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A large body of pharmaceutical legislation has been developed since Directive 65/65/EEC was introduced in the wake of the Thalidomide tragedy. The fundamental aim of the rules for medicinal products in the EU is to safeguard public health. However, this objective must be attained by means which will not hinder the development of the pharmaceutical industry or trade in medicinal products within the EU. Pharmaceutical Acquis is one of the most regulated areas of the Acquis Communautaireand gaining knowledge and understanding of it require significant time, efforts and resources, but it's a precondition for proper planning of your activities.
Broader perspective of regulating medicines in the EU helps in putting regulatory puzzles on the right place. Besides quality, safety and efficacy of medicines and performing clinical trials in line with internationally agreed standards, it includes regulatory incentives for industry aimed to enable both innovative and affordable medicines.
Our pool of seminars is designed to save time and resources and enable you quick and simple understanding of EU rules and requirements on medicinal products.
Both, innovative and generic industry play important role in medicines' availability. Innovative industry brings new medicines and improves people's health. Generic industry plays critical role in producing affordable medicines. It is fair that an innovator spending money and effort in the development of a new medicinal product is protected against piggy-backing, but there are limits to the amount of protection that an innovator is entitled to. From that moment generic competition should be possible. The balanced approach is necessary in regulating generics. Development of EU legislation (including Court cases) in this area brings us to the current understanding of generics from a legal perspective. That's what this presentation is about.
