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EMA marketing authorisation

An EMA centralised marketing authorisation is an authorisation granted by the European Commission, obtained through a single application to the European Medicines Agency, that is valid in all European Union member states and in Iceland, Liechtenstein and Norway[1].

A single evaluation is carried out through the Committee for Medicinal Products for Human Use (CHMP)[2]. If the Committee concludes that the quality, safety and efficacy of the medicinal product is sufficiently proven, it adopts a positive opinion[3]. This opinion is sent to the European Commission to be transformed into a marketing authorisation valid for the whole of the EU[3].

The CHMP is obliged by the regulation to reach decisions within 210 days[4]. The clock is stopped if it is necessary to ask the applicant for clarification or further supporting data[4].

All applications for marketing authorisation of new medicinal products have to include data from paediatric studies previously agreed with the Paediatric Committee, or obtain a waiver or a deferral of these studies[5]. A special type of approval, the paediatric-use marketing authorisation (PUMA), can be granted for medical products intended exclusively for paediatric use[3].

Why it matters to investors

If the CHMP concludes that the quality, safety and efficacy of a medicinal product is sufficiently proven, it adopts a positive opinion, which is sent to the European Commission to be transformed into a marketing authorisation valid for the whole of the EU[3]. The 210-day decision period is subject to a clock stop if it is necessary to ask the applicant for clarification or further supporting data[4].

Related: Orphan drug designation

Sources

  1. "Marketing authorisation" . European Medicines Agency . 17 September 2018. Archived from the original on 3 May 2021 . Retrieved 23 March 2021 . ema.europa.eu (via Wikipedia: European Medicines Agency)
  2. "Committee for Medicinal Products Human Use (CHMP)" . European Medicines Agency (EMA) . 17 September 2018. Archived from the original on 15 August 2022 . Retrieved 26 July 2020 . ema.europa.eu (via Wikipedia: European Medicines Agency)
  3. "Questions and answers on the paediatric use marketing authorisation (PUMA)" (PDF) . European Medicines Agency (EMA). 13 September 2011. Archived from the original (PDF) on 15 April 2016. web.archive.org (via Wikipedia: European Medicines Agency)
  4. "The evaluation of medicines, step-by-step" . European Medicines Agency (EMA). 25 November 2023. Archived from the original on 25 November 2023 . Retrieved 25 November 2023 . ema.europa.eu (via Wikipedia: European Medicines Agency)
  5. "Paediatric Regulation" . European Medicines Agency (EMA). 17 September 2018. Archived from the original on 26 December 2022 . Retrieved 26 December 2022 . ema.europa.eu (via Wikipedia: European Medicines Agency)

Checked 8 October 2026. How we check sources