Alexander Yanev, Associate with Legal Alliance Company
The issue of imposition of a ban (temporary ban) on medicine circulation is regulated, in particular, by the Procedure for imposing a ban (temporary ban) on and restoring circulation of medicines in Ukraine (hereinafter referred to as “the Procedure”) approved by the order of the Ministry of Health of Ukraine dated 22/11/2011 No. 809.
In accordance with para 1.3 of the Procedure, temporary ban on medicine circulation is suspension of the production, importation into the customs territory of Ukraine, storage, transportation, sale and use of some or all of medicine batches for a period not exceeding 90 days.
In accordance with para 4.3 of the Procedure, in the event that the temporary ban (90 days) expires and it is impossible to control the quality of the medicine to the extent stated by the State Administration of Ukraine on Medicinal Products, or in the absence of the required number of samples of a given medicine, the order for ban on circulation thereof shall be adopted.
It should be reminded that in the event that a temporary ban on medicine circulation is imposed, a business entity shall place medicines whose circulation is banned pursuant to the order for a temporary ban, in the designated area (indoors) separately from other products, place “Quarantine” warning sign, create the proper conditions for their storage and take other actions specified in said order.
Despite this, the question arises: if, within 90 days, the State Administration of Ukraine on Medicinal Products fails to issue the order for circulation ban and fails to revoke the order for a temporary ban on medicine circulation, what further actions should the retailer take in relation to the batch (batches) of medicines whose circulation was temporarily banned?
In accordance with para 5.1 of the Procedure, circulation of the medicine shall be restored, where there are grounds for this, following adoption by the State Administration of Ukraine on Medicinal Products of the respective decision.
Thus, if the State Administration of Ukraine on Medicinal Products fails to issue the order for a ban on medicine circulation upon the expiry of 90-day period of the temporary ban, in our opinion, interested retailers should apply to the State Administration of Ukraine on Medicinal Products with an inquiry about the possibility of restoration of circulation thereof. We consider that unless the State Administration of Ukraine on Medicinal Products adopts the respective decision on restoration of circulation of the medicine, no activities associated with the production, importation into the customs territory of Ukraine, storage, transportation, sale and use of such medicines may be carried out.
We would also like to note that according to para 3.5.7 of the Licensing Conditions of the business of production of medicines, wholesale and retail trade in medicines (hereinafter referred to as “the Licensing Conditions”) approved by the order of the Ministry of Health dated 31/10/2011 No. 723, retailers must comply with law requirements on provision of medicine quality control and have a plan for immediate action to remove products from the market.
If it is revealed that the medicines whose circulation is banned (temporarily banned) are being sold, the respective certificate may be drawn up, and if the licensee repeatedly violated the Licensing Conditions during the term of the license, the respective license may be canceled.
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