In your studies 'Drug Regulator Affairs'
Study modules
MDRA-26 (academic year 2024/2025)
Module 2 Pharmaceutical Law
Pharmaceutical law in Germany, the EU and other countries and related laws
| Teaching time | Study time | Type of examination | Credit points |
|---|---|---|---|
| ca. 30 hours | ca. 30 hours | Study paper and oral examination | 6 |
Dr. Angela Graf
AMG in the legal system of civil, criminal and public law standards
- Authorisation procedures for the authorisation, subsequent authorisation and manufacture of medicinal products
- Procedures for the renewal of marketing authorisations
- Revocation and restrictions of marketing authorisations in so-called graduated plan procedures
- Duties and responsibilities of authorised representatives within the meaning of the AMG Manufacturing, control, distribution, information, step-by-step plan
- Control of the import and export of medicinal products
Administrative Procedure Act (VwVfG): Significance for administrative procedures under the German Medicinal Products Act (AMG)
- Main features of an administrative procedure
- Rights of parties involved (e.g. right to: Consultation, inspection of files, protection of trade and business secrets)
- Legal remedies (objection procedure)
- Types, significance and calculation of procedural deadlines with regard to the AMG
- Missing deadlines (effects, requirements for reinstatement)
Authorisation of generics - property rights of the original manufacturer
- Requirements for the dossier
- Validation vs. evaluation of generic applications
- Utilisation of documents of the first applicant
- Limits of the originator's property rights
- Importance of patents, so-called protection certificates and document protection (so-called intellectual property)
EU legal system for the manufacture, authorisation and distribution of medicinal products
- Legal quality of EU standards
- EU system for the authorisation of medicinal products
- System comparison between centralised and decentralised authorisation procedures
Special EU legal requirements for the authorisation of medicinal products
- Accelerated procedure
- Conditional approval, Regulation 507/2006/EC
- Authorisation to impose conditions and follow-up measures (FUM)
- Paediatric Medicinal Products Regulation 1901/2006/EC
Clinical trials of medicinal products
- Requirements and control system according to the AMG and the draft EU directive
- Monitoring tasks of the authorities involved
- Notification and authorisation procedures
- Importance of the ethics committees and the medical code of conduct
- RLegal quality and significance of the GCP guidelines
Product character of the medicinal product in distinction to food and cosmetics
- Definition and relevant demarcation criteria according to EC law, AMG and LMBG
- BSignificance for the marketability of so-called borderline products
Drug Advertising Law (HWG, Heilmittelwerberecht)
- Requirements of EC law and implementation in the HWG and AMG
- Organisation, structure and content of the HWG
- Supervisory powers of the authorities
- BSignificance of competition law under the UWG for the control of pharmaceutical advertising
- Limits of advertising and distribution on the Internet
Narcotics Act
Monitoring the distribution of foodstuffs
| Part 1 | ||
|---|---|---|
| Friday | 11.10.2024 von 08:30 - 18:30 Uhr | Online |
| Saturday | 12.10.2024 von 08:00 - 16:00 Uhr | Online |
| Part 2 | ||
|---|---|---|
| Friday | 25.10.2024 von 08:30 - 18:30 Uhr | Universitätsclub Bonn e.V.. |
| Saturday | 26.10.2024 von 08:00 - 16:00 Uhr | Universitätsclub Bonn e.V. |
| Submission of study paper | Wednesday, 04.12.2024 | |