SubjectsSubjects(version: 949)
Course, academic year 2019/2020
Registration of Drugs and Patent Protection - N110025
Title: Registrace léčiv a patentová ochrana
Guaranteed by: Department of Organic Chemistry (110)
Faculty: Faculty of Chemical Technology
Actual: from 2017 to 2019
Semester: both
Points: 3
E-Credits: 3
Examination process:
Hours per week, examination: 2/0, Ex [HT]
Capacity: winter:70 / unknown (unknown)
summer:unknown / unknown (unknown)
Min. number of students: unlimited
Language: Czech
Teaching methods: full-time
Teaching methods: full-time
For type:  
Additional information: http://předmět vyučován pouze v zimním semestru
Note: you can enroll for the course in winter and in summer semester
Guarantor: Zítková Tereza Ing.
Karkošková Karolína Ing.
Is interchangeable with: B110010
Examination dates   Schedule   
Annotation -
Last update: TAJ101 (02.09.2013)
The essential aim of the subject is to give the basic information about the legal framework for pharmaceuticals and about principles of patent protection on pharmaceuticals
Aim of the course -
Last update: TAJ101 (03.12.2013)

The students will be able to

be well informed about the rules governing the marketing authorisation procedures both from the marketing autorization holderś and the regulatory

authoritys´ points of view

able to choose the optimal marketing authorisation procedure suitable for the medicinal product

to compile and to evaluate registration dossier

familiar with the basic principles of pharmacovigilance

be informed about principles of patent protection on pharmaceuticals.

Literature -
Last update: Kubová Petra Ing. (25.08.2016)

A: Rules Governing Medicinal Products in the European Union

Volume 1 - EU pharmaceutical legislation for medicinal products for human use

Volume 2 - Notice to applicants and regulatory guidelines for medicinal products for human use

A: Essentials of Pharmaceutical Chemistry, Donald Cairns, Pharmaceutical Press, 2008

A: Právní ochrana průmyslového a jiného duševního vlastnictví, Ladislav Jákl, MUP Praha, 2008

Learning resources -
Last update: TAJ101 (02.09.2013)

State Institute for Drug Control

Ministry of Health

European Commission :

European Medicines Agency


Syllabus -
Last update: Kubová Petra Ing. (25.08.2016)

1. Life Cycle of the medicinal product, drug regulation in the Czech Republic and the EU, position of the State Institute for Drug Control (SUKL) in the Czech Republic and EU

2. Availability of medicinal products for patients, borderline products, foodstuffs intended for particular nutritional uses, proprietary medicinal products, individually prepared medicinal products, dispensing regimes, requirements for individual schemes availability of unregistered medicinal product, enforcement

3. Act on pharmaceuticals and related legislation, links to European legislation (primary, secondary legislation, Regulations, Directives, Decisions, Communications, ...), the application of legislation related to the medicinal products

4. Registration procedures in the EU (centralized, mutual recognition procedure, decentralized, national)

5. Protection of intellectual property rights in the area of medicinal products (generics, patent law, supplementary protection certificate - SPC, data exclusivity, judicial proceedings)

6. Identification of medicinal products in the Czech Republic, assessing of the product name, pricing and reimbursement from health insurance, availability of information for professional and general public.

7. Clinical trials, phases of clinical trials, types of clinical trials

8. Structure of the registration dossier, CTD (Common Technical Document), eCTD (electronic Common Technical Document)

9. Quality of medicinal product - pharmaceutical, chemical and biological documentation, active ingredient, DMF (Drug Master File), Ph.Eur. Certificate of Suitability

10. Safety of the medicinal product - preclinical documentation (results of pre-clinical tests,) efficacy - clinical documentation (results of clinical trials)

11. Post-authorization "life" of the medicinal product (PSUR, PSUSA, variations, renewal of marketing authorisation, withdrawal of MA, Referral, fees)

12. Pharmacovigilance and quality defects

13. Information systems and databases in pharmaceuticals (AISLP, IDRAC, EudraPharm, EudraCT, EudraVigilance ...)

14. FDA (Food and Drug Administration), Regulatory Inspections and Audits

Registration requirements -
Last update: TAJ101 (02.09.2013)

Základy farmakologie N111024

Základy farmakochemie N110026

Teaching methods
Activity Credits Hours
Konzultace s vyučujícími 0.2 6
Účast na přednáškách 1 28
Příprava na přednášky, semináře, laboratoře, exkurzi nebo praxi 0.5 14
Příprava na zkoušku a její absolvování 1.3 36
3 / 3 84 / 84
Coursework assessment
Form Significance
Examination test 100