psmf

Pharmacovigilance requirements are constantly evolving and one may not find it difficult to monitor the requirements in EU, US, Canada, Australia, Japan, India, New Zealand, Singapore, Switzerland etc., as these are available in English and we know where to find them. However, we still need to periodically monitor if anything has changed, as any delay […]

Algeria is a North African country, located somewhat close to the European Union. The Centre National de Pharmacovigilance et de Materiovigilance (CNPM) updated the Pharmacovigilance guideline in 2019 and it is more or less on the lines of GVP, with some minor alterations. Some examples include: 1. ICSRs · Domestic Serious – 15 Calendar Days […]

Whenever we think about Pharmacovigilance in France, two things come to mind. First is the French Imputability Method of Causality, and the second is ‘Exploitant.’ The concept of ‘Exploitant’ is specific to France. Under the French legal framework, a Marketing Authorization Holder (MAH) which wants to market a medicinal product in France, needs to hold […]