Categoria: Italian Regulatory Affairs News
Controversy over off-label use continues
The debate continues on off-label use, which is permitted by some governments for the sole purpose of reducing the costs of national health care.
The European monitoring project has been concluded
The European Medicines Agency has completed a major project that explored the possibilities of improving the evaluation of drugs in Europe.
Supplements, prohibitions, and maximum intakes
The Ministry of Health has set new limits and prohibitions on the use of substances in food supplements.
Information on allergens, new indications by the Ministry
The information provided to the final consumer about substances or products that may cause allergies or intolerances are regulated in a specific manner.
Plasma derivatives, a batch has been prohibited
The Italian Medicines Agency has communicated to all the parties in the pharmaceutical distribution chain of the prohibition of the use of a batch of…
Transparency: update February 2015
The new transparency list of medicines included in the list of equivalent drugs is available (Law 178/2002)