RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of November 12, 2014 No. 601

About modification of the Procedure of the state quality control of the medicines imported into Ukraine

The Cabinet of Ministers of Ukraine decides:

Bring in the Procedure of the state quality control of the medicines imported into Ukraine, No. 902 approved by the resolution of the Cabinet of Ministers of Ukraine of September 14, 2005 (The Official Bulletin of Ukraine, 2005, No. 37, Art. 2297; 2010, No. 17 of Art. 787; 2012, No. 65, the Art. 2654), changes which are applied.

Approved by the Resolution of the Cabinet of Ministers of Ukraine of November 12, 2014 No. 601

Changes which are made to the Procedure of the state quality control of the medicines imported into Ukraine

1. In Item 6:

the paragraph one after the words "import active pharmaceutical ingredients (substances)" to add with the words "and products of "in bulk" for own production";

to add paragraph two after words of "ingredients (substances)" with words "and products of "in bulk".

2. Add Item 7 with the paragraph of the following content:

"In case of import of active pharmaceutical ingredients (substances) and products of "in bulk" for the purpose of realization in full to producer of medicines which uses them for own production and has own laboratory certified in the procedure established by the Ministry of Health works with such laboratories under the agreement, the load can be placed in specially allotted zone (room) in warehouse of the producer with possibility of sampling for their laboratory analysis the producer.".

3. The ninth Item 10 to state the paragraph in the following edition:

"Receipts of official information on quality of medicines from competent regulatory authorities of other states.".

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