What is a pharmacovigilance system master file?
What is a pharmacovigilance system master file?
The pharmacovigilance system master file (PSMF) is a detailed description of the pharmacovigilance system used by the MAH with respect to one or more authorised medicinal products. The PSMF is not part of the marketing authorisation (MA) dossier and is maintained independently from the MA.
What details need to be provided in the cover page of PSMF?
Cover Page: 1- The unique number (Revision No.) 2- The name of the MAH, QPPV or LSR (including third party). 3- The name of other concerned MAH(s) (sharing the pharmacovigilance system). If applicable 4- The list of PSMFs/ PSSFs for the MAH (Products with a different pharmacovigilance system) If applicable.
Which GVP module talks about pharmacovigilance system master file?
GVP Module II
GVP Module II – Pharmacovigilance System Master File (PSMF)
What is Mah in pharmacovigilance?
Marketing authorisation holders (MAH) are required to develop a pharmacovigilance system and provide a detailed description of it as part of their Marketing authorisation application (MAA).
What does QPPV stand for?
Qualified Person for Pharmacovigilance
QPPV
| Acronym | Definition |
|---|---|
| QPPV | Qualified Person for Pharmacovigilance (drug safety inspector) |
What is PSMF diet plan?
A protein-sparing modified fast (PSMF) is a type of a very-low-calorie diet (<800 kcal per day) with a high proportion of protein calories and simultaneous restriction of carbohydrate and fat. It includes a protein component, fluids, and vitamin and mineral supplementation.
How many modules are there in GVP?
Background to public consultation on GVP This new guidance on good pharmacovigilance practices (GVP) is organised into Modules, and the first seven Modules on prioritised topics are now available for public consultation.
What does MA holder mean?
MA Holder means the entity that holds the Marketing Approval for a product in a given country.
How many GVP modules are there?
