Executive Regulation of Veterinary Quarantine

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Distribution date: 17 December 2007 | Final date for Comment: 15 February 2008

Organize the procedure and duties of Veterinary Quarantine on the export and import of consignments of live animals and birds, animal products, medical and biological preparation animal equipments

Products Covered: Live animals, its products, and by- products, vet drugs, vaccines and biologicals, animal feed and feed ingredients

Regulation Type: Regular notification

Food safety Animal health Human health

Portaria (Regulation) No. 123 of 21 November 2007, published in Diário Oficial da União (Official Journal) No. 224 of 22 November 2007, page 55, (126 pages, available only in Portuguese). The text can be downloaded at: http://extranet.agricultura.gov.br/sislegis-consulta/servlet/VisualizarAnexo?id=13668

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Distribution date: 14 December 2007 | Final date for Comment: 21 December 2007

The notified text submits for public consultation the draft Instrução Normativa (Normative Instruction) regulating the procedures for the registration in the Integrated System of Foreign Trade (SISCOMEX) of imports of animals and plants, products, derivatives and parts thereof, by-products, waste with economic value and agricultural inputs.

Products Covered: Animals and plants, products, derivatives and parts thereof, by-products, waste with economic value and agricultural inputs

Regulation Type: Regular notification

Food safety Animal health Human health Territory protection Plant health

Notification of the Ministry of Commerce Re: Types of Packaged Goods, Rules and Procedures for Declaring Quantity of Goods and Maximum Permissible Error B.E. 2550 (2007) (13 pages, available in Thai language).

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Distribution date: 14 December 2007

This notification prescribes the types of packaged goods, rules and procedures for declaring quantity of goods and maximum permissible error (tolerable deficiency) and the examination procedures.

Products Covered: Prepackaged Products (HS Chapter 1006, 0201, 0202, 0203, 0204, 0401, 0402, 0404, 0405, 0904, 1902, 1805, 1806, 1701, 3816, 3401, 3402, 3306, 3305, 3814, 3215, 3102, 3103, 3104, 3605, 7415, 4814, 3406, ICS :67, 65.120, 87.040, 87.080, 65.080, 91.100.10, 75, 71.100.70, 85.060, 21.060.50)

Regulation Type: Regular notification

Labelling

Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use; Proposed Rule (30 pages, in English).

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Distribution date: 13 December 2007

The Food and Drug Administration (FDA) proposes to revise and update the regulations applicable to blood and blood components, including Source Plasma and Source Leukocytes, to add donor requirements that are consistent with current practices in the blood industry, and to more closely align the regulations with current FDA recommendations.

Products Covered: Human blood (HS:  3002) (ICS:  11)

Regulation Type: Regular notification

Draft Commission Directive setting up, pursuant to Council Directive 93/15/EEC, a system for the identification and traceability of explosives for civil uses (9 pages, in all official languages of the EU).

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Distribution date: 13 December 2007

Products Covered: Explosives (HS:  3601, 3602, 3603)

Regulation Type: Regular notification

Labelling

Partial amendment to the Minimum Requirements for Radiopharmaceuticals (1 page, available in English).

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Distribution date: 10 December 2007

Products Covered: Drugs (HS:  30)

Regulation Type: Regular notification

Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Companion Document to the Direct Final Rule (4 pages, in English).

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Distribution date: 10 December 2007

The Food and Drug Administration (FDA) has published a companion proposed rule to the direct final rule: http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/E7-23294.htm which amends certain sections of the regulations as the first phase of an incremental approach to modifying the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.

Products Covered: Pharmaceuticals (HS:  Ch. 30;  ICS:  11.120, 71.020)

Regulation Type: Regular notification

Summary of Amendments of the Standard for Biological Product for Animal Use (1 page, available in English). Draft of Amendments of the Standard for Biological Product for Animal Use (35 pages, available in Japanese),

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Distribution date: 07 December 2007

Products Covered: Vaccines for Veterinary medicine (HS:  3002.30)

Regulation Type: Regular notification

Reglamento sobre el Registro, Uso y Control de Fertilizantes y Materias Primas (Regulation governing the registration, use and control of fertilizers and raw materials) (16 pages, in Spanish)

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Distribution date: 03 December 2007 | Final date for Comment: 01 February 2008

The notified Regulation seeks to establish technical, administrative and legal provisions within the framework of the Ley Fitozoosanitaria (Plant and Animal Health Law) with regard to the registration, import, manufacture, formulation, repacking, repackaging, transport, storage, sale, use, handling and export of fertilizers and agricultural raw materials.This Regulation does not apply to substances used as laboratory materials or reagents.

Products Covered: Fertilizers and agricultural raw materials

Regulation Type: Regular notification

Plant health

National Standard of the P.R.C., Athletic Shoes (8 pages, in Chinese).

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Distribution date: 30 November 2007

Products Covered: Athletic Shoes ICS:  61.060,  HS:  3405

Regulation Type: Regular notification

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