BRAZIL/MERCOSUR: TECHNICAL REGULATION FOR DISPOSABLE STERILE HYPODERMIC SYRINGES The following notification is being circulated in accordance with Article 10.6. G/TBT/Notif.97.206. 1. Member to Agreement notifying: BRAZIL/MERCOSUR. If applicable, name of local government involved (Articles 3.2 and 7.2). 2. Agency responsible: Secretaria Nacional de Vigila

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AC T='1'>ria. 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): Disposable sterile hypodermic syringes. 5. Title, number of pages and language(s) of the notified document: Technical Regulation for Disposable Sterile Hypodermic Syringes. 6. Description of content: This regulation specifies requirements for disposable sterile hypodermic syringes made of plastic materials and which are intended to absorb fluids or to inject fluids immediately after being filled. This regulation does not include syringes for the use of insulin, glass syringes, syringes with permanently connected needles, syringes for the use with motor pumps, pre-filled syringes with the injection liquid or syringes provided with the injection, as in a kit, to be filled by a pharmacist. 7. Objective and rationale: To guide manufacturers and importers as to the quality of these appliances. 8. Relevant documents: Resolution MERCOSUL/GMC 37/96. 9. Proposed date of adoption: Not Listed; Proposed date of entry into force: This regulation will come into effect on the same date as the Resolution MERCOSUL/GMC No. 37/96 is implemented by State Members. 10. Final date for comments: Not Listed. 11. Text available from: National enquiry point. (0153)

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