2. Variations

2.1 What are the fees for variations type IA and type IB in Sweden (MRP and national procedure)?

The fees for variations type IA and type IB are included in the annual fee.

2.2 What are the fees for Art. 61(3)-notifications in Sweden (MRP and national procedure)? 

The fees for Art. 61(3)-notifications are included in the annual fee.

2.3 How can I obtain a variation procedure number for a planned type IA grouping for more than one marketing authorisation where Sweden is RMS (e.g. SE/H/xxxx/IA/vvv/G)?

A request for procedure number should be sent by e-mail to the address RIC@mpa.se. In the email, please state name and procedure number (SE/H/nnnn/sss) for the products concerned, and type of variation (classification code).

2.4 How/to whom should the letter of intent for the submission of a worksharing procedure be submitted?

The letter of intent should be submitted using the template found on the CMDv and CMDh websites.

For veterinary medicinal products the letter of intent should be submitted to CMDv.

For human medicinal products the letter of intent should be submitted to the preferred reference authority. When Sweden is preferred reference authority the letter of intent should be submitted to the MPA by e-mail to address RIC@mpa.se.

For further information, please see CMDh Best Practice Guide for variations, Ch. 7, and CMDv Best Practice Guide for variations.

2.5 Which fees are applicable to variation applications submitted as grouping or worksharing?

Information regarding fees for grouped variation applications and worksharing is published on our web site:

 Information on fees 2013-04-24

2.6 How should I submit a new RMP or an updated RMP to update my dossier?

Please see question 2 in  CMDh QUESTIONS & ANSWERS PHARMACOVIGILANCE LEGISLATION REGULATION (EU) NO 1235/2010 AND DIRECTIVE 2010/84/EU.

 
 

Contact us

   
 

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