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.  One can find general advice on safety of herbal medicinal products within the Herbal Safety advice page of this website. 

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. These products can continue to be marketed in accordance with the requirements for these categories of products. These products are regulated by the Malta Standards 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 or a medicinal product. 

1.         Is your Herbal product a Traditional Herbal Medicinal Product (THMP) or a Herbal Medicine (HMP)? 

It is important that you begin by establishing whether your product is classified as a herbal medicine, traditional herbal medicine or none. If it is not a herbal medicinal product or a traditional herbal medicinal product, you do not have to comply with medicines legislation (although you will have to comply with other legislation relevant to your product e.g. that regulating foods or cosmetics).  

2.         How herbal medicines can be authorised to be placed on the Market  

If a herbal product is classified as a medicine, there are two possible regulatory routes by which you can legally supply your herbal medicine. You will need to ensure that your product complies with the necessary requirements.  

2.1.      Registration as Traditional Herbal Medicinal Products: A Simplified Registration Procedure.  

Directive 2004/24/EC of the European Parliament and of the Council, amending, as regards Traditional Herbal Medicinal Products, Directive 2001/83/EC on the Community Code relating to Medicinal Products for Human Use, was published on the 31 March 2004 in the Official Journal of the European Union. This directive came into force on the 30 April 2004 throughout the European Union, thus harmonizing the regulation of Traditional Herbal medicinal Products. As a member state, Malta is obliged to comply with this Directive. The directive was transposed into Maltese legislation, as a legal notice under the Medicines Act, 2003 - Legal notice 379 of 2005. 

A transitional period is allowed for products that were already on the market before September 2010, that fall within the definition of a traditional herbal medicinal product or a medicinal product.  This is to allow enough time for companies to come in line with the necessary requirements.  

For new products that are to be placed on the market after September 2010, the transitional arrangements do not exist and products need to be registered prior to placing on the market.  

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 Herbal on Medicinal Products (HMPC), which meets at the EMA (European Medicines Agency), is finalizing a list of monographs HMPC Monographs and this may help in deciding on the appropriate registration process for your product.  

This list will relate to Community Herbal monographs relevant to the registration and authorization of Traditional Herbal Medicinal Products throughout Europe. These monographs will provide guidance as to the properties of these products, including therapeutic uses, pharmaceutical forms and strengths that would classify them as medicinal products. 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 could then refer to this list rather than have to demonstrate Traditional use and safety.  

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 authorization. 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 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 or a combination of ingredients and a similar intended purpose) has been in medicinal use throughout a period of at least 30 years preceding the date of application, including at least 15 years within the Community.  

Some of the documents that will be required for traditional herbal medicinal simplified registration include:

• Quality dossier covering the quality of the herbal ingredients and the finished product
• Bibliographic review of safety data
• Expert report/s on non-clinical and clinical aspects of safety
• Expert report/s including bibliographic or expert evidence that the medicinal product or corresponding product has been in medicinal use throughout a period of 30 years preceding the date of application (including at least 15 years within the EU)
• any authorization or registration obtained by the applicant in another Member State, or in a third country, to place the medicinal product on the market, and details of any decision to refuse to grant an authorization or registration, whether in the Community or a third country, and the reasons for any such decision
• Draft SmPC (Summary of Product Characteristics)
• Draft package leaflet
• Draft labelling

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. 

2.2       Marketing Authorization in accordance with Article 10a of Directive 2001/83/EC (Well established use)   

After the introduction of the Traditional Herbal Medicinal Product Registration Procedure, it is still possible to obtain a marketing authorization 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 authorization based on demonstration of safety, quality and efficacy.  

Registration requirements for this type of authorization 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 Authorization (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: Registering Herbal medicinal products - Compiling the dossier. 

3.         Deciding which regulatory route is required for your products: 

If your products fall under the medicinal product categories described in sections 2.1 and 2.2 above, they have to meet specific standards of safety and quality. These products will be assessed by the Medicines Authority and granted a product licence or an authorization 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 list of plants and herbal substances that are exclusively used in herbal medicinal products and have no use in foods or food supplements has been compiled.  All products containing these herbal substances or preparations will most likely need to be registered as medicinal or traditional herbal medicinal products to be placed on the market.  Their use in food supplements is not considered acceptable. 

For these products (with no food use) and for all the other products containing other herbal preparations or substances that fall under the classification of a medicinal product, a HERBAL CLASSIFICATION FORM should be filled in for any new herbal products you would like to place on the Maltese market that you think may fall in the two categories above (i.e. medicinal products).  The filled in form should be sent by email to herbals.adm@gov.mt. 

A GUIDANCE DOCUMENT has been prepared to help you fill in the classification form.  If in doubt whether your product is a medicinal product or not, fill in form anyway.  This form will enable the Medicines Authority to help you in the classification of your medicinal product.   

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.   

Products classified as medicinal products for which a registration application form is not received will not be allowed on the market after 31 March 2012. 

If no application form for registration is sent, written confirmation that you are no longer interested in placing the product on the market after 31 March 2012 should be sent 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.  

Update May 2011

The Medicines Authority has finalised the first phase of classification of submitted products.  Of the over 1000 products received for classification, over 700 have been classified as non-medicinal and the importers and wholesale dealers have been informed in writing.  The rest of the products are under consideration and more information may be requested from the stakeholders to enable classification.  Until further notice, all products that are still being classified can continue to be placed on the market as is currently being done.

Any new products that are medicinal products must be registered to be placed on the market in Malta.

For more information on the regulation of herbal medicines in Malta or any herbal related queries please contact: 

Herbals Committee

Medicines Authority, 203, Level 3, Rue D'Argens, Gzira GZR1368

Tel:   + (356) 23439145/23439185

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 authorization/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 you may access the Inspectorate section of the website or send an email to inspectorate.adm@gov.mt. 

Documents and references at a glance: 

EU Legislation:  Directive 2004/24/EC of the European Parliament and of the Council, amending, as regards Traditional Herbal Medicinal Products, amending Directive 2001/83/EC 

Maltese legislation:  Legal Notice 379 of 2005: Herbal Medicinal Products Regulations, 2005 

Medicinal plants and herbal substances  

DECISION TREE  for guidance to decide whether a product falls within the definition of herbal medicinal product or traditional herbal medicinal product 

HERBAL CLASSIFICATION FORM 

GUIDANCE DOCUMENT to fill in the Herbal Classification Form 

European Commission – Herbal Medicinal Products Information 

European Medicines Agency – Committee on Herbal Medicinal Products (HMPC) 

European Medicines Agency - HMPC Monographs

Information Session (Herbal Medicinal Products) Read more [04.05.2010] - Presentations uploaded

Page last updated: 17/5/2011