Community Register

Community Register

The Community Register lists all medicinal products for human and veterinary use as well as orphan medicinal products that have received a marketing authorisation by the Commission 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 anatomical therapeutic chemical (ATC) code and the therapeutic indication together with relevant documents.

In addition to medicinal products that are currently on the EU market, the Register includes information on:

  • Medicinal products that were suspended or withdrawn, or for which a marketing authorisation was refused.
  • Medicinal products for human and veterinary use adopted nationally for which a Commission decision was necessary.
  • Commission decisions adopted in the last six months.
  • Medicinal products authorised by individual EU countries under Article 126a of Directive 2001/83.
  • A general index of active substances covered by Commission decisions.
  • A general index of medicinal products listed by the brand name covered by Commission decisions.

Mutual recognition information - product index

Products authorised by way of mutual recognition, a Mutual Recognition Information (MRI) Product Index and the Veterinary Mutual Recognition Information (VMRI) Product Index exists.

National registers

Some EU countries have established registers of nationally-authorised medicinal products.