The New Draft of the Procedure for State Control Over Quality of Medicinal Products Imported to Ukraine Proposed

On March 30^th, 2017 the State Administration on Medicines and Drugs Control of Ukraine on its official website posted the Draft Resolution of the Cabinet of Ministers of Ukraine “On Amendments to the Procedure for State Control over Quality of Medicinal Products Imported to Ukraine” (hereinafter - the “Draft”). The Draft proposed a new wording of the Procedure for State Control over Quality of Medicinal Products Imported to Ukraine approved by Resolution of the Cabinet of Ministers of Ukraine No. 902 as of March 14^th, 2005 (hereafter – the “Procedure”).

The following are significant differences between the Draft and still effective Procedure:

1. The Procedure will govern relations in the area of state quality control of medical immunobiological drugs used, produced or offered for use in medical practice in Ukraine.

2. The Ministry of Health of Ukraine was proposed to decide on forms of application for granting conclusions on the quality of a medicinal product imported to Ukraine, as well as the list of the imported medicinal products.

3. The application for granting a conclusion on the quality of a medicinal product imported to Ukraine should be accompanied by copies of the documents, certified by the applicant, confirming compliance with the conditions of storage at all stages of distribution from a producer to an importer (device print outs).

4. In addition to informing the State Administration on Medicines and Drugs Control of Ukraine on conducted laboratory tests (including the date of importation of medicinal products, their name, batch number, quantity, manufacturer, registration availability and results of laboratory analysis) and measures taken in connection with the discovery of substandard APIs (substances) and in bulk products, it is proposed to require commercial entities to provide it with documentary evidence of such actions.

5. It provides for expansion of the list of medicinal products that should undergo laboratory analysis. In particular, in addition to a series of medicinal products imported into Ukraine for the first time, vaccines, toxoids, tuberculosis allergen, tetanus toxoid and rabies immunoglobulin will be subjected to laboratory analysis (in terms of quality to ensure efficiency and safety).

6. It is proposed to allow carrying out the laboratory analysis by the examination of quality control of medicinal products series (QC protocols series and analytical reports) provided by the manufacturer for:

• medicinal products control of which may be limited by the lack of available reference materials, standards, panels and in the absence of technical equipment to ensure conduct of laboratory analysis;
• medicinal products of limited use (orphan-drug, that is medicinal product intended for the diagnosis, prevention or treatment of rare disease).

7. In case the Draft is adopted, the laboratory analysis will also be conducted if for the last 2 years circulation of other series of medicinal products was banned, regardless of whether they were removed from circulation or not. Let us remind you that under the current Procedure the reason enough for laboratory analysis is a ban on circulation of medicinal products of other series (regardless of the period or the date of its introduction), which were withdrawn from circulation in due course.

8. It prescribed to cancel the requirement to obtain a conclusion on the same series of medicinal products on the following conditions: if series of medicinal product were imported as one batch for various commercial entities, are stored in one customs warehouse, (if necessary) with a positive laboratory test results of quality of samples taken from one of them. In this case it is proposed to control such series of medicinal product only visually.