TECNOLOGIA FARMACEUTICA 1 - LEGISLAZIONE FARMACEUTICA E LABORATORIO GALENICO A - LModule LEGISLAZIONE FARMACEUTICA E LABORATORIO GALENICO
Academic Year 2024/2025 - Teacher: CARMELO PUGLIAExpected 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
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
- P. MINGHETTI - Legislazione Farmaceutica – decima edizione - Casa Editrice Ambrosiana
- F.U.I. XII Ed.
Course Planning
| Subjects | Text References | |
|---|---|---|
| 1 | Organizzazione sanitaria nazionale e sopranazionale | |
| 2 | Il servizio farmaceutico e sua organizzazione territoriale | |
| 3 | Classificazione dei medicamenti (DLvo 219/2006) | |
| 4 | Disciplina di dispensazione al pubblico dei medicamenti | |
| 5 | Il sistema delle autorizzazioni per la produzione e l’immissione in commercio dei farmaci | |
| 6 | Farmacopea ufficiale italiana | |
| 7 | Il prezzo dei medicinali | |
| 8 | Normativa riguardante le sostanze stupefacenti e psicotrope | |
| 9 | Norme di buona fabbricazione | |
| 10 | Normative relative alla commercializzazione di cosmetici, omeopatici, fitoterapici, integratori alimentari, presidi medico-chirurgici e articoli sanitari | |
| 11 | tariffazione di formule magistrali ed officinali nonché modalità di spedizione delle medesime, secondo la vigente legislazione |
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?