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Posted 02 January 2013 | By Louise Zornoza,
Health Canada has opened a consultation regarding the new Prescription Drug List that is scheduled replace the existing Schedule F of the Food and Drug Regulations. The regulatory process to add or remove a drug from Schedule F will be replaced by an administrative process, requiring the amendment of all existing regulations and draft regulations that have been developed.
Health Canada has also prepared a draft guidance document that explains the principles and factors that the agency will consider when deciding whether a drug would best be sold as a prescription drug or a non-prescription product. A proposed Prescription Drug List provides a user-friendly format for human use and for veterinary use, but does not include ingredients listed in the Controlled Drugs and Substances Act Schedules.
A question-and-answer document has also been released to assist the public in understanding the changes mandated by the Jobs, Growth and Long-term Prosperity Act (Bill C-38), which received Royal Assent on June 29, 2012. The deadline for comments is 7 March 2013.
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Tags: Schedule F, pharmaceutical, guidance, drug, regulations
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