Article 5(3) opinions on any scientific matter: human medicines

Table of contents

This page lists the opinions drawn up by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) under Article 5(3) of the Regulation establishing the EMA, concerning any scientific matter related to the evaluation of medicines for use in humans.

The Committee must draw up such an opinion at the request of the Executive Director of the EMA or of the European Commission. It may also draw up an opinion following a request from a Member State.

Where the scientific issue concerns both human and veterinary medicines, the Committee may adopt a common opinion with the Committee for Medicinal Products for Veterinary Use (CVMP).

Requests for this type of scientific opinion fall under Article 5(3) of Regulation (EC) No 726/2004.

Nitrosamine impurities in human medicinal products (Updated 18/02/2021)

Bisphosphonates and osteonecrosis of the jaw

Non-selective non-steroidal anti-inflammatory drugs (NSAIDs)


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