Objectives and achievements of regulations in The Netherlands
The Committee for the Evaluation of Medicines in The Netherlands was established in 1963. It is responsible for the evaluation and registration of medicines and has full responsibility for deciding whether a medicine should enter the market.
In 1978 the Committee’s original responsibility for proprietary medicines was extended and now includes generics.
In 1987 a division was set up within the Ministry of Welfare, Health and Cultural Affairs, comprising three units; registration, management and clinical assessments. Each works in conjunction with the Committee.
A decision regarding an application for registration has to be sent to the applicant within 120 days. Hearings are held to discuss serious objections, after which additional data may be submitted.
In 1987 221 applications for pharmaceutical specialities and 93 for generics were made. A sharp increase in the annual registration fee in January 1987 resulted in a large number of products being withdrawn from the market.
Through the influence of international development in the EEC the criteria and requirements for registration of medicines are harmonized and the role of the Committee for the Evaluation of Medicines is likely to decrease in the near future.
KeywordsMarketing Authorization Parallel Import Environmental Hygiene Cultural Affair Homeopathic Preparation
Unable to display preview. Download preview PDF.