To the attention of Marketing Authorisation Holders
1. Type IA and IB variations outside MA terms are to be notified to the NAMMD by 15 December 2011
2. These variations are to be sent initially at the NAMMD e-mail address, variatii@anm.ro; subsequently, any type of submission at the Registry office are to be submitted to the official address as well; submission may be performed daily.
3. Variations are no longer to be sent as a group, for the entire portfolio of a company, divided into 2 notifications: one notification for variations leading to change of MA terms and another not involving change of MA terms
a. To avoid crowds at the Registry office and/or blocking of the NAMMD server, variations are to be submitted as a group for each product, i.e. those to MA terms separately from those outside MA terms, not necessarily however in conjunction with all the other products included in the company’s portfolio (gradually, commensurate with their filling in status by the MAH representative).
b. Initially, the submission is performed by e-mail and afterwards at the Registry office (in accordance with section 2). Only the notification/ implementation form are to be submitted at the Registry office and possibly the supplementations/responses to requests as well.
4. Variations are submitted together with supporting documents (approvals in other Member States, regardless of procedure type, assessment reports,) only if currently available at the company’s local representative
a. The purpose of the waiver is to avoid delays in notification to the NAMMD
b. Only resubmission of the Application remains a priority, including the “Current/Proposed” heading and, where required, together with additional documentation/supplementations requested during assessment.
5. Variations leading to change of MA terms receive NAMMD the approval letter together with the amending documents, and the date of implementation by the MAH is the date of NAMMD approval.
6. Variations implemented by the MAH for 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to need supplementation of the dossier and/or rectification of already implemented Annexes, such variations have to be withdrawn and implemented in accordance with NAMMD approved terms
7. Submission for variations assessment through national procedure is done in accordance with the classification specified in Order of the Minister of Health No. 1483/2010 and fees are in line with the current tariff system in force (in the same manner as for mutual recognition procedure)
8. Variations submitted between 5 January and 1 December 2011 will NOT fall under the scope of the aforementioned sections; these are assessed by the NAMMD
9. 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.