CRED ERP 25

8. The European Commission decision making process

The EC reviews the ‘opinion’ of the EMA and prepares and issues the Final Commission Decision (the EU Marketing Authorisation)

• Day 239: Commission prepares draft decision • Standing Committee Phase • Draft decision forwarded to Competent National Authorities (in national language) • Within 22 days, Member States are to advise whether they approve, reject or abstain • If issues raised, Standing Committee Meeting convened • If favourable opinion (232/321 votes) – decision adopted • If negative opinion, opinion forwarded to Council • Day 277: Commission Decision Issued • Commission adopts final decision within 15 days of Standing Committee Phase • Decision published in the Official Journal of the European Commission.

9. Questions? If you have questions/clarifications then please note them here and raise them during Q&A or alternatively send any questions you would like to raise during the course to the following e-mail address: meetings@topra.org