ROYAL DECREE PROHIBITING CERTAIN ACTS UNDER ARTICLE 6 OF THE LAW ON MEDICAMENTS DATED 25 MARCH 1964 IN CONNECTION WITH AIDS TO IN VITRO DIAGNOSIS IN AIDS TESTING, FOR USE BY THE PATIENT HIMSELF The following notification is being circulated in accordance with Article 10.6. G/TBT/Notif.97.46. 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, Inspection Pharmaceutique Ge

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AC T='1'>rale, Centre Administratif National, Quartier Ve

AC T='1'>sale, B-1010 Brussels. Agency or authority designated to handle comments regarding the notification can be indicated if different from above. 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): Aids to in vitro diagnosis: any means that is a reagent, reagent product, compound, instrument, device or system used alone or in combination and intended by the manufacturer for in vitro use in the examination of human body samples to obtain information on physical condition, health, sickness or congenital malformations. The aids concerned are intended for in vitro diagnosis in AIDS testing for use by the patient himself. 5. Title, number of pages and language(s) of the notified document: Royal Decree Prohibiting Certain Acts under Article 6 of the Law on Medicaments dated 25 March 1964 in connection with aids to in vitro diagnosis in AIDS testing, for use by the patient himself. 6. Description of content: The import, export, manufacture, preparation, transport, distribution, storage, preservation, putting up for sale, transfer free of charge or for a consideration of aids to in vitro diagnosis in AIDS testing, for use by the patient himself. 7. Objective and rationale: The problems of the use of AIDS tests by the patient himself must be provisionally regulated, pending the elaboration of a directive on aids to in vitro diagnosis. 8. Relevant documents: Aids to in vitro diagnosis are classed as medicaments under Article 1 bis, Section 1, 3 degrees of the Law on Medicaments, dated 25 March 1964. 9. Proposeddate of adoption: 60 days; Proposed date of 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. (0087)

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