Legal & Regulatory > United Kingdom > Traditional Medicines and OTC Products

The legal framework for traditional medicines and OTC products in United Kingdom. Prepared in association with Clyde & Co, a leading law firm in United Kingdom, this is an extract from The Pharma Legal Handbook: United Kingdom, available to purchase here for USD 99.

1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?

No specific definition of complementary and alternative medicines (CAMs) is used in the UK, though “complementary” would typically refer to a CAM when used together with conventional medicines and “alternative” when used instead of a conventional medicine. There is obviously overlap between the two categories as many CAMs can be used in both ways. CAMs also cover both products and therapeutic techniques or practices.

The main product CAMs are herbal medicines and homeopathic remedies, which have the specific regulatory regimes discussed below. A further example is the essential oils used in aromatherapy. In general essential oils will only need to be licensed if they are sold as a medicine or if medicinal claims are made regarding them on labels, promotional material or websites. In such circumstances, the same considerations apply as for herbal medicines.

Therapeutic CAMs are typically practices such as acupuncture, massage therapy, osteopathy and chiropractic. Regulation of such CAMs is through the practitioners to ensure that they are properly qualified and adhere to codes of practice. Their regulation is discussed further at the end of this answer.

(i) Herbal Medicines

The regulation of herbal medicine is governed by European Directive on Traditional Herbal Medicinal Products (2004/24/EC), which is now implemented in the UK through Part 7 of the HMR. Under the HMR a product is only treated as a herbal medicine if its active ingredients are herbal substances and/or herbal preparations. “Herbal substances” are plants or part of a plant, algae, fungi or lichen, or the exudate of a plant, and can be fresh or dried but otherwise must be unprocessed. “Herbal preparations” are obtained by subjecting herbal substances to processes such as extraction, distillation, purification, concentration and fermentation.

A herbal medicine that makes medicinal claims for its use must:

• be licensed as a conventional medicine by the obtaining of a marketing authorisation through one of the routes described in the answer to Question 3 in Regulatory, Pricing and Reimbursement Overview; or
• be registered under the Traditional Herbal Medicines Registration Scheme (THMRS), which is administered by the MHRA, typically enabling the medicine to then be sold OTC.

The key difference between these routes is that for a herbal medicine to be authorised as a conventional medicine, its quality, safety and efficacy must be demonstrated through clinical trials. In contrast, registration under the THMRS does not require any evidence of efficacy through trials. Instead, permitted indications are based on traditional use, provided that the pharmacological effects are plausible on the basis of longstanding use and experience.

The requirements for registration under the THMRS are then that:

• the medicine has a history of traditional use for a continuous period of at least 30 years, with at least 15 years of this usage being within the EU;
• the applicant can file evidence of safety from a bibliographic review of safety data together with an expert report;
• the applicant can show adherence to appropriate manufacturing standards; and
• appropriate information will be provided to users in the form of a patient information leaflet.
  In addition, a product will only be eligible for registration under the THMRS if:
• by virtue of its composition and indications, it is appropriate for use without need of a medical practitioner for diagnosis, prescription or monitoring the product’s use;
• it is for administration externally, orally or inhalation; and
• it does not contain an ingredient that is either banned in herbal medicines by Part 1 of Schedule 20 of the HMR or that cannot be used in doses exceeding those given in Part 2 of Schedule 20.

These requirements mean that herbal medicines suitable for registration under the THMRS are those for minor conditions that can be treated by self-medication (for example, colds, coughs, indigestion, headaches and sleep problems). As a result, most herbal medicines registered under the scheme will be suitable for sale OTC, though some might be restricted to pharmacy sale. Registered medicines will have a registration number that starts with the letters THR. The MHRA also recommends that manufacturers use its THR certification mark on their product labels and in their patient information leaflets, but this is not compulsory.

Indications for serious conditions, or that require injection, cannot be registered through the THMRS but must be authorised as a conventional medicine. The same applies if the applicant cannot provide the necessary evidence of safety.

In addition, the HMR allows unlicensed herbal medicines to be prepared in response to a personal request to a practitioner for that practitioner to use his/ her judgment as to the treatment required. Further requirements are that the preparation takes place at the practitioner’s premises and the medicine does not contain a banned ingredient or one at a impermissible dosage.

(ii) Homeopathic Medicines

There are 3 ways in which homeopathic products may be licensed: under a product licence of right, under the so-called simplified registration scheme or under the National Rule Scheme (NRS). Both of the latter two schemes are administered by the MHRA.

Product licences of right were issued to all medicinal products on the market at the time of implementation of the Medicines Act 1968. This was intended to be a temporary arrangement, and while it was for conventional medicines, a significant number of homeopathic medicines remain licence of right despite the MHRA encouraging manufacturers to convert to one of the two registration schemes.

