Qualifying Notice - Sativex

2005-12-16

Contact: BCANS Enquiries

Therapeutic Products Directorate
Finance Building, 2nd Floor
Tunney's Pasture
Address Locator: 0202D2
Ottawa, Ontario
K1A 1B9

December 17, 2004

9427-G0846\1-21

[employee name removed]
Director of Regulatory Affairs
GW Pharma Limited
Porton Down Science Park
Salisbury, Wiltshire, U.K.
SP4 0JQ

Notice of Compliance with Conditions - Qualifying Notice

Dear [employee name removed]

This Notice of Compliance with conditions (NOC/c) Qualifying Notice, issued in accordance with the Health Canada NOC/c policy, is to advise you that information submitted in support of the New Drug Submission for SATIVEX (cannabis sativa L.extracts TetranabinexTM and NabidiolexTM eqivalent to 27 mg/ml delta-9 tetrahydrocannabinol and 25 mg/ml cannabidiol), Control Number 091289, qualifies to be considered for approval, under the NOC/c policy. In keeping with the provisions outlined in the NOC/c policy, the following additional information is required to complete the assessment:

  1. A draft Letter of Undertaking signed by the Chief Executive Officer, or designated signing authority, of GW Pharmaceuticals Limited having a form and content satisfactory to Health Canada, including commitments to provide the following:

    1. A protocol for well designed and controlled studies of at least 15 weeks for the relief of neuropathic pain in patients with Multiple Sclerosis. The proposed studies should confirm the promising efficacy results of the 4-week Cannabis Based Medicine Extract (CBME) study in which CBME was used to relieve central neuropathic pain in patients with Multiple Sclerosis. The confirmatory studies are expected to employ established, clinically meaningful and validated efficacy outcome measures and to be sufficiently powered to provide clinically and statistically significant efficacy results. The confirmatory studies should be initiated within a timeframe that is satisfactory to Health Canada in order to avoid regulatory action preventing the marketing of Sativex® in Canada.

    2. Safety data from the above noted confirmatory studies that include the evaluation of routine safety outcomes and the evaluation of safety outcomes specific to Sativex®. Additional long-term safety data from safety extension studies should also be provided.

    3. Periodic Safety Update (PSUR-Cs) on a semi-annual basis. PSURs should be prepared in accordance with ICH Guidelines and should include events reported for delta-9-tetrahydrocannabinol/ cannabidiol products manufactured by GW Pharmaceuticals Limited.

  2. A draft of the "Dear Healthcare Professional Letter" detailing the conditional approval of Sativex® for the indication of symptomatic relief of neuropathic pain in Multiple Sclerosis.

  3. A draft of the "Fact Sheet" outlining in lay language the potential risks, benefits and side effects for Sativex® for the indication of symptomatic relief of neuropathic pain in Multiple Sclerosis.

  4. A draft of the Product Monograph which is consistent with the requirements outlined in Section 5.2.1 of the Guidance for Industry; Notice of Compliance with Conditions including, at the beginning of each major section, prominent boxed text disclosing the nature of the market authorization granted for Sativex® and the need to conduct confirmatory studies.

  5. A letter signed by the Chief Executive Officer, or designated signing authority, indicating that GWPharmaceuticals Limited agrees to have this submission considered under the NOC/c policy. Please be reminded that in agreeing to accept an NOC under the NOC/c policy, GW Pharmaceuticals Limited consents to the posting of the NOC/c-QN on Health Canada's website and commits to submit additional trials related to safety as well as other remaining studies, once complete.

I wish to advise you that this Qualifying Notice is being issued in accordance with Health Canada's guidance and policy on the Management of Drug Submissions and Notice of Compliance with Conditions, respectively. Sponsors are instructed to submit a complete response (refer to "Guidance for Industry; Notice of Compliance with Conditions") to the outstanding information within 30 calendar days of the date of this letter.

In order to facilitate and to ensure proper processing, please include a revised Submission Certificate with your response, quote the product name and control number, and address all correspondence to Chief, Submission and Information Policy Division, Bureau of Operational Services, Therapeutic Products Directorate, Finance Building, Tunney's Pasture, Address Locator 0201A1, Ottawa, Ontario, K1A 0L2.

Yours sincerely,

Original signed by

Siddika Mithani, Ph.D.
Director
Bureau of Cardiology, Allergy & Neurological Sciences
Tel: (613) 954-6498
Fax: (613) 941-1668

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