The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

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

Origin/Publisher:

EG Kommission

Document Type:
Annnex
Content:
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.

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK