Notice: Prescription Drug List (PDL): Levonorgestrel

November 28, 2014
Our file number: 14-114638-719

The purpose of this Notice of Intent to Amend is to notify that, as a result of consultation, Health Canada will revise the listing for levonorgestrel on the Prescription Drug List (PDL). Only the Human part of the PDL is to be revised; the listing for Veterinary use will remain unchanged. Health Canada has conducted a scientific review of levonorgestrel against a set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations. The wording, which remains unchanged from what was proposed in the August 15, 2014 Notice of Consultation, is:

Drugs containing any of the following: Sex Hormones

Including (but not limited to):

Qualifier: except Levonorgestrel when sold as a single ingredient in an oral dosage form containing no more than 1.5 milligrams (mg)

Effective Date: 6 months from date of this Notice

Consultation summary:

The proposal to amend the PDL was communicated to provincial and territorial Ministries of Health, medical and pharmacy licensing bodies, and industry, consumer and professional associations through a Notice of Consultation posted on Health Canada's website on August 15, 2014. The 75 day consultation period which ended October 29, 2014 has been completed.

Only one comment was received and it was favourable.

Based on the results of this consultation, the Minister of Health intends to revise the listing for levonorgestrel by increasing the concentration from 0.75 mg to 1.5 mg for human non-prescription use. This revision will be in effect six months from the date of this Notice through a Notice of Amendment posted on the Health Canada website.

Should you have any questions on this update to the Prescription Drug List, please contact:

Prescription Drug Status Committee
Health Canada
Holland Cross, Tower B, 2nd Floor
1600 Scott Street
Address Locator 3102C3
Ottawa, Ontario
K1A 0K9

Email: drug_prescription_status-statut_d'ordonnance_des_drogues@hc-sc.gc.ca
Phone: 613-957-1058
Fax: 613-941-5035