Pharmaceutical legislation and deontology

Course Code :2004FBDFAR
Study domain:Pharmaceutical Sciences
Academic year:2019-2020
Semester:1st semester
Sequentiality:
Contact hours:22.5
Credits:3
Study load (hours):84
Contract restrictions: No contract restriction
Language of instruction:Dutch
Exam period:exam in the 1st semester
Lecturer(s)Luc Van Santvliet

3. Course contents *

The national legislation regarding medicinal products and health products and the practice of pharmacy consists of a large number of laws and decrees, which are no always presented in a co-ordinated way. They are often based on EU directives. The course will try to provide guidance in the subject and to discuss the legislation with focus on the legislation applicable to public pharmacies.
The definition of a medicinal product and other heath products is explained. The monopoly of the pharmacist, the requirements for a public pharmacy and the establishment of pharmacies are discussed. The dispensing of medicinal products as important task of a pharmacist and the specifi legal requirements regarding toxic substances, narcotics and psychotropic substances are described in detail. Attention is paid to the compliance of medicinal products and unauthorised practices in the field of medicinal products. Also publicity and information with regard to medicinal products are discussed.
Marketing authorisation and registration of medicinal products, the manufacture, import and wholesale distribution of medicinal product, clinical biology and hospital pharmacy are briefly discussed, in particular those aspects relevant to the public pharmacy.
In a separate chapter the specific requirements for medicinal product for veterinary use are elaborated.
A reprentative of the FAMHP gives a presentation on pharmacovigilance in Belgium and the role of the pharmacist.
The composition and the objectives of the competent authorities responsible for the enforcement of the pharmaceutical legislation, i.e. the Federal Agency for Medicinal Products and Health Products, the European Medicines Agency and the Medical Committees are discussed.
Finally, the organisation, goals, sanctions and ethical code of the ‘Orde der Apothekers’ are explained in order to familiarise the future pharmacist with his professional ethiscs. Representatives of the Orde will present the organisation.
At the end of the course, there is a virtual inspection of a public pharmacy to test the knowledge acquired during the course.