“The Council of Ministers n. 52 of 6 April 2006, on the proposal of the Minister for Community Policies, La Malfa, and the Minister of Health, approved a legislative decree for the transposition of Community Directives 2001/83 and 2003/94 on medicines for human use; the transposition has given rise to a codification of the matter (with the exception of the aspects concerning the prices and supply of medicines with costs borne by the National Health Service) which therefore contemplates the placing on the market, the special rules for homeopathic and herbal medicines , the authorization regime, importation, good manufacturing guidelines, labeling and package leaflets, wholesale, advertising, pharmacovigilance and sanctions”. (www.governo.it)
However, we deem it appropriate to inform you of what was published this morning by "The sun 24 hours” on page 26:
“Medicines. The Council of Ministers has given the definitive green light to the Code of Medicines: a legislative decree which transposes the community directives 2001/83 and 2003/94 on medicines for human use which had been sent to Parliament in early December 2005. the provision regulates the entire life cycle of pharmaceutical products (with the exception of clinical trials). Prescriptions not covered by the National Health Service will be valid doubled from 3 to 6 months, but cannot be used more than 10 times. The rules on prizes, tips and favors promised or granted by informants to doctors and pharmacists are also becoming stricter: they could lead to a fine from 400 to one thousand euros, arrest of up to one year and suspension from practicing the profession”.
Angelo de Rita
