Interim Order Respecting the Sale of the Vaccine for the Novel Influenza A H1N1 Virus

Expired October 13, 2010

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Whereas the Minister of Health believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment;

Therefore, the Minister of Health, pursuant to subsection 30.1(1)^a of the Food and Drugs Act^b, hereby makes the annexed Interim Order Respecting the Sale of the Vaccine for the Novel Influenza A H1N1 Virus.

Ottawa, October 13, 2009

Original signed by:
Leona Aglukkaq
Minister of Health

Interim Order Respecting the Sale of the Vaccine for the Novel Influenza A H1N1 Virus

Interpretation

1. The following definitions apply in this Interim Order.

• "Regulations" means the Food and Drug Regulations; (règlement)
• “regulatory body” means the European Medicines Agency and any government agency, or other entity, that has a legal right to control the use or sale of drugs and that may take enforcement action to ensure that drugs marketed within its jurisdiction comply with legal requirements; (organisme réglementaire)
• "vaccine" means an immunizing agent used to provide protection against the novel influenza A H1N1 virus in humans. (vaccin)

2. Unless the context requires otherwise, words and expressions used in this Interim Order have the same meaning as in the Regulations.

3. (1) For the application of the Regulations with respect to the sale of the vaccine,

1. a reference to the prohibitions under section C.08.002 of the Regulations shall be read as a reference to the prohibitions under section 5;
2. a reference to a new drug submission under section C.08.002 of the Regulations shall be read as a reference to a vaccine submission under section 6;
3. a reference to a supplement to a new drug submission under section C.08.003 of the Regulations shall be read as a reference to a supplement to a vaccine submission under section 7;
4. a reference to a notice of compliance issued under section C.08.004 of the Regulations shall be read as a reference to an authorization for sale issued under section 11; and
5. a reference to suspension under section C.08.006 of the Regulations shall be read as a reference to suspension under section 16 or a reference to revocation under section 17, as the case may be.

(2)Subsection (1) does not apply to Division 8 of Part C of the Regulations, unless otherwise provided.

Application

4. (1) Section C.08.002 of the Regulations does not apply to the sale of the vaccine if an authorization for sale has been issued.

(2)Section C.08.002 of the Regulations applies to the sale of the vaccine if the authorization for sale has been suspended or revoked.

Prohibition

5. (1) No person shall sell or advertise the vaccine unless the following conditions are met:

1. the manufacturer has filed with the Minister a vaccine submission, in a form established by the Minister;
2. the Minister has issued an authorization for sale;
3. the authorization for sale has not been suspended or revoked; and
4. the manufacturer has submitted to the Minister specimens of the final version of any labels, including package inserts, product brochures and file cards, intended for use in connection with the vaccine, and a statement setting out the proposed date on which those labels will first be used.

(2) Subsection (1) does not apply if a notice of compliance has been issued for the vaccine under paragraph C.08.004(1)(a) of the Regulations.

Vaccine Submission

6. (1) The vaccine submission shall contain sufficient information and material to enable the Minister to determine whether to issue an authorization for sale and shall include the following:

1. the information set out in paragraphs C.08.002(2)(a) to (m) of the Regulations, excluding paragraphs (g) and (h);
2. the information set out in section C.08.005.1 of the Regulations, if any;
3. any information in the possession of, or available to, the manufacturer concerning the safety and effectiveness of the vaccine for the purpose and under the conditions of use recommended, including information, if any, respecting clinical trials;
4. a plan to allow for the collection, assessment and reporting to the Minister of information related to the safety and effectiveness of the vaccine; and
5. any available assessment report regarding the vaccine prepared by a regulatory body outside of Canada.

(2) The manufacturer shall, at the request of the Minister, submit the following information and material:

1. the names and addresses of the manufacturers of each of the ingredients of the vaccine and the names and addresses of the manufacturers of the vaccine in the dosage form in which it is proposed that the vaccine be sold;
2. samples of the ingredients of the vaccine;
3. samples of the vaccine in the dosage form in which it is proposed that the vaccine be sold; and
4. any additional information or material respecting the safety and effectiveness of the vaccine.

7. (1) Despite section 5, no person shall sell a vaccine in respect of which an authorization for sale has been issued to the manufacturer and has not been suspended or revoked, if any of the matters referred to in subsection (2) are significantly different from the information or material contained in the vaccine submission, unless

1. the manufacturer has filed with the Minister a supplement to the vaccine submission;
2. the Minister has issued an authorization for sale to the manufacturer in respect of the supplement;
3. the authorization for sale in respect of the supplement has not been suspended or revoked; and
4. the manufacturer has submitted to the Minister specimens of the final version of any labels, including package inserts, product brochures and file cards, intended for use in connection with the vaccine, if a change with respect to any of the matters referred to in subsection (2) is made that would require a change to the label.

(2) The matters referred to for the purposes of subsection (1), in relation to the vaccine, are those set out in paragraphs C.08.003(2)(a) to (i) of the Regulations, as applicable.

