Academic Year 2023/2024 - Teacher: CARMELO PUGLIA

Expected Learning Outcomes

To give the basic knowledge for the preparation and control of dosage forms together with the basic concepts relating to the pharmaceutical legislation.

Course Structure

Frontal lectures and laboratory exercises. Should teaching be carried out in mixed mode or remotely, it may be necessary to introduce changes with respect to previous statements, in line with the programme planned and outlined in the syllabus.

Required Prerequisites

No particular prerequisites are required.

Detailed Course Content

Pharmaceutical socioeconomy and regulations: National and supranational health organization. The pharmaceutical service and its territorial organization. Drug classification (Dlvo 219/2006). Regulations on medicinal selling. The authorization system for the manufacturing and selling of drugs. Medicinal prices. Regulation on narcotic and psychotropic substances. Good manufacturing procedures. Regulations on the market of cosmetics, homeopathics, phytotherapeutics, dietary supplements, and medical devices.

Laboratory exercises: Lessons and exercises about the formulation and the prices of galenic and evaluation of shipment of a medical recipe according to the recent regulations; individual practical formulation of the major pharmaceutical forms dispensable in pharmacies; quality control of some pharmaceutical forms prepared in the laboratory, according to Eur. Ph.

Textbook Information

  1. P. MINGHETTI - Legislazione Farmaceutica – decima edizione - Casa Editrice Ambrosiana
  2. F.U.I. XII  Ed.

Course Planning

 SubjectsText References
1Organizzazione sanitaria nazionale e sopranazionaletesto 3 - capitoli 1 e 2
2Il servizio farmaceutico e sua organizzazione territorialetesto 3 - capitoli 4 e 5
3Classificazione dei medicamenti (DLvo 219/2006)testo 3 - capitolo 7
4Disciplina di dispensazione al pubblico dei medicamentitesto 3 - capitolo 9
5Il sistema delle autorizzazioni per la produzione e l’immissione in commercio dei farmacitesto 3 - capitolo 7
6Farmacopea ufficiale italiana testo 3 - capitolo 8
7Il prezzo dei medicinalitesto 3 - capitolo 8
8Normativa riguardante le sostanze stupefacenti e psicotropetesto 3 - capitolo 10
9Norme di buona fabbricazionetesto 3 - Appendice C pag.740-750
10Normative relative alla commercializzazione di cosmetici, omeopatici, fitoterapici, integratori alimentari, presidi medico-chirurgici e articoli sanitaritesto 3 - capitoli 7, 12 e 13
11tariffazione di formule magistrali ed officinali nonché modalità di spedizione delle medesime, secondo la vigente legislazioneLezioni introduttive al laboratorio di tecnologia farmaceutica e consultazione del quaderno di tecnologia farmaceutica

Learning Assessment

Examples of frequently asked questions and / or exercises

1. Define the different types of medical prescription and explain for which category of drugs it is mandatory

2. The administrative classification of medicines according to law 219/2006 

3. Report the contents of the Tables of the Official Italian Pharmacopoeia 

4. The public pharmacy and the private pharmacy: what are the differences in administrative and management terms?

5. What are the characteristics of a dossier for the AIC request?