Ukraine: new licensing requirements for the production and distribution of medicines

On March 3, 2009 the State Committee of Ukraine on Policy and Entrepreneurship, and the State Inspection for Control over the Quality of Medicinal Products approved Joint Order No. 44/27 “On New Licensing Conditions for Conducting of Economic Activity of Production, Wholesale and Retail Sale of the Medicinal Products” (the “Order”).

The principal change introduced by the Order is a manufacturer’s obligation to comply with good manufacturing practice in the production of medicinal products. An exemption is given only for the production of traditional medicinal products.

Other changes introduced by the Order include that:

• a licensee is now obliged to appoint an authorised person responsible for the issue of permits to distribute medicinal products;
• a manufacturer is now obliged to approve internal technical and procedural regulations, or other similar documents, setting out requirements for the production of medicinal products, their packaging, storage conditions and shelf life, as well as methods of control for all of the above;
• a manufacturer is now provided with the possibility of producing medicinal products which are not registered in Ukraine;
• a manufacturer is now provided with the possibility of producing medicinal products based on a commercial contract with a third party;
• medicinal products may now only be sold through respective pharmaceutical institutions, i.e. warehouses, pharmacies, their branches and pharmacy units;
• a distributor is now obliged to keep a quality certificate (hard or electronic copy) for all medicinal products for up to three years from the date of their sale; and
• a wholesaler is now obliged to keep records evidencing transactions involving medicinal products (indicating the date, the type of medicinal products, their quantity and series of received and supplied medicinal products, licensing information about a purchaser/supplier) for three years from the conclusion of the transactions.

Other requirements established by the Order relate to the qualification of personnel employed with a manufacturer or pharmaceutical institutions, material and the technical base of a licensee etc.

Licences which were issued before the adoption of the Order remain in force for the period they were issued.

Law: Joint Order No. 44/27 of the State Committee of Ukraine on Policy and Entrepreneurship and the State Inspection for Control over the Quality of Medicinal Products On New Licensing Conditions for Conducting of Economic Activity of Production, Wholesale and Retail Sale of the Medicinal Products, dated 3 March 2009