Effective regulation of herbal medicinal products is considered necessary in order to ensure that safe products of appropriate quality continue to be available. Herbal medicinal products are medicines and therefore they are likely to have an effect on the body and should be used with care. Manufacturers, importers and wholesale dealers of medicinal products containing herbal preparations and substances need to meet the requirements of current regulations on herbal medicinal products.
While many herbal products are medicines, others are not, and so do not require a registration as medicinal products. There are a number of herbal ingredients that have accepted usage in a range of different categories besides medicines, including food, cosmetics or general consumer products. Herbal ingredients classified as medicinal are regulated by the Medicines Authority while herbal ingredients not classified as medicinal are regulated by the Malta Competition and Consumer Affairs Authority.
Herbal medicinal products, regulated by the Medicines Authority, fall into two main categories, depending on whether they fulfil the criteria for the definition of a traditional herbal medicinal product (THMP) or a herbal medicinal product (with a well-established use).
Directive 2004/24/EC amending Directive 2001/83/EC as regards Traditional Herbal Medicinal Products was transposed into Maltese legislation, as a legal notice under the Medicines Act, 2003 - Legal Notice 379 of 2005.
Products registered under the Traditional Herbal Medicinal Procedure will need to meet specific standards of quality and safety. They need to be accompanied by agreed indications, based on traditional usage and systematic patient information allowing the safe use of the product.
The Committee on Herbal Medicinal Products, which meets at the European Medicines Agency, compiles a list of monographs (HMPC Monographs) relevant to the registration and authorisation of Traditional Herbal Medicinal Products throughout Europe. The principle underlying the list is to remove the need for many companies each to have to produce similar evidence of traditional use and safety where this has already been clearly accepted. An applicant seeking to register a product containing a substance on the list in the form and for the indications as specified on the list can refer to this list rather than have to demonstrate traditional use and safety. The applicant does however need to demonstrate quality.
The Simplified Registration Procedure can also be used for products containing herbal medicinal products in combination with vitamins/minerals, provided that the action of the vitamins and minerals is ancillary to that of the herbal active ingredient(s) regarding the specified claimed indication.
In accordance with the legislation, herbal substances which are prescription only are not eligible for the simplified procedure, and should apply for a marketing authorisation. Herbal medicinal products intended for injection will also not be granted a registration under the simplified procedure. Simplified registrations will be permitted for herbal medicines that are taken orally, for external use or by inhalation.
For this simplified registration procedure, several criteria must be met, including evidence that the medicinal product, or a corresponding product (having the same active ingredient/s and a similar intended purpose) has been in medicinal use throughout a period of at least 30 years preceeding the date of application, including at least 15 years within the Community.
The Simplified Registration for THMPs cannot be used for Homeopathic Products (regulated by Directive 2001/83/EC). For these products the 'simplified procedure for homeopathic products' should be followed.
For further information on dossier requirements for registration please refer to this document: Registering Herbal medicinal products - Compiling the dossier
After the introduction of the THMP Registration Procedure, it is still possible to obtain a marketing authorisation for herbal medicines where the required levels of safety, quality and efficacy can be demonstrated. The existing arrangements will continue under which herbal medicinal products (like any other medicines) may be eligible for a full marketing authorisation based on demonstration of safety, quality and efficacy.
Registration requirements for this type of authorisation are similar to those of other medicinal products and are subject to all the requirements of the regulations under the Medicines Act, 2003. Herbal products that do not contain herbal preparations or substances that would place them under the category of medicinal products but are still presented for treating or preventing disease may still fall within the definition of medicinal product. Please refer to the Guide on what is a medicinal product for more information.
More information on registration requirements can be obtained from Chapter 1 Marketing Authorisation (November 2005) on the Commission website where other guidelines on the format of the dossier, SmPC etc can also be found.
Further information on dossier requirements for registration for both types of registration procedure can be found in this document.
If a product falls under the medicinal product categories described in the sections above, it has to meet specific standards of safety and quality. These products will be assessed by the Medicines Authority and granted a product licence or an authorisation to allow them to continue to be placed on the market. This will ensure that the public is protected against low grade and possibly unsafe products.
A self-explanatory Decision Tree will help you decide whether your products fall within the definition of herbal medicinal products or traditional herbal medicinal products.
If a product is classified as a herbal medicinal product, a marketing authorisation application should be submitted to the Medicines Authority.
It is the responsibility of the person/ company placing the product on the market to make sure that this is done in accordance with the required legislation.
For more information on the regulation of herbal medicines in Malta or any herbal related queries please contact:
Borderline Classification Committee
Medicines Authority, Sir Temi Zammit Buildings, Life Sciences Park, San Gwann, SGN 3000, Malta
Tel: (356) 23439000
Fax: (356) 23439161
Email: herbals.adm@gov.mt
Each company placing herbal medicinal products on the market will also be required to hold an importer's or a wholesale dealer's licence issued by the Licensing Authority as well as an authorisation/product registration for each individual herbal medicinal product on the market, as is the case with other medicinal products (as specified in Medicines Act, 2003 (as amended), Articles 54-65).
For more detailed information of manufacturing, wholesale dealing, importation of medicinal products in Malta please go to this link.
Documents and references at a glance
The provisions for registration of traditional herbal medicinal products can be found in Chapter 2a of Directive 2001/83/EC that was introduced by Directive 2004/24/EC in April 2004. Further information can be found at the European Commission website.
European Medicines Agency - Committee on Herbal Medicinal Products (HMPC)
Updated on: 13 August 2018