1. The change in drug status must first be approved by Therapeutics
Products Directorate and the Drug Schedule Status Committee.
- This has now happened.
2. Letter:
- The next step in the process is an early consultation letter to stakeholders
that outlines the proposed switch of Plan B from prescription to non-prescription
status. The letter will provide for a 30-day comment period. The letter is
being posted on the TPD website.
3. Canada Gazette 1 (CGI)
- Once the letter has been sent out, preparation will begin on drafting the regulatory amendment and the Regulatory Impact Analysis Statement (RIAS). This outlines why OTC status is acceptable/justified. The RIAS cannot be completed, until the comment period for the letter has expired. Any comments received will have to be taken into consideration and addressed in the RIAS.
- The time required for this step depends on the number and complexity of the comments received and who has to be consulted in addressing the issues for the RIAS. Timeframes generally range from 3 to 6 months, but could take less for a priority review; partly dependent on the complexity of the proposal. We may be looking at sometime in the fall for publication in CGI.
- Following publication in the Canada Gazette, Part I, a 75-day comment period is allowed. Again, comments received must be addressed in the RIAS for Canada Gazette, Part II (CGII) publication.
4. Canada Gazette 2
- The timeframe to publication in CGII ranges from 3 to 6 months after the end of the CGI comment period. Once final decision is published in CGII, then company can commence sale of the product as non-prescription.
Note:
The company has given permission for Health Canada to openly discuss the status of the Plan B submission. It has cleared the first regulatory hurdle, but must still go through the other stages.
The provinces regulate the practice of medicine, not Health Canada. Health Canada is not involved in the projects undertaken in some of the provinces to make the drug available through the pharmacist. Provincial/Territorial Regulatory Bodies may be in a position to delegate prescription authority for a drug to pharmacists. This isn't the same as free access to a non-prescription drug. The pharmacists have been delegated to prescribe the
drug and are required to take additional training.
Health Canada cannot require the intervention of a health care professional in the sale of a non-Rx drug. The Provinces/Territories determine the level of intervention from health care professionals and assign the corresponding schedule (i.e. behind the counter, etc).
Federal regulations require that a licensed practitioner dispense Rx drugs. The province determines the definition of a practitioner. The change in status requires evidence from the manufacturer to support that it is safe and effective under the conditions of non-prescription use.
