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Transcript
WORLD TRADE G/TBT/N/CAN/217 29 October 2007 ORGANIZATION (07-4673) Committee on Technical Barriers to Trade Original: English/ French NOTIFICATION The following notification is being circulated in accordance with Article 10.6. 1. Member to Agreement notifying: CANADA If applicable, name of local government involved (Articles 3.2 and 7.2): 2. Agency responsible: Department of Health Name and address (including telephone and fax numbers, e-mail and web-site addresses, if available) of agency or authority designated to handle comments regarding the notification shall be indicated if different from above: Canadian Enquiry Point 200-270 Albert Street Ottawa, Ontario Canada, K1P 6N7 Tel.: (+1) 61 3238 3222 Fax.: (+1) 61 3569 7808 E-mail: [email protected] 3. Notified under Article 2.9.2 [ X ], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], other: 4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Prescription status of medicinal ingredients for veterinary use (ICS: 11.220). 5. Title, number of pages and language(s) of the notified document: Proposed Amendment to the Food and Drug Regulations (Project No. 1530 - Schedule F) (3 pages, available in English and French). 6. Description of content: This notification announces the availability of a letter that provides an opportunity to comment on the proposed addition of two medicinal ingredients to Part I of Schedule F to the Food and Drug Regulations. Description of the medicinal ingredients: - Pimobendan is a cardiovascular drug for use in dogs. It is indicated for the treatment of congestive heart failure associated with a weakened heart and heart valves. Direct supervision by a veterinarian is required to diagnose congestive heart failure and identify the underlying disease. The animal may also require treatment with other drugs. Pimobendan is known to have undesirable or severe side effects at normal therapeutic dosage levels. . /. G/TBT/N/CAN/217 Page 2 - Pirlimycin and its salts is an antimicrobial indicated for the treatment of mammary gland infection in lactating dairy cows caused by the bacteria, Staphylococcus aureus. Diagnosis by a veterinarian is required prior to use because pirlimycin and its salts should not be used in animals with mastitis caused by other bacterial strains. Individualized instruction by a veterinarian is required to demonstrate the correct use of the drug because incorrect use may result in more severe mastitis. The degree of regulatory control afforded by Schedule F (prescription drug) status coincides with the risk factors associated with each medicinal ingredient. Oversight by a veterinarian is necessary to ensure that appropriate risk/benefit information is considered before the drug containing the medicinal ingredient is administered and that the drug therapy is properly monitored. Schedule F is a list of medicinal ingredients, the sale of which is controlled under sections C.01.041 to C.01.049 of the Food and Drug Regulations. Part I of Schedule F lists ingredients that require a prescription for human use and for veterinary use. Part II of Schedule F lists ingredients that require a prescription for human use, but do not require a prescription for veterinary use if so labelled or if in a form unsuitable for human use. 7. Objective and rationale, including the nature of urgent problems where applicable: Protection of animal health 8. Relevant documents: Therapeutic Products Directorate (TPD) website: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/notice-avis/index_e.html, Project No. 1530, letter posted: 3 October 2007. 9. Proposed date of adoption: Normally within 6 to 8 months from the posting of the letter on the TPD website. Proposed date of entry into force: On the date the measure is adopted. 10. Final date for comments: 17 December 2007 11. Texts available from: National enquiry point [ X ] or address, telephone and fax numbers, e-mail and web-site addresses, if available of the other body: The electronic version of Project No. 1530 can be downloaded at: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/noticeavis/project_projet_1530_e.html