This notice can be provided in two cases:
- results outside specifications (OOS) of the finished product at release,
- problems with labelling or package leaflets.
Reminder: Other deviations observed during manufacture or controls, without affecting compliance with the specifications of the finished release product or its stability, must be treated under the responsibility of the pharmaceutical authority, without requesting an opinion from the ANMV (See Annex XVI to Good Manufacturing Practices (GMP)). These deviations must be thoroughly investigated and documented, and the causes must be corrected. If necessary, an application to amend the MA must be submitted to the ANMV.
We draw your attention to the fact that a request for a notice for the release of a particular lot can only be made in the event of a non-compliance of the finished product at release or of a labelling or package leaflet problem of the finished product.
The ANMV does not give advice on the release of consignments of non-compliant raw material. If a raw material is controlled non-compliant, it is the responsibility of the pharmacist responsible to assess the non-compliance and decide whether or not to use that raw material in the manufacture of the finished product.