Herbal and Homeopathic Medicines

Herbal Medicines are medicinal products which have herbal substances or preparations as active ingredients. Traditional Herbal Medicines, also known as folk medicines, are based on presumed pharmacological effects based on long-lasting tradition of use for various given indications.

Herbal medicines may follow a well-established use pathway for registration; however, the more common one is Traditional Herbal Registration (THR).

Homeopathy is a pseudoscientific system of alternative medicine based on “like cures like” principles as established by Samuel Hahnemann who was the originator. Herbal medicines are products which contain highly dilute active ingredients for which the higher the dilution is, the stronger the potency. In both UK and Ireland, products can be registered under a Simplified Scheme with no approved indication or a National Rules scheme for which an indication is evaluated and approved by health authorities.

UK & Ireland Services

Herbal Medicines

  • Dossier gap analysis

  • Regulatory strategy

  • New THR applications

  • Dossier life cycle

  • Copy approval

  • Gathering supportive data

  • Pharmacovigilance

Homeopathic Medicines

  • Dossier gap analysis

  • Regulatory strategy

  • New National Rules (NR) and Simplified Scheme Applications

  • Dossier life cycle

  • Copy approval

  • Gathering supportive data

  • Pharmacovigilance

Traditional Herbal Medicines in the UK 

Definition

As defined in the Human Medicines Regulations (2012), a product is an herbal medicinal product if the active ingredients are herbal substances and/or herbal preparations only.

An herbal substance is a plant or part of a plant, algae, fungi or lichen, or an unprocessed exudate of a plant, defined by the plant part used and the botanical name of the plant, either fresh or dried, but otherwise unprocessed.

Not all herbal products are medicines, and some of them may be classified as a food supplement or cosmetic product. It is important to assess the appropriate route to market before selling herbal products in the UK.

Traditional Herbal Registration Scheme

The claims selected for the application via the THR scheme must be suitable for such products.

According to the MHRA, “Products eligible for the registration scheme: will have indications exclusively appropriate to traditional herbal medicinal products which, by virtue of their composition and purpose, are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment. The Traditional Herbal Registration Scheme is restricted to products for oral or external use and/or inhalation.

Products registered must include a statement in their labelling, patient information leaflet and advertising that the product is a traditional herbal medicinal product for use in specified indication(s) exclusively based on long-standing use.”

Tradition of Use

In order to obtain approval for the desired product indication, manufacturers must show evidence that the herbal medicinal product has been used to treat the stated minor condition for a minimum of 30 years:

  • For products intended to be marketed in the whole of the UK or Northern Ireland only, at least 15 years of the 30 years of use must relate to use in the EU/EEA.
  • For products intended to be marketed in Great Britain (England, Wales and Scotland) only, the MHRA may be able to accept the 15 years of traditional evidence from a wider range of countries in addition to the UK and EU/EEA countries. Suitable countries must have similar pharmacovigilance requirements to the UK, this ensures safety issues have been identified by the third countries where applicable.
Documentation Required
  • Technical dossier in eCTD format covering the quality criteria of the herbal product.
  • Review of safety with an expert report by an appropriately qualified professional. Including clinical and non-clinical areas.
  • Summary of product characteristics
  • Draft Labels

Unlike conventional medicines, a THR application will contain the evidence of traditional use in module 5 of the eCTD.

Homeopathic Medicines in the UK

There are two regulatory schemes in the UK which can be followed to bring homeopathic products onto the market:

  • the Simplified Registration Scheme
  • the National Rules (NR) Scheme

For both of those schemes, the application must be in eCTD format, however, there are major differences of what can be achieved through each of them.

Simplified Registration Scheme

The scheme does not allow for indications in relation to the product – meaning, no claims can be made about the product.

The active ingredients must be diluted enough to guarantee safety. The minimum dilution accepted for a homeopathic medicinal product under the simplified scheme is 1 in 10,000 dilution.

To qualify for this scheme, the products must be for oral or external use (injections excluded), the product must be sufficiently diluted and no therapeutic claims can be made.

National Rules (NR) Scheme

Under the NR scheme there is no restriction on the first dilution to be authorised or the pharmaceutical form. You can claim that your product is used within the UK homeopathic tradition for the relief or treatment of minor symptoms and conditions which don’t require the supervision of a doctor.

You must submit data that demonstrates quality, safety and use within the UK homeopathic tradition and you must include details of your labelling and product literature with your application.

Homeopathic Stocks

In order to market homeopathic medicines in the UK, including Northern Ireland, the homeopathic stocks used in the product must be made following a homeopathic manufacturing procedure described in the European Pharmacopoeia, British Pharmacopoeia or a pharmacopoeia used officially in another EEA country (e.g. German Homeopathic Pharmacopoeia, French Homeopathic Pharmacopoeia).

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