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Our pool of seminars is designed to save time and resources, and to enable quick and simple understanding of EU rules and requirements on medicinal products.
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 definitions of specific types of medicinal products.
This presentation highlights the importance of proper understanding of the term »medicinal product«, used in EU legislation. It’s also important to understand definitions of specific types of medicinal products that reflect their specific characteristics.
Long before placing the product on the EU market it is necessary to answer the question: Is my product a medicinal product? It’s a precondition for proper planning, performing activities and solving dilemmas on product categorisation. It requires both, regulatory and scientific approach.
This seminar will help you in a simple and comprehensive way to understand and interpret correctly the two-part definition of a medicinal product, definitions of specific medicines and the scope of EU pharmaceutical legislation and applicability of rules for governing them.
