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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 by setting very strict requirements for the granting of marketing authorisation for medicinal products and the post-marketing monitoring. Besides general rules to be applied to any medicinal product, specific rules have been developed for specific types of medicines taking into consideration products' characteristics.
Pharmaceutical Acquis is one of the most regulated areas of the Acquis Communautaire. The starting point for understanding its governing principles is proper understanding of the term »medicinal product«, used in EU legislation as well as understanding the scope of other legislation regulated in the EU since it is not allowed to market identical products concerning their composition, function and intended use, under different product categories
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.
This presentation highlights the importance of proper understanding the scope of EU legislation on different products e.g. medicinal products, food supplement, medical devices, cosmetic products …
Borderline cases are considered to be the cases where it is not from the beginning clear whether a given product is a medicinal product or belongs to some other product category. Borderlines are not separately regulated in the EU because they are not a separate category of products. Borderline cases are not rare in practice. Categorisation of borderline products affects industry, competent authorities and other stakeholders, including users due to products’ (un)availability. Proper product categorisation is important for applying relevant regulatory rules and public health protection.
This seminar will help you in a simple and comprehensive way to understand the categorisation criteria and guide you through their use in practice.It will help you to solve a dilemma: Is my product a medicinal product, food supplement, medical device or cosmetic product?
