4.1 For which EU referrals will the MPA send a request to the MAH to submit a variation application?
For products included in the commission decision, the decision shall be implemented within thirty days from its notification. According to the Commission's classification guideline for variations, the implementation of referrals in accordance with art 30 and 31 of Directive 2001/83/EC and art 34 and 35 of Directive 2001/82/EC shall be made through a variation application (IA/C.I.1.a, IA/B.V.b.1.a).
Following adoption of the opinion, the MPA encourage MAH’s to contact the regulatory administration department if there are questions regarding the procedure for implementation. In some cases, the MPA contact the concerned MAH via email to request a variation application, see table below. However, the MAH may of course submit the variation without awaiting a request from the MPA.
See also
CMDh:s Q&A 2.10
CMDh:s Post referral guidance
|
Article
(2001/83/EC, 2001/82/EC) |
Implementation via variation (YES/NO) |
Request from the MPA (YES/NO) |
|
29, 33 |
NO
Implementation is handled within the case that was referred |
NO
MPA await updated texts from the MAH (if applicable) |
|
30, 34 |
YES |
SE becomes RMS in the new MRP: YES
SE becomes CMS in the new MRP: NO* |
|
31**, 35** |
YES |
SE remains as RMS: YES
The product remains as purely nationally authorised: YES
SE remains as CMS: NO*
SE becomes RMS in the new MRP: YES |
* A variation application shall be submitted even if the MPA does not send a request to the MAH.
** For complete harmonisations, all products are transferred into MRP in order to maintain the gained harmonisation.