Article 5(3) opinions

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.

• EMA issues advice on use of Paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19: rolling review starts in parallel (16/12/2021)

• Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 February 2023: EMA's CHMP recommends the refusal of a marketing authorisation for Lagevrio (molnupiravir) (24/02/2023)
• EMA reviewing new data on effectiveness of Lagevrio (molnupiravir) for the treatment of COVID-19 (14/12/2021)
• EMA receives application for marketing authorisation for Lagevrio (molnupiravir) for treating patients with COVID 19 (23/11/2021)
• EMA issues advice on use of Lagevrio (molnupiravir) for the treatment of COVID-19 (19/11/2021)

• EMA issues advice on use of sotrovimab (VIR-7831) for treating COVID-19 (21/05/2021)

• Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
• Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 September 2021 (17/09/2021)
• AstraZeneca’s COVID-19 vaccine: benefits and risks in context (23/04/2021)
• AstraZeneca’s COVID-19 vaccine: EMA to provide further context on risk of very rare blood clots with low blood platelets (14/04/2021)

• EMA issues advice on use of regdanvimab for treating COVID-19 (26/03/2021)

• EMA issues advice on use of antibody combination (bamlanivimab / etesevimab) (05/03/2021)

• EMA issues advice on use of REGN-COV2 antibody combination (casirivimab / imdevimab) (26/02/2021)

• EMA endorses use of dexamethasone in COVID-19 patients on oxygen or mechanical ventilation (18/09/2020)

• EMA finalises opinion on presence of nitrosamines in medicines (09/07/2020)
• EMA advises companies on steps to take to avoid nitrosamines in human medicines(26/09/2019)
• EMA to provide guidance on avoiding nitrosamines in human medicines(13/09/2019)

• Investigation into GLP-1-based diabetes therapies concluded (26/07/2013)
• Pancreatic safety of incretin-based drugs - FDA and EMA assessment

• European Medicines Agency completes review of protamine-containing medicines (16/11/2012)

• European Medicines Agency reviews hypothesis on Pandemrix and development of narcolepsy (19/10/2012)

• European Medicines Agency finalises review of recent published data on cardiovascular safety of NSAIDs (19/10/2012)

• European Medicines Agency concludes review of dose recommendations for anti-tuberculosis medicines used in children (17/02/2012)

• European Medicines Agency concludes that benefit-risk balance of angiotensin-II-receptor antagonists remains positive (20/10/2011)

• European Medicines Agency concludes on use of celecoxib in familial adenomatous polyposis (20/05/2011)

• European Medicines Agency recommends action plan to deal with possible presence of endotoxins in Baxter peritoneal dialysis solutions (17/12/2010)

• European Medicines Agency confirms that presence of unexpected viral DNA in live attenuated vaccines does not raise public health concerns (18/11/2010)

• European Medicines Agency gives guidance for use of antiviral medicines in case of a novel influenza A/H1N1 pandemic (08/05/2009)

• European Medicines Agency recommends measures to manage contamination of heparin-containing medicines (05/06/2008)

• European Medicines Agency review concludes positive benefit-risk balance for non-selective NSAIDs (24/10/2006)