Guidelines & Codes
Update to Section 8.3 Standard Requirements for New
Multi-Source (Generic) Prescription Medicines
[NZRGM, Volume 1, 5th edition]
Added to web site: September 2003
Dosing guidelines
The following policies have been adopted and re-confirmed with respect to divided dosing.
Tablets:
a) All "scored" tablets, are required to be capable of being divided with an acceptable degree of uniformity.
b) If a tablet is not intended to be divided, or has not been proven to be capable of providing a divided dose, then the "Presentation" and "Dosage & Administration" sections of the tablet's data sheet should contain the following statement: "Do not halve tablet".
Safety Packaging
Medsafe's policy on safety packaging for anti-depressant medicines has been confirmed. Medsafe requires all anti-depressants, marketed as a solid oral dose form, to be contained within safety packaging. The current legislative definition of safety packaging in NZ is blister strip packaging. (Regulation 2 of the Medicines Regulations 1984)