Distribution date: 08 December 2015

Products Covered: 3303.00.00.00, 3304.10.00.00, 3304.20.00.00, 3304.30.00.00, 3304.91.00.00, 3305.10.00.00, 3305.20.00.00, 3305.30.00.00, 3305.90.00.00, 3306.10.00.00, 3306.90.00.00, 3307.10.00.00, 3307.20.00.00, 3307.30.00.00, and 3307.90.90.00. ;Perfumes and toilet waters (HS 330300); Lip make-up preparations (HS 330410); Eye make-up preparations (HS 330420); Manicure or pedicure preparations (HS 330430); Powders, whether or not compressed (HS 330491); Shampoos (HS 330510); Preparations for permanent waving or straightening (HS 330520); Hair lacquers (HS 330530); Other (HS 330590); Dentifrices (HS 330610); Other (HS 330690); Pre-shave, shaving or after-shave preparations (HS 330710); Personal deodorants and antiperspirants (HS 330720); Perfumed bath salts and other bath preparations (HS 330730); Other (HS 330790). ;

Regulation Type: Addendum to Regular Notification

Distribution date: 08 December 2015

Products Covered: 3303.00.00.00, 3304.10.00.00, 3304.20.00.00, 3304.30.00.00, 3304.91.00.00, 3305.10.00.00, 3305.20.00.00, 3305.30.00.00, 3305.90.00.00, 3306.10.00.00, 3306.90.00.00, 3307.10.00.00, 3307.20.00.00, 3307.30.00.00, and 3307.90.90.00. ;Perfumes and toilet waters (HS 330300); Lip make-up preparations (HS 330410); Eye make-up preparations (HS 330420); Manicure or pedicure preparations (HS 330430); Powders, whether or not compressed (HS 330491); Shampoos (HS 330510); Preparations for permanent waving or straightening (HS 330520); Hair lacquers (HS 330530); Other (HS 330590); Dentifrices (HS 330610); Other (HS 330690); Pre-shave, shaving or after-shave preparations (HS 330710); Personal deodorants and antiperspirants (HS 330720); Perfumed bath salts and other bath preparations (HS 330730); Other (HS 330790). ;

Regulation Type: Addendum to Regular Notification

Distribution date: 03 December 2015 | Final date for Comment: 01 February 2016

<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;">The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to revise the listing for Adrenocortical Hormones or their salts or derivatives on the Human Prescription Drug List (PDL) to permit the non-prescription use of Fluticasone propionate for certain uses.</span></span>

Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS: 3004.90)

Regulation Type: Regular notification

Distribution date: 03 December 2015 | Final date for Comment: 01 February 2016

<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;">The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to revise the listing for Adrenocortical Hormones or their salts or derivatives on the Human Prescription Drug List (PDL) to permit the non-prescription use of Fluticasone propionate for certain uses.</span></span>

Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS: 3004.90)

Regulation Type: Regular notification

Distribution date: 03 December 2015 | Final date for Comment: 01 February 2016

<p>Water dispenser (hereinafter referred as "the commodities") has been subject to mandatory inspection under the Commodity Inspection Act by the Bureau of Standards Metrology and Inspection (BSMI) since 1 May 1990. To enhance consumer protection and promote efficiency of energy use, the BSMI will revise the inspection standards of the commodities from [CNS 3765 (2005), IEC 60335-2-15 (2005-08), CNS 13516 (1999),CNS 13783-1(2004)] to [CNS 60335-1(2014-11), CNS 60335-2-15(2014-12), CNS 13516(2014-10),CNS 13783-1(2013-10)], and will expand the test items and methods by adding requirements from Section 6.9 "Capacity of inner tank" and 6.11 "Standardized standby loss of every 24 hours, Est,24" of the standard CNS 13516 (2014-10).</p><p>In addition to the safety and energy efficiency requirements for water dispenser, the BSMI proposes to require marking of presence conditions of restricted substances. Such markings shall be made in accordance with Section 5 of CNS 15663 (2013-07) on the body, packages, stickers or the instruction books of the product. For those who utilize website as a means to announce "the presence conditions of the restricted substances," the website address shall be clearly stated on the body, packages, stickers or the instruction books of the product.&nbsp; <br />The conformity assessment procedure for Water Dispenser remains the same, i.e. Registration of Product Certification (RPC) or Type-Approved Batch Inspection (TABI).</p>

Products Covered: Water dispensers (CCCN 8418.69.90.00.9B,8516.10.00.00.9E)

