The requirements for the labelling of a medicinal product distributed in France are defined in part by Annexes III A and III B of the marketing authorisation and in part by the Public Health Code. The MA holder is responsible for ensuring that parts III A and III B adjust to regulatory developments and the product’s lifecycle.
Cevidra will provide you with the expertise you need to bring all packaging elements into line with French regulations. Any amendment to Annexes III A and III B must be cleared by an authority following the submission of an amendment application by the MA holder.
The French mock-ups are prepared jointly by the MAH and the exploitant in France before they are submitted to the French Agency for approval.
Once approved by the authorities, the mock-ups are used as a reference for the manufacture of the medicinal product packaging components. The manufacturing of packaging components is the responsibility of the manufacturer, a process in which the exploitant intervenes to ensure that packaging meets local requirements. This process is of course a prerequisite for the marketing of a medicinal product in France.