Regulatory Updates
Proposed Amendment to the Food and Drug Regulations (1346 - Maximum Residue Limits for Veterinary Drugs) (available in English and French; pages 1479-1484).
Distribution date: 19 May 2004
Amendments to the Regulations are proposed to establish safe limits for residues of the veterinary drugs ceftiofur, monensin, pirlimycin and teflubenzuron in foods originating from animals treated with these particular drugs. These veterinary drugs are an important tool in the production of healthy animals which are destined for use as food. Extensive studies have determined that the food commodities containing residues of ceftiofur, monensin, pirlimycin and teflubenzuron at levels up to the maximum residue limits (MRLs) listed in the proposed amendments are safe for consumption. These MRLs would apply to foods produced domestically or imported into Canada.
Products Covered: Veterinary drugs (ICS: 11.220)
Regulation Type: Regular notification
Proposed Amendment to the Food and Drug Regulations (1346 - Maximum Residue Limits for Veterinary Drugs) (available in English and French; pages 1479-1484).
Distribution date: 19 May 2004
Amendments to the Regulations are proposed to establish safe limits for residues of the veterinary drugs ceftiofur, monensin, pirlimycin and teflubenzuron in foods originating from animals treated with these particular drugs. These veterinary drugs are an important tool in the production of healthy animals which are destined for use as food. Extensive studies have determined that the food commodities containing residues of ceftiofur, monensin, pirlimycin and teflubenzuron at levels up to the maximum residue limits (MRLs) listed in the proposed amendments are safe for consumption. These MRLs would apply to foods produced domestically or imported into Canada.
Products Covered: Veterinary drugs (ICS: 11.220)
Regulation Type: Regular notification
Revision of the standards and specifications for foods and food additives under the Food Sanitation Law (Additional establishment of residue limits for veterinary drugs) (available in English, 4 pages).
Distribution date: 05 May 2004
Establishment of maximum residue limits for veterinary drugs, Febantel, Fenbendazole and Oxfendazole, in foods.
Products Covered: Terrestrial mammals (muscle, fat, liver, kidney and other edible offal), poultry (muscle, liver and other edible offal), milk, globefish
Regulation Type: Regular notification
Revision of the standards and specifications for foods and food additives under the Food Sanitation Law (Additional establishment of residue limits for veterinary drugs) (available in English, 4 pages).
Distribution date: 05 May 2004
Establishment of maximum residue limits for veterinary drugs, Febantel, Fenbendazole and Oxfendazole, in foods.
Products Covered: Terrestrial mammals (muscle, fat, liver, kidney and other edible offal), poultry (muscle, liver and other edible offal), milk, globefish
Regulation Type: Regular notification
Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products (19 pages, in English)
Distribution date: 05 May 2004
The Food and Drug Administration (FDA) is proposing to amend its regulations governing the format and content of labeling for human drug products for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355). The proposed rule would require the addition of a statement that includes a toll-free number and advises that the number is to be used only for reporting side effects and is not intended for medical advice (the side effects statement). When finalized, this rule will bring FDA regulations into compliance with provisions of the Best Pharmaceuticals for Children Act (the BPCA).
Products Covered: Human Drug Products (HS Chapter 3003) (ICS 11.120)
Regulation Type: Regular notification
Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products (19 pages, in English)
Distribution date: 05 May 2004
The Food and Drug Administration (FDA) is proposing to amend its regulations governing the format and content of labeling for human drug products for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355). The proposed rule would require the addition of a statement that includes a toll-free number and advises that the number is to be used only for reporting side effects and is not intended for medical advice (the side effects statement). When finalized, this rule will bring FDA regulations into compliance with provisions of the Best Pharmaceuticals for Children Act (the BPCA).
Products Covered: Human Drug Products (HS Chapter 3003) (ICS 11.120)
Regulation Type: Regular notification
Partial revision of the Minimum Requirements for Biological Ingredients (2 pages, available in English)
Distribution date: 30 April 2004
Products Covered: Drugs, quasi-drugs, cosmetics and medical devices (HS:30)
Regulation Type: Regular notification
Partial revision of the Minimum Requirements for Biological Ingredients (2 pages, available in English)
Distribution date: 30 April 2004
Products Covered: Drugs, quasi-drugs, cosmetics and medical devices (HS:30)
Regulation Type: Regular notification
Import health standard in English for the importation of Surgical Catgut into New Zealand from all countries (available in English, 5 pages).
Distribution date: 27 April 2004
This import health standard allows for the importation of Surgical Catgut into New Zealand from all countries. It includes the following safeguards against diseases of concern: Catgut that was manufactured from ovine or bovine tissues was sourced from countries or zones free of Bovine Spongiform Encephalopathy (BSE) according to the OIE Code. Catgut that was manufactured from ovine tissues was sourced from countries or zones free of scrapie according to the OIE Code.
Products Covered: Surgical catgut from all countries.
Regulation Type: Regular notification
Import health standard in English for the importation of Surgical Catgut into New Zealand from all countries (available in English, 5 pages).
Distribution date: 27 April 2004
This import health standard allows for the importation of Surgical Catgut into New Zealand from all countries. It includes the following safeguards against diseases of concern: Catgut that was manufactured from ovine or bovine tissues was sourced from countries or zones free of Bovine Spongiform Encephalopathy (BSE) according to the OIE Code. Catgut that was manufactured from ovine tissues was sourced from countries or zones free of scrapie according to the OIE Code.
Products Covered: Surgical catgut from all countries.
Regulation Type: Regular notification
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