The "Guideline on good pharmacovigilance practices", Module VI obliges marketing authorization holders, among other things, to monitor the local medical press. Publications relating to any adverse drug reactions are to be identified and fed into the…

In order to achieve the highest possible level of health protection, very high quality requirements are placed on the manufacture of medicinal products. As a result, only drugs whose quality, efficacy and safety are guaranteed are released for…

The distributor informed its supplied customers in a letter dated November 14, 2012, that a deviation in the manufacturing process, which was identified during an internal audit, may result in a reduced efficacy of the product. The potential…

The batches of Fluad and Sandovac influenza vaccines that were temporarily suspended two weeks ago due to a suspected quality defect (white particles in the bulk vaccine) were re-released on Nov. 9, 2012.

New confirmed cases in the province of Matera.

Other confirmed cases of autochthonous infection on Madeira Island.

The marketing authorization holder informed its supplied customers in a letter dated October 24, 2012, that there is a possible pyrogen contamination in the two batches listed above.

Unless marketing authorization holders have made use of the legal provision (Section 94 c (10) of the Austrian Medicines Act) and submitted the required renewal documents for a specific medicinal product to AGES Medizinmarktaufsicht by June 30, 2012,…

The marketing authorization holder, in consultation with the French authority, informed its supplied customers by letter dated 10/10/2012 that batch C079 is being recalled because it has a different volume/activity indication on the bottle label…

The BMG, BMI, BMF and BASG participated in this year's action week. The operation took place this year from 25.09. to 02.10.2012. In total, more than 100 countries worldwide participated in the organized action. The aim was to simultaneously and in a…