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A new Royal Decree has been implemented on 7 August 1995 and published on 11 October 1995 in the Belgian State Gazette.
This Royal Decree modifies the Royal Decree of 6 June 1960 regarding the manufacture and wholesale distribution of pharmaceuticals, as already amended several times.
The amendment relates to the following medical devices: surgical ligatures, sterile dressings, sterile material for injection, perfusion, transfusion and drainage, sounds and catheters, substitution and internal prosthesis (implants).
For these specific products, when they are imported from another Member State of the European Community, the marketing authorisation holders are exempt from demonstrating the compliance of the relevant products with Belgian laws and regulations and, more in particular, from a full quantitative and qualitative analysis of at least all their active constituents, provided that the imported products are accompanied by a control report signed by the qualified person in the country of exportation whose qualification is recognised and attested by the competent authorities of that country.
This amendment completes a previous modification of the above Royal Decree of 1960 which similarly had the purpose to dispense marketing authorisation holders from the above analysis for medical products (exclusive of the above medical devices) imported from other EC countries when they have already been supervised in compliance with EC Directives 65/65, 75/318, 75/319 (human use) or Directives 81/851 and 81/852 (animal use).
A complete analysis remains necessary, however, for medical products imported from outside the EC and certain medical products which are not covered by the above amendments. Such analysis must be performed by the industrial pharmacist employed by the company concerned or by a supervisory laboratory approved by the Ministry of Public Health.
The content of this article is intended to provide general information on the subject matter. It is not a substitute for specialist advice.
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