COVID-19 medicines: Article 18 and Article 5(3) reviews
The European Medicines Agency (EMA) may review COVID-19 vaccines and treatments under Article 18 of the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123).
This is intended to support national decision-making on the possible use of these medicines before a formal authorisation is issued.
During an Article 18 review, EMA's Emergency Task Force (ETF) reviews the available data on the use of the medicine and submits this to the Committee for Medicinal Products for Human Use (CHMP) for an opinion.
Article 18 reviews of COVID-19 vaccines replaced those previously conducted under Article 5 (3) of Regulation establishing EMA (Regulation (EC) No 726/2004) when the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123) took effect in March 2022.
EMA's ETF is currently not reviewing data on any vaccine under under Article 18 of the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123).
EMA's CHMP has reviewed data on the following vaccines, under Article 5(3) of Regulation (EC) No 726/2004:
| Vaccine | Key milestones | More information |
|---|---|---|
| Vaxzevria (previously COVID-19 Vaccine AstraZeneca) | Start of review: 14/04/2021 Interim opinion: 23/04/2021 | Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 September 2021 AstraZeneca’s COVID-19 vaccine: EMA to provide further context on risk of very rare blood clots with low blood platelets AstraZeneca’s COVID-19 vaccine: benefits and risks in context Article 5(3) opinions: Use of Vaxzevria to prevent COVID-19 |
For more information, see:
EMA's ETF is reviewing the available data on the use of the following medicines to treat certain patients with COVID-19, under Article 18 of the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123):
| Treatment | Key milestones | More information |
|---|---|---|
| Sabizabulin | Start of review under Article 18: 27/07/2022 | EMA reviewing data on sabizabulin for COVID-19 |
The following medicines can be used in the EU to treat COVID-19, after EMA's CHMP completed its review under Article 5(3) of Regulation (EC) No 726/2004:
*EMA’s CHMP is also evaluating a marketing authorisation application for this medicine. For more information, see:
For more information on Article 5(3) evaluations, see: