Partial amendment to the Minimum Requirements for Biological Products (1 pages, in English).

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Distribution date: 25 October 2013 | Final date for Comment: 24 December 2013

The Minimum Requirements for Biological Products is to be partially amended to add the standard for a vaccine product to be newly approved.

Products Covered: Drugs (HS: 30)

Regulation Type: Regular notification

Human health

Partial amendment to the Minimum Requirements for Biological Products (1 pages, in English).

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Distribution date: 25 October 2013 | Final date for Comment: 24 December 2013

The Minimum Requirements for Biological Products is to be partially amended to add the standard for a vaccine product to be newly approved.

Products Covered: Drugs (HS: 30)

Regulation Type: Regular notification

Human health

Draft of the Eurasian Economic Commission Collegium Decision on amendments to the Customs Union Commission Decision on Common forms of veterinary certificates for goods subject to veterinary control from third countries as of 7 April 2011 No. 607

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Distribution date: 29 October 2013 | Final date for Comment: 28 December 2013

The document introduces amendments to CU legislation specially to the CU form of veterinary certificate No. 36. The document adjusts veterinary certificate with the relevant Common veterinary requirements (Chapter 37). Amendments to the Chapter 37 of the Common veterinary requirements were notified in G/SPS/N/RUS/36 (17 October 2013).These amendments precise that requirements on absence of botulinic toxin applied only for canned pet feed.

Products Covered: Common list of goods subject to veterinary control, adopted by the Customs Union (CU) Commission Decision on application of veterinary and sanitary measures in the CU as of 18 June 2010 No. 317

Regulation Type: Regular notification

Animal feed Animal health Contaminants Toxins

Draft of the Eurasian Economic Commission Collegium Decision on amendments to the Customs Union Commission Decision on Common forms of veterinary certificates for goods subject to veterinary control from third countries as of 7 April 2011 No. 607

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Distribution date: 29 October 2013 | Final date for Comment: 28 December 2013

The document introduces amendments to CU legislation specially to the CU form of veterinary certificate No. 36. The document adjusts veterinary certificate with the relevant Common veterinary requirements (Chapter 37). Amendments to the Chapter 37 of the Common veterinary requirements were notified in G/SPS/N/RUS/36 (17 October 2013).These amendments precise that requirements on absence of botulinic toxin applied only for canned pet feed.

Products Covered: Common list of goods subject to veterinary control, adopted by the Customs Union (CU) Commission Decision on application of veterinary and sanitary measures in the CU as of 18 June 2010 No. 317

Regulation Type: Regular notification

Animal feed Animal health Contaminants Toxins

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Law (revision of agricultural chemical residue standards)

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Distribution date: 11 November 2013 | Final date for Comment: 10 January 2014

Proposed maximum residue limits (MRLs) for the following agricultural chemicals: Pesticide: Dicamba Veterinary drug/feed additive: Narasin

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) - Dairy produce, birds' eggs and natural honey (HS Codes: 04.01, 04.07 and 04.08) - Products of animal origin (HS Code: 05.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.08, 07.09 and 07.10) - 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, 12.07 and 12.12) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)

Regulation Type: Regular notification

Human health Pesticides Food safety Maximum residue limits (MRLs)

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Law (revision of agricultural chemical residue standards)

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Distribution date: 11 November 2013 | Final date for Comment: 10 January 2014

Proposed maximum residue limits (MRLs) for the following agricultural chemicals: Pesticide: Dicamba Veterinary drug/feed additive: Narasin

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) - Dairy produce, birds' eggs and natural honey (HS Codes: 04.01, 04.07 and 04.08) - Products of animal origin (HS Code: 05.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.08, 07.09 and 07.10) - 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, 12.07 and 12.12) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)

Regulation Type: Regular notification

Human health Pesticides Food safety Maximum residue limits (MRLs)

Partial revision of the Japanese Pharmacopoeia, Sixteenth edition (6 pages, in English).

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Distribution date: 13 November 2013 | Final date for Comment: 12 January 2014

Under the provision of Article 41 of the Pharmaceutical Affairs Law, the Japanese Pharmacopoeia, Sixteenth edition is to be revised.

Products Covered: Drugs(HS:30)

Regulation Type: Regular notification

Human health

Partial revision of the Japanese Pharmacopoeia, Sixteenth edition (6 pages, in English).

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Distribution date: 13 November 2013 | Final date for Comment: 12 January 2014

Under the provision of Article 41 of the Pharmaceutical Affairs Law, the Japanese Pharmacopoeia, Sixteenth edition is to be revised.

Products Covered: Drugs(HS:30)

Regulation Type: Regular notification

Human health

Notice of Consultation - Prescription Drug List (PDL): Omeprazole (2 pages, in English; 2 pages, in French).

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Distribution date: 13 November 2013 | Final date for Comment: 12 January 2014

<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:Calibri;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-bidi-font-size:11.0pt;">The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to revise the Human Prescription Drug List for Omeprazole or its salts to be sold as a non-prescription product when sold as a 14-day treatment of frequent heartburn at a daily dose of 20 mg.</span></span>

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

Regulation Type: Regular notification

Human health

Notice of Consultation - Prescription Drug List (PDL): Omeprazole (2 pages, in English; 2 pages, in French).

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Distribution date: 13 November 2013 | Final date for Comment: 12 January 2014

<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:Calibri;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-bidi-font-size:11.0pt;">The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to revise the Human Prescription Drug List for Omeprazole or its salts to be sold as a non-prescription product when sold as a 14-day treatment of frequent heartburn at a daily dose of 20 mg.</span></span>

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

Regulation Type: Regular notification

Human health

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