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EC-USA MRA, Sectoral Annex on Good Manufacturing Practices (GMP)
Internet:http://ec.europa.eu/enterprise/pharmaceuticals/mra/doc/mraecus.pdf
Origin/Publisher:EG Kommission
Content:The provisions of this Annex govern the exchange between the Parties and normal endorsement by the receiving authority of official Good Manufacturing Practices (GMPs) inspection reports after a transitional period aimed at determination of the equivalence of the regulatory systems of the Parties, which is the cornerstone of this Annex.
Document Type:Annex