Transfer of the marketing authorisation holder from one company to another and where there is no link between the companies (different legal entity).
The new EU legislation gives an opportunity for a last renewal for products with a national marketing authorisation (MA) where the renewal date is 1 July, 2006 or later.
Consequently, the Norwegian Medicines Agency has decided to change the MA transfer procedure with effect from 1 July, 2006.
The transfer of a MA from one company to another is not described in the EU legislation and is therefore considered to be a national matter. The Norwegian Medicines Agency considers this type of change a type IB no 1 variation. This is to ensure that at the same time a change in the product name, where applicable, is amended accordingly.
An application for transfer of the MA and change in the product name can be applied for in the same application form. However, if the product has obtained a MA through the Mutual Recognition or Decentralised Procedure, the transfer of the MA-holder has to be applied for nationally, while the change of product name has to be applied for as a separate type IB variation through the Mutual Recognition Procedure.
The following documentation has to be submitted:
- Variation application form for type IB no 1
- An agreement of the transfer signed by both companies where it is confirmed that no other changes than the change of MA has been made
- Fee NOK 1.500,- per product name (may include more than one MA-number)
- SPC where the changes are highlighted
- Package insert where the changes are highlighted
- Label (including, if relevant, new design)
The answer from the Agency will be:
A letter confirming the transfer of the MA-holder together with the approved SPC, package insert and labelling sent to the new MA-holder. A copy of the letter will be forwarded to the former MA-holder.
Change in the name and/or address of the marketing authorisation holder (ma). The ma-holder remains the same legal entity
This will be a variation Type IA no 1.
The following documentation has to be submitted:
- Variation application form for variation type IA no 1
- A formal document from a relevant official body (e.g. Chamber of Commerce) in which the new name or new address is mentioned (f.i. a statement from the MA-holder regarding a transfer to a different part of the same company)
- Fee NOK 1500.- per product name (may include more than one MA-number )
- SPC where the changes are highlighted
- PI where the changes are highlighted
- Label (only for one of the products if there are many, incl. if relevant, new design)
If the change concerns several products it is sufficient to fill in only one application form with «See enclosed list». A complete list of the products concerned, is enclosed.
Answer from the Agency will be:
«Notification is valid» together with approved SPC and label. The PI will usually be taken into consideration.