Processing time for applications

Application for MA

• Centralised marketing authorisations: 30 days from date of the European Commission decision.
• National marketing authorisations: 210 days (from the receipt of application without clockstopp).
• Decentralised procedure (DC)/Mutual reocognition procedure (MRP): 25 days after high quality translations on texts have been sent to the IMA.
• Parallel import licenses: 30 days from receipt of full application.

Variations

• National marketing authorisations (IA, IB, II) - Changes to texts: MA which are harmonised with another country: 30 days from the receipt of completed application in the country that the MA is harmonised with and high quality translations are submitted if applicable. MA which are not harmonised with another country: 90 days from the received application.
• National marketing authorisation (II): MA which are harmonised with another country: 30 days from receipt of completed application in the country which the MA is harmonised with. MA which are not harmonised with another country: 90 or 120 days from received application, depending on the nature of the application.
• DCP/MRP: 60 days after end of application if there are no changes to the texts, otherwise 25 days after high quality translations have been sent to the IMA.

Renewal of marketing authorisations

• Centralised marketing authorisations: 30 days from the date of the European Commission decision.
• National marketing authorisations: 90 days from received application.
• DCP/MRP: 30 days after end of application if no changes are made to texts, otherwise 25 days after the IMA receives high quality translations.

Other applications

• Withdrawal of MA or withdrawal of a medicinal product from the market: 45 days.
• Labelling (mock-ups): 60 days.