BELGIUM: INSPECTION AND ANALYSIS OF STARTING MATERIALS USED BY DISPENSING CHEMISTS The following notification is being circulated in accordance with Article 10.6. G/TBT/Notif. 96.17. 1. Member to Agreement notifying: BELGIUM. If applicable, name of local government involved (Articles 3.2 and 7.2): 2. Agency responsible: Ministry of Public Health, Pharmaceutical Inspectorate, CAE, Quartier Vesale, 1010 Brussels. 3. Notified under Article 2.9.2. 4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Starting materials, i.e. all substances or compounds which are not in themselves medicinal products, purchased by the dispensing chemist for distribution as such or after undergoing processing, or for incorporation in an officinal or magistral preparation. 5. Title and number of pages of the notified document: Draft Royal Decree on the Inspection and Analysis of Starting Materials Used by Dispensing Chemists. 6. Description of content: The draft concerned lays down the obligations of dispensing chemists with regard to control. The chemist may be released from the duty to perform analysis in certain cases, when he uses starting materials obtained from an authorized supplier. The aim of the system is to introduce an optional system of authorizations. 7. Objective and rationale: To encourage the use of starting materials of suitable quality for the preparation of officinal or magistral preparations. 8. Relevant documents: Opinion dated 11 May 1995 by the Commission of the European Communities (P12/1323/50.176) for the repeal and replacement of the Royal Decree dated 20 October 1994 concerning the inspection and analysis of starting materials used by dispensing chemists. 9. Proposed date of adoption and entry into force: 60 days. 10. Final date for comments: N/A. 11. Texts available from: National enquiry point (X) or address and telefax number of other body. CIBELNOR. (064)

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