BELGIUM: HUMAN BLOOD AND BLOOD PRODUCTS The following notification is being circulated in accordance with Article 10.6. G/TBT/Notif. 95.137. 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 and the Environment, Therapeutic Practice Service, Quartier Vesale V. 605, 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): Human blood and labile blood products, i.e. blood derivatives for therapeutic use which are only viable for a short period of time if they are no longer stored properly. 5. Title and number of pages of the notified document: Royal Order on the Taking, Preparing, Storing and Delivering of Human Blood and Blood Products. 6. Description of content: This draft implements the Law of 5 July 1994 on human blood and blood products. It fixes the criteria for approving centres and establishments which take, prepare, store and deliver human blood and blood products. The criteria for approval are particularly aimed at guaranteeing self-sufficiency in assuring availability and quality. For this purpose, the draft specifies the obligations of the centres and establishments, the conditions under which they must operate, the methods of donor recruitment, the conditions for storing and preparing blood and blood products, as well as quality criteria. It also specifies the conditions for use of plastic containers. 7. Objective and rationale: The purpose of the draft Order is to define the terms of implementation of the Law of 5 July 1994 on human blood and blood products. The aim of the measures taken is to ensure self-sufficiency of supply, to guarantee the purity of the product and free donation of blood. 8. Relevant documents: Law of 5 July 1994 on human blood and blood products. Royal Order of 10 November 1971 on the taking, preparing, storing and delivering of human blood and blood products for therapeutic use, and amending legislation. 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 or address and telefax number of other body: CIBELNOR. (138)

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