Health measure establishing the national pharmacovigilance system for medicines and biological products for veterinary use
Distribution date: 02 February 2018
The Republic of Colombia hereby notifies that draft Colombian Agricultural Institute (ICA) Resolution "Establishing the national pharmacovigilance system for medicines and biological products for veterinary use", notified on 14 March 2017 by the World Trade Organization in document G/SPS/N/COL/266, was issued pursuant to Colombian Agricultural Institute (ICA) Resolution No. 00010204 of 22 August 2017, which entered into force on 24 August 2017. Text available at: https://members.wto.org/crnattachments/2018/SPS/COL/18_0661_00_s.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
Good Agricultural Practice of Traditional Chinese Medicinal Materials (Draft)
Distribution date: 31 January 2018 | Final date for Comment: 01 April 2018
Good Agricultural Practice of Traditional Chinese Medicinal Materials is the basic requirements for the production and quality control of Chinese medicinal materials, which applies to the whole process of planting, breeding or tending in traditional Chinese medicine enterprises. It consists of 14 chapters and 145 articles. The titles of chapters are general principles, quality management, institutions and personnel, facility instrument and tools, production bases and so on. Stability and controllability of the quality in the process of Chinese medicinal materials production is at the core in this practice, and the modern concept, consciousness and principle of risk management are also embedded in the whole process of Chinese medicinal materials production.
Products Covered: Drugs ICS: 11.120.10, HS: 30
Regulation Type: Regular notification
The Republic of Colombia hereby advises that the draft Resolution of the Supervisory Authority for Industry and Trade "Adding a ninth chapter to Title VI of the Single Circular, and regulating the metrological control of evidential breathalysers", notified on 25 August 2017 by the World Trade Organization in document G/TBT/N/COL/226, was issued on 28 December 2017 pursuant to Resolution No. 88919 of the Supervisory Authority for Industry and Trade, which will enter into force on 30 June 2018. Text available from: http://extranet.comunidadandina.org/SIRT/public/index.aspx Enquiry Point: Contact person: Daniel Héctor Rico R. Calle 28 N° 13A – 15, tercer piso Bogotá, D.C., Colombia Tel.: (+57-1) 606 7676, Ext. 1690 and 1340 Email: [email protected]; [email protected] Websites: http://www.sical.gov.co/reglamentos-tecnicos http://www.mincit.gov.co/publicaciones.php?id=33051
Distribution date: 31 January 2018
Products Covered: Breathalysers (90.27.80.90.00 and 90.27.10.90.00)
Regulation Type: Addendum to Regular Notification
The draft of the Order of Ministry of Agrarian Policy and Food of Ukraine "On approval of the basic requirements for production of veterinary drugs and rules of food manufacturing practice of veterinary drugs"
Distribution date: 30 January 2018 | Final date for Comment: 31 March 2018
The draft Order establishes requirements for: - the manufacturing of veterinary drugs, produced in Ukraine;- the circulation of veterinary drugs on the internal market; and- the export of veterinary drugs, as well as those that have been imported into Ukraine.
Products Covered: Veterinary drugs
Regulation Type: Regular notification
The Law of Ukraine "On state control to check compliance with the legislation on food, feed, animal by-products, animal health and welfare"
Distribution date: 30 January 2018
The Law of Ukraine regulates the legal and organizational affairs of state control to check compliance with: the legislation on food, feed, animal health and welfare by food business operators; and the legislation on imports of animal by-products into Ukraine.
Products Covered: HS Code(s): 01; 02; 03; 04; 05; 15; 16; 31; 41; 51; ICS Code(s): 65
Regulation Type: Regular notification
Ordinance Nº. 149, 26 december 2017 (Portaria MAPA/SDA Nº 149, de 26 de Dezembro de 2017)
Distribution date: 29 January 2018 | Final date for Comment: 28 February 2018
Draft Technical Regulation establishing standards for the registration of pesticides for agricultural use in crops of ornamental plants, and those uses in products already registered.
Products Covered: HS 31
Regulation Type: Regular notification
Draft Commission Implementing Decision on the identification of 1,7,7-trimethyl-3-(phenylmethylene) bicyclo[2.2.1]heptan-2-one (3-benzylidene camphor) as a substance of very high concern pursuant to Article 57(f) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (4 pages, in English)
Distribution date: 29 January 2018 | Final date for Comment: 30 March 2018
This draft Commission Decision aims at identifying 3-benzylidene camphor as a substance of very high concern due to its endocrine disrupting properties whose effects to the environment give rise to an equivalent level of concern according to Article 57(f) of Regulation (EC) No 1907/2006 (REACH).
Products Covered: Chemical substance 1,7,7-trimethyl-3-(phenylmethylene)bicyclo[2.2.1]heptan-2-one (3-benzylidene camphor) (EC No. 239-139-9, CAS No. 15087-24-8, HS code 291439)
Regulation Type: Regular notification
Turkish Food Codex Communiqué Edible Caseins and Caseinates
Distribution date: 26 January 2018 | Final date for Comment: 27 March 2018
This draft is related to preparation, processing, labeling, preservation, storage, transport, market supply and product characteristics of the edible caseins and caseinates for human consumption in accordance with the technique and hygienic reguirements.
Products Covered: Caseins and caseinates which are intended for human consumption and mixtures thereof
Regulation Type: Regular notification
Pharmacists' Regulations (Cosmetics) 5778-2018 The draft regulations, notified in G/TBT/N/ISR/709/Add.1, dated 7 June 2017, have been amended and replaced by the Israel Ministry of Health, following comments submitted by WTO member states. The full text of the revised regulations (Hebrew only) is available online at:
Distribution date: 23 January 2018
Products Covered: Cosmetics (HS: Chapter 33; ICS: 71.100.70).
Regulation Type: Addendum to Regular Notification
This addendum aims at informing that the National Institute of Metrology, Quality and Technology – INMETRO and the Ministry of Environment are proposing to give trading partners an opportunity to provide comments and suggestions in relation to the Draft Bill establishing maximum limit of lead in paints and materials similar to Surface coating, elaborated in the category of the National Commission Chemical Safety Agency (CONASQ), with a coordination of the Ministry of the Environment (Ministério do Meio Ambiente-MMA). The comments should be forwarded exclusively through the electronic form available at www.mma.gov.br until 4 March 2018. Due to an IT incident we are looking forward to receiving the previously sent comments again. The full text is available in Portuguese and can be downloaded at:
Distribution date: 23 January 2018
Products Covered: HS-Chapter 32 - paints
Regulation Type: Addendum to Regular Notification
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