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University of Parma
Course catalogue
Università degli Studi di Parma
course catalogue

PHARMACEUTICAL LEGISLATION
cod. 18379

Academic year 2009/10
2° year of course - First semester
Professor
Academic discipline
Farmaceutico tecnologico applicativo (CHIM/09)
Field
Discipline chimiche
Type of training activity
Characterising
32 hours
of face-to-face activities
4 credits
hub: -
course unit
in - - -
lectures timetable unavailable
exam calls

Integrated course unit module: PHARMACEUTICAL FORMS-PHARMACEUTICAL LEGISLATION

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Learning objectives

<br />To provide a knowledge of the rules of law regarding the health italian organisation, the drug, the cosmetic and herbal products.  

Prerequisites

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Course unit content

<br /> - Notes of the European Directives concerning the medicines and of the pharmacist profession.<br />- Italian and European Pharmacopoeia.<br />- Health Italian Organisation: Ministry of Health, Local Health Authority, National Health Service.<br />- Pharmaceuticals representative.<br />- Classification of pharmacies.<br />- Classifications of medicines: patent medicine, generic drug, over the counter, galenic preparation.  <br />- Regulations concerning production, storage and trade of medicines.<br />- The physician¿s prescriptions.<br />- Veterinary medicines.<br />- Narcotics.<br />- Poisons.<br />- Regulations concerning cosmetics products, herbal products, medical devices, diagnostics in vitro and biocides.<br />- Pharmacovigilance.<br /> 

Full programme

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Bibliography

<br />M. Marchetti, P. Minghetti, ¿Esami di Farmacia ¿ Legislazione farmaceutica¿, Casa Editrice Ambrosiana (1999).<br />Farmacopea Ufficiale della Repubblica Italiana, XI Edizione, Istituto Poligrafico e Zecca dello Stato, Roma (2002).

Teaching methods

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Assessment methods and criteria

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Other information

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