EC plots harmonisation of marketing authorisation rules


Considers revising (EC) No. 1234/2008

The European Commission (EC) is pushing forward with developing proposals to harmonise the way that European Union (EU) countries allow variations to national marketing authorisations for pharmaceutical products. It is considering revising the EU’s variations regulation (EC) No. 1234/2008 to help companies make and abide by these legal changes.

The Bundesverband der Pharmazeutischen Industrie (BPI), Germany’s pharmaceutical industry association, has welcomed the idea. The association said in formal consultation that ‘different variation requirements throughout Europe are difficult to handle’. Meanwhile, the European Federation of Pharmaceutical Industries and Associations (EFPIA) went further, noting that the implementation of the current regulation had not been handled in a coordinated fashion.

‘This has created a very complex regulatory environment for companies to manage variations,’ said the EFPIA, which called on the EC to set a firm implementation deadline. It is also considering whether regulators needed to prioritise variation applications ‘with the most impact on public health’.

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