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. State name and procedure number (SE/H/nnnn/sss) for the products concerned, and type of variation (klassification code).
2.4 How/to whom should the letter of intent for the submission of a worksharing procedure be submitted?
When SE (Sweden) is RMS for all products and the MAH propose SE to be the preferred reference authority (RA) the letter of intent should be submitted to the MPA and not the CMDh. The letter of intent should be sent by e-mail to address RIC@mpa.se.
See also the CMDh:s Best Practice Guide for variations, Ch. 7 (http://www.hma.eu/96.html). In case the intended worksharing procedure includes products with more than one RMS, the letter of intent should be submitted to the CMDh.
Note, for veterinary medicinal products, the letter of intent should in all cases be submitted to the CMDv.
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 2011-01-03