Regulatory Updates
Projet d'acte modificateur de la loi fédérale sur les médicaments et les dispositifs médicaux (Loi sur les produits thérapeutiques, LPTh) (Draft Act amending the Federal Law on Medicinal Products and Medical Devices (Law on Therapeutic Products, LPTh)) (12 pages, available in French, German and Italian)
Distribution date: 27 March 2018 | Final date for Comment: 26 May 2018
The European Union has adopted two new regulations: one on medical devices, and the other on in-vitro diagnostic devices. It aims to improve the quality and safety of medical devices, to harmonize the implementation of legislation in the EU, and thereby increase the safety of patients. In the context of the partial revision of the Law on Therapeutic Products, the legislation relating to the regulation of medical devices has been redrafted and adapted to the new EU legislation. The partially revised law establishes, inter alia, the obligations for economic operators and the adapted requirements for medical devices, the conformity assessment procedure, and the registration and identification of products that must be brought into line with the corresponding EU provisions (the regulation on medical devices and the regulation on in-vitro diagnostic devices). In parallel, the legislation in force regarding medical devices has been reviewed in terms of existing measures, and adapted where necessary.
Products Covered: (HS code(s): 3002, 3003, 3004, 3006, 900130, 900140, 900150, 9003, 9004, 9018, 9019, 9020, 9021); (ICS code(s): 11.040, 11.040.60, 11.040.70, 11.120, 11.180)
Regulation Type: Regular notification
Uganda would like to inform WTO Members that the standard; DUS 756:2017, Urea fertilizer grade — Specification; which Uganda notified in G/TBT/N/UGA/724 was adopted on 12 December 2017.
Distribution date: 27 March 2018
Products Covered: Urea fertilizer.
Regulation Type: Addendum to Regular Notification
Uganda would like to inform WTO Members that the standard; DUS 758:2017, Calcium ammonium nitrate fertilizer — Specification; which Uganda notified in G/TBT/N/UGA/726 was adopted on 12 December 2017.
Distribution date: 27 March 2018
Products Covered: Calcium ammonium nitrate fertilizer.
Regulation Type: Addendum to Regular Notification
Uganda would like to inform WTO Members that the standard; DUS 757:2017, Ammonium sulphate nitrate fertilizer — Specification; which Uganda notified in G/TBT/N/UGA/725 was adopted on 12 December 2017.
Distribution date: 27 March 2018
Products Covered: Ammonium sulphate nitrate fertilizer.
Regulation Type: Addendum to Regular Notification
Uganda would like to inform WTO Members that the standard; DUS 760:2017, Potassium chloride (muriate of potash) fertilizer grade — Specification; which Uganda notified in G/TBT/N/UGA/728 was adopted on 12 December 2017.
Distribution date: 27 March 2018
Products Covered: Potassium chloride fertilizer, muriate of potash fertilizer.
Regulation Type: Addendum to Regular Notification
Uganda would like to inform WTO Members that the standard; DUS 759:2017, Monoammonium phosphate (MAP) and Diammonium phosphate (DAP) fertilizers — Specification; which Uganda notified in G/TBT/N/UGA/727 was adopted on 12 December 2017.
Distribution date: 27 March 2018
Products Covered: Monoammonium phosphate fertilizers, diammonium phosphate fertilizers .
Regulation Type: Addendum to Regular Notification
Uganda would like to inform WTO Members that the standard; DUS 1756-3:2017, Commercial blasting explosives – Specification – Part 3: Part Ammonium Nitrate for explosives; which Uganda notified in G/TBT/N/UGA/707 was adopted on 12 December 2017.
Distribution date: 26 March 2018
Products Covered: Commercial blasting explosives, Ammonium Nitrate.
Regulation Type: Addendum to Regular Notification
Uganda would like to inform WTO Members that the standard; DUS 1838:2017, Standard Test Method for Length Change of Hardened Hydraulic-Cement Mortar and Concrete; which Uganda notified in G/TBT/N/UGA/737 was adopted on 12 December 2017.
Distribution date: 26 March 2018
Products Covered: Hardened Hydraulic Cement Mortar, Hardened Hydraulic Concrete.
Regulation Type: Addendum to Regular Notification
Uganda would like to inform WTO Members that the standard; DUS 1756-1:2017, Commercial blasting explosives — Specification — Part 1: Emulsion Explosive; which Uganda notified in G/TBT/N/UGA/685 was adopted on 12 December 2017.
Distribution date: 26 March 2018
Products Covered: Commercial blasting explosives.
Regulation Type: Addendum to Regular Notification
Uganda would like to inform WTO Members that the standard; DUS 762:2017, Illuminating candles – Specification; which Uganda notified in G/TBT/N/UGA/729 was adopted on 12 December 2017.
Distribution date: 26 March 2018
Products Covered: Illuminating candles.
Regulation Type: Addendum to Regular Notification
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