Draft Resolution of the Cabinet of Ministers of Ukraine "On Amendments to the Procedure for State Quality Control of Medicinal Products Imported to Ukraine"

Quality requirements (TBT)

Medicinal products 

Link to ePing

11.120 - Pharmaceutics

At the beginning of the imposition of martial law, the Government of Ukraine has established that a conclusion about the quality of imported medicinal products, including registered medicinal products in foreign packaging manufactured for the needs of foreign markets, that do not comply with the approved registration documents, may be issued, inter alia, without the mandatory availability of a document confirming that the conditions of manufacture of medicinal products comply with the requirements for the manufacture of medicinal products in Ukraine, except for active pharmaceutical ingredients (substances).At the same time, the confirmation of compliance of the manufacturing conditions of medicinal products with the GMP requirements in force in Ukraine was introduced to prove that medicinal products are constantly manufactured and controlled in accordance with quality standards that are appropriate for their intended use.  According to Compilation of Community Procedures on Inspections and Exchange of Information (EC EMA/572454/2014)  only a GMP inspector can assess the compliance of production with GMP requirements.In order to provide Ukrainian consumers with quality and safe medicinal products, the draft Resolution of the Cabinet of Ministers of Ukraine cancels the possibility of issuing a conclusion about the quality of imported medicinal products without a document confirming that the conditions of production of medicinal products meet the requirements for the production of medicinal products in Ukraine, except for active pharmaceutical ingredients (substances).

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