Opinions on medicines for use outside the European Union

  • Email
  • Help

This page lists the opinions given by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), in co-operation with the World Health Organization (WHO), on medicines for human use that are intended exclusively for markets outside of the European Union (EU).

Medicines eligible for this procedure are used to prevent or treat diseases of major public-health interest. These include vaccines used in the WHO Expanded Programme on Immunization or for protection against a public-health priority disease, as well as medicines for WHO target diseases such as HIV/AIDS, malaria, or tuberculosis.

These opinions are given in accordance with Article 58 of Regulation (EC) No 726/2004.

Public assessment reports

Withdrawals of application

Withdrawals

How helpful is this page?

Average rating:

 Based on 51 ratings

Add your rating:

See all ratings
14 ratings
6 ratings
5 ratings
12 ratings
14 ratings
    

Tell us more

More information

Article 58