TIS 2012-2543 (2000) Cold Reduced Carbon Steel Coil, Strip and Sheet of Commercial and Drawing Qualities (17 pages, in Thai)

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Distribution date: 27 August 2001

Thai Industrial Standards Institute (TISI) has proposed to enforce TIS 2012-2543 (2000) as a mandatory standard. This standard covers cold reduced carbon steel coil, strip and sheet of commercial and drawing qualities. Classifies the product according to application into four grades. Specifies mass, dimensions and tolerances, permissible variations, appearance, general characteristics, mechanical properties, chemical compositions, marking and labelling, sampling and criteria for conformity and testing.

Products Covered: Steel (HS: 72.09, ICS: 77.080.20)

Regulation Type: Regular notification

Notification of the Department of Commercial Registration on Characteristic and Quality Specification of Engine Oil (8 pages, available in Thai language)

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Distribution date: 12 June 2001

The Notification - covers engine oil for four-stroke gasoline engines and diesel engines; - specifies chemical and physical characteristics (e.g. viscosity, viscosity index; flash point, pour point, corrosion, water content, sediment content and foaming characteristics); - specifies engine performance characteristic and quality. All engine oil blenders, importers and traders who possess their own trade name or trademark shall report the engine performance characteristic and quality to the Director General and shall be granted and approved by DCR prior to trade.

Products Covered: Lubricants, industrial oils and related products (HS: 2710, ICS: 75.100)

Regulation Type: Regular notification

Draft Amendment of Hazardous Substance Act (No. …) B.E. … (2 pages, available in Thai language)

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Distribution date: 12 June 2001

All prohibitions under the Convention on the Prohibition of the Development, Production, Stockpiling and Use of Chemical Weapons and on their Destruction are taken into account by this amendment of the Hazardous Substance Act. The user or supporter who undertakes an offence against the mentioned law with regard to the prohibitions under the Convention shall be subject to the same penalty as its principal offender. This penal legislation is also extended to any activity prohibited under the Convention undertaken anywhere by natural persons of Thai nationality.

Products Covered: Organic chemicals in general (HS: 3508, ICS: 71.080.01)

Regulation Type: Regular notification

Amendment to the Poisonous and Deleterious Substances Designation Order (1 page, in English)

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Distribution date: 04 April 2001

Products Covered: Poisonous substance:  Narasin (HS:  29)

Regulation Type: Regular notification

Order of the Ministry of Public Health No. 1140/2543 Re: Revision of the Drug Recipe which Contains Phenylpropanolamine as a Constituent.

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Distribution date: 26 February 2001

The Thai authority decided to remove Phenylpropanolamine (PPA) from all drug products as there is evidence that PPA may cause haemorrhage stroke (bleeding into the brain). This order prescribes as follows: 1. Phenylpropanolamine (PPA) or their salts or those written otherwise but which are equivalent to PPA or their salts, must be removed from all drug products. 2. Producers or importers must apply for licences before 17 June 2001.

Products Covered: Medicaments HS Chapter 30.04, (ICS:  11.120.10)

Regulation Type: Regular notification

Federal Motor Vehicle Safety Standards: Motor Vehicle Brake Fluids (5 pages, in English)

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Distribution date: 24 January 2001

This document proposes technical modifications in two of the tests included in the standard on brake fluids, i.e., the evaporation test and the corrosion test. This document also requests comments concerning retention of the evaporation test. A committee of the Society of Automotive Engineers, which originally developed the test, recently voted to delete the test from its standard on brake fluid. While the administration has tentatively concluded that the test should remain in our standard, we are requesting comments on that issue.

Products Covered: Vehicle Brake Fluids (HS Chapter 3819) (ICS 75.120)

Regulation Type: Regular notification

Agreement on Mutual Recognition in Relation to Conformity Assessment between New Zealand and the European Community

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Distribution date: 14 October 1999

Products Covered: The Agreement covers several product categories, called "sectors". The sectors which are covered are: medicinal products good manufacturing practice inspection and batch certification (30, HS 2), machinery (84, HS 2), low voltage equipment (85, HS 2), telecommunications terminal equipment (8517, HS 4), electromagnetic compatibility (85, HS 2), medical devices (9018, HS 4), and pressure equipment.

Regulation Type: Article 10.7 (TBT)

Agreement on Mutual Recognition in Relation to Conformity Assessment between Switzerland and Canada.

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Distribution date: 30 August 1999

Products Covered: This Agreement applies to products traded between Switzerland and Canada as well as to procedures which are subject to specified legislative, regulatory and administrative provisions pertaining to conformity assessment and technical regulations, as detailed in five sectoral annexes to the Agreement, in the areas of: Telecommunications terminal equipment (ch. 85.17), Electromagnetic compatibility (EMC) & Electrical Safety (ch. 85, except 85.17), Good Manufacturing Practices (ch. 30) and Medical Devices (ch. 90.18, 90.19, 91.20, 91.21, 19.22).

Regulation Type: Article 10.7 (TBT)

International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Three Draft Guidance Documents:Impurities in New Veterinary Medicinal Products;Stability Testing for Medicated Premixes; and Impurities in New Veterinary Drug Substances; all with request for comments (4 pages, plus the 3 guidance documents)

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Distribution date: 29 July 1999

The Food and Drug Administration (FDA) is announcing the availability for comment of three draft guidance documents developed by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products. Document 1 provides guidance recommendations for applications for marketing authorizations on the content and qualification of impurities in new veterinary medicinal products produced from chemically synthesized new active substances not previously registered in a member state. Document 2 is an annex to the parent guidance VICH GL3 entitled "Stability Testing of New Drug Substances and Products in the Veterinary Field". This draft guidance document is the annex and addresses of the recommendations for stability testing of veterinary medicinal Type A medicated articles (referred to as medicated premix drug products in the draft guidance) intended for submission for approval to the European Communities, Japan, and the United States. Document 3 is draft guidance for industry entitled "Impurities in New Veterinary Drug Substances" and is intended to assist in developing registration applications for approval of veterinary medicinal products submitted to the European Communities, Japan and the United States

Products Covered: Veterinary medicinal products

Regulation Type: Regular notification

Feed additives Veterinary drugs Food safety Animal feed Animal health Human health

New Animal Drug Applications; Sheep as a Minor Species (3 pages)

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Distribution date: 29 July 1999

The Food and Drug Administration (FDA) is proposing to amend its regulations to reclassify sheep as a minor species for all data collection purposes. This would allow sponsors of supplemental new animal drug applications (NADA's) to extrapolate human food safety data from a major species such as cattle to sheep. In particular, this will allow the extrapolation of the tolerances for residues of new animal drugs in cattle to sheep.

Products Covered: Animal drugs

Regulation Type: Regular notification

Animal health Human health Food safety Maximum residue limits (MRLs) Veterinary drugs

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