines approved by the order of the Ministry of health protection of Ukraine of 30.10.2002 No. 391, registered in the Ministry of Justice of Ukraine 22.11.2002 for change No. 908/7196,, having been reworded as follows it which is applied.

2. Stetsiva V. V. in accordance with the established procedure to provide to the director of the department of regulatory policy in the field of drug circulation and products in health care system of the Ministry of Health of Ukraine provision of this order on state registration in the Ministry of Justice of Ukraine and the publication in mass media.

3. I reserve control of execution of this order.

4. This order becomes effective from the date of its official publication.

Approved by the Order of the Ministry of Health of Ukraine of October 30, 2002, No. 391

(in edition of the Order of the Ministry of health protection of Ukraine of July 5, 2011 No. 387)

Procedure for carrying out certification of production of medicines

I. General provisions

1.1. This Procedure No. 1419 "Some measures for quality assurance of medicines "taking into account requirements of directives 2001/83/EC, 2003/94/EC of the European Parliament and Council of the European Union (further - the EU), recommendations of the international system of cooperation of pharmaceutical inspections is developed according to the Law of Ukraine "About medicines", Regulations on the Ministry of Health of Ukraine, No. approved by the Presidential decree of Ukraine of 13.04.2011 467, resolutions of the Cabinet of Ministers of Ukraine of 28.10.2004 (PIC / S) (the document RI 002) and the World Health Organization (WHO TRS No. 863, 1996, TRS No. 908, 2003).

1.2. Certification of production of medicines on compliance to requirements of proper production practice (daleesertifikation) is entered for the purpose of increase and quality assurance of medicines, non-admission to the address in Ukraine of low-quality medicines, creation of conditions for export of domestic medicines by confirmation of conformity of production of the medicines to the requirements of proper production practice (GMP) existing in Ukraine harmonized with requirements of GMP of the EU.

1.3. Certification is performed on voluntary basis.

1.4. Certification is carried out by Public service of Ukraine on medicines (further - Derzhliksluzhba of Ukraine) for residents and nonresidents.

1.5. According to this Procedure certification of production of medicines on the production sites specified in the statement for issue of the certificate of conformity to requirements of proper production practice (in the statement on issue of the conclusion about confirmation of conformity to requirements of proper production practice) according to appendix 1 to this Procedure is carried out (further - the Statement). For carrying out certification of production, performing release of finished pharmaceutical products from the i№bulk form, production of all products in the form of "i№bulk" which is used in the course of release of these medicines shall have the certificates or the conclusions issued according to this Procedure.

1.6. According to this Poryadku Derzhliksluzhba of Ukraine issues the document confirming compliance of production of medicines to the requirements of GMP existing in Ukraine: the certificate of conformity to requirements of proper production practice (further - the Certificate) or the conclusion on confirmation of conformity to requirements of proper production practice (further - the Conclusion).

II. Determination of terms

The terms applied in this Procedure have the following value:

the certified laboratory - laboratory on quality control and safety of medicines which underwent industry certification of Derzhliksluzhboyu of Ukraine according to Procedure for the carrying out industry certification of laboratories for quality control and safety of medicines approved by the order of the Ministry of Health of Ukraine of 14.01.2004 No. 10, registered in the Ministry of Justice of Ukraine 30.01.2004 for No. 130/8729;

production of medicines - the activities connected with serial release of medicines which include everything or at least one of stages of engineering procedure, including purchase of materials and products, packing, packagings and/or markings, storages, the corresponding control, issue of permission to release, and also wholesale trade (distribution) by self-produced products;

the conclusion on confirmation of conformity to requirements of proper production practice - the document issued to Derzhliksluzhboyu of Ukraine, certifying that by results of the carried-out expertize the official document about compliance of production of medicines to requirements of GMP issued by authorized regulatory body of the member country of PIC/S is considered confirming compliance of production of medicines to the requirements of GMP existing in Ukraine;

specialists - specialists of the companies, organizations, the organizations answering to the established criteria are involved (basic education, high professional level, work experience, no conflict of interest, maintaining confidentiality) and Derzhliksluzhboyu of Ukraine for conducting specialized examination, inspection (check), the laboratory analysis of quality of samples of medicines in certification process can be attracted;

the applicant - legal entity or physical person, the owner of the registration certificate (the trade license) and/or licenses for production of medicine which submitted the application for issue of the certificate or Conclusion;

sample (test) from series - the part from series which is selected thus and in such quantity that is representative for all series;

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