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REGULATORY INFORMATION

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Guidelines & Codes

New Zealand Regulatory Guidelines for Medicines

Vol 1.
Combining and updating previous editions of Volumes 1 and 2
Guidance notes for applicants for consent to distribute new and changed medicines and related products (October 2001)
[Note: this is a 280-page (5,620KB) Word document so may take some time to download]
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Online version (Windows Help file 493KB)
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Vol 3. Interim Good Clinical Research Practice guideline Microsoft Word 190KB (August 1998)
Amendments/Additions to Volume 3 (see below)

Vol 4. Consumer Medicine Information Microsoft Word 3,452KB (September 2001)

Amendments/Additions to the Second Edition (August 1998) of NZRGM Volume 3: Interim Good Clinical Research Practice guideline

April 2000

Appendix B Applying for an exemption under Section 30

The Chairman of SCOTT has a new address.
Four copies of the completed application form and supporting data should be sent to the Chairman of SCOTT, currently:

Postal Address:
Assoc. Prof. R. Robson
PO Box 2856
Christchurch
(Attention: Ms Susan Isaacs)

Courier Address:
Assoc. Prof. R. Robson
c/- The Pegasus Centre
31 Tuam St
Christchurch
(Attention: Ms Susan Isaacs)