Questions and Answers for the submission of Variations according to commission regulation (EC) 1084/2003
Please note that the Variations Commission Regulation (EC) 1084/2003 will cease to be applicable as of 1st January 2010
The Questions & Answers below will be subject to review.
A Questions & Answers document for the submission of Variations according to the Commission Regulation (EC) 1234/2008 is now available HERE
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Simplified handling of Variations
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- Question 1
When is simplified handling of variations in MRP after a merger acceptable?
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If the MAH in case of a merger wants to change the name of manufacturers and/or the name and address of the MAH (where the legal entity remains the same) in different CMSs for a number of products in different strengths and pharmaceutical forms, it is possible to submit one variation per medicinal product (MA) including the changes due to the merger mentioned above.
Identical notifications/variations are entitled to have the same chronological number.
In cases where a simplified handling of variations in the MRP has been agreed, the fees remain under national consideration.
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- The Question 2 has been deleted
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General Q&As
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Transfer of Marketing Authorisation
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- Question 27
How should applicants deal with a transfer of MA for a product registered through MRP or DCP?
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The transfer of MA should be processed at national level as there is a change of the legal entity. The fees are set by each CMS and the management of the procedure is dealt with by each CMS.
The current registered MAH should send a notification to the RMS to specify which CMSs and MAHs are concerned with this national procedure.
Remark: The change in the name and/or address of the MAH (i.e. the MAH remains the same legal entity) for a product registered through MRP or DCP, is processed at MRP level via a tType IA, No.1 variation.
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Numbering of follow-up submissions and commitments
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- Question 28
Which MRP/DCP number should be assigned to follow-up submissions and commitments?
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Follow-up submissions and commitments should be numbered according to the following number CC/D/nnnn/sss/FU/vvv, in which the element
- CC is the initial of the Reference Member State (two letter code)
- D is 'H' for medicinal products for human use
- nnnn is the 'Medicinal Product Number' characterisind the medicinal product
- sss is the 'Speciality Number' characterising the strength and/or pharmaceutical form of a medicinal product
- vvvv is the chronological number
Principles:
Irrespective of the type of submission (follow-up submission or commitment) there is a continuous number of the submitted follow-up submission and commitments.
Basis for the continuous numbering is the medicinal product characterised by 'Medicinal Product Number'.
Only identical follow-up submissions/commitments are entitled to have the same chronological number.
Follow-up submissions/commitments have their own series of sequential numbers and are separate to other procedures.
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Submission of Variations before a Marketing Authorisation has been granted
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- Question 29
Is it possible to submit Variations to a medicinal product authorised via Mutual Recognition or Decentralised Procedure in the situation where the Marketing Authorisation has not been granted in all involved Member States?
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The CMD(h) has agreed that in the situations where not all Member States involved in a MRP or DCP have granted a Marketing Authorisation withing 30 days after finalisation of the procedure, Marketing Authorisation Holders can submit Variations after this date, provided that high quality translations of the agreed SPC, PL and Labelling have been submitted to all involved MSs.
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