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Manufacturing and Importation Authorisation:
A new Community format for a Manufacturing and Importation Authorisation document has been established in accordance with Art. 47 of Directive 2004/27/EC and Art. 51 of Directive 2004/28/EC, amending Directives 2001/83/EC and 2001/82/EC respectively. The new format superseded the 1999 format, upon which it was based.

The Community format for the Manufacturing and Importation Authorisation document is published in the Compilation of Community Procedures, which can be found at the following location: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/compilation-community-procedures-inspections-exchange-information_en.pdf.

Manufacturing and Importation Authorisations are to be entered into EudraGMDP, as referred to in Art. 40(4) of Directive 2001/83/EC and Art. 44(4) of Directive 2001/82/EC.
 
 
 
     
 
 
 
 
The EudraGMDP database is maintained and operated by the EMA. Access to the general public is granted in order to enhance availability of information related to the EMA mandate. The content of the database is provided by the National Competent Authorities (NCA) of the EEA. For this reason, the EMA accepts no responsibility or liability whatsoever (including but not limited to any direct or consequential loss or damage it might occur to you and/or any other third party) arising out of or in connection with the information on this database. Any questions about the content should be addressed to the relevant NCA. Please click here to get list of NCA's.
Due to the restrictions caused by COVID-19, the period of validity of MIA's, WDA's, GMP and GDP certificates is automatically extended until the end of 2022, except where clarifying remarks in the document state otherwise. Manufacturers, importers and distributors must continue to comply with GMP/GDP and all other legal obligations. On-site inspections are conducted where and when possible. Competent authorities reserve the right to perform risk based supervision of sites by either on-site inspections or distant assessments and, based on the outcome, may continue to issue, withdraw or restrict GMP/GDP certificates, as appropriate

For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

Documents issued by UK authorities up to and including 31 December 2020 remain available for consultation in EudraGMDP. However, they are no longer included or updated from 1 January 2021, with the exception of the documents pertaining to sites located in Northern Ireland.

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