We await the final decision to include veterinary medicines in the scope of the mutual recognition agreement currently concluded between the European Community (EU) and the United States, which allows the recognition of GMP inspections in other Member States. The application of the MRA is currently focusing on the successful implementation of MRI sections that are relevant to cGMP monitoring or routine inspections. application-specific inspections, such as. B pre-authorization inspections fall within the scope of MRI; However, since these inspections are based on requests filed with a specific regulatory authority, additional coordination and evaluations are needed in the United States and the EU. Current products within the scope of the agreement include finished medicines for human consumption marketed in various pharmaceutical forms such as tablets, capsules, ointments and injection products, commercial biologics, intermediate products and pharmaceutical active ingredients (IPAs). On 1 November 2017, the EU and the US first signed the MRA for current products, with eight EU countries benefiting immediately from the agreement. After that date, there were many progressive authorisations, with Ireland approved on 1 June 2018. The 28 EU countries are now included in the scope of this agreement. The agreement does not currently apply to veterinary medicines, but the EU and FDA have agreed that veterinary drugs will be included by 15 December 2019 and discussions have already taken place between technical experts. The European Union (EU) and the United States have concluded a comprehensive Mutual Recognition Agreement (MRA) following the recognition of Slovakia by the U.S. Food and Drug Administration (FDA). The MRA will allow both organizations to rely on inspections of production sites for certain drugs for human use in their respective territories. The transition period for medicines for human use, which is covered by the agreement, ended on 11 July 2019: one of the main benefits for European companies is the waiver of batch testing for imports of medicines from the United States.
In the EU, the qualified person (PQ) is relieved of his responsibility for carrying out the checks in accordance with Article 22, paragraph 1, paragraph b), directives 75/319/EEC of the Council, provided these checks have been carried out in the United States.