EC-Australia MRA, Sectoral Annex: Medicinal Products GMP Inspection and Batch Certification
Titel:
EC-Australia MRA, Sectoral Annex: Medicinal Products GMP Inspection and Batch Certification
Internet:
Herkunft/Verlag:
EG Kommission
Inhalt:
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.