SubjectsSubjects(version: 964)
Course, academic year 2024/2025
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Basics of Legislation - Drug Policy in EU - GAF119
Title: Základy právních nauk
Guaranteed by: Department of Social and Clinical Pharmacy (16-16220)
Faculty: Faculty of Pharmacy in Hradec Králové
Actual: from 2014
Semester: summer
Points: 0
E-Credits: 2
Examination process: summer s.:
Hours per week, examination: summer s.:2/0, Ex [HT]
Capacity: unknown / unknown (unknown)
Min. number of students: unlimited
4EU+: no
Virtual mobility / capacity: no
Key competences:  
State of the course: not taught
Language: English
Teaching methods: full-time
Level:  
Explanation: (F,1.r.)
Note: course can be enrolled in outside the study plan
enabled for web enrollment
Guarantor: doc. PhDr. František Dohnal, CSc.
Classification: Pharmacy > General Subjects
Examination dates   Schedule   
Annotation -
Annotation: general problems, society and law, private law, public law, pharmaceutical law, EU law.
Last update: OLIVOVA/FAF.CUNI.CZ (26.06.2008)
Literature -

Compulsory:

1. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use

2. Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

3. Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems.

4. Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products

Last update: OLIVOVA/FAF.CUNI.CZ (26.06.2008)
Teaching methods -

Teaching method: lectures, exam.

Last update: OLIVOVA/FAF.CUNI.CZ (26.06.2008)
Syllabus -

Syllabus:

General problems

Private law

Brief introduction to the history of civil (Roman) law and to common law.

Basic institutions of private law: legal subjectivity, natural person, legal person, representation, liability, corporate law.

Public law

Introduction to public law with regard to pharmacy: basic principles of public law (including criminal law).

EU law

Structure of EU, sources of EU law, relation between EU law and national laws

Pharmaceutical law in EU

Regulations and directives governing EU pharmaceutical law.

Last update: OLIVOVA/FAF.CUNI.CZ (26.06.2008)
 
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