31.07.2012
To the attention of Marketing Authorisation Holders
1. Type IA and IB variations to MA terms or outside such terms, submitted in 2011, in accordance with Order of the Minister of Health No. 874/2006, are to be notified to the NAMMD starting with 15 August 2012
2. The period for notification submission is 2 months from the specified date and the deadline is 14 October 2012
3. Between 15 August and 1 November 2012, applications for expedited approval of other variations are no longer forwarded to the NAMMD
4. Type IA and IB variations to MA terms or outside such terms, submitted in 2011, will be initially sent to NAMMD e-mail addresses tanta.ulieru@anm.ro and simona.badoi@anm.ro; subsequently, for any type of submission at the Registry office, these will be sent to the official address; submission may be performed daily.
5. Notifications for variations are submitted separately. Two notifications are submitted for every variation to a medicinal product, as follows:
a. form for implementation of Type IA/IB variations to MA terms
and
b. form for notification of implementation, in accordance with Annex 1 to SCD No. 30/2010, of Type IA/IB variations outside MA terms
6. Variations are NOT to be sent as a group, for the entire company portfolio.
7. Prior to NAMMD notification, the following will be confirmed:
a. the fill-in status of applications for variation, with inclusion in the proper category and adequate fill-in in headings “Current”, “Proposed”
b. the payment form
c. compliance with conditions for documents submission, in accordance with the Guideline on the content of the dossier for Type IA and IB variations
8. Only the notification form /implementation form and the supplementations/responses to information requests are submitted to the Registry office.
9. Variations are submitted together with supporting documents (approvals in other Member States, regardless of procedure type, assessment reports)
10. For variations to MA terms, the NAMMD issues the approval letter and amending documents and the date for implementation by the MAH is the date of NAMMD approval.
11. For variations OUTSIDE MA terms as implemented by MAHs, which the NAMMD decides on assessment of other variations to need supplementation of the dossier and/or rectification of already implemented Annexes, such variations have to be withdrawn and implemented in accordance with NAMMD approved terms
12. Variations submitted at the end of December 2011, in accordance with Order of the Minister of Health No. 1483/2010, are NOT within the scope of the points above; these are to be handled subsequently.
13. Type IA and IB variations to MA terms/outside MA terms, consecutive to one or several Type II variations, are OUTSIDE the scope of the points above; these are considered on NAMMD assessment of the main variation.