(3) A supplement to a vaccine submission, with respect to the matters that are significantly different from those contained in the vaccine submission, shall contain sufficient information and material to enable the Minister to determine whether to issue an authorization for sale.

8. A manufacturer who has filed a vaccine submission or supplement and has any relating clinical case reports or raw data shall keep those reports or data and shall, upon request by the Minister, submit them to the Minister.

9. The Minister may examine any information or material filed with the Minister by any person under Division 5 or section C.08.002, C.08.002.1, C.08.003, C.08.005 or C.08.005.1 of the Regulations, or under section 6 or 7 of this Interim Order, to determine whether to issue an authorization for sale.

Delivery Prior to Authorization for Sale

10. Despite section 5 and the Regulations, the Minister may, prior to the issuance of an authorization for sale, permit the vaccine for which a submission has been filed to be delivered to locations specified by the Minister, if the Minister considers that the delivery of the vaccine is necessary in order to facilitate timely access to the vaccine by the public.

Authorization for Sale

11. The Minister shall issue an authorization for sale to the manufacturer if

1. the vaccine submission or supplement complies with section 6 or 7, as the case may be; and
2. in light of the information available to the Minister, it is reasonable to believe that
   1. the vaccine may be effective in providing protection against the novel influenza A H1N1 virus, and
   2. the known and potential benefits of the vaccine outweigh the known and potential risks.

12. (1) The Minister may set out terms and conditions in the authorization for sale respecting the plan to allow for the collection, assessment and reporting to the Minister of information related to the safety and effectiveness of the vaccine.

(2) The Minister may amend the terms and conditions of the authorization for sale if the Minister believes on reasonable grounds that an amendment is necessary to prevent injury to human health.

(3) For the purpose of subsection (2) the Minister may examine any information or material filed with the Minister by any person under Division 5 or section C.08.002, C.08.002.1, C.08.003, C.08.005 or C.08.005.1 of the Regulations, or under section 6 or 7 of this Interim Order.

Labelling

13. The manufacturer shall include on the outer label of every package of the vaccine a statement indicating that the Department has authorized the sale of the vaccine based on limited clinical testing in humans.

14. Subsection C.01.005(1) of the Regulations does not apply to the vaccine.

Records

15. The manufacturer shall establish and maintain records regarding the vaccine, in a manner that enables an audit to be made, respecting the matters set out in paragraphs C.08.007(a) to (h) of the Regulations.

Suspension

16. The Minister may suspend an authorization for sale if

1. any of the conditions set out in paragraphs C.08.006(2)(a) to (f) of the Regulations, excluding paragraph (b), is met, with any reference to a notice of compliance in those paragraphs being read as a reference to an authorization for sale; or
2. upon receipt of a notice from the Minister, the manufacturer cannot establish that the plan referred to in paragraph 6(1)(d), and the terms and conditions respecting the plan, if any, have been complied with.

Revocation

17. The Minister shall revoke the authorization for sale if

1. the Minister considers that the conditions set out in paragraph 11(b) are no longer met; or
2. a notice of compliance has been issued for the vaccine under paragraph C.08.004(1)(a) of the Regulations.

Explanatory Note

(This note is not part of the Interim Order.)

Infection with the novel influenza A H1N1 virus has the potential to cause serious and life-threatening disease which has been associated with several fatalities. It will likely not be possible for a manufacturer of the vaccine to collect evidence of safety and clinical effectiveness necessary for a Notice of Compliance to be issued under the Food and Drug Regulations in time to provide the public with protection against the spread of the virus during the current flu season. There is a need to balance timely access to the vaccine with the time needed to assess the safety and effectiveness of the vaccine. Therefore, an Interim Order is required to provide an alternate pathway to allow for the authorization for sale of the vaccine.

Under this Interim Order, the manufacturer is required to submit all the safety and effectiveness data available at the time of the vaccine submission as well as a plan to allow for the collection, assessment and reporting of information about the vaccine's safety and effectiveness. This plan is reviewed as part of the vaccine submission process and the manufacturer is required to adhere to the plan once the vaccine is authorized for sale under this Interim Order.

Based on all of the information available, the Minister will authorize the sale of the vaccine if it is reasonable to believe that the vaccine may be effective in providing protection against the novel influenza A H1N1 virus, and the known and potential benefits of the vaccine outweigh the known and potential risks. The Minister may add terms and conditions to the authorization for sale respecting the manufacturer's plan to collect assess and report safety and effectiveness information. The Minister may suspend the authorization for sale if the manufacturer does not comply with the plan.

The authorization for sale will be revoked if the Minister considers that the known and potential benefits of the vaccine no longer outweigh the known and potential risks. It will also be revoked if a Notice of Compliance is issued.

In order to facilitate timely access to the vaccine throughout Canada, this Interim Order also permits the Minister to allow the manufacturer to deliver the vaccine to locations specified by the Minister prior to its authorization for sale.

a S.C. 2004, c. 15, s. 66
b R.S., c. F-27