Homeopathic medicinal product

Assessment

The Botanicals and Novel Foods Unit of the MEB decides, on evaluating the marketing authorisation application prepared by the applicant, whether a homeopathic product is safe and complies with current quality standards for the manufacture of a medicinal product.

Some of the requirements are specific to the homeopathic nature of the medicinal product (such as the dilution factor), but assessment of quality is based to a considerable extent on the same standards as for non-homeopathic medicinal products. The quality of both the raw material and the mother tincture are determined. The consumer is thereby guaranteed a safe homeopathic product of consistent quality. The consumer can also assume that the package leaflet contains accurate, balanced information. This also applies when different homeopathic stocks are used, which is common in homeopathic medicine.

These principles are upheld by homeopathic prescribers, the manufacturers' association and the homeopathic consumer organisation. 

There is a very important difference between the assessment of homeopathic products and that of conventional, non-homeopathic medicinal products, namely the way in which efficacy is assessed. The MEB is of the opinion that assessment of the efficacy of a medicinal product must always be carried out in accordance with scientific criteria. Clinical research is strictly controlled by numerous regulations.

The MEB holds the view that it must be quite clear how medicinal products are assessed and to what extent medicinal products that are covered by specific legislation are or are not assessed in accordance with the usual clinical-scientific criteria for efficacy. For this reason, the MEB considers it important that the information on a homeopathic medicinal product states that the assessment was based on other than scientific criteria.

For homeopathic medicinal products with an over-the-counter indication, it must be demonstrated that homeopathic use is described in the homeopathic literature. In addition, it must be possible to use a homeopathic product for a particular indication safely without the intervention of a doctor. The MEB does not permit any indications that refer to conditions requiring medical diagnosis by a doctor or for which specific therapy is required. On the basis of the information provided, the consumer can then take a decision regarding use of a homeopathic medicinal product for the treatment of his or her complaint. 

The pharmaceutical forms for homeopathic medicinal products are described in the European Pharmacopoeia. Such products are most commonly administered orally, as tablets, globules (small spheres), granules (larger spheres) or drops. Homeopathic medicinal products can also be administered topically (for example as a cream). The quality of both the excipients and the pharmaceutical form must comply with current European Pharmacopoeia standards.

Monographs specific to homeopathic medicinal products are increasingly being added to the European Pharmacopoeia.

Product information requirements

Summary of the Product Characteristics (SmPC)

A Summary of Product Characteristics (SmPC) has to be drawn up for all article 16 products. An SmPC is a summary of the product information and a precursor to the patient information leaflet. The difference is that the SmPC is written in technical language while in the patient information leaflet the terminology is adapted to make it easier for patients to understand.

As homeopathic medicinal products are assessed differently from conventional medicinal products, the structure of the SmPC is also slightly different. Section 5, which normally contains information on pharmacological properties, is changed to Properties. This section can contain a description of the specific homeopathic properties of the product couched in very general terms.

Sections 2, 3, 4.2 (relevant parts), and 6.1 to 6.6 are treated in the same way as for conventional medicinal products.

Patient information leaflet

Only article 16 products have a patient information leaflet.

For homeopathic medicinal products, the following wording is added in the general part:

"Wanneer na 14 dagen onafgebroken gebruik geen verbetering van de klachten wordt bemerkt of wanneer de klachten terugkeren, raadpleeg dan uw arts’ in plaats van ‘Raadpleeg een arts indien de verschijnselen verergeren of binnen 14 dagen niet verbeteren".

Dossier advice

If you intend to submit a marketing authorisation application for a product, you are advised to contact the MEB beforehand. Then you can find out more precisely what information needs to be submitted and what the requirements are. You can also ascertain whether the data available is sufficient for marketing authorisation. Experience shows that this saves a considerable amount of time and money later on.

If you would like a meeting to obtain advice, contact the Botanicals and Novel Foods Unit of the MEB.

Homeopathic Drug Master File (HDMF)

In analogy with the European Drug Master File procedure for active substances, use can also be made of a comparable procedure for homeopathic medicinal products, provided that certain conditions are met. However, the HDMF procedure may only be used if reference is made to a previously authorised dossier.

The following parts of the dossier must be included in the marketing authorisation application submitted by the future marketing authorisation holder:

• Name and address of the manufacturer of the homeopathic stock
• Definition of the raw material used
• Method used to prepare the homeopathic stock, with reference to the official pharmacopoeia
• Specifications of the raw material and the analytical methods used
• Specifications of the homeopathic stock and the analytical methods used
• Origin and purification or processing (if applicable) of the raw material (indicate how the material is purified/processed/stored)
• Details of validation of the assay methods (methods described in an official pharmacopoeia do not require validation)
• Potential impurities arising from the source, purification and degradation (routine testing for potential impurities must always be carried out, unless it can be justified that this is unnecessary)
• Results of analysis of both the raw material and the homeopathic stock
• Stability data for both the raw material and the homeopathic stock
• A statement that no change will be made to the manufacturing procedure or the specifications without informing the applicant, who will then submit an application to vary the marketing authorisation

All product-specific information must obviously also be included in the dossier (particularly that relating to the finished product: information on the manufacturing process, specifications, analytical results and stability).

Public assessment reports homeopathic medicinal products

The MEB publishes national assessment reports containing a brief discussion of data from the marketing authorisation dossier. The reports indicate the data which served as a basis for granting marketing authorisation or which caused the product information to be changed at a later stage. This information can promote good pharmacotherapy on the part of doctors, pharmacists and other healthcare professionals and students.

The content of a marketing authorisation dossier is regarded as confidential. To this end, the MEB has established a covenant with the pharmaceutical companies in the Netherlands on the issue of public reports. It contains general agreements on publication and the role of companies in the production of the report.

The MEB produces national public assessment reports on products authorised in the Netherlands that contain a new active ingredient and are assessed for the first time in Europe by the Netherlands. Following this national marketing authorisation, a mutual recognition procedure can be started in other European Union countries.

European public assessment reports are also drawn up by other European Union countries. This happens when a product is first assessed in another European Union country and is granted marketing authorisation in the Netherlands under a mutual recognition procedure. These public assessment reports are published on the Human MRIndex of the HMA.

The MEB’s national public assessment reports contain a brief discussion of data from the marketing authorisation dossier. The reports indicate the data which served as a basis for granting marketing authorisation or which caused the product information to be changed at a later stage. This information may contribute to good pharmacotherapy by doctors, pharmacists or others involved with medicinal products for professional or study reasons.