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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.
Significant economic and social changes have brought better education and availability of information on diseases and medicines, better standard of living, longer life expectancy, aging and growing of population as well as raised patient awareness and economic pressure to the health insurance funds. It enabled the more relaxed approach to the decisions on prescription status of 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.
We are witnessing the trend of shifting an increasing number of medicines from Rx-OTC. It reflects social and economic development, but it is not a new habit. The whole medicine was at the very beginning based on self-medication. The “come-back” to the original approach is occurring under different conditions. A much higher level of development of individuals, society and state-of-the-art science and technology as well as strict regulation of the switching are the safeguard for public health.
Preparing strategy and documentation for the Rx-OTC switch requires knowledge, time and resources. This presentation guides you through the EU requirements for switching medicines from Rx-OTC, gives you an overview of the principles in self-medication and evolution of EU legislative approach including detailed criteria and requirements and addresses the implications.
