Medicines

Draft Order of the Ministry of Health of Ukraine "On Approval of the Procedure for Confirming the Compliance of Medicine Manufacturing Facilities Located Outside Ukraine with the Good Manufacturing Practice Requirements Established in Ukraine"; (93 page(s), in Ukrainian)

The draft Order has been developed in accordance with the requirements of Articles 47 and 108 of the Law of Ukraine "On Medicines" No. 2469-IX of 28 July 2022, taking into account relevant European Union legislation. In accordance with Article 47(4) of the Law, confirmation of compliance of medicine manufacturing with the Good Manufacturing Practice requirements established in Ukraine, including for manufacturing facilities located outside Ukraine, shall be carried out by the state control authority through the inspection of manufacturing facilities conducted in a manner aligned with European Union legislation, taking into account the inspection procedures and information exchange practices applied in the European Union for the manufacture and distribution of medicines, and based on a risk-based planning approach (except for imported active pharmaceutical ingredients).

The draft Order establishes the legal and organisational framework for the procedure for confirming compliance of manufacturing conditions of medicines at manufacturing facilities located outside Ukraine with the Good Manufacturing Practice (GMP) requirements established in Ukraine.

In particular, it provides for:

·        the inspection of medicine manufacturing facilities located outside Ukraine;

·        the recognition of official GMP compliance documents issued by competent authorities of countries with Stringent Regulatory Authorities (SRAs);

·        the issuance by the state control authority of documents confirming GMP compliance;

·        the definition of the powers and rights of officials of the state control authority in conducting the GMP compliance confirmation procedure;

·        the rights and obligations of medicine manufacturers located outside Ukraine in the course of such procedure.

This procedure applies to medicine manufacturers located outside the territory of Ukraine that hold a manufacturing licence (where such licensing is required under the national legislation of the country in which the manufacturing facilities are located) and that apply for the registration of medicines in Ukraine, as well as to applicants and their authorised representatives in accordance with the procedure established by law.

It is also established that the procedure for confirming the compliance of medicine manufacturing with GMP requirements established in Ukraine that has been commenced but not completed prior to the entry into force of this Order, shall be completed in accordance with the Procedure for Confirmation of Compliance of Manufacturing Conditions of Medicines with the Requirements of Good Manufacturing Practice, approved by Order of the Ministry of Health of Ukraine No. 1130 of 27 December 2012 (as amended by Order No. 1346 of 9 June 2020), which, for the purposes of conducting such a procedure until its completion, shall apply in the version in force as of the date of entry into force of this Order. Decisions adopted upon completion of such a procedure shall be issued using the forms approved by this Order. Upon the adoption of this draft Order, Order of the Ministry of Health of Ukraine No. 1130 of 27 December 2012 "On Approval of the Procedure for Confirmation of Compliance of Manufacturing Conditions of Medicines with the Requirements of Good Manufacturing Practice" shall cease to have effect.