France : New drug ad vetting system will need careful promotional planning

摘要

Pharmaceutical companies wanting to promote their medicines to French health professionals now have another bureaucratic hurdle to leap, thanks to the regulatory reform introduced in the wake of the Mediator drug affairFrom June, all promotional materials for prescription drugs has to be vetted by the regulatory agency, ANSM, before they can be used. Whereas previously companies could simply send copies of the materials to the regulator and then go ahead and distribute them, now they must first apply to ANSM for a permit (dubbed "visa PM" -"prescription medicale") for each promotional item. Moreover, if a product is the subject of a benefit-risk review following a safety signal, it cannot be promoted until the review is completed. Companies will need to check their promotional content very carefully before submitting it to the regulator; they will also need to plan promotional campaigns well in advance to take account of both the time taken to issue a permit and the possibility that it might be refused.