| Type-IA variation (Administrative changes)-A.4. |
Definition: Change in the name and /or address of a manufacturer or an ASMF holder or a supplier of the API, starting material where no Ph. Eur. certificate of suitability is part of the approved dossier.
Required documentation:
1. A formal document from a relevant official body (eg. chamber of commerce) in which the new and/or address is mentioned
2. Amendment of the relevant sections of the dossier
3. In case of change in the name of the holder of the API holder, updated letter of access. |
Type-IAIN variation (quality change)-B.I.a.1.a
(Change in the manufacturer (including where relevant quality control testing sites) of the active substance (AS), where no Ph. Eur. certificate of suitability is part of the approved dossier) |
Definition: The proposed manufacturer is part of the same pharmaceutical group as the currently approved manufacturer
Required documentation:
1. Amendment of the relevant sections of the dossier.
2. A declaration on similarity of API synthetic route, specifications and test procedure for both API suppliers.
3. Either a TSE Ph. Eur. certificate of suitability for any new source of material (where applicable).
4. Batch analysis data for at least two batches (minimum pilot scale) of the API from the current and proposed manufacturers/sites.
5. Detailed information in Module-1, 1.2 Application form, section 2.5 outline the ‘present’ and ‘proposed’ manufacturers.
6. QP declaration for each of API manufacturing facility. |