EMA increase of fees from 1 April 2018

Every year, the European Medicines Agency (EMA)  adjusts its fees on 1 April, in line with the European Union (EU) inflation rate for the previous year. On 1 April 2018 general, non-pharmacovigilance fees payable to EMA by applicants and marketing-authorisation holders (MAH) are increasing by 1.7%. Applications received after the 31 March 2018 will be charged the…

Parabens – Is there a risk by taking medicinal products containing them?

Parabens are preservatives which avoid microbiological contamination of drug products (by mushrooms or microorganisms) and stop the degradation of active substances (which diminishes the medicinal product efficacy). Parabens are present in certain foods, cosmetics and medicinal products. Their type and concentration are different depending on the concerned product. They are esters of the para-hydroxybenzoic acid…

Biosimilars

Afssaps’ MA (Marketing Authorisation) commission discussed biosimilars on the 12th of May 2011. An information paper was published on 13/05/2011. A biosimilar (similar biological medicinal product) is a medicinal product which is similar to a reference biological medicinal product that has been already authorized in the European Union. The principle of similarity applies to any…

Safer herbal medicinal products

The Directive 2001/83/CE of 6th November 2001, on the Community code relating to medicinal products for human use, demands that all marketing authorization requests for a medicinal product must be accompanied by a dossier containing information and documents demonstrating the quality, safety and efficacy of the product. However, a significant number of traditional medicinal products,…