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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. 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.
One of the main purposes of the first directive on medicinal products was to define the procedure for granting MA in the EU. The idea has developed over time along development of the society, science and technology. Today, national procedure and EU procedures show harmonisation and globalisation trends and the need to leave the space for industry to make a choice providing that public health remains protected.
This presentation is intended to provide you with an overview of the procedures for marketing authorisation of medicines, available in the EU, their mandatory or optional use and their pros & cons. We’ll present the National procedure, the Mutual Recognition Procedure, the Decentralised Procedure, the Centralised Procedure and some other options as the fast track procedures or the simplified procedures, allowed to be used under specified conditions and explain their principles. Understanding the advantages and disadvantages of individual procedures facilitates the decision-making process.
