The European Medicines Agency (EMA) has updated the agency’s Brexit-related guidance documents. These documents are supporting pharmaceutical companies in preparing for the United Kingdom’s (UK) withdrawal from the European Union (EU). Now, the “Questions and Answers” document has been updated (Rev 04, published on 1 February 2019).
All medicinal products manufactured or imported into the Union (EEA) need to be manufactured in accordance with EU GMP (see also Commission Directive 2003/94/EC, Recital (1) and Commission Directive 1991/412/EEC). After a successful inspection by the competent authority or inspectorate, a Certificate of Good Manufacturing Practice (the “GMP Certificate”) is issued. GMP Certificates issued by a competent authority within the EU/EEA are recognised and accepted by other EU/EEA authorities no additional (EU) inspections occur...[EMA]