Volodymyr Ignatov, executive director of AIPM Ukraine , noted several critical points in the context of the new requirements of the License Terms, which come into force on March 1, 2016.

First, a requirement is established for the licensee (importer) to conclude a tripartite agreement with the manufacturer or supplier of this medicinal product and the owner of the registration certificate for the specified medicinal product.

Secondly, new requirements have been established for the implementation by importers of quality control of medicinal products and the release of batches of the drug upon import, some of which are duplicated by the current Resolution of the Cabinet of Ministers of Ukraine No. 902 of 09/14/2005 “On Approval of the Procedure for State Quality Control of Medicinal Products Imported into Ukraine “. Thus, to ensure the quality of medicinal products, the importer must implement and operate a pharmaceutical quality system that includes good manufacturing practices, good distribution practices, good storage practices, and quality risk management. The pharmaceutical quality system must be defined and documented. The licensee will need to approve a document containing a description of the pharmaceutical quality system, including the responsibilities of management personnel.

Third, the importer must keep control and/or archival samples of each batch of finished products.

Ignatov V.A. reminded that back in 2013, when market operators raised the issue of introducing total quality control of medicinal products, no mechanisms were found to implement the relevant requirements of the Licensing Terms.

In order to prevent a situation that may arise from March 1 of this year, the active and constructive work of representatives of distributors and foreign companies is carried out together with the State Service of Ukraine for Medicinal Products (hereinafter – the State Service of Medicines of Ukraine), which, pursuant to the Law of Ukraine “On Licensing of Types of Economic activity” together with the business community developed a draft resolution of the CMU “On approval of the Licensing conditions for conducting business activities in the production, wholesale, retail trade and import of medicinal products (except for active pharmaceutical ingredients)”. The result of the business dialogue with the regulator should be the optimization and liberalization of certain requirements for importers of medicines, in particular regarding laboratory control of imported medicines, as well as the postponement of the entry into force of the relevant requirements for importers to March 1, 2018.

Volodymyr Ignatov noted that making changes to the current Licensing conditions for the import of medicinal products does not make sense, since the time frames for development and their approval are identical to the adoption of a government resolution.

According to the material “APTEKA Weekly”