EU Directive (2004/24/EC which amends 2001/83/EC) regarding the registration of Traditional Herbal Medicinal Products (THMP) came into force on 30th April 2004. This has been adopted and implemented by all EU member states, with various deadline dates.
Please contact CambReg for specific information relating to individual countries, European procedures and Community Monographs.
The UK has already transposed this Directive into national law. The new scheme dictates that all unlicensed herbal products on the UK market needed to be registered or licensed by 30th April 2011.
Our in-house herbal expertise can help you become compliant quickly and in the most cost effective manner. We can help you plan your route, avoid pitfalls and work within your budget leaving you free to concentrate on the marketing of your product.
Most UK herbal medicines fell into the Unlicensed Herbal Medicines category. These products wer exempt from the normal requirements for a medicine to hold a product licence or market authorisation provided they met both of the following criteria:
They were legally on the UK market as an unlicensed herbal remedy in accordance with Section 12(2) of the Medicines Act 1968.
They were legally on the UK market before 30th April 2004.
Under these conditions, a herbal medication could remain on the UK market until the 2011 deadline. To continue marketing after the 2011 deadline , these products will have to be either registered under the Traditional Herbal Medicines Registration Scheme (THMRS) or else they have to obtain a Market Authorisation (MA).
The Traditional Herbal Medicines Registration Scheme (THMRS) was introduced to protect public health. It demands much more information regarding safety, quality and efficacy than was previously required for unlicensed herbal products, thus bringing them in line with any other licensed medicines.
You will only be able to register your product using the THR scheme if it is intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment. In addition, the product must be an oral, external and/ or inhalation preparation.
The data requirements can be summarised as:
• Bibliographic or expert evidence demonstrating 'traditional use'.
• Authoritative literature on herbalism.
• Testimony of recognised experts on herbalism.
The normal requirement to produce data to prove efficacy is replaced by a requirement to demonstrate 30 years traditional use for the required medicinal indication. Normally, at least 15 years of this usage must have been within the EU.
In addition to the above, you will also need to provide a bibliographic review of safety data together with an expert report. An important aspect of safety is that the products, including their indications, must be suitable for over the counter sale and use without medical supervision.
The normal quality requirements applicable to licensed medicines will apply. Compliance with Good Manufacturing Practice (GMP) will be required. There will also be a requirement to hold a manufacturer's licence, a wholesale dealer's licence or a wholesale dealer's (import) licence where appropriate.
You may need to register your herbal medicine as a conventional medicine. This process requires a ‘full’ data package demonstrating safety, quality and efficacy.
Why might you need to obtain a licence for your product?
If your product does not meet the criteria set out in the THMRS (for example, if you cannot produce bibliographic or expert evidence to support a claim for 30 year’s traditional use) you will need a licence to apply for a full MA.
A full marketing authorisation (MA) or licence for your product will take longer than the “simplified procedure” for the registration of products under the THMRS.
Regulatory Submission Strategy
Do you know which regulatory route(s) your product is eligible for?
We can devise a strategy that combines commercial and regulatory needs!
Plan for early submission by building a CTD as you move through your project.
Dossier compilation and advising on regulatory procedures forms the core of our business. Our highly skilled admin support team keeps costs down and gets projects completed on time and within budget.