Food and Drugs Act and Regulations

Food and Drugs Act and Regulations 

• Natural Health Products Regulations  

Amendments:

To the Food and Drug Regulations

Pre-notifications

• Regulations Amending the Food and Drug Regulations (1447 - Good Manufacturing Practices) (October 11, 2006)

• Amendment to the Food and Drug Regulations, Project No. 743, Non-medicinal Ingredients (August 14, 2006)

• Regulations Amending the Food and Drug Regulations (1390 - Data Protection)
• Regulations Amending the Food and Drug Regulations (1422 - Schedule F)
• Regulations Amending the Food and Drug Regulations (1384 - Schedule F)
• Regulations Amending the Food and Drug Regulations (1383 - Schedule F)
• Regulations Amending the Food and Drug Regulations (1381 - Schedule F)
• Regulations Amending the Food and Drug Regulations (1367 - Schedule F)
• Regulations Amending the Food and Drug Regulations (1421 - Schedule F)
• Notice of Intent to Develop Environmental Assessment Regulations for Products Regulated under The Food and Drugs Act

Canada Gazette - Part I

• Regulations Amending Certain Regulations Made under the Food and Drugs Act - Project 1539 (June 16, 2007)

• Withdrawal of regulatory proposal - Project 1474 (June 16, 2007)

• Food and Drug Regulations Amendment - Interim Marketing Authorization
• Regulations Amending the Medical Devices Regulations (Developing Countries)
• Regulations Amending the Food and Drug Regulations (1402-Drugs for Developing Countries)
• Regulations Amending the Food and Drug Regulations (1416-Nutrition Labelling, Nutrient Content Claims and Health Claims)
• Schedule 1373: Schedule F  
• Regulations amending the Food & Drug Regulations re: licensed dealers (September 19, 2003)
• Schedule 1108: Prohibited Substances
• Schedule 1243: Scheduling of Zaleplon, Zolpidem and Zopiclone
• Schedule 743: Non-medicinal Ingredient Labelling

Canada Gazette - Part II

• Regulations Amending the Food and Drug Regulations (1385 — Vitamin K) (October 19, 2005)

• Schedule 1397: Schedule F
• Schedule 1398: Addition of Ferric Ferrocyanide to Paragraph C.01.040.2(4)(a)
• Schedule 1386: Kaolin
  

To Schedule F

Pre-notifications

• Project #1595 Proposed Addition of 1 Medicinal Ingredient (Dabigatran and its salts and derivatives) to Schedule F (November 11, 2008)

• Project #1595 Proposed Addition of 1 Medicinal Ingredient (Nelarabine) to Schedule F (November 5, 2008)

• Project #1595 Proposed Addition of 1 Medicinal Ingredient (Rivaroxaban) to Schedule F (November 5, 2008)

• Project #1595 Proposed Addition of 1 Medicinal Ingredient (Nilotinib and its salts) to Schedule F (September 19, 2008)

• Project #1584 Notice of Intent to Amend Schedule F (Naproxen and its salts) (March 5, 2008)

• Project #1590 Proposed Addition of 1 Medicinal Ingredient (Lenalidomide) to Schedule F (February 27, 2008)

• Project #1578 Proposed Addition of 1 Medicinal Ingredient (Lanreotide and its salts) to Schedule F (December 7, 2007)

• Project #1578 Proposed Addition of 1 Medicinal Ingredient (Aliskiren and its salts) to Schedule F (December 7, 2007)

• Project #1578 Proposed Addition of 1 Medicinal Ingredient (Raltegravir and its salts) to Schedule F (December 7, 2007)

• Project #1578 Proposed Addition of 1 Medicinal Ingredient (Anidulafungin) to Schedule F (November 15, 2007)

• Project #1578 Proposed Addition of 1 Medicinal Ingredient (Acamprosate) to Schedule F (November 15, 2007)

• Project #1583 Notice of Intent to Amend Schedule F (Duloxetine and its salts) (November 2, 2007)

• Project #1583 Notice of Intent to Amend Schedule F (Paliperidone and its salts and its derivatives) (November 2, 2007)

• Project #1583 Notice of Intent to Amend Schedule F (Maraviroc) (November 2, 2007)

• Project #1583 Notice of Intent to Amend Schedule F (Daptomycin) (November 2, 2007)

• Project #1583 Notice of Intent to Amend Schedule F (Aprepitant and its derivatives) (November 2, 2007)

• Project #1583 Notice of Intent to Amend Schedule F (Ziprasidone and its salts) (November 2, 2007)

• Project #1540: Notice of Intent to Amend Schedule F (Dasatanib) (April 20, 2007)

• Project #1441: Proposed Addition of 1 Medicinal Ingredient (Zaleplon) to Schedule F (August 17, 2006)

• Project #1431: Proposed Addition of 1 Medicinal Ingredient (Quinine and its salts and derivatives) to Schedule F (May 29, 2006)
• Project #1405: Proposed Addition of 7 Medicinal Ingredients (Atazanavir and its salts; Fulvestrant; Gefitinib; Gemifloxacin and its salts; Hetastarch and its derivatives; Ibandronic acid and its salts; Ponazuril) to Schedule F (November 15, 2005)
• Schedule 1397: Schedule F Update (January 2004)  

