Letter No. 392 / 01-14 / 18 as of April 10th, 2018 addressed to business entities engaging in medicines production, wholesale and retail trade and use for medical aid in Kyiv region has been published on the website of the State Service of Ukraine on Medicines and Drugs Control. The letter explained the prohibition on circulation of medicines and measures to be taken by the business entities in case of such a prohibition.
Under para 2.1 of the Procedure for Prohibition Imposition (Temporary Prohibition) and Restoration of Medicines Circulation in Ukraine approved by Order of the Ministry of Health of Ukraine No. 809 as of November 22nd, 2011 (hereinafter – the Procedure), in case law-quality, fake or unregistered medicines have been detected in circulation, the State Service of Ukraine on Medicines and Drugs Control imposes a temporary prohibition on circulation of the medicine and submits an offer to the Ministry of Health to make a decision on termination of registration certificate for a relevant medicine.
As the State Service of Ukraine on Medicines and Drugs Control of Kyiv region points out, section IV of the Procedure lists measures to be taken by business entities that have a series of medicines prohibited for circulation, in particular:
1. In case the order of the State Service to impose a temporary prohibition on the circulation of a medicine series is received, business entities take measures within the time specified in this order to perform the requirements with respect to medicine circulation set by the order (clause 4.1.2 of the Procedure).
2. Business entities are obliged to place the medicines, the circulation of which is prohibited by the order establishing a temporary prohibition, in a specially designated zone (premises) in quarantine (para 4.1.3 of the Procedure).
3. In case of receiving an order imposing a prohibition on the circulation of a medicine, business entities must, within the time specified in this order, take measures to perform the requirements established by such an order (para 4.4 of the Procedure).
4. A business entity transmits to the territorial offices of the State Service of Ukraine on Medicines and Drugs Control a message on the measures taken to implement the order, together with copies of documents confirming the fact of destruction, disposal or return of the medicine to the supplier (producer) (para 4.5 of the Procedure).
In pharmacies and healthcare facilities responsibility for the effective management of medicines quality system at their wholesale and retail trade and control of medicines quality are vested in an authorized person. One of the responsibilities is an obligation to keep a record of decisions (orders) of the State Service on the quality of medicines in electronic and / or paper form and to take the measures specified in these decisions.
Contact the author: Natalia Spivak, associate at Legal Alliance Company, spivak@l-a.com.ua
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