Memorandum of Understanding between the Health Products and Food Branch of the Department of Health of Canada and the European Directorate for the Quality of Medicines and Healthcare of the Council of Europe regarding Conformity of Substances for Pharmaceutical Use

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• I. Purpose
• II. Definitions
• III. Scope
• IV. Use of Information
• V. Roles
• VI. Commencement, Review, Amendment and Termination
• Appendix A

The Health Products and Food Branch of the Department of Health of Canada (HPFB) and the European Directorate for the Quality of Medicines and Healthcare of the Council of Europe (EDQM), hereinafter jointly referred to as "the Participants";

Recognizing that the Participants share a common goal to protect public health and safety by assessing the quality of Substances for Pharmaceutical Use ("Substances") that are used in the production or preparation of pharmaceutical products;

Recalling that Canada is an observer to the Council of Europe and officially recognizes the European Pharmacopoeia as a standard;

Have reached the following understanding:

I. Purpose

1. This Memorandum of Understanding (MOU) establishes an arrangement between HPFB and EDQM for collaboration and the exchange of information relating to the assessment of Substances as conducted by EDQM through its certification procedure and as conducted by HPFB during the course of applicable product assessments. This MOU is also intended to facilitate each Participant's assessment processes and decision-making practices.
2. This MOU does not modify existing cooperative activities nor does it preclude entering into separate arrangements for specific activities that can be handled more efficiently by special arrangements.
3. Nothing in this MOU is intended to diminish or otherwise affect the authority of either Participant in carrying out its regulatory responsibilities and/or certification responsibilities as the case may be.
4. The Participants do not intend for this MOU to have legal effect.

II. Definitions

Substances for Pharmaceutical Use (also considered to be for Medicinal or Therapeutic Use) means any ingredient, whether an excipient or active pharmaceutical ingredient or a mixture as defined in a compendial monograph, used in the manufacture of a drug for use as a pharmaceutical product.

Certificate of Suitability means the designation granted by EDQM to certify that a Substance is compliant with the monographs of the European Pharmacopoeia. The EDQM Certificate of Suitability is intended to be used for substances for which a monograph (general monograph and/or specific monograph) has been adopted by the European Pharmacopoeia Commission including:

• Organic or inorganic substances (active or excipients), manufactured or extracted
• Substances produced by fermentation as indirect gene products, which are metabolites of microorganisms, irrespective of whether or not the microorganisms have been modified by traditional procedures or r-DNA technology
• Products with risk of transmitting agents of animal spongiform encephalopathies (TSE).
• Certificates of Suitability are not issued for direct gene products (proteins), products obtained from human tissues, vaccines and blood products and preparations.¹

Canadian Drug Master File means a reference source in the form of a dossier that provides proprietary information, which is not available to the manufacturer of the dosage form or to a sponsor of a submission when they are not the dosage form manufacturer, about specific processes and components used in the manufacturing, processing, and packaging of a pharmaceutical product meant for human or animal use.

III. Scope

1. The types of information and documentation that may be exchanged include but are not necessarily limited to:
   1. Laws, regulations, policies, guidance documents, procedures and other documents relating to the assessment of the Substances for which the Participants have responsibility;
   2. Information contained in or related to the Certificate of Suitability dossier and the Canadian Drug Master File, including assessment reports;
   3. Information on technology, e.g., information management systems, database systems, and other related computer applications that support the assessment of Substances and tracking of dossiers and/or assessment reports.
2. Collaborative activities may include the exchange of personnel, research and the planning of joint workshops, conferences, seminars or meetings.
3. Participants will also endeavour to invite each other to their scientific meetings and/or certification training events.

IV. Use of Information

1. Information shared or exchanged will only be used for the purposes of this MOU.
2. Information exchanged under this MOU may include confidential information exempt from public disclosure under the laws and regulations of Canada and the Council of Europe/European Community. Information that is exempt from public disclosure will only be shared according to the procedures and policies of the Participants as permitted by their respective laws and regulations. Neither HPFB nor EDQM will divulge confidential information, including, but not limited to, trade secret information or personal information, without the consent of the provider of such information. With regard to any confidential information that may be provided to HPFB by EDQM or to EDQM by HPFB, such transmissions will be made in accordance with the Confidentiality Provisions set out in Appendix A of this MOU, and in accordance with any other requirements of the Participants.

V. Roles

1. The Participants acknowledge that the administration of this MOU, including the management of issues arising from the application of the MOU and the evaluation and communication of the application of the MOU, will rest with the administrator of each Participant. Administrators will be:
   1. for EDQM, the person holding the position of Executive Director, EDQM; and
   2. for HPFB, the person holding the position of Associate Director General, Policy, Planning and International Affairs, HPFB.
2. The Participants acknowledge that written requests for information and documentation should be made to the identified contact person for each Participant. The contact person will carry out the day-to-day operations and monitor the application of the MOU. The contact person will be:
   1. for EDQM, the person holding the position of Head of the Certification Division, EDQM; and
   2. for HPFB, the person holding the position of Manager, International Programs Division, Therapeutic Products Directorate, HPFB.
3. The Participants acknowledge that they will establish a mechanism for bilateral meetings (in person or by teleconference / videoconference) on an annual or as-needed basis as a means of facilitating the application and functioning of this MOU.
4. The Participants acknowledge that they will notify each other of changes in their respective legislation, regulations, operational policies, practices and procedures relating to matters covered by this MOU, and which might impact on their ability to cooperate as intended by this MOU.
5. The Participants acknowledge that if any information or documentation is provided to the other, it will be free of charge.

