Direktif Mengenai Syarat Pendaftaran Produk Farmaseutikal Dari Luar Negara Berkaitan Keperluan Amalan Perkilangan Baik (APB) (3 pages, in Malay).
Distribution date: 05 March 2012 | Final date for Comment: 04 May 2012
The directive describes that all registration application of pharmaceutical product(s) which are manufactured in overseas countries will only be considered if the manufacturer of the product(s) is in a *PIC/S Participating Authority country or *ICH member country or the manufacturer has been inspected by a PIC/S Participating Authority or ICH member country National Drug Regulatory Agency (NDRA). ; *PIC/S: Pharmaceutical Inspection Co-operation Scheme ; *ICH: International Conference on Harmonization ;
Products Covered: Pharmaceutical products that are manufactured in overseas countries (ICS: 11.120.01; HS: 30.06).
Regulation Type: Regular notification
Direktif Mengenai Syarat Pendaftaran Produk Farmaseutikal Dari Luar Negara Berkaitan Keperluan Amalan Perkilangan Baik (APB) (3 pages, in Malay).
Distribution date: 05 March 2012 | Final date for Comment: 04 May 2012
The directive describes that all registration application of pharmaceutical product(s) which are manufactured in overseas countries will only be considered if the manufacturer of the product(s) is in a *PIC/S Participating Authority country or *ICH member country or the manufacturer has been inspected by a PIC/S Participating Authority or ICH member country National Drug Regulatory Agency (NDRA). ; *PIC/S: Pharmaceutical Inspection Co-operation Scheme ; *ICH: International Conference on Harmonization ;
Products Covered: Pharmaceutical products that are manufactured in overseas countries (ICS: 11.120.01; HS: 30.06).
Regulation Type: Regular notification
1. Feed Act 2009 (25 pages, in English) ; 2. Feed (Licence to Import Feed and/or Feed Additive) Regulations 2011 (27 pages, in English and Malay). ; 3. Feed (Labelling of Feed and Feed Additive) Regulations 2011 (7 pages, in English and Malay). ; 4. Feed (Prohibited Use of Antibiotics, Hormones or Other Chemicals) Regulations 2011 (13 pages, in English and Malay). ; 5. Feed (Manufacture and Sale of Feed and Feed Additive) Regulations 2011 (29 pages, in English and Malay). ; 6. Feed (Methods of Analysis of Feed and the Form of Certificate of Analysis) Regulations 2011 (17 pages, in English and Malay). ;
Distribution date: 05 March 2012 | Final date for Comment: 04 May 2012
Feed Act 2009 and Feed Regulations 2011 were developed to provide information and explanations to regulate feed quality by controlling the importation, manufacture, sale and use of feed and feed additive, to ensure that feed satisfies nutritional requirement of animals, is not harmful to animals and is not contaminated so that animals and animal products are safe for human consumption and other usage, and for other matters incidental thereto.
Products Covered: Feed and feed additives (ICS: 65.120).
Regulation Type: Regular notification
1. Feed Act 2009 (25 pages, in English) ; 2. Feed (Licence to Import Feed and/or Feed Additive) Regulations 2011 (27 pages, in English and Malay). ; 3. Feed (Labelling of Feed and Feed Additive) Regulations 2011 (7 pages, in English and Malay). ; 4. Feed (Prohibited Use of Antibiotics, Hormones or Other Chemicals) Regulations 2011 (13 pages, in English and Malay). ; 5. Feed (Manufacture and Sale of Feed and Feed Additive) Regulations 2011 (29 pages, in English and Malay). ; 6. Feed (Methods of Analysis of Feed and the Form of Certificate of Analysis) Regulations 2011 (17 pages, in English and Malay). ;
Distribution date: 05 March 2012 | Final date for Comment: 04 May 2012
Feed Act 2009 and Feed Regulations 2011 were developed to provide information and explanations to regulate feed quality by controlling the importation, manufacture, sale and use of feed and feed additive, to ensure that feed satisfies nutritional requirement of animals, is not harmful to animals and is not contaminated so that animals and animal products are safe for human consumption and other usage, and for other matters incidental thereto.
Products Covered: Feed and feed additives (ICS: 65.120).
