European Commission proposes medicine marketing authorisation variation reform

An EU Regulation laying down clear procedures for pharmaceutical manufacturers needing to vary the terms of their market approvals for particular medicines has been proposed by the European Commission.

The legislation would build upon the existing EU market approval regulations EC/1084/2003 and EC/1085/2003.

The reform has been prompted by concerns that the existing system for handling changes in marketing authorisation was cumbersome. A Commission memorandum on the reform said it was "appropriate..to establish a simpler, clearer and more flexible legal framework, while guaranteeing the same level of public and animal health protection."

Under the proposals, only changes that "have the highest potential impact on the quality, safety or efficacy of medicinal products" would "require a complete scientific assessment.. as for new marketing authorisation applications".

For certain "minor variations" outlined in the proposal, manufacturers could change the terms of the marketing authorisation without "any prior approval", but notify public authorities within a year, while some other minor variations would have to be reported immediately because of the need for "the continuous supervision of the medicinal product concerned".

Under the proposal, each variation would require a separate submission, with groupings of variations allowed in certain cases, "to facilitate [their] review.. and reduce the administrative burden".