Subsection 1: General provisions applicable to manufacture and import.

Before removing or partially or totally covering the safety features provided for in article R. 5121-138-2, the pharmaceutical establishment which manufactures medicinal products shall check that the medicinal product concerned is genuine and has not been tampered with.

When the pharmacist in charge of a manufacturer, importer or operator of medicinal products other than investigational medicinal products, generators, kits or precursors referred to in 3° of article L. 4211-1 becomes aware, after a batch of medicinal products or products has been marketed, of an incident or accident which has occurred during the manufacture or distribution of this batch and which may result in a risk to public health,…

The provisions of articles R. 5124-49 to R. 5124-55 are applicable to manufacturers and importers of dressing articles or articles presented as complying with the pharmacopoeia mentioned in 2° of article L. 4211-1, or divided officinal products mentioned in 4° of article L. 5121-1. The obligations laid down by these articles are applied by reference to the pharmacopoeia monographs which describe them.