Provisions for Overseas Inspection of Drugs and Medical Devices (Draft)
Distribution date: 18 January 2018 | Final date for Comment: 19 March 2018
Provisions for Overseas Inspection of Drugs and Medical Devices is applicable to the overseas development and production inspection of drugs and medical devices which are already on the market or will be on the market in China. The provisions consist of 5 chapters and 35 articles. 5 Chapters including general provisions, determination of the inspection task, inspection, audit and processing, and supplementary articles. The provisions specify the initiation, inspection and follow-up treatment of overseas drug and medical device inspection.
Products Covered: Drug ICS: 11.120.10 HS: 30 Medical device ICS: 11 HS: 9018, 9019, 9020, 9021, 9022
Regulation Type: Regular notification
Good Data and Record Management Practices (Draft)
Distribution date: 18 January 2018 | Final date for Comment: 19 March 2018
Good Data and Record Management Practices (GDRP) include general provisions, quality management, personnel, basic requirements of data, system and supplementary provisions, which is applicable to drug development, manufacture, distribution, post-marketing surveillance and evaluation The data in GDRP should be complete as well as attributable, legible, contemporaneous, original and accurate, commonly referred to as "ALCOA".
Products Covered: Drugs ICS: 11.120.10 HS: 30
Regulation Type: Regular notification
Regulation for Supervision and Administration of Internet Drug Trading (Draft)
Distribution date: 18 January 2018 | Final date for Comment: 19 March 2018
This regulation is formulated in order to strengthen the supervision and administration of internet drug trading, standardize the behavior of internet drug trading and ensure the safety of public drug use. There are six chapters and fifty-seven articles in this regulation, including general principles, administration of internet drug sale, administration of internet drug transaction service platform, supervision and administration, legal liability and supplementary provisions.
Products Covered: Drugs ICS: 11.120.10. HS: 30
Regulation Type: 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 | Final date for Comment: 29 April 2025
Products Covered: HS-Chapter 32 - paints
Regulation Type: Addendum to 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 | Final date for Comment: 29 April 2025
Products Covered: Cosmetics (HS: Chapter 33; ICS: 71.100.70).
Regulation Type: Addendum to 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
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
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
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 | Final date for Comment: 29 April 2025
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
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
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