Examples of Marketing Authorisation in a sentence
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT • Risk Management Plan (RMP) The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
The essential point is that all relevant details demonstrating compliance with the Marketing Authorisation and the Ph. Eur.
Marketing Authorisation Holders are responsible for the accuracy and correctness of the content of the published RMP summaries.
Notice to Marketing Authorisation Holders: Pharmacovigilance Guidelines: 29 January 1999: CPMP/PhVWP/108/99 corr.2. International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use: ICH Harmonised Tripartite Guideline.
They should comply with the relevant parts of Product Specification Files, Manufacturing and Marketing Authorisation dossiers, as appropriate.