Duplicate application

In Sweden a duplicate application must be an exact copy of the mother application and should be submitted at the same time as the mother application. If these conditions are fulfilled, a lower fee is applicable.

Application

Duplicate applications can be submitted to the Swedish Medical Products Agency through the mutual recognition, decentralised and national procedure. 

In documents from the CMDh and the CMDv, 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 Regulation (EU) 2019/6 (medicinal products for veterinary use), as amended
• different trade name
• same or different applicant/marketing authorisation holder.

CMDh:

CMDv:

Definition

In Sweden, a duplicate application is:

• an application for approval of a marketing authorisation which completely corresponds to another application for a marketing authorisation (a so-called mother application), except for the trade name and the applicant, and
• which is received by the Swedish Medical Products Agency at the same time as the mother application. 

An exact copy of the mother application means, e.g.:

• same pack sizes
• same manufacturers
• same batch release site
• same packaging sites and
• same risk management plans.

What must differ is the product name and what may differ is the applicant.

Fee for a duplicate application

According to the definition above, the lower fee is only applicable when the duplicate application is received at the same time as the mother application.

Ordinance (Swedish):

Duplicate statement

In order for the Swedish Medical Products Agency to handle these applications correctly and bill the correct fee, the certificate, "Statement for duplicate applications" shall be completed and submitted together with the application.