The provisions governing the variation of marketing authorisations granted under Regulation 726/2004 for CAP (central authorized products) applies from 2nd November 2012.
The revision of the Variations Regulation has resulted in changes in time relative to the amendment of the marketing authorisation. For variations that do require amendments of the marketing authorisation within two months, listed in Article 23(1a)(a), the Commission will amend the marketing authorisation to reflect the variation accordingly. Other variations will receive an amendment of the marketing authorisation within a year.
Variations listed in Article 23(1a)(a) may only be implemented once the Commission has amended the marketing authorisation. Variations that do not require any amendment of the marketing authorisation or follow a yearly update of the respective Commission decision can be implemented once the MAH has been informed of the favourable outcome by the European Medicines Agency. When a variation includes changes to the product information the MAH must wait for the finalisation of the linguistic-review process by the European Medicines Agency before implementing the variation.
The Norwegian Medicines Agency will continue to update our database continuously. We will however no longer publish the Norwegian product information on our website, as from now on there will be a link to the annexes at the European Medicines Agency website.
MAHs do no longer need to send the latest approved Norwegian product information in Word format to the Norwegian Medicine Agency.
In some cases, i.e. new pack size, the Norwegian Medicines Agency will send a request for the required additional information to update our database.