Privatsphäre-Einstellungen

In the Joint Notification on the advice of applicants during marketing authorisation procedures and of marketing authorisation holders in other authorisation procedures according to the German Drug Law and according to para 17c of the Law on Veterinary Epidemics in conjunction with the Ordinance on veterinary vaccines dated 4 September 1998 the Federal Institute for Drugs and Medicinal Devices (BfArM), the Federal Institute for Consumer Protection and Veterinary Medicines (BgVV) and the Paul-Ehrlich-Institute (PEI) had informed the applicants on the pos-sibility of advice. On 12 February 2003 the BfArM had published supplementary remarks on this very general joint notification explaining in details the proce-dure of getting such advice.
Meanwhile an ad-hoc group of VFA’s subcommittee Dug Regulatory Affairs (DRA) has elaborated comments from the industry’s viewpoint which have been directly incorporated in the BfArM’s document. On 11 September 2003 these comments were ap-proved by the subcommittee DRA. In the following the BfArM document including VFA’s comments is published.