Introductory Regulatory Guidance
Is my product a medicine? The first thing you need to do is work out if your product is a medicine. You need to answer the below 2 questions: •
Does your product have a therapeutic purpose or do you want to state a therapeutic claim?
•
Does your product contain a scheduled ingredient?
Does your product have a therapeutic purpose or do you want to state a therapeutic claim? If your product has a therapeutic purpose or makes a therapeutic claim then it is a medicine, related product or medical device. A therapeutic purpose is defined in section 4 of the Medicines Act 1981. It includes the treatment, diagnosis and prevention of disease, or the modification of a physiological function. It also includes effecting contraception or inducing anaesthesia. It can be difficult to determine whether a claim implies a therapeutic purpose. For advice on this, the Association of New Zealand Advertisers website has guidelines on therapeutic claims and provides examples of claims that do not imply a therapeutic purpose. [See reference 9 for guidelines]
For further advice, there are a number of regulatory consultants who can help. Tip: Please see appendix for list of regulatory consultants Does your product contain a scheduled ingredient? If your product contains a scheduled ingredient then it is a medicine. Medicines are generally scheduled (ie, classified) according to their active ingredients. The First Schedule to the Medicines Regulations 1984 is a list of ingredients classified as prescription, restricted or pharmacy-only medicines. You can check your ingredients using Medsafe’s searchable database. Search by both the name you know the ingredient by and any synonyms. If you do this and get a 'no substances were found' result, it is unlikely that the ingredient is scheduled under the Medicines Regulations 1984. [Link: https://www.medsafe.govt.nz/profs/class/classintro.asp ] Note - if you find the ingredient is not scheduled, your product may still be a medicine if the ingredient has a therapeutic purpose. For example, certain strengths of paracetamol are unscheduled but this ingredient has a therapeutic purpose and so the product is a medicine.
Healthcare & Pharmaceutical Landscape of NZ
33
