Health Canada Mutual Recognition Agreement

4. A certificate of compliance or other documentation relating to a product issued by a compliance assessment body, which is then withdrawn by the joint committee or the application authority, remains valid, unless a specific decision by the relevant regulator is made on the basis of health and safety considerations for the withdrawal of the product from the market. For the purposes of this agreement, the points of contact for all technical issues are: for example. B the exchange of inspection reports, inspector training, technical requirements: The authorities responsible for the designation of compliance assessment bodies under this agreement are: 9.1 The ongoing monitoring of VPO compliance programmes, deemed equivalent at the end of the jam phase, and any subsequent decisions on this equivalency must be made within the framework of a mutually developed and managed equivalency programme. This program is managed by the Joint Sector Group. 7.5.2 Those not considered equivalent to the other party`s GMP compliance program are not mentioned in Schedule 2 at the end of the transitional period. Proposals to limit the recognition of an authority`s equivalency or exclude it from the schedule should be based on objective criteria and documented evidence. 8.2 In the event that, during or at the end of the transition period, a proposal inviting a competent/notifying authority to restrict the scope of recognition of a designated CAB or to exclude it from the list of accredited or designated bodies in accordance with the procedures set out in the framework agreement, such a proposal is based on objective reasons and must be properly documented in writing to the joint committee. Unless the parties have written agreements, commitments from mutual recognition agreements contained by one party with a country not party to this agreement have no effect or effect on the other party. Ensure the development/existence and mutual understanding of the GMP compliance program of each party`s regulators. Elements of the GMP compliance program are used to determine the equivalence of relevant regulatory programs.

Disclosure of non-public confidential technical, commercial and scientific information to the other party, including trade secrets and protected information, remains governed by the relevant laws of each party in order to assess product compliance with regulatory requirements for the safety, efficacy and quality of the product covered by this agreement. 3. Contracting parties may amend each transitional period by mutual agreement through the joint committee established under this agreement, taking into account the recommendations of the relevant joint sector groups.

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