MAH-transfer to another legal entity

Place a comment

Sweden

- Application containing:

  • Proof of establishment
  • Wholesaler licence
  • Proposed product information
  • Transfer agreement

Norway

Type IB variation application containing:

  • Application form
  • Transfer agreement
  • Proposed product information

Denmark

In Denmark, the package leaflet and labeling must be corrected by the company in accordance with the authorized change, but any proposed changes should not be submitted.

Type IB variation application containing:

  • Application form
  • Transfer agreement
  • Proposed SPC

Change of article number required.

Finland

  • Transfer agreement
  • Proposed product information
  • Proof of payment

Iceland

Application containing:

  • Application form (without specific variation number and guideline pages)
  • Transfer agreement
  • Proposed product information

If the new MAH is new to the market, a description of the new MAH’s pharmacovigilance system should be submitted.

If the name of the MAH is included in the name of the medicinal product, an application to change the name of the medicinal product must be submitted at the same time.

Applications for the appointment of a new representative or the removal of an existing representative is to be submitted by the Marketing Authorization Holder.

This list was last updated: 2011-08-11.

blog comments powered by Disqus