Regulation Type: Regular notification
RESPONSE to comments received regarding draft Mexican Official Standard PROY-NOM-248-SSA1-2006: "Good manufacturing practices for establishments engaged in the manufacture of herbal remedies"
Distribution date: 28 February 2012
On 24 February 2012, the Mexican Ministry of the Economy published in the Official Journal (Diario Oficial de la Federación) (http://www.dof.gob.mx) the RESPONSE to the comments received regarding draft Mexican Official Standard PROY-NOM-248-SSA1-2006, published on 28 April 2009.Text available at:http://www.dof.gob.mx/nota_detalle.php?codigo=5235264&fecha=24/02/2012http://members.wto.org/crnattachments/2012/sps/MEX/12_0788_00_s.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
RESPONSE to comments received regarding draft Mexican Official Standard PROY-NOM-248-SSA1-2006: "Good manufacturing practices for establishments engaged in the manufacture of herbal remedies"
Distribution date: 28 February 2012
On 24 February 2012, the Mexican Ministry of the Economy published in the Official Journal (Diario Oficial de la Federación) (http://www.dof.gob.mx) the RESPONSE to the comments received regarding draft Mexican Official Standard PROY-NOM-248-SSA1-2006, published on 28 April 2009.Text available at:http://www.dof.gob.mx/nota_detalle.php?codigo=5235264&fecha=24/02/2012http://members.wto.org/crnattachments/2012/sps/MEX/12_0788_00_s.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
Proposal for a Directive of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to the making available on the market and supervision of explosives for civil uses (COM(2011) 771) (86 pages, in English, French and Spanish
Distribution date: 27 February 2012 | Final date for Comment: 27 April 2012
This proposed Directive is a recast of Directive 93/15/EC to align it to Decision No 768/2008/EC establishing a common framework for the marketing of products. ; The changes made to the provisions of Council Directive 93/15/EEC concern: the definitions, the obligations of economic operators, the presumption of conformity provided by harmonised standards, the declaration of conformity, CE marking, notified bodies, the safeguard clause procedure and the conformity assessment procedures. ; The proposal does not change the scope of Council Directive 93/15/EEC and the essential safety requirements. It is part of a package of 9 European Directives to be aligned to the New Legislative Framework. ;
Products Covered: Explosives (HS: 3601, 3602, 3603).
Regulation Type: Regular notification
Proposal for a Directive of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to the making available on the market and supervision of explosives for civil uses (COM(2011) 771) (86 pages, in English, French and Spanish
Distribution date: 27 February 2012 | Final date for Comment: 27 April 2012
This proposed Directive is a recast of Directive 93/15/EC to align it to Decision No 768/2008/EC establishing a common framework for the marketing of products. ; The changes made to the provisions of Council Directive 93/15/EEC concern: the definitions, the obligations of economic operators, the presumption of conformity provided by harmonised standards, the declaration of conformity, CE marking, notified bodies, the safeguard clause procedure and the conformity assessment procedures. ; The proposal does not change the scope of Council Directive 93/15/EEC and the essential safety requirements. It is part of a package of 9 European Directives to be aligned to the New Legislative Framework. ;
Products Covered: Explosives (HS: 3601, 3602, 3603).
Regulation Type: Regular notification
Proposal for a Directive of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to the making available on the market of pyrotechnic articles (COM(2011) 764) ( 96 pages, in English, French and Spanish).
Distribution date: 27 February 2012 | Final date for Comment: 27 April 2012
This proposed Directive is a recast of Directive 2007/23/EC to align it to the New Legislative Framework and in particular to Decision No 768/2008/EC. ; The changes made to the provisions of Directive 2007/23/EC concern: the definitions, the obligations of economic operators, the presumption of conformity provided by harmonised standards, the declaration of conformity, CE marking, notified bodies, the safeguard clause procedure and the conformity assessment procedures. ; The proposal does not change the scope of the Directive and the essential safety requirements, except for the essential safety requirements relating to the use of commercial blasting agents and military explosives, which some pyrotechnic articles, notably automotive pyrotechnic articles such as air bag gas generators, contain in small amounts. ;
Products Covered: Fireworks and other pyrotechnic articles (HS 3604).
Regulation Type: Regular notification
Proposal for a Directive of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to the making available on the market of pyrotechnic articles (COM(2011) 764) ( 96 pages, in English, French and Spanish).
Distribution date: 27 February 2012 | Final date for Comment: 27 April 2012
This proposed Directive is a recast of Directive 2007/23/EC to align it to the New Legislative Framework and in particular to Decision No 768/2008/EC. ; The changes made to the provisions of Directive 2007/23/EC concern: the definitions, the obligations of economic operators, the presumption of conformity provided by harmonised standards, the declaration of conformity, CE marking, notified bodies, the safeguard clause procedure and the conformity assessment procedures. ; The proposal does not change the scope of the Directive and the essential safety requirements, except for the essential safety requirements relating to the use of commercial blasting agents and military explosives, which some pyrotechnic articles, notably automotive pyrotechnic articles such as air bag gas generators, contain in small amounts. ;
Products Covered: Fireworks and other pyrotechnic articles (HS 3604).
Regulation Type: Regular notification
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