Variations regarding marketing authorisation
Commission Regulation (EU) No 712/2012 amending Variations Regulation (EC) No 1234/2008 entered into force on 24th August 2012.
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.
Article 61(3) Notifications regarding nationally approved medicinal products in Norway
Article 61(3) notifications are changes to the package leaflet (PIL) and/or the labelling not affecting the Summary of Product Characteristics (SmPC).
61(3) notifications for medicinal products authorized through the national procedure are submitted to email@example.com, with the filled in form attached.
Some changes to the labelling can be submitted for information only (in Norwegian). This applies to some 61(3)-notifications and the requirements for such notifications are listed in this document.
For veterinary products changes to the package leaflet and/or the labelling not affecting the SmPC must be made by submitting a C.II.6 variation.
What is not considered a 61(3) notification?
Corrections/updates to the Norwegian product information.
We encourage the applicant to include corrections to the SmPC/PIL as part of an ongoing or an upcoming procedure amending the product informaion (type I or type II).
Changes to the SmPC
An update of the SmPC to implement changes in the SmPC, not already covered by the classification guideline and for which no new data are required, should be submitted as a C.I.z, type IB variation (CMDh Q&A on variations).
Important information regarding MRP variation applications and art 61(3) notifications
Please submit the SmPC/SPC, PL and labelling as separate Word files and use the latest version of the QRD templates.
Norwegian labelling text shall be submitted if there are changes in common labelling. Please submit mock-ups if there are significant changes in design or layout. Note that mock-ups must be in line with the current guidelines and that NoMA may request updated mock-ups when needed.
Expected reponse time for approval
The tables in the below document intends to give the time frame and the format of the expected response from NoMA, if any, regarding variation applications according to the variation Regulation, as well as Notifications 61(3) according to the national legislation § 9-2 Legemiddelforskriften ref Art 61(3) Dir 2001/83/EC.