VI. Commencement, Review, Amendment and Termination

1. This MOU will come into effect on the day on which it is signed by the last Participant.
2. On the first anniversary of this MOU, the Participants will review the flow of information between them under this MOU and the scope of the arrangement, to determine if an amendment(s) is required.
3. The MOU may be amended at any time with the written consent of the Participants. Any such amendment will come into effect on the date determined by the Participants.
4. Either Participant may terminate this MOU by written notice to the other Participant. The MOU will then terminate 30 calendar days after the receipt of the notice to terminate.

Signed in duplicate, on this 20^th day of March, 2007, at Strasbourg, France in the English and French languages, each version being equally valid.

Appendix A

Confidentiality Provisions

I. Purpose

1. The purpose of these confidentiality provisions is to allow for the sharing of confidential information related to regulatory cooperation activities. Examples of the types of information to be shared can be found in Part III (Scope) of the MOU.
2. As outlined in Part IV (Use of Information) of the MOU, transmissions of confidential information are to be made in accordance with these confidentiality provisions.

II. Confidentiality measures to be taken by the EDQM

1. EDQM will only release confidential information, which includes but is not limited to trade secret information, to HPFB, if it obtains the prior consent of the legal entity or person from which the confidential information was received (hereinafter "the provider of the confidential information"). When seeking such consent, EDQM will inform the provider of the confidential information of the purposes for which HPFB might use the information, and that HPFB has accepted to treat the information as confidential in so far as it is not already lawfully in the public domain in Canada.
2. EDQM will inform HPFB of the response of the provider of the confidential information to a request for consent.
3. Unless otherwise required by applicable laws and regulations, EDQM will make all reasonable efforts to protect confidential information it receives from HPFB from disclosure to any third parties. EDQM will not release confidential information to any persons other than EDQM staff, or on a need to know basis for work falling under this MOU, to contractors who have a comparable legal obligation of confidentiality as EDQM, except with the written consent from HPFB or written confirmation from HPFB that the information is lawfully in the public domain.
4. Refusal by the provider of the confidential information to share such information will not affect the regulatory processes for which such information was originally provided.
5. EDQM understands that some of the information it receives from HPFB may include confidential information exempt from public disclosure under Canadian laws and regulations.
6. EDQM will protect from public disclosure the confidential information provided to it in confidence by HPFB, subject to any applicable laws and regulations.
7. EDQM will not publicly disclose HPFB-provided confidential information without the written authorization of HPFB, or a written statement from HPFB that the information is lawfully in the public domain.
8. EDQM will inform HPFB within two working days of any effort made to obtain HPFB-provided confidential information from EDQM by judicial or legislative mandate. If such judicial or legislative mandate orders disclosure of HPFB-provided confidential information, EDQM will take all reasonable measures to ensure that the information will be disclosed in a manner that is in accordance with the order and that protects the information from unauthorized public disclosure.
9. EDQM will promptly inform HPFB of any changes to the Council of Europe/European Community laws, regulations, policies or procedures that would affect EDQM's ability to honour the provisions in this document.

III. Confidentiality measures to be taken by HPFB

1. HPFB will only release confidential information, which includes but is not limited to trade secret information, to EDQM, if it obtains the prior consent of the provider of the confidential information. When seeking such consent, HPFB will inform the provider of the confidential information of the purposes for which EDQM might use the information, and that EDQM has accepted to treat the information as confidential in so far as it is not already lawfully in the public domain.
2. HPFB will inform EDQM of the response of the provider of the confidential information to a request for consent.
3. Unless otherwise required by applicable laws and regulations, HPFB will make all reasonable efforts to protect confidential information it receives from EDQM from disclosure to any third parties. HPFB will not release confidential information to any persons other than HPFB staff, or on a need to know basis for work falling under this MOU, to contractors who have a comparable legal obligation of confidentiality as HPFB, except with the written consent from EDQM or written confirmation from EDQM that the information is lawfully in the public domain.
4. Refusal by the provider of the confidential information to share such information will not affect the regulatory processes for which such information was originally provided.
5. HPFB understands that some of the information it receives from EDQM may include confidential information exempt from public disclosure under Council of Europe/European Community laws and regulations.
6. HPFB will protect from public disclosure the confidential information provided to it in confidence by EDQM, subject to applicable laws and regulations.
7. HPFB will not publicly disclose EDQM-provided confidential information without the written authorization of EDQM, or a written statement from EDQM that the information is lawfully in the public domain.
8. HPFB will inform EDQM within two working days of any effort made to obtain EDQM-provided confidential information from HPFB by judicial or legislative mandate. If such judicial or legislative mandate orders disclosure of EDQM-provided confidential information, HPFB will take all reasonable measures to ensure that the information will be disclosed in a manner that is in accordance with the order and that protects the information from unauthorized public disclosure.
9. HPFB will promptly inform EDQM of any changes to Canadian laws, regulations, policies or procedures that would affect HPFB's ability to honour the provisions in this document.

¹ Resolution AP-CSP (99) 4 and any subsequent amendments: Council of Europe Public Health Committee (Partial Agreement)