Canada Gazette - Part I

• Project #1554: Proposed Addition of one medicinal ingredient, (Progesterone and its derivatives except when sold in an implant for veterinary use for growth promotion) (January 19, 2008)  
• Schedule 1385: Vitamin K (January 2004/April 2005)  
• Schedule 1203: Addition of nine new drug substances (Feburary 2000)
• Zaleplon, Zolpidem, Zopiclone (June 29/02)

Canada Gazette Part II

• Regulations Amending the Food and Drug Regulations (Project 1576 - Oxaliplatin and Ranibizumab) to Schedule F (September 5, 2008)  
• Regulations Amending the Food and Drug Regulations (Project 1575 - Inhaled human insulin) to Schedule F  (June 25, 2008)
• Regulations Amending the Food and Drug Regulations (Project 1550 - Acamprosate and its salts, varenicline and its salts) to Schedule F (June 25, 2008)
• Regulations Amending the Food and Drug Regulations (Project 1536 - Micafungin and its salts, sitaxentan and its salts) to Schedule F (June 25, 2008)
• Regulations Amending the Food and Drug Regulations (Project 1530 - Pimobendan and Pirlimycin and its salts) to Schedule F (June 25, 2008)
• Regulations Amending the Food and Drug Regulations (Project 1508 - Nicotinic acid) (June 25, 2008)
• Regulations Amending the Food and Drug Regulations (Project 1541 - Diclofenac and its salts) (April 3, 2008)
• Regulations Amending the Food and Drug Regulations (Project 1551 - Lanthanum salts) (February 7, 2008)
• Regulations Amending the Food and Drug Regulations (Project 1476, 1502, 1511 and 1512 - Abatacept; Entecavir; Erlotinib and its salts; Histrelin and its salts; Lutropin alfa; Pregabalin and its salts and derivatives; Solifenacin and its salts; Sunitinib and its salts; Trospium chloride)  (October 25, 2007)
• Regulations Amending the Food and Drug Regulations (Project 1478 and 1491 - Resocortol and its derivatives; Deracoxib) (October 25, 2007)
• Project #1535: Proposed Addition of one medicinal ingredient (Calcium salts when sold for the treatment of hyperphosphatemia) to Schedule F (August 20, 2007)
• Regulations Amending the Food and Drug Regulations (Project 1434 - Agalsidase alfa; Botulinum toxin, Type B; Laronidase; Miglustat; Muromonab-CD3; Pegfilgrastim; Pemetrexed and its salts; Rasburicase; Teriparatide and its salts; Vardenafil and its salts) to Schedule F) (May 16, 2007)
• Regulations Amending the Food and Drug Regulations (Project 1496 and 1510 - Ranitidine and its salts; Famotidine and its salts) (February 22, 2007)
• Regulations Amending the Food and Drug Regulations (Project 1481 - Alemtuzumab; Azelaic acid; Bevacizumab; Cetuximab; Darifenacin and its salts; Efalizumab; Emtricitabine; Nitric Oxide; Palifermin; Pegvisomant; Tipranavir and its salts) (February 22, 2007)
• Regulations Amending the Food and Drug Regulations (Project 1463 - Paricalcitol; Pegaptanib and its salts) (February 22, 2007)
• Regulations Amending the Food and Drug Regulations (Project 1452 - Cloriogonadotropin alpha) (February 22, 2007)
• Regulations Amending the Food and Drug Regulations (Project 1449 - Atomoxetine and its salts; Escitalopram and its salts; Omalizumab) (February 22, 2007)
• Regulations Amending the Food and Drug Regulations (Project 1445 - Alefacept) (February 22, 2007)
• Regulations Amending the Food and Drug Regulations (Project 1439 - Adalimumab; Cinacalcet and its salts; Eletriptan and its salts; Frovatriptan and its salts, Voriconazole) (February 22, 2007)
• Regulations Amending the Food and Drug Regulations (Project 1421-Clobetasone butyrate) (October 19, 2006)
• Regulations Amending the Food and Drug Regulations (Project 1451) (September 21, 2006)
• Regulations Amending the Food and Drug Regulations (Project 1448-Danofloxacin) (September 21, 2006)
• Regulations Amending the Food and Drug Regulations (Project 1405) (September 21, 2006)
• Regulations Amending the Food and Drug Regulations (Project 1330-Sibutramine and its salts) (September 21, 2006)
• Regulations Amending the Food and Drug Regulations (Project 1184-Modafinil and its salts) (September 21, 2006)
• Regulations Amending the Food and Drug Regulations (Project 1373) (June 22, 2006)
• Regulations Amending the Food and Drug Regulations (Project 1370 Nicotine lozenge) (June 22, 2006)
• Regulations Amending the Food and Drug Regulations (Ketamine) (August 31, 2005)
• Schedule 1247: Establishment Licenses and Good Manufacturing Practices
• Schedule 1272: Levonorgestrel (May 2005)
• Schedule 1329: Amendments to Schedule F (May 2004)

To the Natural Health Products Regulations

Canada Gazette - Part II

• Regulations Amending the Natural Health Products Regulations (Vitamin K) (October 19, 2005)

• Regulations amending the NHPR (Special Access) - June 2004

Related Documents

• Information on a Regulatory Framework for Natural Health Products (August 2003)
• Revised "Transfer of Authority to Fill Prescriptions by Facsimile Transmission" Model Policy
• Mandatory Patient Package Inserts
• Manufacturing and Compounding Drug Products in Canada
• Report on the Transfer of Authority to Fill Prescriptions by Electronic Transmission
• A Proposal for Electronic Prescription Security Standards
• Overview of Drug Advertising