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How to Register Herbal Medicines
Do you currently sell herbal medicines, homeopathic remedies or nutraceuticals? If the answer is yes then before April 2011 you will need regulatory approval to allow you to continue to legally sell your herbal products. There are a variety of ways in which this can be achieved. Worried, confused – don’t be we can help.
Download your free guide to registering herbal medicines
The legislation of herbal medicines is currently governed by Section 12 of the Medicines Act 1968. At the moment most herbal medicines used in the UK are sold as unlicensed herbal remedies. This can only apply to products that have not been industrially produced. There are two aspects to the current legislation: Section 12(1) covers the supply of herbal medicines to individuals following a face-to-face consultation and Section 12(2) which is used for manufactured unlicensed herbal remedies sold in shops without a consultation. Products must meet specific exemption certificates, must be made from simple processes, have no brand name and make no medicinal claims.
However, Section 12(2) licenses are being phased out. Since April 2004 when a new European Directive on Traditional Herbal Medicinal products came into force (2004/24/EC) unlicensed manufactured herbal medicines can no longer be placed on the market under this section of the Medicines Act. The purpose of this change is to help protect public health by requiring specific standards of safety and quality for herbal medicines. This directive has been adopted by all EU member states.
Unlicensed manufactured herbal medicines placed on the market under section 12(2) before April 2004 need to comply with these new requirements in the UK by April 2011. This may seem a very distant deadline but this would be a dangerous attitude to adopt. You need to be taking action now if you are to have all of your products legally on the market by 2011.
There are a variety of ways in which this can be achieved. We have produced a free guide to registering your products. This guide provides an overview of what is involved and is designed to help you decide how best to progress.
If you have any questions once you have read the document, contact us and we will be happy share our expertise with you to achieve your objectives.