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In your studies 'Drug Regulator Affairs'

©Frank Luerweg / Universität Bonn

Study modules 

MDRA-26 (academic year 2024/2025)

Module 2 Pharmaceutical Law

Pharmaceutical law in Germany, the EU and other countries and related laws

  • Overview
  • 1
  • 2
  • 3
  • 4
  • 5
  • 6
  • 7
  • 8
  • 9
  • 10
  • 11
  • 12
Teaching time Study time Type of examination Credit points
ca. 30 hours ca. 30 hours Study paper and oral examination 6
Module leader
Dr. Angela Graf

Module contents

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

Study plan

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  

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