Document from CIS Legislation database © 2003-2022 SojuzPravoInform LLC

Registered by the

Ministry of Justice of Ukraine

December 28, 2012

No. 2218/22530

ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of December 7, 2012 No. 1008

About approval of the Procedure for certification of quality of medicines for international trade and confirmation for active pharmaceutical ingredients which are exported

(as amended of the Order of the Ministry of Health of Ukraine of 09.11.2016 No. 1195)

According to Articles 2, 11, 13, 14, 18 Laws of Ukraine "About medicines", Items 1 and 4 of the Regulations on Public service of Ukraine on medicines approved by the Presidential decree of Ukraine of April 08, 2011 No. 440, Item 1 of the resolution of the Cabinet of Ministers of Ukraine of October 28, 2004 No. 1419 "Some measures for quality assurance of medicines" taking into account requirements of Directives of the European Parliament and Council of the European Union (daleees) 2001/83/EU of November 06, 2001 "About the Code of the Commonwealth concerning the medicines intended for consumption by the person" (with changes), 2003/94/EU of October 08, 2003 "The principles and regulations of proper production practice concerning medicines for consumption by the person" and documents of the World Health Organization (WHO TRS No. 823, of 1992, 863, of 1996, TRS No. 908, of 2003) I ORDER to TRS No.:

1. Approve the Procedure for certification of quality of medicines for international trade and confirmation for active pharmaceutical ingredients which are exported which is applied.

3. To the head of department of medicines and medical products of the Ministry of Health of Ukraine Konoshevich L. V. in accordance with the established procedure to provide submission of this order on state registration in the Ministry of Justice of Ukraine and the publication in mass media.

4. To impose control over the implementation of this order on the deputy minister - the chief of staff of Bogachyov R. M.

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

Acting Minister

O. Tolstanov

Approved by the Order of the Ministry of Health of Ukraine of December 7, 2012, No. 1008

Procedure for certification of quality of medicines for international trade and confirmation for active pharmaceutical ingredients which are exported

I. General provisions

1.1. This Procedure No. 1419 "Some measures for quality assurance of medicines", taking into account requirements of Directives of the European Parliament and Council of the European Union 2001/83/EC of November 06, 2001 "About the Code of the Commonwealth concerning the medicines intended for consumption by the person" is developed according to Articles 2, of 11, of 13, of 14, 18 Laws of Ukraine "About medicines", Items 1, 4 Provisions on Public service of Ukraine on medicines, No. approved by the Presidential decree of Ukraine of April 08, 2011 440, Item 1 of the resolution of the Cabinet of Ministers of Ukraine of October 28, 2004 (with changes), 2003/94/EC of October 08, 2003 "The principles and regulations of proper production practice concerning medicines for consumption by the person" and documents of the World Health Organization (further WHO) (WHO TRS No. 823, 1992, TRS No. 863, 1996, TRS No. 908, 2003).

1.2. Certification of quality of medicines for international trade is performed for the purpose of creation of proper conditions for export of domestic medicines by confirmation of conformity of their quality and conditions of their production to acting in Ukraine and international requirements of proper production practice (further - GMP).

1.3. Confirmation for active pharmaceutical ingredients which are exported is performed for the purpose of creation of proper conditions for export of domestic active pharmaceutical ingredients to the European Union for the medicines intended for consumption by the person according to article 46b (Directive 2001/83/EC 2)(b) "About the Code of the Commonwealth concerning the medicines intended for consumption by the person" by confirmation of conformity of their quality and conditions of their production to the requirements of GMP existing in Ukraine which are equivalent to requirements of GMP of the European Union.

1.4. Certification of quality of medicines for international trade and confirmation for active pharmaceutical ingredients which are exported is performed by Gosleksluzhboy according to the written address of the applicant on a voluntary basis.

1.5. This Procedure extends to all subjects of managing irrespective of their patterns of ownership and subordination which have licenses for production of medicines in Ukraine, and also persons authorized by them in the procedure established by the legislation.

1.6. According to this Poryadku Gosleksluzhba issues such documents:

the certificate of medicine which form is given in appendix 1 to this Procedure;

the statement for the licensed status of medicinal means (means) (further the statement for the licensed status) which form is given in appendix 2 to this Procedure;

certificate of series of medicine;

confirmation for active pharmaceutical ingredients which are exported to the European Union (EU) for the medicines intended for consumption by the person according to article 46b (Directive 2001/83/EC 2)(b) "About the Code of the Commonwealth concerning the medicines intended for consumption by the person" (further - confirmation for active pharmaceutical ingredients which are exported) whose form is given in appendix 3 to this Procedure.

1.7. The certificate of series of medicine contains data on separate series of medicine.

The certificate of series of medicine can be issued by Gosleksluzhboy, for example, for vaccines, serums and other biological medicines. For this purpose Gosleksluzhba performs the laboratory analysis of their quality by the direction of the selected samples of medicines in authorized laboratory which underwent industry certification Gosleksluzhboy according to the Procedure for 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 January 14, 2004 No. 10, registered in the Ministry of Justice of Ukraine on January 30, 2004 for No. 130/8729. The certificate of series issued by Gosleksluzhboy is attached to each series of medicine.

1.8. In this Procedure terms are used in such value:

Warning!!!

This is not a full text of document! Document shown in Demo mode!

If you have active License, please Login, or get License for Full Access.

With Full access you can get: full text of document, original text of document in Russian, attachments (if exist) and see History and Statistics of your work.

Get License for Full Access Now

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info

Effectively work with search system

Database include more 50000 documents. You can find needed documents using search system. For effective work you can mix any on documents parameters: country, documents type, date range, teams or tags.
More about search system

Get help

If you cannot find the required document, or you do not know where to begin, go to Help section.

In this section, we’ve tried to describe in detail the features and capabilities of the system, as well as the most effective techniques for working with the database.

You also may open the section Frequently asked questions. This section provides answers to questions set by users.

Search engine created by SojuzPravoInform LLC. UI/UX design by Intelliants.