IMB will be modifying the format of the current Manufacturer’s Authorisation so that the information presented will be compatible with the EU format for a Manufacturer’s / Importer’s Authorisation
14 July 2008
Categories:
EudraGMP & Manufacturer’s / Importer’s Authorisation (MIA)
In April 2007 the EMEA launched a database called EudraGMP, which contains information on manufacturing and importation authorisations issued by EEA competent authorities. It also contains information on GMP certificates, which Member State competent authorities issue following each satisfactory GMP inspection.
As noted on the EMEA’s website www.emea.europa.eu/Inspections/EudraGMP.html, it is planned to provide access to the general public to manufacturing and importation authorisations and certain GMP certificates, with the exception of any information of commercially and/or personally confidential nature. It is anticipated that the component of EudraGMP which can be accessed by the public will go live later this year.
The IMB will be modifying the format of the current Manufacturer’s Authorisation so that the information presented will be compatible with the EudraGMP database and EU format for a Manufacturer’s / Importer’s Authorisation. The Compliance Department will contact each authorised manufacturer in the coming months to verify the accuracy of the information before issuing the revised authorisation document and entering the authorisation details onto the EudraGMP database.