The European Medicines Agency posted this question-and-answer information on its highly informative website this Tuesday:

"Can I interchange multiple licences in the context of parallel distribution?

The EMEA checks the compliance of the parallel-distributed product with the terms of the Community Marketing Authorisation for the concerned centrally authorised product in the language concerned.

Since this Community marketing authorisation is specific for a given centrally authorised product to be marketed under that particular invented name it is not acceptable for the parallel distributor to interchange them in the context of parallel distribution.

Parallel distributors wishing to distribute products which are available on the Community market under two or more invented names, need to submit to the EMEA a separate PD notification for each centrally authorised product.

Moreover, in accordance with Community legislation the name given to a medicinal product by the company may be either a) an invented name (brand name/trade name) or b) a common/scientific name together with the name of the manufacturer.

Since this means that the originator MAH is not allowed to interchange these, flexibility in this respect to a parallel distributor is also not allowed.

The same principle applies as to the use of the active substance description of the product".