Assessment times for issuance of marketing authorisations in Concerned Member State cases 2019

Under the mutual recognition procedure and the decentralised procedure, we have 30 days to issue a marketing authorisation from the date when we receive an acceptable Danish summary of product characteristics (SmPC).

Status in 2019 as at end-December 2019: 96 % of the cases finished within the performance requirement's maximum of 30 days (23 days on average):

• Human medicines: 95 % of the cases finished within the performance requirement's maximum of 30 days (23 days on average).
• Veterinary medicines: 98 % of the cases finished within the performance requirement's maximum of 30 days (20 days on average).

Chart 1: Average assessment times for issuance of marketing authorisations with Denmark as Concerned Member State (CMS)

See table 1-3 for CMS cases

The Danish Medicines Agency has established a best practice agreement on the issuance of marketing authorisations in connection with MRP/DCP applications where Denmark is Concerned Member State. According to this agreement, the maximum assessment time allowed is 30 days from the date on which we receive an acceptable Danish version of the authorised SPC until issuance of a marketing authorisation.