The simplified scheme is governed by Part 6 of the HMR. For registration under it:

• the product must be for oral or external use only;
• no product indications are permitted and no therapeutic claims can be made; and
• data must be submitted on the product’s quality, including that it is sufficiently dilute to guarantee safety (the first dilution must be at least 1 in 10,000).

The NRS applies to any homeopathic medicine that does not satisfy the requirements of the simplified scheme. The scheme is based upon the rules for marketing authorisations for a conventional medicine except that there is no requirement for pre-clinical and clinical data. Therefore the applicant must submit a dossier demonstrating pharmaceutical quality and batch-to-batch homogeneity of its product, its safety and its efficacy. However, the NRS is limited to products that are indicated for the relief of minor symptoms and minor conditions, which the MHRA describes as “those which can ordinarily and with reasonable safety be relieved or treated without the supervision or intervention of a doctor”. The MHRA’s guidance on the NRS includes a list of indicative conditions, which are similar to those listed for traditional herbal medicines above. As a result of the documentary burden and limitation to minor indications, the NRS is little used.

(iii) Other CAMs

Osteopathy and chiropractic are regulated by statute requiring practitioners to register with the General Osteopathic Council and comply with its code of practice (the Osteopathic Practice Standards). For all other complementary/alternative therapies regulation is through voluntary associations and their codes of practice. An example is the Complementary and Natural Healthcare Council, which was set up with the support of the UK government to provide a voluntary register of practitioners and which has a Code of Conduct, Ethics and Performance that all registrants must adhere to.

2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?

Yes, licensed or registered CAMs can be advertised directly to the public subject to the following rules. However, the advertising of unlicensed medicines, including unlicensed CAMs, is prohibited.

(i) Herbal Medicines

If a herbal medicine is licensed through the conventional medicine route, then the same provisions apply on advertising as for conventional medicines. These are discussed in the answer to Question 17 in Marketing, Manufacturing, Packaging & Labeling, Advertising.

As with conventional medicines, advertising of traditional herbal medicines registered under the THMRS is governed by Part 14 of the HMR but with the additional requirement that the advertisement must contain the words “Traditional herbal medicinal product for use in …” followed by a statement of the registered indications and then the words “exclusively based on long standing use”.

The MHRA has also issued specific guidance on the advertising of traditional herbal medicines in Appendix 1 of the Blue Guide. This guidance stresses that the above wording required by the HMR must be followed exactly. It also advises that an advert must contain at least one indication for use of the product, which must be clear and accurate (including any wording on the severity of the indication for which the product is registered, e.g. that it is for mild colds or coughs only). The rest of the guidance is primarily concerned with the claims that can be made and is discussed in answer to Question 46 below.

(ii) Homeopathic Medicines

The advertising of homeopathic medicines registered under the simplified scheme and the NRS is also governed by Part 14 of the HMR.

For homeopathic medicines registered under the simplified scheme, additional requirements apply over and above those for conventional medicines. These are that adverts must not mention any specific therapeutic indication and must not contain any details beyond those required for the product’s label. Appendix 2 of the MHRA’s Blue Guide adds to this that no therapeutic claims may be made.

For homeopathic medicines authorised under the NRS, the Blue Guide says that advertising can include the homeopathic use for the product and can make promotional claims consistent with the authorised indication, though “it must be clearly stated that the product is a homeopathic medicinal product used within the UK homeopathic tradition for that indication”.

3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?

(i) Herbal Medicines

Appendix 1 of the Blue Guide states that any additional claims for a traditional herbal medicine to the main indication claim (discussed in the previous answer) must be clearly set in the context that the product indications are based exclusively on long standing use. Therefore a statement such as “traditionally used as a remedy/treatment for …” is likely to be acceptable whereas claims such as “clinically proven” or “effective for …” are unlikely to be accepted. Similarly, even if limited clinical trials have been conducted, the MHRA’s position is that reference to them risks exaggerating the product’s benefits and so misleading consumers. This is particularly so in short advertisements where there is unlikely to be sufficient space to make it clear that, notwithstanding the trials, the product was registered on the basis that there was insufficient data to demonstrate efficacy.

(ii) Homeopathic Medicines

Advertising suggesting that efficacy is based on clinical trial data is not acceptable because of the risk of exaggerating the products benefits and misleading consumers.

(iii) Rules applicable to both Registered Herbal and Homeopathic Medicines

Registered traditional herbal medicines and homeopathic medicines are subject to the general rules on misleading advertising discussed in the answer to Question 17 in Marketing, Manufacturing, Packaging & Labeling, Advertising. The Blue Guide summarises these rules by saying that advertising must not:

• give the impression that a medical consultation or surgery is unnecessary;
• suggest that the effects of taking the medicine are guaranteed, are free of side effects or better than (or equivalent to) another identifiable treatment or product;
• suggest that health could be enhanced by taking the medicine or affected by not taking it;
• refer to recommendations from e.g. a scientist or healthcare professional that could encourage the consumption of medicines;
• suggest that the medicine is a foodstuff or cosmetic (or other consumer product);
• suggest that a medicine’s safety or efficacy is due to it being natural;
• be such as to lead to erroneous self-diagnosis;
• refer to claims of recovery in improper, alarming or misleading terms or use such terms in respect of pictorial representations of changes in the body due to disease or the action of a medicine.

