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,…

Supplement 7.1 of the European Pharmacopoeia

The European Pharmacopoeia (Ph. Eur.) is a reference work for the quality control of medicines in the signatory states of the Convention. 36 Member States and the European Union are signatory to the Convention on the Elaboration of a European Pharmacopoeia. 8 European countries, 14 non-european countries and the World Health Organization (WHO) are observers….

Information to include on leaflets of medicinal products authorised by AEMPS

The Circular information Nº 1/2011 of AEMPS, the Spanish Medicinal and Health Products Agency, published on 24 March 2011 (corrected on 8 April 2011), states the information that must be included on the leaflets of medicinal products. The Patient Information Leaflets (PIL) must indicate where an updated version of them can be obtained and how…