Medicines

Draft Resolution of the Cabinet of Ministers of Ukraine "Certain Issues of State Supervision (Control) in the Field of Medicinal Products"; (119 page(s), in Ukrainian)

The draft Resolution has been developed to establish a unified mechanism for state supervision (control) in the field of medicinal products, aligned with the legislation of the European Union.

The draft Resolution proposes to approve:

• the Procedure for Conducting Pre-Licensing Inspections, which establishes the procedure for verifying the material and technical facilities, personnel qualifications and quality assurance arrangements prior to granting licences for the manufacture, wholesale and retail distribution, and import of medicinal products (excluding active pharmaceutical ingredients);

• the Procedure for Conducting Scheduled and Unscheduled Inspections of Compliance by Licensees with Licensing Conditions and Good Practices, as well as Inspections for Verifying Compliance with Good Practice Requirements and Inspections of Foreign Manufacturers of Medicinal Products, which establishes procedures for inspections of licensees, other relevant economic operators (including brokers) and foreign manufacturers;

• the Procedure for Sampling Medicinal Products for Laboratory Quality Control, which establishes procedures for sampling medicinal products, including investigational medicinal products and active pharmaceutical ingredients, for laboratory quality control at relevant stages of the supply chain.

• the Procedure for Conducting Test Purchases of Medicinal Products during Their Sale (Dispensing) to the Public. The draft Resolution also provides transitional provisions allowing certain manufacturers, importers and wholesale distributors to continue operating without GMP and/or GDP certificates during martial law and for six months after its termination or cancellation, and provides that inspections of importers of investigational medicinal products and manufacturers, importers and distributors of active pharmaceutical ingredients will apply from 1 January 2028.