Arrangement between the Veterinary Drugs Directorate of Health Canada and the Veterinary Medicines Directorate of the Department for Environment, Food and Rural Affairs in respect of the sharing of confidential information

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The Veterinary Drugs Directorate of Health Canada (VDD) and the Veterinary Medicines Directorate (VMD) executive Agency of the Department for Environment, Food and Rural Affairs of the United Kingdom, as the respective authorities responsible for the regulation of veterinary drugs/medicinal products in Canada and the United Kingdom (collectively hereinafter referred to as "the Participants"),

Recognizing the need to enhance their relationship with increased cooperation in respect of the sharing of confidential information,

Recognizing that each Participant has jurisdiction over specific products and defines those products differently and that collaboration under this Arrangement is intended to cover all products regulated by, and common to, the Participants and permit meaningful collaboration between them (This may include, but is not limited to, veterinary medicinal products (referred to as veterinary drugs in Canada),

Have come to the following understanding:

Provision of information

1. The purpose of this Arrangement is to strengthen communication between the Participants and enhance their ability to protect and promote the health and safety of their respective populations.  This Arrangement will also facilitate increased and accelerated access to safe, effective and high quality products, as well as provides improved regulatory performance and safety as a result of the involvement of the best regulatory expertise from both countries.
2. 1. The VMD will provide comprehensive information on its business activities on its website, and by mailings such as MAVIS (Marketing Authorisations Veterinary Information Service).
   2. VMD will provide the VDD with all such information routinely sent by mailings including annual reports and published business plans. VDD will consult with these sources prior to requesting information from VMD.
3. 1. Each Participant understands that information exchanged between them may include confidential information that is not in the public domain in the country of the Participant providing the information.  Participants will advise one another of the confidential status of the information at the time it is shared.
   2. Each Participant understands that confidential information will be shared in confidence, and will be shared in accordance with the laws as well as the policies and procedures permitted by those laws applicable to the respective Participant. 
   3. Each Participant will make every reasonable effort to prevent:
      1. the public release of confidential information that has been shared for the purposes set out in this arrangement; and
      2. any other release of this information for purposes not set out in this arrangement. 
4. Subject to confidentiality constraints set out herein, the VMD and VDD will provide each other with copies of other available information on relevant activities or matters within our jurisdiction. This includes but is not confined to:
   1. VMD's information on the type of applications and the proposed Summary of Product Characteristics (SPC) for pending applications,
   2. VDD's active list of submissions under review
   3. relevant extracts from the supporting data for authorised products,
   4. copies of assessments reviews or evaluations conducted by the Participant or on its behalf,
   5. copies of decisions on applications and
   6. copies of reports and information on pharmacovigilance data for individual Products or Product groups.
5. 1. The Participants understand that the provision of information will be subject to statutory provisions in the UK and Canada respectively regarding access to information. To the extent that these statutory provisions allow it, any confidential information requested will be provided to the Participant making the request on the understanding that the information will be kept confidential and not released to any person other than members of the requesting Participant who need to know the information for work purposes and who will have a legally enforceable obligation, such as, but not limited to, an employment contract, an agency agreement, confidentiality contract, or other document that permits those persons to use the information for the purposes of this Arrangement and requires them to protect the confidentiality of the information in accordance with the laws that are applicable to the Participant who receives the information.
   2. This confidentiality arrangement will not apply if the Participant that originally disclosed the information consents to its release.
6. The Participants understand that confidential information may be shared with, or used by, the other Participant, or shared with the third parties set out in the paragraph above without the prior written consent of the individual or entity to whom the information relates so long as this relates to the purposes contemplated in this Arrangement and such disclosure or use is in accordance with the laws as well as the policies and procedures permitted by those laws applicable to the respective Participant as noted in paragraphs 3(b) and 5. 
7. 1. The Participants will consult with each other on each occasion where there is a request for public disclosure or disclosure to third parties other than those set out in the preceding paragraph of confidential information received from either Participant.
   2. Each Participant will make all reasonable efforts to inform the other of any effort made pursuant to a judicial, legislative or other authority to obtain confidential information that has been provided by one Participant to the other Participant.  If public disclosure is required pursuant to such authority, the other Participant will make all reasonable efforts to ensure that the information is disclosed in a manner that protects the information from any subsequent disclosure that is not authorized by the judicial, legislative or other authority.
8. Each Participant will make all reasonable efforts to inform the other Participant of any changes to their respective laws, policies or procedures that may affect their treatment of confidential information obtained from the other Participant.
9. Each Participant will protect the confidentiality of information in accordance with their respective laws as well as the policies and procedures permitted by those laws.  The Participants consider it crucial to the sustainability of this Arrangement and future cooperation that confidential information shared between their respective agencies or branches be protected according to their respective laws from unauthorized use and disclosure.
10. 1. The Participants acknowledge that requests for information will be made to designated officers responsible for the administration of this Arrangement within their own agency or branch.  Unless otherwise notified in writing by one Participant to the other, the contact points for matters relating to this Arrangement are as follows:
       1. for VDD, the International & Branch Liaison Officer; and
       2. for VMD, the Director of Authorisations.
    2. The Participants may change their point of contact by giving a written notice to the other Participant.
11. This Arrangement does not compromise the regulatory authority of either Participant to carry out their respective responsibilities, nor does it create legally binding obligations on either Participant or between them to share information with each other.
12. The co-operative arrangements set out above will be carried out without costs or charges being levied to the Participant requesting the information.
13. The Participants will engage in broader cooperation with each other. This will include, but not be confined to:
    1. pursuing opportunities for concurrent assessment of veterinary medicine
    2. applications
    3. cooperation on reviews of existing veterinary medicines
    4. sharing information in relation to the licensing of veterinary medicines manufacturers
    5. sharing information on approaches to electronic submission and management of applications
14. 1. This Arrangement will come into effect on the date of its signature by the Participants.
    2. The Participants may terminate this Arrangement   by giving a 30 days written notice to the other Participant or upon their mutual consent. Upon termination of this Arrangement, the Participants will continue to protect confidential information from unauthorized disclosure and use in accordance with their respective laws as well as the practices and procedures permitted by those laws.
    3. The Participants may amend this Arrangement at any time upon their mutual written consent.

Signed in duplicate at VDD on this 7th day of June 2010 / VMD on this 18th day of May 2010. in the English and French languages, each version being equally valid.