What is the procedure for registering a pharmaceutical product in another EU (European Union) country?
As soon as more than 1 EU country is involved in the registration, EU regulations apply. There are some differ-ences, but in general the requirements (for product quality, effectiveness and safety) for the Austrian national au-thorization are based on the EU regulations for authorization. The Austrian authorization process is regulated by the AMG (Arzneimittelgesetz – Law on Pharmaceutical Products). The EU authorization requires that the authorization be carried out using the same criteria in every country and that, in the end, the SPC (summary of product characteristics) is identical in all countries. There are two types of authorization procedure: the local and the central. Local authorization procedure (= procedure of mutual approval): • An RMS (Reference Member State) examines the drug. • Other member states, that will also be authorizing the drug – they are termed CMS (Concerned Member State) – inspect the application based on the appraisal of the RMS. • For a product to be autho
As soon as more than 1 EU country is involved in the registration, EU regulations apply. There are some differ-ences, but in general the requirements (for product quality, effectiveness and safety) for the Austrian national au-thorization are based on the EU regulations for authorization. The Austrian authorization process is regulated by the AMG (Arzneimittelgesetz – Law on Pharmaceutical Products). The EU authorization requires that the authorization be carried out using the same criteria in every country and that, in the end, the SPC (summary of product characteristics) is identical in all countries. There are two types of authorization procedure: the local and the central. Local authorization procedure (= procedure of mutual approval): • An RMS (Reference Member State) examines the drug. • Other member states, that will also be authorizing the drug – they are termed CMS (Concerned Member State) – inspect the application based on the appraisal of the RMS. • For a product to be autho
