PHARMACEUTICAL LEGISLATION
Learning outcomes of the course unit
To provide a knowledge of the rules of law regarding the health italian organisation, the drug, the cosmetic and herbal products.
Course contents summary
- Notes of the European Directives concerning the medicines and of the pharmacist profession.
- Italian and European Pharmacopoeia.
- Health Italian Organisation: Ministry of Health, Local Health Authority, National Health Service.
- Pharmaceuticals representative.
- Classification of pharmacies.
- Classifications of medicines: patent medicine, generic drug, over the counter, galenic preparation.
- Regulations concerning production, storage and trade of medicines.
- The physician¿s prescriptions.
- Veterinary medicines.
- Narcotics.
- Poisons.
- Regulations concerning cosmetics products, herbal products, medical devices, diagnostics in vitro and biocides.
- Pharmacovigilance.
Recommended readings
M. Marchetti, P. Minghetti, ¿Esami di Farmacia ¿ Legislazione farmaceutica¿, Casa Editrice Ambrosiana (1999).
Farmacopea Ufficiale della Repubblica Italiana, XI Edizione, Istituto Poligrafico e Zecca dello Stato, Roma (2002).
