TECNOLOGIA FARMACEUTICA 1 - LEGISLAZIONE FARMACEUTICA E LABORATORIO GALENICO M - ZModule LEGISLAZIONE FARMACEUTICA E LABORATORIO GALENICO
Academic Year 2026/2027 - 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
Lectures and individual laboratory practical sessions. Should the course be delivered in a blended or fully remote format, the necessary adjustments may be made to the arrangements described above in order to ensure compliance with the programme outlined in the syllabus.
Students may use AI as a tool to support their studies, in compliance with applicable legislation, including regulations concerning copyright and the use of intellectual works, as described in Section 5.1 of the guidelines (https://www.unict.it/it/ateneo/cidia-centro-l%E2%80%99informatica-la-digitalizzazione-e-l%E2%80%99intelligenza-artificiale).
Required Prerequisites
No particular prerequisites are required.
Attendance of Lessons
Mandatory attendance in accordance with the provisions of the Educational Regulations of the CTF Degree Programme, as set out in the following link: http://www.dsf.unict.it/corsi/lm-13_ctf/regolamento-didattico
Information for Students with Disabilities and/or Specific Learning Disorders (SLD)
To ensure equal opportunities and in compliance with current legislation, students concerned may request a personal meeting in order to plan any appropriate compensatory and/or exemption measures, taking into account the learning objectives and their specific needs.
Students may also contact the CInAP (Centre for Active and Participatory Integration – Disability and/or Specific Learning Disorders Services) faculty contact person for our Department, Prof. Santina Chiechio.
Detailed Course Content
Pharmaceutical Legislation: Healthcare professions and the practice of pharmacy; Administrative classification of pharmacies and the territorial distribution system; Organization of community pharmacies and other establishments authorized to dispense medicinal products and practice pharmacy; Classification of medicinal products (Legislative Decree 219/2006); The authorization system for the manufacture and marketing of medicinal products; Regulations concerning narcotic and psychotropic substances: prescriptions for narcotic drugs, pharmacists’ obligations regarding purchase, storage and disposal procedures, formal requirements for completing and maintaining documentation, management of the incoming/outgoing register and purchase vouchers; Regulations concerning doping substances: pharmacists’ obligations; Regulations concerning veterinary medicinal products: veterinary prescriptions and electronic veterinary prescriptions, traceability and pharmacovigilance of veterinary medicinal products, and animal health and welfare feed; Regulations governing the marketing of homeopathic medicinal products, herbal medicinal products, food supplements, medical devices, medical-surgical products and healthcare items.
Compounding Laboratory: Management of medicinal products for human use and regulations governing the dispensing of medicinal products to the public; Italian Official Pharmacopoeia; Management of poisons: storage procedures and pharmacists’ obligations; Extemporaneous magistral and officinal preparations: preparation and quality control of personalized medicinal products in the pharmacy laboratory, based on medical prescriptions or Pharmacopoeias; Pricing and application of Good Preparation Practices.
The following seminar activities will also be offered:
- Oxygen and oxygen therapy: storage and instructions on methods of administration.
- Vaccines: Recommended vaccinations and vaccination schedules; pre-vaccination triage; preparation and administration of vaccines in pharmacies; management of emergencies and adverse reactions following vaccination.
- Digital healthcare and medicinal product traceability: information flows and the New Health Information System (NSIS); Electronic Health Record (EHR) and pharmaceutical dossier; databases; unique identification of medicinal product packages; monitoring of services provided through direct distribution and distribution on behalf of the National Health Service.
- Patient relations: patient counseling, provision of accurate information, health education, promotion of healthy lifestyles; screening and disease prevention campaigns, and vaccination prophylaxis.
Textbook Information
- P. MINGHETTI - Legislazione Farmaceutica – undicesima edizione - Casa Editrice Ambrosiana
- F.U.I. XII Ed.
- LOLISCIO N. La farmacia un campo minato - Il manuale del farmacista - Guida pratica 2025 - Società Editrice Esculapio
Course Planning
| Subjects | Text References | |
|---|---|---|
| 1 | Il servizio farmaceutico e sua organizzazione territoriale | |
| 2 | Classificazione dei medicamenti (DLvo 219/2006) | |
| 3 | Disciplina di dispensazione al pubblico dei medicamenti | |
| 4 | Il sistema delle autorizzazioni per la produzione e l’immissione in commercio dei farmaci | |
| 5 | Farmacopea ufficiale italiana | |
| 6 | Il prezzo dei medicinali | |
| 7 | Normativa riguardante le sostanze stupefacenti e psicotrope e dopanti | |
| 8 | Norme di buona fabbricazione | |
| 9 | Normativa sui medicinali per uso veterinario: la prescrizione medica veterinaria e la ricetta elettronica veterinaria, la tracciabilità e la farmacovigilanza dei medicinali veterinari, alimenti per il benessere animale. | |
| 10 | Normative relative alla commercializzazione di omeopatici, fitoterapici, integratori alimentari, dispositivi medici, 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
Learning Assessment Procedures
Oral examination and practical assessment related to the activities carried out in the teaching laboratory.
Examination dates are published on the Degree Programme website at the following link: https://www.dsf.unict.it/sites/default/files/2025-07-24-calendario%20esami%20CTF.pdf
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?