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Guideline: EC-USA MRA, Sectoral Annex on Good Manufacturing Practices (GMP)

Titel:EC-USA MRA, Sectoral Annex on Good Manufacturing Practices (GMP)
Internet:http://ec.europa.eu/health/files/international/doc/mraecus_en.pdf
Herkunft/Verlag:EG Kommission
Inhalt: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.
Dokumentenart:Annex