Duplicate applications

Applicants can obtain more than one marketing authorisation for the same medicinal product by submitting one or several duplicate applications. In connection with the changes of the ordinance (SFS 2010:1167) concerning fees for the governmental control of medicinal products, which came into force January 1, 2017, the definition of a duplicate application was changed. The lower fee is only applicable when the duplicate application is received at the same time as the application it refers to (below called mother application). Please find below a practical guide on how to submit duplicate applications to the Medical products Agency within the in the mutual recognition, decentralised and national procedure.

In the document from the CMDh "Recommendations on multiple/duplicate applications in mutual recognition and decentralised procedures" (see link to the right) and the CMDv document "Recommendations on duplicate applications in mutual recognition and decentralised procedures" (see link to the right) a duplicate application is defined by reference to the first application or to the first marketing authorisation as follows:

  • Same dossier (copy of modules 1, 2, 3, 4 and 5 (medicinal products for human use) or copy of part I, II, III and IV (medicinal products for veterinary use)
  • Same legal basis in accordance with Directive 2001/83/EC (medicinal products for human use) or 2001/82/EC (medicinal products for veterinary use), as amended
  • Different trade name
  • Same or different applicant/marketing authorisation holder

In Sweden a duplicate application should be an exact copy of the mother application, which means for example the same pack sizes, manufacturers, responsible for batch release, packaging sites and risk management plans. What shall differ is the product name and what may differ is the applicant.

By an amendment of the ordinance (SFS 2010:1167) concerning fees for the governmental control of medicinal products, the definition of a duplicate application has been changed. As of January 1, 2017 a duplicate application is an application for approval of a marketing authorisation which completely corresponds to another application for a marketing authorisation, except for the trade name and the applicant, and which is received by the Medical Products Agency at the same time as the application it refers to. Consequently the lower fee is only applicable when the duplicate application is received at the same time as the mother application.

In order for the Medical Products Agency to handle these applications correctly and bill the correct fee (see link to the right), the certificate, "Statement for duplicate applications - human medicinal products" or "Statement for duplicate applications - veterinary medicinal products" shall be completed and submitted together with the application, the forms can be found to the right under the heading "Forms and guidance."

 
 

Forms and guidance

 

External links

CMDh (Co-ordination group for Mutual recognition and Decentralised procedures – human) documents/guidelines

 CMDh - Recommendations on multiple/duplicate applications in mutual recognition and decentralised procedures

CMDv (Co-ordination group for Mutual recognition and Decentralised procedures – veterinary) documents/guidelines

 CMDv – Recommendation on duplicate applications in mutual recognition and decentralised procedures

   
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information