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The State Service of Ukraine on Medicines and Drugs Control Responded to the Appeal Regarding Double Regulation at Medicines Import

07/ 05/ 2018
  The State Service of Ukraine on Medicines and Drugs Control expressed its position regarding additional obligations of control quality of drugs by importers in response to appeal by the Public Council State Service of Ukraine on Medicines and Drugs Control No. 2603/01 as of March 26th, 2018. Thus, in its response, the State Service reported that there is no double regulation, although there are both import licensing and state regulation of medicines quality. The subject of the regulation of the former is commercial activities related to import of medicines, and of the latter – quality of drugs. Mechanism for state quality control is described in the Procedure for State Control Over Medicines Imported to Ukraine approved by Resolution of the Cabinet of Ministers No. 902 as of September 14th, 2005 and in the Procedure for Control Over Conformity of Immunobiological Drugs Used in Medicine to the State and International Standards approved by Order of the Ministry of Health of Ukraine No. 698 as of October 1st, 2014. The specified control refers to visual control by medicines quality state inspectors of package samples of each series of medicines imported to Ukraine, and if there are grounds therefor – laboratory analysis of samples selected from such series of medicines. On March 1st, 2018 some provisions of the License Terms for Commercial Activities of Production, Wholesale and Retail Trade and Import of Medicines (Except for Active Pharmaceutical Ingredients) approved by Resolution of the Cabinet of Ministers of Ukraine No. 929 as of November 30th, 2016 (hereinafter – the License Terms) came into force. The provisions obliges importers to exercise entry control over quality of the imported product. Thus, in accordance with para 195 of the License Terms, at importing medicines (except for active pharmaceutical ingredients) a licensee must import medicines in such a way as to ensure their conformity to the intended use, requirements of a registration file and exclude the risk for patients related to insufficient safety, quality or effectiveness of the medicines. Obligations to ensure the conformity of medicines are imposed directly on the authorized person of the business entity, who in case of detection of violations should reject the medicines, clearly identify them and store them separately in zones with limited access until decisions about further actions in relation to them are made. The investigation of situations on detected inconsistencies is also carried out by the authorized person. The State Service notes that market participants had a 5-year transition period to adapt to new conditions. Therefore, it is irrelevant to refer to unpreparedness to apply the new import rules. Thus, the State Service supports the strengthening by the License Terms of responsibility for the quality of medicines for the licensees business entities which put their products into circulation in Ukraine. The Service also states that there are no competent authorized persons and advises to pay attention first to the proper professional training of such experts. Thus, UFIK State-Owned Enterprise governed by the State Service has already introduced training workshops to solve the problem. We will also note that in 2018 the moratorium on inspections by the State Service was cancelled. Accordingly, market entities engaged in import are in the group of risk and must ensure quality control at import in accordance with the new legislation. Contact the author: Natalia Spivak, associate at Legal Alliance Company, spivak@l-a.com.ua

The State Service of Ukraine on Medicines and Drugs Control expressed its position regarding additional obligations of control quality of drugs by importers in response to appeal by the Public Council State Service of Ukraine on Medicines and Drugs Control No. 2603/01 as of March 26th, 2018. Thus, in its response, the State Service reported that there is no double regulation, although there are both import licensing and state regulation of medicines quality. The subject of the regulation of the former is commercial activities related to import of medicines, and of the latter – quality of drugs.

Mechanism for state quality control is described in the Procedure for State Control Over Medicines Imported to Ukraine approved by Resolution of the Cabinet of Ministers No. 902 as of September 14th, 2005 and in the Procedure for Control Over Conformity of Immunobiological Drugs Used in Medicine to the State and International Standards approved by Order of the Ministry of Health of Ukraine No. 698 as of October 1st, 2014.

The specified control refers to visual control by medicines quality state inspectors of package samples of each series of medicines imported to Ukraine, and if there are grounds therefor – laboratory analysis of samples selected from such series of medicines.

On March 1st, 2018 some provisions of the License Terms for Commercial Activities of Production, Wholesale and Retail Trade and Import of Medicines (Except for Active Pharmaceutical Ingredients) approved by Resolution of the Cabinet of Ministers of Ukraine No. 929 as of November 30th, 2016 (hereinafter – the License Terms) came into force. The provisions obliges importers to exercise entry control over quality of the imported product.

Thus, in accordance with para 195 of the License Terms, at importing medicines (except for active pharmaceutical ingredients) a licensee must import medicines in such a way as to ensure their conformity to the intended use, requirements of a registration file and exclude the risk for patients related to insufficient safety, quality or effectiveness of the medicines.

Obligations to ensure the conformity of medicines are imposed directly on the authorized person of the business entity, who in case of detection of violations should reject the medicines, clearly identify them and store them separately in zones with limited access until decisions about further actions in relation to them are made. The investigation of situations on detected inconsistencies is also carried out by the authorized person.

The State Service notes that market participants had a 5-year transition period to adapt to new conditions. Therefore, it is irrelevant to refer to unpreparedness to apply the new import rules.

Thus, the State Service supports the strengthening by the License Terms of responsibility for the quality of medicines for the licensees business entities which put their products into circulation in Ukraine. The Service also states that there are no competent authorized persons and advises to pay attention first to the proper professional training of such experts. Thus, UFIK State-Owned Enterprise governed by the State Service has already introduced training workshops to solve the problem.

We will also note that in 2018 the moratorium on inspections by the State Service was cancelled. Accordingly, market entities engaged in import are in the group of risk and must ensure quality control at import in accordance with the new legislation.

Contact the author: Natalia Spivak, associate at Legal Alliance Companyspivak@l-a.com.ua

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