ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of November 8, 2013 No. 960

About approval of Changes in Licensed conditions of implementation of economic activity on import of medicines

According to part one of article 17 of the Law of Ukraine "About medicines", "About licensing of certain types of economic activity" I order to part two of article 9 of the Law of Ukraine:

1. Approve Changes in the Licensed conditions of implementation of economic activity on import of medicines approved by the order of the Ministry of Health of Ukraine of February 20, 2013 No. 143, registered in the Ministry of Justice of Ukraine on February 22, 2013 for No. 307/22839 (further - Licensed conditions) which are applied.

2. Repeal the order of the Ministry of Health of Ukraine of May 30, 2013 No. 453 "About approval of Changes in Licensed conditions of implementation of economic activity on import of medicines", registered in the Ministry of Justice of Ukraine on June 17, 2013 at No. 976/23508.

3. (L. Konoshevich) in accordance with the established procedure to provide to management of medicines and medical products submission of this order on state registration in the Ministry of Justice of Ukraine.

4. To impose control of execution of this order on the deputy minister - the chief of staff of G. Bogachyov.

5. This order becomes effective since December 1, 2013, except:

Items 3.4 and 3.9 of the Section III of Licensed conditions which become effective since December 1, 2014;

Item 2.12 of the Section II, subitem 3.6.12 of Item 3. 6, Items 3. 1, 3.7, 3.11 Section III of Licensed conditions which become effective since March 1, 2016.

Approved by the Order of the Ministry of Health of Ukraine of November 8, 2013 No. 960

Changes in the Licensed conditions of implementation of economic activity on import of medicines approved by the order of the Ministry of Health of Ukraine of February 20, 2013 No. 143, registered in the Ministry of Justice of Ukraine on February 22, 2013 for No. 307/22839

1. In the Section I:

1) in paragraph three of Item 1.2 of the word "and " about charity and charitable organizations " shall be replaced with words "," about charity and charitable organizations "and" about accomplishment of programs of Global fund for fight against AIDS, tuberculosis and malaria in Ukraine ".";

Item 1.6 to state 2) in the following edition:

"1.6. Documents, the stipulated in Article 10 Laws of Ukraine "About licensing of certain types of economic activity are enclosed to the application", namely:

the copy of the file of the importer approved as the subject of managing in the form given in appendix 10 to these Licensed conditions.

The statement for licensing and documents attached to it are accepted under the list of documents, enclosed to the application for licensing in the form given in appendix 2 to these Licensed conditions which copy is issued to the applicant with mark about date of documents acceptance by Gosleksluzhboy of Ukraine and the signature of the authorized officer.

All documents submitted by the applicant are created in separate case.";

Item 1.17 to state 3) in the following edition:

"1.17. For each place of implementation of economic activity of the isolated structural division which will perform economic activity based on the license received by the licensee Gosleksluzhba of Ukraine issues to the licensee the copy of the license certified by it which is registered in register of statements and the granted licenses for implementation of economic activity on import of medicines. The copy of the license certified by Gosleksluzhboy of Ukraine is the document confirming the right of the licensee to implementation of certain type of economic activity in the place of implementation of economic activity, specified in the copy of the license.

The copy of the license is issued according to the procedure, provided for licensing.".

2. In the Section II:

1) the second offer of Item 2.2 to add with words and figures ", except cases, the specified in paragraphs three and the fourth Item 1.2 of the Section I of these Licensed conditions";

2) to add the Section with new Items of the following content:

"2.8. Import of medicines is performed in the presence of the managing approved by subject which intends to perform economic activity on import of medicines or performs economic activity on import of medicines, the file of the importer with observance of requirements of the operating State Pharmacopoeia of Ukraine and/or the European pharmacopeia, and in the absence of requirements in these pharmacopeias - other leading pharmacopeias (The British pharmacopeia, pharmacopeia of the USA, pharmacopeia of Japan), other normative and technical documents and regulatory legal acts which establish requirements to medicine, its packagings, to conditions and storage durations and methods of quality control of medicine.

Import of medicines is performed with observance of requirements of the specified normative and technical documents, regulatory legal acts and requirements of proper production practice in the part concerning activities for import of the medicines established in the Section III of these Licensed conditions.

Production of the medicines imported on the territory of Ukraine shall meet the requirements of proper production practice of medicines. Confirmation of conformity of conditions of production of medicines to requirements of proper production practice is performed according to Procedure for carrying out confirmation of conformity of conditions of production of medicines to the requirements of proper production practice approved by the order of the Ministry of Health of Ukraine of December 27, 2012 No. 1130, registered in the Ministry of Justice of Ukraine on January 21, 2013 for No. 133/22665.

Action of this Item does not extend to active pharmaceutical ingredients.

2.9. The licensee shall keep documents, confirmatory: purchase, import to the territory of Ukraine, storage, transportation, wholesale trade (distribution), destruction or utilization of medicines.

2.10. The licensee shall notify Gosleksluzhbu of Ukraine on all changes of the data specified in the documents enclosed to the application for licensing. In case of such changes the licensee shall submit within ten working days to body of licensing (personally or the registered mail) the adequate notice in writing together with documents and/or their copies which confirm the specified changes, certified of the procedure established by the legislation.

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