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EC-Australia MRA, Sectoral Annex: Medicinal Products GMP Inspection and Batch Certification


EG Kommission

The provisions of this Sectoral Annex cover all medicinal products which are industrially manufactured in Australia and the European Community, and to which Good Manufacturing Practice (GMP) requirements apply. For medicinal products covered by this Sectoral Annex, each Party shall recognise the conclusions of inspections of manufacturers carried out by the relevant inspection services of the other Party and the relevant manufacturing authorisations granted by the Competent Authorities of the other Party. In addition, the manufacturer’s certification of the conformity of each batch to its specifications shall be recognised by the other Party without re-control at import.

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