Hi all:

Hurray! Health Canada is consulting finally, on changing the status of  an
emergency contraception drug ( aka the Morning After pill --marketed in
Canada as Plan B) to non prescription status!

  There is a 30 day turn around time for this stage of the process. There
is lots of information on WWW about this and why it is important so I won't
repeat it here...
  I am also  attaching a summary of the overall process for those of you
who are unfamiliar with this..

Please pass on to relevant contacts--- thanks,
Madeline Boscoe,
Women's Health Clinic, Winnipeg


Food and Drugs Act
Proposal to amend the Food and Drug Regulations Schedule 1272 - Emergency
Contraceptive

Attached is a copy of a proposal to amend the Food and Drug Regulations.

(See attached file: sch_1272-e.wpd)

The document will also available on the Therapeutic Products Directorate
website at http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/

Comment on this proposal may be forwarded to:  Karen Ash, Policy Division,
Bureau of Policy, Therapeutic Products Directorate, 1600 Scott Street,
Holland Cross, Tower B, 2nd Floor, Address Locator:  3102C5, Ottawa,
Ontario, K1A 0K9,   Fax number:  (613) 941-6458, or by e-mail:
[log in to unmask], within 30 days.

Comment on this proposal will be considered prior to its publication in
Canada Gazette,Part I.


Re: Process to Change Drug Status:

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 which outlines the proposed switch of Plan B from prescription
to nonprescription 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 sometine 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. CGII
- 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 CG2, 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. HC is
not involved in the projects understaken 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 additinal 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 Rx drugs are dispensed by a licensed
practitioner. The definiiton of a practitioner is determined by the
province. The change in status requires evidence from the manufacturer to
support that it is safe and effective under the conditions of
non-prescription use.

To unsubscribe send one line: unsubscribe click4hp to: [log in to unmask] . To view archives or modify subscription see: http://listserv.yorku.ca/archives/click4hp.html