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.
National procedure/Mutual Recognition Procedure
Transfer of the Marketing Authorization Holder (MAH) from one company to another (other legal entity).
The transfer of a Marketing Authorisation (MA) from one company to another legal entity is not classified in the Variation Regulation. The Norwegian medicines Agency consider this as a A. Administrative variation, z) other variation, Type IB.
Please be aware that if the name of the medicinal product contains the name of the MA Holder, a notification of change in name must also be submitted. This is classified as an administrative variation nr A.2 in the Variation Regulation.
Change in MA Holder will also imply variation to the pharmacovigliance system. This is in the new Variation Regulation classified as a variation no. C.I.8 “ Introduction of a new pharmacovigliance system”.
If the product is approved via the Mutual Recognition- or Decentralised Procedure, The transfer of MA to a new legal entity is regarded a purely national variation, while the change in name and variation to the pharmacovigliance system will have to be notified through the EU-procedure.
All information applicable for the product, like renewal date, is also valid after the transfer.
The following is to be submitted for the notification of change in MA Holder to another legal entity:
Application form ticked: A. Administrative variation, z)other variation Type IB
- Confirmation from both parties on the agreement of transfer. It should also be confirmed that the transfer do not imply other changes to the product.
- Summary of Product Information, SmPC
- Patient Information Leaflet, PIL
- Labelling (mock-ups)
Response from the Norwegian Medicines Agency
The new MA Holder will receive a confirmation of the transfer, together with approved SmPC, PIL and labeling. The previous MA Holder receives a copy of the confirmation.
Change in name and address of the MA Holder – same legal entity
This is classified as Variation A.1, Type IAIN , where the MA Holder may change the name and/or address, but where the legal entity is the same.
Conditions and documentation: See the Commission guideline
In the case where several products are to be transferred, only one application form will need to be submitted, with an annexed list of applicable products.
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 firstname.lastname@example.org, with the filled in form attached.
Art 61(3) notification national procedure
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
From 1st of October 2022 the Norwegian Medicines Agency (NoMA) is going to approve Norwegian labelling when common labelling is revised. Previously, NoMA required only mock-ups when the common labelling was changed. Please submit mock-ups if there are 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. Mock-ups and Norwegian labelling shall be submitted if there are changes in common labelling and design.
Please submit the SmPC/SPC, PL and labelling as separate Word files and use the latest version of the QRD templates.
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.
Completion of variations- feedback from the Norwegian Medicines Agency