Master's Course "Drug Regulatory Affairs"

Study Modules

Modul 02 (WS 2017 / SS 2018)

Pharmaceutical Law

attendance approx. Seminar Paper Method of examination Credit
approx. 30 h approx. 30 h seminar paper and written examination 6

Module Supervisor

  • Prof. Burkhard Sträter


The German Drug Law in the legal context of civil, penal and public-law standards
  • Approval procedures for marketing authorization, renewal of marketing authorization and manufacture of pharmaceuticals
  • Procedures for extending marketing authorizations
  • Revocation and limitations of marketing authorizations in the so-called Step Plan Procedure
  • Tasks and responsibilities of the Production, Control Sales, Information, Stage Plan officers as defined by the German Drug Law
  • Control of pharmaceutical imports and exports
Law on Administrative Procedure (VwVfG): Relevance to administrative procedures according to the German Drug Law (AMG)
  • Basic principles of an administrative procedure
  • Rights of those involved (e.g. right to: a hearing, examination of files, protection of company and business secrets)
  • Legal remedy (objection procedure)
  • Types, relevance and calculation of procedural deadlines in respect of the AMG
  • Failure to meet deadlines (consequences, requirements for reinstatement)
Marketing authorization of generics – intellectual property rights of the original manufacturer
  • Requirements for the dossier
  • Utilization of documents of the first registrant
  • Limits to the intellectual property rights of the originator– Significance of patents, so-called protection certificates and document protection
The EU legal system relating to the production, marketing authorization and marketing of pharmaceuticals
  • Judicial quality of EU standards
  • EU system for the marketing authorization of pharmaceuticals
  • Comparison of the centralized and decentralized marketing authorization procedures
Conditions for the importation, parallel imporation and mail order supply of pharmaceuticals
  • Significance of the free movement of goods and the country-of-origin principle
  • Requirements for and differences between importation from EU member states and importation from non-EU countries
  • Mutual Recognition Agreements (MRAs)
  • Practice of the European Count in respect of parallel imports
  • Liberalization of mail-order trade by the Healthcare System Modernization Law (GMG)
Clinical drug testing
  • Requrements and control system according to the German Drug Law and the EU guidance note draft
  • Supervisory functions of the authorities concerned
  • Notification and approval procedures
  • Significance of ethics committees and the professional code of conduct for doctors
  • Judicial quality and significance of the the GCP guidelines

Characteristics of pharmaceuticals in contradistinction to foods and cosmetics

  • Definition and essential distinuishing criteria according to EU law, the German Drug Law and the Food and Feed Code (LFGB)
  • Significance formoterol the marketability of so-called borderline products
Pharmaceutical advertising law
  • Provisions of EU law and their implementation in the German Pharmaceutical Advertising Law (HWG) and the German Drug Law (AMG)
  • Structure and content of the HWG
  • Supervisory powers of the authorities
  • Significance of the the Advertising Law for the control of pharmaceutical advertising according to the German Law against Unfair Competition (UWG)
  • Limits of advertising and marketing on the internet

Significance of special laws on the production and use of pharmaceuticals – overview

  • The DNA Technology Law, Transfusion Law
Significance of special laws on the production and use of pharmaceuticals – overview
  • The Narcotics Law

Study plan

Part 1:    
Friday   13 October 2017 from 8.30 a.m. – 6.30 p.m.
Saturday   14 October 2017 from 8.00 a.m. – 4.00 p.m.



Alanus Hochschule, Campus II, Villestr. 3, 53347 Alfter

Part 2:    
Friday   20 October 2017 from 8.30 a.m. – 6.30 p.m.
Saturday   21 October 2017 from 8.00 a.m. – 4.00 p.m.
Location:    Uni-Club
    Deadline seminar paper: 20 November 2017

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