Changes which lead to a GMP Inspection

Companies that manufacture medicines must have an authorisation, a so called Manufacturing and Importation Authorisation. For this document a Community format has been established in accordance with Art. 47 of Directive 2004/27/EC and Art. 51 of Directive 2004/28/EC. This Community format is published in the Compilation of Community Procedures. Manufacturing and Importation Authorisations are issued by the national component authority after a successful GMP inspection and are entered into EudraGMDP.

Manufacturing and Importation Authorisation holders (MAIH) are inspected regularly by GMP inspectors. However it is important to notice that the MAIHs must not change the terms of the authorisation without prior approval of the authority.

These "terms" are for example:

• new types of formulations are now produced
• relocations
• new (company) name

Some changes do not necessarily require the manufacturing authorisation to be changed, but still require notification to the national competent authority.

The Danish Medicines Agency has now published an overview of the type of changes in the GMP area which should be submitted to the agency. These will be assessed "to necessitate the submission of information to the Danish Medicines Agency and perhaps inspection before the change can be implemented".

Although aimed at manufacturers based in Denmark, this overview gives also guidance to other MAIHs in the EU.