Ema Marketing Authorisation Timeline

Timetable accelerated assessment request for initial marketing authorisation applications pdf 52 62 kb first published.

Ema marketing authorisation timeline. Ema decide if oral explanation is also required. The commission s secretariat general then notifies the decision to the marketing authorisation holder. The submission to the ema of up to date information on all medicinal products for which you have a marketing authorisation within the european economic area also known as the requirements in connection with art. 57 2 of the xevmpd.

Marketing authorisations are initially valid for five years. European medicines agency pre authorisation procedural advice for users of the centralised procedure ema 821278 2015 page 4 135 1 10 5. Regulatory submission timeline david mccoubrey regulatory affairs lead almac group. 6 2 decentralized procedure.

Differences between exceptional circumstances and conditional marketing. Wp reports i new applications opinions i 4 log rsi looi s lunch time. New applications opinions lunch time iii o l e l tiiii. Updated content to reflect that the uk cannot act as a reference members state rms for approval of marketing authorisations in decentralised and mutual recognition licensing.

The adoption of the decision should take place within 67 days of the opinion of the ema. The decision is subsequently published in the union register. Once granted by the european commission the centralised marketing authorisation is valid in all european union eu member states iceland norway and liechtenstein. At the end of the procedure the draft assessment report spc labelling and package leaflet as proposed by the reference member state are approved.

The marketing authorisation holder mah is responsible for ensuring that where relevant all relevant conditions and documentation are met and the submission of this information and dossiers are. Results in one marketing authorization valid in all eu eea member states eu marketing authorization procedures. Oral explanation i 4 log rsi looi s i 5 article 20 i 6 referrals i 4 log rsi looi s i 6 referrals orgam i 3 ii opinions i 4 rsi ii iv eligibility. An identical application for marketing authorisation is submitted simultaneously to the competent authorities of the reference member state and of the concerned member states.