Guidelines & Codes
Amendments to Section 12
[NZRGM, Volume 1, 5th edition]
Added to web site: Nov 2002
- New Section 12.10.18
Labelling of multivitamin preparations.
For products containing four or more active ingredients, which are all vitamins and/or minerals, the statement "Vitamin and Mineral supplement", or similar, is acceptable as the "appropriate designation" required to be present on the PDP. This does not remove the legislative requirement for all active ingredients and their quantitative particulars, together with all required warning statements, to still be present somewhere on the label. - Replacement section 12.6
Sample/starter Packs
Sample packs are considered to be packs that are distributed by companies by means of gift or sample as opposed to packs for which a payment is required. These packs are required by Amendment 6 to the Medicines Regulations 1984, Regulation 3 (4) to include the dose/directions for use on the label.
Section 2 of The Medicines Act 1981 defines a 'label' as 'any written, pictorial, or other descriptive matter marked on or affixed to the container'.
All packs intended for use as a 'gift or sample' will be considered as sample packs for the purposes of this guideline, regardless of whether they are identified as sample packs or starter packs, or not identified but distributed as such.
The size of sample packs should not exceed 1/3 of the smallest trade pack, except where this is not practical, e.g. ear and eye drops, small aerosols, ampoules etc, and in this instance the smallest trade pack may be used.
Sample packs are required to be labelled with dosage instructions/directions for use information in the same manner as is required for OTC medicines. (This includes the provision that where all required dosage instructions/directions for use information does not fit onto the label, it can be included in a package insert, providing there is adequate reference to this on the labelling).
If the proposed sample pack is intended as a 'starter pack', then the Medsafe approved starting dose must be the dosage information on the label.
The above guidelines will be included in the next edition of the New Zealand Regulatory Guidelines for Medicines, Volume 1, but will become effective from the date of publication on the Medsafe website.