Supreme Decree amending the Regulations on Pharmaceutical Establishments (6 pages, in Spanish).

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Distribution date: 14 February 2012

The notified draft Supreme Decree contains four articles which amend the Regulations on Pharmaceutical Establishments, approved by Supreme Decree No. 0142011SA, with a view to complementing the implementation of Law No. 29459 (Law on pharmaceutical products, medical devices and sanitary products).

Products Covered: Perfumes and toilet waters (excl. aftershave lotions, personal deodorants and hair lotions) (HS code(s): 3303); Beauty or make-up preparations and preparations for the care of the skin, incl. sunscreen or sun tan preparations (excl. medicaments); manicure or pedicure preparations (HS code(s): 3304); Preparations for use on the hair (HS code(s): 3305); Soap; organic surface-active products and preparations for use as soap, in the form of bars, cakes, moulded pieces or shapes, whether or not containing soap; organic surface-active products and preparations for washing the skin, in the form of liquid or cream and put up for retail sale, whether or not containing soap; paper, wadding, felt and nonwovens, impregnated, coated or covered with soap or detergent (HS code(s): 3401); Organic surface-active agents (excl. soap); surface-active preparations, washing preparations, incl. auxiliary washing preparations, and cleaning preparations, whether or not containing soap (excl. those of heading 3401) (HS code(s): 3402); Insecticides, rodenticides, fungicides, herbicides, anti-sprouting products and plant-growth regulators, disinfectants and similar products, put up for retail sale or as preparations or articles, e.g. sulphur-treated bands, wicks and candles, and fly-papers (HS code(s): 3808); Finishing agents, dye carriers to accelerate the dyeing or fixing of dyestuffs, and other products and preparations, e.g. dressings and mordants of a kind used in the textile or similar industries, n.e.s. (excl. those with a basis of amylaceous substances) (HS code(s): 380991); Toilet paper and similar paper, cellulose wadding or webs of cellulose fibres, of a kind used for household or sanitary purposes, in rolls of a width

Regulation Type: Regular notification

Human health

Supreme Decree amending the Regulations on Pharmaceutical Establishments (6 pages, in Spanish).

Product Image

Distribution date: 14 February 2012

The notified draft Supreme Decree contains four articles which amend the Regulations on Pharmaceutical Establishments, approved by Supreme Decree No. 0142011SA, with a view to complementing the implementation of Law No. 29459 (Law on pharmaceutical products, medical devices and sanitary products).

Products Covered: Perfumes and toilet waters (excl. aftershave lotions, personal deodorants and hair lotions) (HS code(s): 3303); Beauty or make-up preparations and preparations for the care of the skin, incl. sunscreen or sun tan preparations (excl. medicaments); manicure or pedicure preparations (HS code(s): 3304); Preparations for use on the hair (HS code(s): 3305); Soap; organic surface-active products and preparations for use as soap, in the form of bars, cakes, moulded pieces or shapes, whether or not containing soap; organic surface-active products and preparations for washing the skin, in the form of liquid or cream and put up for retail sale, whether or not containing soap; paper, wadding, felt and nonwovens, impregnated, coated or covered with soap or detergent (HS code(s): 3401); Organic surface-active agents (excl. soap); surface-active preparations, washing preparations, incl. auxiliary washing preparations, and cleaning preparations, whether or not containing soap (excl. those of heading 3401) (HS code(s): 3402); Insecticides, rodenticides, fungicides, herbicides, anti-sprouting products and plant-growth regulators, disinfectants and similar products, put up for retail sale or as preparations or articles, e.g. sulphur-treated bands, wicks and candles, and fly-papers (HS code(s): 3808); Finishing agents, dye carriers to accelerate the dyeing or fixing of dyestuffs, and other products and preparations, e.g. dressings and mordants of a kind used in the textile or similar industries, n.e.s. (excl. those with a basis of amylaceous substances) (HS code(s): 380991); Toilet paper and similar paper, cellulose wadding or webs of cellulose fibres, of a kind used for household or sanitary purposes, in rolls of a width

Regulation Type: Regular notification

Human health

Revision of the standards and specifications for foods and food additives under the Food Sanitation Act (revision of agricultural chemical residue standards)

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Distribution date: 10 February 2012 | Final date for Comment: 10 April 2012

Proposed maximum residue limits (MRLs) for agricultural chemicals. Pesticides: "Aldicarb and Aldoxycarb", "Benfluralin" and "Chlorantraniliprole".

Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) - Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.02, 03.03, 03.04, 03.05, 03.06, 03.07) - Dairy produce and birds' eggs (HS Codes: 04.01, 04.07 and 04.08) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.01, 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01,12.02, 12.04, 12.05, 12.06, 12.07, 12.10 and 12.12) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02, 15.06, 15.08 and 15.12) - Cocoa and cocoa preparations (18.01) - Beverages, spirits and vinegar (22.01)

Regulation Type: Regular notification

Food safety Human health Pesticides Maximum residue limits (MRLs)

Revision of the standards and specifications for foods and food additives under the Food Sanitation Act (revision of agricultural chemical residue standards)

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Distribution date: 10 February 2012 | Final date for Comment: 10 April 2012

Proposed maximum residue limits (MRLs) for agricultural chemicals. Pesticides: "Aldicarb and Aldoxycarb", "Benfluralin" and "Chlorantraniliprole".

Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) - Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.02, 03.03, 03.04, 03.05, 03.06, 03.07) - Dairy produce and birds' eggs (HS Codes: 04.01, 04.07 and 04.08) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.01, 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01,12.02, 12.04, 12.05, 12.06, 12.07, 12.10 and 12.12) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02, 15.06, 15.08 and 15.12) - Cocoa and cocoa preparations (18.01) - Beverages, spirits and vinegar (22.01)

Regulation Type: Regular notification

Food safety Human health Pesticides Maximum residue limits (MRLs)

Draft Resolution on Enteral Nutrition

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Distribution date: 09 February 2012 | Final date for Comment: 19 March 2012

This draft technical resolution establishes nutrient compounds and substances for enteral nutrition.This draft resolution aims to establish nutrient compounds and other substances that can be used in formulas for enteral nutrition.It is not included in this draft resolution the modified formulas for enteral nutrition for children under three-years old, which nutrients and other substances are specified in specific technical regulation.It will be granted a period of 18 (eighteen) months, from the date of adoption of this Resolution, for the establishments to make the necessary adjustments to attend this technical regulation.

Products Covered: Enteral nutrition

Regulation Type: Regular notification

Food safety Human health

Draft Resolution on Enteral Nutrition

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Distribution date: 09 February 2012 | Final date for Comment: 19 March 2012

This draft technical resolution establishes nutrient compounds and substances for enteral nutrition.This draft resolution aims to establish nutrient compounds and other substances that can be used in formulas for enteral nutrition.It is not included in this draft resolution the modified formulas for enteral nutrition for children under three-years old, which nutrients and other substances are specified in specific technical regulation.It will be granted a period of 18 (eighteen) months, from the date of adoption of this Resolution, for the establishments to make the necessary adjustments to attend this technical regulation.

Products Covered: Enteral nutrition

Regulation Type: Regular notification

Food safety Human health

Draft Resolution on Enteral Nutrition

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Distribution date: 09 February 2012 | Final date for Comment: 19 March 2012

This draft technical resolution establishes the formulas for enteral nutrition.This draft Resolution applies to formulas of enteral nutrition that aims the feeding of patients under enteral nutrition therapy.It revokes resolution ANVS nº 449, 9 September 1999.

Products Covered: Enteral nutrition

Regulation Type: Regular notification

Food safety Human health

Draft Resolution on Enteral Nutrition

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Distribution date: 09 February 2012 | Final date for Comment: 19 March 2012

This draft technical resolution establishes the formulas for enteral nutrition.This draft Resolution applies to formulas of enteral nutrition that aims the feeding of patients under enteral nutrition therapy.It revokes resolution ANVS nº 449, 9 September 1999.

Products Covered: Enteral nutrition

Regulation Type: Regular notification

Food safety Human health

RTCA 65.05.62.11, Requisitos para el Registro de Plaguicidas Botánicos, de Uso Agrícola (Central American Technical Regulation (RTCA) No. 65.05.62.11: Requirements for the registration of botanical pesticides for agricultural use)

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Distribution date: 08 February 2012 | Final date for Comment: 08 April 2012

The notified Technical Regulation lays down the requirements for the registration of botanical pesticides for agricultural use. It applies to the registration of agricultural botanical pesticides which are produced, formulated, packaged, repacked/repackaged, imported, exported, distributed and marketed in countries of the Central American region. Botanical pesticides used for experimental purposes are exempt from registration.

Products Covered: International Classification for Standards (ICS) code 65.100

Regulation Type: Regular notification

Pesticides Plant health

RTCA 65.05.62.11, Requisitos para el Registro de Plaguicidas Botánicos, de Uso Agrícola (Central American Technical Regulation (RTCA) No. 65.05.62.11: Requirements for the registration of botanical pesticides for agricultural use)

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Distribution date: 08 February 2012 | Final date for Comment: 08 April 2012

The notified Technical Regulation lays down the requirements for the registration of botanical pesticides for agricultural use. It applies to the registration of agricultural botanical pesticides which are produced, formulated, packaged, repacked/repackaged, imported, exported, distributed and marketed in countries of the Central American region. Botanical pesticides used for experimental purposes are exempt from registration.

Products Covered: International Classification for Standards (ICS) code 65.100

Regulation Type: Regular notification

Pesticides Plant health

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