cod. 1004487

Academic year 2019/20
4° year of course - First semester
Academic discipline
Farmaceutico tecnologico applicativo (CHIM/09)
Discipline chimiche, farmaceutiche e tecnologiche
Type of training activity
40 hours
of face-to-face activities
5 credits
hub: PARMA
course unit

Learning objectives

Pharmaceutical Regulations will provide an in-depth knowledge of the pharmaceutical legislation concerning, in particular, the practice of community pharmacists who directly provide the essential pharmaceutical service to the citizens or the pharmacist who works in contexts indirectly related to the pharmaceutical service.


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Course unit content

The first section of the subject is devoted to general presentations related to European regulations, Italian Healthcare system and Health professions registries.
The second part of the subject is dedicated to the administrative classification of pharmacies, public selection for the allocation of new pharmacies, informal and formal substitution of pharmacy owner, temporary administration, professional ethics of the pharmacist, continuing Medical Education (CME).
The final section of the subject is dealing with required standards for the production and trade of human medicinal products, classification of medicinal products, pharmacopoeias, dispensing of medicinal products subject to prescription to the public, medicinal products not subject to medical prescription, regulations specific for veterinary medicinal products, regulations for medical devices.

Full programme

International regulations
Italian Healthcare system
Classification of pharmacies and distribution on the territory
Ethics of the pharmacist
Continuing Medical Education (CME)
Standards for the production and trade of medicinal products for human
Classification of medicines
Discipline dispensing the medicines to the public
Medicinal products not subject to medical prescription
Rules for Veterinary Medicinal Products
Rules interesting medical devices, in vitro diagnostic, biocides and sanitary


M. MARCHETTI, P. MINGHETTI: "Legislazione Farmaceutica", Casa Editrice Ambrosiana, Ultima Ed.; FARMACOPEA UFFICIALE ITALIANA XII ed., Istituto Poligrafico dello Stato; European Pharmacopoeia

Teaching methods

Lectures with the aid of computer tools for the projection of lessons

Assessment methods and criteria

As a further opportunity of evaluation, to students attending the lesson is proposed an evaluation of the semester learning through written test at the end of the teaching of each module. The test consists in multiple choice questionnaire.

In alternative an evaluation via oral examination is also possible at the exam sessions.

Other information

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