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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. It takes time and money to follow it. Work on variations takes ca 70% of the regulatory work. Work on specific regulatory areas often requires broader perspective, necessary to allow putting regulatory puzzles together.
This presentation gives you a brief overview on how variations to marketing authorisations are regulated in the EU, on the types of variations/changes to marketing authorisations of medicines in the EU, on the classification criteria, procedures for their notification/approval and mechanisms for simplifying the work on variations. Understanding general principles of variations to marketing authorisations in the EU including the categorisation flowchart, facilitates planning and decision-making processes and saves substantial time devoted to the regulatory work on variations.
