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Member states request all affected authorisation holders to provide some information in a spreadsheet. This spreadsheet should be completed for each product containing an AIR 2 active substance, also for generic products but there is no need for “clone” (back-to-back) products which are based fully on letters of access.
Even if the applicants may not be certain at this stage whether they intend to support the product at Art 43 renewal, they should include product details. Columns which do not apply should be left blank.
For example, the spreadsheet to be used for the central zone is available via
https://circabc.europa.eu/d/a/workspace/SpacesStore/4f23c4a3-4b8e-4836-8a6b-5bcb20e67cdd/art%2043%20renewal%20products%20table.xls
This information has been/will be sent by each MS to all affected authorisation holders in that MS.
The deadlines to submit these spreadsheets are as follows: until the 31 August 2014 for the Central zone and until 30 September 2014 for the Southern zone.
Authorisation holders may reply to each individual MS, but multinational companies may prefer to collate their responses at the zonal level and send the information to a common contact in the respective zone. For multinationals, please see below for contact details:
Central zone: This email address is being protected from spambots. You need JavaScript enabled to view it.
Southern zone: This email address is being protected from spambots. You need JavaScript enabled to view it. with copy to This email address is being protected from spambots. You need JavaScript enabled to view it. and This email address is being protected from spambots. You need JavaScript enabled to view it.
Northern zone: For the Northern Zone there is still no information available.
For more information, please contact
Dr. Albrecht Heidemann at This email address is being protected from spambots. You need JavaScript enabled to view it.