Brussels aims to reduce marketing authorisation confusion
EC guidance encourages pharma companies to use abridged market authorisation procedure
The European Commission has released additional guidance encouraging pharmaceutical companies to use a special cheaper abridged market authorisation procedure for medicines mirroring those already being sold legally.
The guidance follows the release of advice last March (2010) on ‘duplicate marketing authorisation applications’, under the EU’s centralised vetting procedure.
This allowed companies to fast track applications for medicines where they fit criteria under article 82(1) of the EU’s central marketing approval regulation No 726/2004. It is increasingly being used instead of national applications.
However, since March 2010, the EC said there had been confusion over when these article 82(1) applications were appropriate, noting a ‘trend for applicants to submit applications…without requesting the [fast track] authorisation’ because companies wrongly considered a medicine was ‘not a ‘true’ duplicate’.
Releasing clarified guidance, Brussels added that ‘in the light of this misinterpretation’ companies should always consult the European Medicines Agency (EMA) ‘to seek advice in case of doubt.’