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16 August 2017
Plain language labelling regulations for non-prescription drugs
Proposed amendments to Food and Drug Regulations
Health Canada publishes regulations permitting import of drugs
Consultation on possible changes to generic drug equivalence
On June 13 2017 Health Canada issued a statement regarding the same-day coming into force of the Plain Language Labelling Regulations for non-prescription drug products. Health Canada has released a related guide entitled Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products.
The Plain Language Labelling Regulations for prescription products and those administered or obtained through a health professional have been in force since June 2015.
On June 17 2017 proposed amendments to the Food and Drug Regulations were published that would allow the minister of health to add or amend terms and conditions to an authorisation for opioid sales. The minister could then require the opioid authorisation holder to implement a risk management programme to identify, mitigate and monitor risks associated with opioid use.
The amendments will also require a warning sticker and patient information handout to accompany the sale of all prescription opioids. Comments may be provided until August 31 2017. In the news release announcing the amendments, Health Canada stated that "[w]hen finalized, this will be the first time that the Government of Canada will use the power granted by Vanessa's Law to apply terms and conditions".
Health Canada proposed amendments to the Food and Drug Regulations that would provide for import and use of drugs authorised for sale in the United States, the European Union or Switzerland to meet an urgent public health need (for more information see "Health Canada update").
As announced in a Health Canada news release, the amended regulations were released on June 20 2017 and an initial list of drugs (covering certain drugs for the treatment of opioid dependence and tuberculosis) was also published. Through this regulatory pathway public health officials may seek access to a drug and its addition to the list by notifying Health Canada of an urgent public health need for the drug within their jurisdictions.(1)
Health Canada is soliciting comments until October 13 2017 regarding possible changes to the Food and Drug Regulations relating to establishing pharmaceutical equivalence between a proposed generic drug product and a Canadian reference product (CRP).(2)
Under the proposed changes, a notice of compliance constituting a "declaration of therapeutic equivalence" to a CRP could be issued to a generic product when the generic product and CRP are "pharmaceutical equivalents" (same medicinal ingredient in same dosage form) or "pharmaceutical alternatives" (different salts, esters or complexes of the medicinal ingredient, or different but comparable dosage forms to the CRP), if the generic for which bioequivalence has been demonstrated has the same route of administration and the same safety and effectiveness as the CRP.
The regulations currently define 'pharmaceutical equivalent' as:
"a new drug that, in comparison with another drug, contains identical amounts of the identical medicinal ingredients, in comparable dosage forms, but that does not necessarily contain the same non-medicinal ingredients."
Health Canada's current interpretation of 'identical medicinal ingredient' is set out in its 2003 policy and 2015 interim supplemental policy. The proposed changes would also define 'medicinal ingredient' as the active substance that contains the therapeutic moiety in the drug product that is administered or consumed, rather than the starting active pharmaceutical ingredient or input material.
For further information on this topic please contact Urszula Wojtyra or Brandon Heard at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email (email@example.com or firstname.lastname@example.org). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
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