4. What are the regulatory requirements for over-the- counter (non-prescription) medications?

OTC medicines include pharmacy-only and GSL medicines and the requirements for them are discussed in Regulatory, Pricing and Reimbursement Overview. In addition, as indicated above, registered traditional herbal medicines and licensed homeopathic medicines may be sold OTC from registered pharmacies and other outlets such as health food shops and clinics. The requirements for registration or licensing of these medicines are discussed in the answer to Question 1 above. However, most homeopathic medicines are unlicensed and so can only be prepared and sold in a registered pharmacy. They are prepared in accordance with the methods and standards set out in homeopathic pharmacopoeias for supply to individual patients.

5. Are there any limitations on locations or channels through which OTC products may be sold?

See the answer to the previous question and the answer to Question 14 of Regulatory, Pricing and Reimbursement Overview.

6. What health, advertising, and marketing claims may be made for OTC products?

See the answers to Question 17 in Marketing, Manufacturing, Packaging & Labeling, Advertising and Question 2 above.

7. Can OTC products be marketed or advertised directly to the public?

See the answers to Question 17 in Marketing, Manufacturing, Packaging & Labeling, Advertising and Question 2 above.

8. What is the mechanism by which a prescription-only product can be converted to an OTC product?

A POM may be converted to an OTC product (either pharmacy-only or GSL) by applying to the MHRA for reclassification. Reclassification has been encouraged by the MHRA (and the UK government), when it is acceptably safe to allow it. This is reflected in regulation 62(5) of the HMR which allows reclassification if “the [MHRA] considers that the product can with reasonable safety be sold or supplied otherwise than by, or under the supervision of, a pharmacist”. “Reasonable safety” is defined on the MHRA’s website as “where the hazard to health, the risk of misuse, or the need to take special precautions in handling is small and where wider sale would be a convenience to the purchaser”.

An application for reclassification needs to be supported by good evidence evaluating the risks to the public and how it will be managed. Such evidence may be in the form of clinical studies, opinions from healthcare practitioners and the relevant public associations. An SmPC and patient information leaflet should also be filed with the application. In response to an application, the MHRA may take advice from its committees of external experts, consult stakeholders (e.g. health professionals and relevant patient groups) and/or run a 21 day public consultation.

The proviso to the above is that, if the application is a “me-too” (i.e. an MAH has already applied for reclassification of an analogous product), then the standard procedures for variation of a marketing authorisation can be followed. The variation application must give details of the reclassified, analogous product.

The outcome of an application may be that a POM is moved entirely to pharmacy-only or GSL status or it may be additionally classified as pharmacy-only or GSL for certain conditions and/or dosages.

9. What are the requirements for the importation of either traditional medicines or OTC products?

A pre-condition to the import of a traditional herbal medicine or other OTC product is that the product is authorised or licensed for marketing in the UK. Then, in overview, the importer will need to apply to the MHRA for:

• a wholesaler licence if the importation is from within the EEA for supply in the UK; or
• a manufacturer/importer licence for importation from outside the EEA for supply in the UK.

To qualify for a wholesaler or manufacturer licence requires compliance with GMP or GDP respectively.
If the importer is not the MAH or licence holder for the product then it should notify the MAH or licence holder and, if the marketing authorisation was issued by the EMA, then it must notify the EMA as well. There are also trade mark considerations where the importation is parallel importation (i.e. the medicines are branded with a registered trade mark and are being imported into the UK without the consent of the brand owner). As there is no international exhaustion in the UK (or EU), importation of a branded medicine from outside the EEA without consent will constitute trade mark infringement. If the importation is from a country within the EEA, then the trade mark owner’s rights will be exhausted so long as the label affixed by the importer does not adversely affect the guarantee of origin provided by the brand name. But if the product is repackaged or more prominently re-labelled then, to avoid trade mark infringement, the importer has to comply with the 5 conditions set out by the CJEU in Bristol-Myers Squibb v Paranova (C-427/93) (extended to re-labelling, or over-stickering, by Boehringer Ingelheim v Swingard (C-348/04)). These conditions are that:

• the repackaging or re-labelling must be necessary to market the product;
• the repackaging or re-labelling does not effect the original condition of the product;
• the new packaging or labelling clearly states who repackaged or re-labelled the product and the name of the manufacturer;
• the presentation of the product must not damage the reputation of the trade mark or its owner; and
• the importer must give advance notice to the trade mark owner of the parallel importation and, on request, provide a specimen of the proposed new packaging or re-labelled product.

Failure to meet just one of these conditions will enable the trade mark owner to lawfully oppose the importation.