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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
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