News and updates on pharmaceuticals
The Community Register lists all medicinal products for human and veterinary use as well as orphan medicinal products that have received a marketing authorisation through the centralised procedure.
The information provided in the Register can be accessed either by searching for the name of the product, the name of the active substance (INN) or the EU registration number.
This information includes: the name of the medicinal product, the EU registration number, the name and address of the marketing authorisation holder, the active substance, the international non-proprietary name, the ATC code, the therapeutic indication and the date of issue of the marketing authorisation valid throughout the EU. Detailed information on the European Commission procedures is also available together with relevant documents.
In addition to medicinal products that are currently on the EU market, a listing of medicinal products that were suspended or withdrawn and a listing of medicinal products for which a marketing authorisation was refused are also available.
The Register also provides information on medicinal products for human and veterinary use adopted nationally for which a Commission decision was necessary. These medicinal products, listed by the name of their active substance, as the commercial name may vary from State to State, are listed under the heading EU Referrals. In addition to details concerning the products, information on the European Commission procedures and the relevant documents are also available.
Information on traditional herbal medicinal products for human use, is also available in the Register. This includes: the marketing authorisation number, a list of Member States in which the product is authorised, the name of the medicinal product, the marketing authorisation holder and relevant address, and the date of issue of the marketing authorisation.
Other information that can be found in the Register includes a listing of the Commission decisions adopted in the last six months; a general index of active substances adopted in the EU and a general index of medicinal products listed by the brand name adopted in the EU.
Mutual recognition information - product index ; national
For products that are not authorised by way of the centralised authorisation procedure, but authorised by way of mutual recognition, the head of medicines agencies have established a Mutual recognition information - product index.
Moreover, some Member States have established Member States registers of nationally-authorised medicinal products.