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


EG Kommission

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

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