Obtaining an EU marketing authorisation, step-by-step
From 25 March 2021, marketing authorisation applicants for orphan medicines and medicines to treat cancer will be invited to take part in a pilot project by declaring their market launch intentions on a voluntary and confidential basis.
The pilot aims to help regulators understand why delays may occur in the marketing of certain medicines in EU Member States after they receive a marketing authorisation.
EMA will invite marketing authorisation applicants to share this information via an online survey at the time of validation or when they receive the CHMP opinion.
They will be also asked to provide feedback on challenges and limiting factors they face in ensuring the availability of their medicines in the EU.
The pilot project ran for 18 months until August 2022. The pilot is now closed.
The European Commission, EMA and the national competent authorities are running this pilot in the context of the Pharmaceutical strategy for Europe.
More information and guidance for applicants is available on the European Commission's website and in the question-and-answer (Q&A) document below.
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