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RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of September 14, 2005 No. 902

About approval of the Procedure of the state quality control of medicines which are imported into Ukraine

(as amended on 15-04-2022)

The Cabinet of Ministers of Ukraine decides:

1. Approve the Procedure of the state quality control of medicines which are imported into Ukraine it (is applied).

2. This resolution becomes effective since January 1, 2006.

Acting as Prime Minister of Ukraine

Yu.Ekhanurov

 

Approved by the Resolution of the Cabinet of Ministers of Ukraine of September 14, 2005, No. 902

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

1. This Procedure determines the mechanism of the state quality control of medicines which are imported into Ukraine which is performed for the purpose of non-admission of the address of the counterfeited, low-quality and unregistered medicines.

2. Action of this Procedure extends to all subjects of managing who import medicines into Ukraine.

Action of this Procedure does not extend to the relations in the field of the state quality control of medical immunobiological supplies which are used, made or offered to application in medical practice in Ukraine.

During the period of action of warlike situation and/or within six months from the date of the termination or cancellation of warlike situation action of this Procedure does not extend to the medicines which are subject to purchase by results of the procurement procedure which is carried out by the specialized organization which conducts procurement, in pursuance of the transaction on purchase between the Ministry of Health and the relevant specialized organization which conducts procurement, before the termination or cancellation of warlike situation and/or within six months from the date of the termination or cancellation of warlike situation.

During the period of action of warlike situation and/or within six months from the date of the termination or cancellation of warlike situation on the territory of Ukraine the medicines registered in Ukraine which are subject to purchase by results of the procurement procedure which is carried out by the specialized organization which conducts procurement, only in pursuance of the transaction on purchase between the Ministry of Health and the relevant specialized organization which conducts procurement, in the presence of the quality certificate of series of medicine which is issued by the producer, and also the registered medicines in foreign packaging made for needs of the markets of other countries which does not correspond to the approved registration materials on medicine, accompanied by the instruction approved in Ukraine for medical application and the guaranty letter of the producer/applicant in which it is specified can be imported that the imported medicine is identical registered in Ukraine.

3. On the territory of Ukraine the medicines registered in Ukraine in the presence of the quality certificate issued by their producer - the certificate of the analysis or the certificate of series (further - the quality certificate) which certifies compliance of medicines of the specification of quality of methods of quality control of medicines are imported.

The unregistered medicines can be imported into Ukraine in cases, the stipulated in Article 17 Laws of Ukraine "About medicines", according to the procedure, determined by the Ministry of Health.

3-1. During the period of action of warlike situation and/or within six months from the date of the termination or cancellation of warlike situation for the purpose of providing healthcare institutions with necessary medicines import to customs area of Ukraine for the purpose of the further address can be performed:

medicines which expiration date did not expire however do not conform to requirements to restriction of expiration date of medicines which are imported, determined by parts one and the fourth article 17 of the Law of Ukraine "About medicines", in case of provision of reasons for possibility of use of such medicines till the expiry date;

the registered medicines in foreign packaging made for needs of the markets of other countries which does not correspond to the approved registration materials on medicine, accompanied by the instruction approved in Ukraine for medical application and the guaranty letter of the producer/applicant in which it is specified that the imported medicine is identical registered in Ukraine;

the unregistered medicines, except those which are made by the companies of the state officially recognized as Ukraine the state aggressor accompanied by the quality certificate of the producer on each series of medicine, with its transfer in Ukrainian and transfer into instruction Ukrainian for medical application only for providing Armed Forces and healthcare institutions (except pharmaceutical institutions), without sales right.

Determine that for action of warlike situation:

the application for issue of the conclusion about quality of the imported medicine is submitted and the conclusion about quality of the imported medicine is issued in electronic form;

the conclusion about quality of the imported medicine, including the registered medicine in foreign packaging made for needs of the markets of other countries which does not correspond to the approved registration documents is issued without carrying out laboratory quality control, the bases for which are determined by this Procedure, to the separate solution of Gosleksluzhby, without obligatory availability of the document confirming compliance of conditions of production of medicines to requirements to production of medicines in Ukraine except active pharmaceutical ingredients (substances). In that case responsibility for control of quality of series of medicines is born by authorized persons of subjects of managing which according to the Licensed conditions of implementation of economic activity on production of medicines, wholesale and retail trade by medicines, import of medicines (except active pharmaceutical ingredients) approved by the resolution of the Cabinet of Ministers of Ukraine of November 30, 2016 No. 929 (The Official Bulletin of Ukraine, 2016, No. 99, stations 3217), bear responsibility for quality and safety of the medicines imported by them.

4. The state quality control is exercised by Gosleksluzhba and its territorial authorities (further - state control bodies).

For ensuring proper implementation of the state quality control of medicines the State Customs Service submits to Gosleksluzhbe information on the medicines imported on the territory of Ukraine.

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