The Medicines Control Agency has said that medicines should not be included in the scope of a proposed revision of the European Community's general product safety directive (GPSD).
As part of a consultation round on the proposed revision, which is being pushed through by France while it holds the EC presidency, the MCA says that existing directives specific to medicines provide for pre-marketing assessment of the safety, quality and efficacy of medicines, as well as post-marketing surveillance and procedures for dealing with unsafe medicines. It takes the view that the proposed revised GPSD contains provisions that go further than those in medicines directives.
In particular, these concern systems for product recall, which would have to provide for the recall of products from individual consumers.
It is not clear how these requirements would interact with existing obligations under medicines law, and these require further clarification, the MCA says.
It believes that the requirements are not appropriate to medicines because they are already subject to rigorous safety controls.