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    Audit of the Estonian State Agency of Medicines by Health Canada completed with positive conclusion

    03.11.2010
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    The audit in the Estonian State Agency of Medicines was conducted in the framework of Mutual Recognition Agreement (MRA) between the European Community and Canada, Sectoral Annex on Good Manufacturing Practice.

    Health Canada has concluded the equivalency of systems in place in Estonia and in the State Agency of Medicines.

    For additional information on MRAs please see the webpage of European Medicines Agency
    Home > Regulatory > Human medicines >Inspections > Mutual Recognition Agreements
    Extracts:
    Scope and coverage of MRA Sectoral Annex on Good Manufacturing Practice
    /.../ MRA partner country and the EU Member States mutually recognise
    - the relevant manufacturing authorisations granted by the competent authorities of the other Party,
    - the conclusions of inspections of manufacturers carried out by the relevant inspection services of the other Party,
    - the manufacturers’ certification of the conformity of each batch to its specifications by the respective Party without re-control at import.
    EC - Canada MRA
    The Sectoral Annex on Good Manufacturing Practice started its operational phase on 1 February 2003. The list of products covered under the Annex includes human and veterinary medicinal products. Veterinary immunological products are not included. The Annex is not in operation for pre-approval inspections and stable medicinal products derived from human blood or human plasma. The two-way alert system is in operation.