Regulation Type: Regular notification

Distribution date: 03 December 2015 | Final date for Comment: 01 February 2016

<p>Water dispenser (hereinafter referred as "the commodities") has been subject to mandatory inspection under the Commodity Inspection Act by the Bureau of Standards Metrology and Inspection (BSMI) since 1 May 1990. To enhance consumer protection and promote efficiency of energy use, the BSMI will revise the inspection standards of the commodities from [CNS 3765 (2005), IEC 60335-2-15 (2005-08), CNS 13516 (1999),CNS 13783-1(2004)] to [CNS 60335-1(2014-11), CNS 60335-2-15(2014-12), CNS 13516(2014-10),CNS 13783-1(2013-10)], and will expand the test items and methods by adding requirements from Section 6.9 "Capacity of inner tank" and 6.11 "Standardized standby loss of every 24 hours, Est,24" of the standard CNS 13516 (2014-10).</p><p>In addition to the safety and energy efficiency requirements for water dispenser, the BSMI proposes to require marking of presence conditions of restricted substances. Such markings shall be made in accordance with Section 5 of CNS 15663 (2013-07) on the body, packages, stickers or the instruction books of the product. For those who utilize website as a means to announce "the presence conditions of the restricted substances," the website address shall be clearly stated on the body, packages, stickers or the instruction books of the product.&nbsp; <br />The conformity assessment procedure for Water Dispenser remains the same, i.e. Registration of Product Certification (RPC) or Type-Approved Batch Inspection (TABI).</p>

Products Covered: Water dispensers (CCCN 8418.69.90.00.9B,8516.10.00.00.9E)

Regulation Type: Regular notification

Distribution date: 01 December 2015 | Final date for Comment: 30 January 2016

Due to the inconsistencies with the current situation from emerging disease, it is deemed appropriate to repeal Pathogen and Animal Toxin Act B.E. 2525 and B.E.2544 and establish the Pathogen and Animal Toxin Act B.E. 2558. The new Act has been amended as follows: 1. Establishing the Committee on Pathogen and Animal Toxin; 2. Authorizing the Minister of Public Health to issue the regulations, rules, procedures, and conditions to protect and prevent public health from Pathogen and Animal Toxin; 3. Amending the regulatory controls on manufacturing, distribution, possession, importation, exportation or transit, and transportation of Pathogen and Animal Toxin in accordance with WHO by classifying the risk group; 4. Amending the provision on civil liability and penalty; 5. Amending the provision on administrative fees. The measure is based on a WHO Standard as follows: 1. World Health Organization - Laboratory Biosafety Manual - Third Edition, 2004; 2. Guidance on regulations for the Transport of Infectious Substances 2013-2014.

Products Covered: 1) Micro-organism and product thereof, that cause of disease in Human being and Livestock animal; 2) Animal toxin, that harm to Human and Livestock animal; 3) Biological agent and Product of animal toxin, that cause of disease in Human being and Livestock animal (HS Code: 3002.90.00)

Regulation Type: Regular notification

Distribution date: 01 December 2015 | Final date for Comment: 30 January 2016

Due to the inconsistencies with the current situation from emerging disease, it is deemed appropriate to repeal Pathogen and Animal Toxin Act B.E. 2525 and B.E.2544 and establish the Pathogen and Animal Toxin Act B.E. 2558. The new Act has been amended as follows: 1. Establishing the Committee on Pathogen and Animal Toxin; 2. Authorizing the Minister of Public Health to issue the regulations, rules, procedures, and conditions to protect and prevent public health from Pathogen and Animal Toxin; 3. Amending the regulatory controls on manufacturing, distribution, possession, importation, exportation or transit, and transportation of Pathogen and Animal Toxin in accordance with WHO by classifying the risk group; 4. Amending the provision on civil liability and penalty; 5. Amending the provision on administrative fees. The measure is based on a WHO Standard as follows: 1. World Health Organization - Laboratory Biosafety Manual - Third Edition, 2004; 2. Guidance on regulations for the Transport of Infectious Substances 2013-2014.

Products Covered: 1) Micro-organism and product thereof, that cause of disease in Human being and Livestock animal; 2) Animal toxin, that harm to Human and Livestock animal; 3) Biological agent and Product of animal toxin, that cause of disease in Human being and Livestock animal (HS Code: 3002.90.00)

Regulation Type: Regular notification

Distribution date: 01 December 2015

Interministerial Ordinance nº 701, 31 August 2015, regarding a monetary update on registration and GMP certification fees related to health products in Brazil. This Ordinance promoted a monetary update on registration and GMP certification fees related to health products in Brazil. It was necessary once the values of ANVISA's fees were obsolete since its creation in 1999, with accumulated losses of 193.5% according to Brazilian official inflation rate. So it is considered not to be a tribute increase, but a currency value reconstitution.

Products Covered: Monetary update on registration and GMP certification fees related to health products

Regulation Type: Regular notification

Distribution date: 01 December 2015

Interministerial Ordinance nº 701, 31 August 2015, regarding a monetary update on registration and GMP certification fees related to health products in Brazil. This Ordinance promoted a monetary update on registration and GMP certification fees related to health products in Brazil. It was necessary once the values of ANVISA's fees were obsolete since its creation in 1999, with accumulated losses of 193.5% according to Brazilian official inflation rate. So it is considered not to be a tribute increase, but a currency value reconstitution.

Products Covered: Monetary update on registration and GMP certification fees related to health products

Regulation Type: Regular notification