To the attention of Marketing Authorisation Holders
The following are applied as of 5 August 2013 concerning applications for variations to marketing authorisations granted through national procedure:
1. Validation letters, applications for validation/invalidation are to be forwarded via e-mail to MAH contact persons;
2. Targeted answers (clarifications) to NAMMD requests for validation purposes are forwarded via e-mail by holder assigned persons to the official e-mail addresses below;
3. Supplements to documentation required for validation of variations are submitted to the NAMMD Registry in electronic format, together with the cover letter and the e-mail message requiring supplementation of documentation; these are recorded as supplements to initial documentation submitted;
4. NAMMD requests for clarification/supplementation of documentation during assessment are forwarded via e-mail to holder assigned persons;
5. Targeted answers (clarifications) to NAMMD requests throughout assessment are forwarded via e-mail by holder assigned persons to the official e-mail addresses specified below;
6. Supplements to the dossier during assessment are submitted to the NAMMD Registry in electronic format together with the cover letter and the e-mail message requiring dossier supplementation; these are recorded as supplements to the initial dossier submitted;
7. At the end of the assessment period, the NAMMD issues letters of approval/rejection concerning the variations in question, as required.
To ensure NAMMD-Holder proper communication, holders are invited to provide the names and e-mail addresses of the (preferably two) persons assigned for communication with the Agency. These are to be forwarded to the attention of the National Procedure Department, via manufacturer associations, as required.
NAMMD e-mail addresses for handling of variations through national procedure are as follows:
– email@example.com – for handling of changes to data and administrative data concerning synthesis products;
– firstname.lastname@example.org – for handling of changes to chemical-pharmaceutical biological data and administrative data related to biologicals;
– email@example.com – for handling of changes to medicinal product information, trade name and ATC code changes included;
– firstname.lastname@example.org – for handling of pharmacovigilance changes.
As regards grouped variations, handling of changes is performed via the e-mail box assigned to the group defining variation. Applications for variation to marketing authorisation terms are submitted in accordance with Regulation 1234 of 2008, as amended, and Law 95/2006, as amended.
Type IA and IAIN variations may be implemented prior to submission of respective applications to the NAMMD.
At least 15 days prior to submission of the application for variation, the Holder is required to submit the letter of intent and the filled-in payment form.
As requested, the NAMMD regulates the tariff for variations to marketing authorisation terms.
Details on the handling of variations through national procedure are given in the Decision to be submitted to the NAMMD Scientific Council.