Pilot project ‘Market Launch Intentions of Centrally Authorized Products’

On 5 March 2021 the EMA published the guidance on the practical questions and answers about the pilot project.

From 25 March 2021, marketing authorization 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 authorization.

EMA will invite marketing authorization 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 will run for 18 months, until August 2022.

The European Commission, EMA and the national competent authorities are running this pilot in the context of the Pharmaceutical strategy for Europe.

Read the pdf 
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