Marketing authorisation application for herbal medicinal product
Herbal medicinal products, also referred to as phytotherapeutic products, are medicinal products whose active ingredients contain exclusively plants, parts of plants or plant materials or combinations thereof, in crude or processed form. Just like all other medicinal products, herbals require authorisation. This means that they may only be traded after authorisation by the MEB.
The legal criteria that the MEB uses in order to come to a decision are:
As far as efficacy is concerned, an exception is made for herbal medicinal products with a long tradition of use in the European Union: these products are known as traditional herbal medicinal products. The efficacy of these products is assessed not by clinical testing but on the basis of a long history of use and experience.
All other medicinal products, including non-traditional herbal medicinal products, have to be proven to be effective before they can be authorised.
Supporting evidence of traditional use
Traditional use must be demonstrated with bibliographic or expert evidence, for example using:
- marketing data, brochures, etcetera;
- references to manuals, such as the Farmacotherapeutisch compendium (J. van Hellemont), Pharmacotherapeutisch vademecum, old editions by Martindale, Rote Liste, Informatorium;
- official lists of licensed/authorised traditional herbal medicinal products in other member states of the European Union;
- reports from experts such as pharmacognosists, herbalists, doctors and pharmacists;
- national pharmacopoeias of member states that were used in the past, or the British Herbal Pharmacopoeia;
- Hoppe HA. Drogenkunde;
- List PH, Hörhammer L. Hagers Handbuch der Pharmaceutischen Praxis. Für Apotheker Arzneimittelhersteller Ärzte und Medizinalbeamte;
- Madaus G. Lehrbuch der biologischen Heilmittel.
The supporting evidence must show that product or a corresponding product has been used in medical practice for at least 30 years. Reference to a source published 30 years ago is not sufficient, as this simply demonstrates that the product was in use 30 years ago. There must also be a connection between the duration of use and the claimed use. A corresponding herbal medicinal product may also be referred to in order to support the length of use claim. Here, 'corresponding' means that it has the same active ingredients (regardless of the excipients used), an equivalent concentration and posology, an identical or comparable intended effect and an identical or comparable method of administration. If the composition of the product has changed, removal of substances is acceptable, but additions are not.
The assessment of application dossiers is done by the Botanicals and Novel Foods unit.
The Botanicals department of the MEB assesses the application on the basis of criteria laid down in the Dutch Medicines Act (Geneesmiddelenwet). Once it has finished the assessment, the Botanicals department provides the Board with a recommendation. The MEB then decides whether the traditional herbal medicinal product can be used safely and whether it meets the
quality standards for the preparation of a medicinal product. Part of the criteria is specific for the demonstration of the traditional nature of the medicinal product. Efficacy is assessed on the basis of a simplified procedure.
Once the MEB has given a positive assessment of the medicinal product, the manufacturer receives marketing authorisation. The medicinal product is then added to the Register of Medicinal Products and given a marketing authorisation number. The "Summary of Product Characteristics" or product information is part of the marketing authorisation. This is the scientific text which contains all the key data about the product. Package leaflets are based on this text. Manufacturers submit a draft for these texts but the final version is drawn up by the MEB.
The MEB also decides on the legal status of the medicinal product, indicating whether it can only be obtained with a GP's prescription or can be purchased without a prescription from a drugstore, for example.
Applicants have the choice between two forms of marketing authorisation for a medicinal product: a national marketing authorisation and a European marketing authorisation.
The decentralised and mutual recognition procedures can only be completed if:
- A Community herbal monograph has been drawn up; or
- The herbal medicine consists of herbal substances, herbal preparations or combinations thereof, which are mentioned in the list drawn up by EMA’s Committee for Herbal Medicinal Products.
Product information requirements
The indication must be described as follows: “Traditioneel kruidengeneesmiddel bij …indicatie…, toegepast uitsluitend op basis van langdurig gebruik en niet op klinisch bewijs”.
Package leaflet and label
Along with a description of the indication, the following warning must appear both on the label and in the package leaflet: "Consult your doctor if your symptoms persist during the use of this medicinal product or if adverse effects not mentioned in the package leaflet occur."
In addition, all the requirements relating to labels and package leaflets for conventional medicinal products ( see Human medicines/Medical package leaflets) also apply to traditional herbal medicinal products.
Legal basis for authorisation
The amendments to Directive 2001/83/EC came into effect on 1 November 2005 in all the Member States of the European Union. This allows traditional herbal medicinal products to be authorised as a medicinal product through a simplified procedure.
A condition for acquiring a marketing authorisation under the Directive is that the herbal medicinal product must have been used in medical practice for at least 30 years prior to the application date, and it must have been used in the European Union for at least 15 of those years. Furthermore, the product should only be used orally and/or externally and/or by inhalation, with an indication for use in conditions where a doctor is not required to establish the diagnosis, prescribe treatment or monitor the patient: in other words, exclusively for OTC indications.
Combinations with vitamins and minerals are permitted provided that the action of the vitamins and/or minerals can be shown to be ancillary to that of the herbal active ingredients regarding the specified indication.
Under Directive 2001/83/EC, herbal medicinal products that have already gone through the normal marketing authorisation procedure cannot be listed as traditional herbal medicinal products. The pharmacological effects and efficacy of traditional herbs must be demonstrated on the basis of a long history of use and experience.
Before submitting a dossier, the applicant can request advice from the MEB about the dossier requirements. The applicant can subsequently submit a complete dossier for evaluation.
You can arrange an appointment to discuss the matter with one of the assessors in the Botanicals and Novel Foods unit. They can advise you on the structure and content of the dossier. It is therefore recommended that you submit a summary of information about the product by email beforehand. This information will be treated confidentially.