The European Medicines Agency (EMA) has updated the agency’s Brexit-related guidance documents. The updated documents support pharmaceutical companies in preparing for the United Kingdom’s (UK) withdrawal from the European Union (EU). All medicinal products that are manufactured or imported into the European Economic Area (EEA) must be follow EU Good Manufacturing Practices (GMP). Once a successful inspection is conducted by the competent authority, a GMP Certificate is issued. GMP Certificates that are issued by a competent authority within the EU are recognised by other EU authorities. This means no additional EU inspections occur. In the case of importing from third countries into the EU, the supervisory authorities are the competent authorities of the Member State that granted the import authorisation and they will need to inspect.

Brexit: Will UK Inspection Reports and GMP Certificates still be valid?

If you would like to discuss your specific requirements relating to Brexit readiness and how MIAS Pharma can help you, get in touch with us today at +353 (1) 846 3605 or