The European Directive on Traditional Herbal Medicinal Products (THMPD), formally the Directive 2004/24/EC amending, as regards traditional herbal medicinal products,
Directive 2001/83/EC
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relates to medicinal products for human use in mainly countries that are part of the European Union. The Directive dealt with the disparitie ...
on the Community code relating to medicinal products for human use, was established by the
European Parliament
The European Parliament (EP) is one of the legislative bodies of the European Union and one of its seven institutions. Together with the Council of the European Union (known as the Council and informally as the Council of Ministers), it adopts ...
and
Council
A council is a group of people who come together to consult, deliberate, or make decisions. A council may function as a legislature, especially at a town, city or county/shire level, but most legislative bodies at the state/provincial or natio ...
on 31 March 2004 to provide a simplified regulatory
approval process for
traditional
A tradition is a belief or behavior (folk custom) passed down within a group or society with symbolic meaning or special significance with origins in the past. A component of cultural expressions and folklore, common examples include holidays or ...
herbal medicines
Herbal medicine (also herbalism) is the study of pharmacognosy and the use of medicinal plants, which are a basis of traditional medicine. With worldwide research into pharmacology, some herbal medicines have been translated into modern remedies ...
in the
European Union
The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been des ...
(EU).
Previously, there was no formal EU wide authorisation procedure, so each EU member state regulated these types of products at the national level.
Under this regulation, all herbal medicinal products are required to obtain an authorisation to market within the EU. Those products marketed before this legislation came into force can continue to market their product until 30 April 2011, under the transitional measures defined in the Traditional Herbal Medicinal Products Directive. Once this time limit has expired, all herbal medicinal products must have prior authorisation before they can be marketed in the EU.
For those herbal medicinal products that were not on the market before 30 April 2004, an authorisation must be obtained prior to marketing.
The only herbal medicines that are exempted from the provisions of the Traditional Herbal Medicinal Products Directive are those unlicensed remedies that are made up for a patient following a consultation with a
herbalist
Herbal medicine (also herbalism) is the study of pharmacognosy and the use of medicinal plants, which are a basis of traditional medicine. With worldwide research into pharmacology, some herbal medicines have been translated into modern remed ...
.
Herbal medicines must be now manufactured under
Good Manufacturing Practice
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutica ...
(GMP) to ensure the quality of the finished product and also demonstrate safety.
Under the Traditional Herbal Medicinal Products Directive, a company needs to demonstrate that the herbal medicine has been in use within the EU for at least 30 years or 15 years within the EU and 30 years outside the EU.
There is concern that some herbal remedies of 30 years ago, which are no longer in widespread use, could still be sold but that valid new herbs which cannot meet the 30-year rule may require to be withdrawn from sale. The rule could also mean that it may not be possible to license some traditional herbal medicines which were in common use more than 30 years ago, but have since fallen into disuse.
There are key eligibility criteria for a herbal medicine to qualify under this legislation:
* Only herbal medicines that are
administered orally, externally, or by inhalation are suitable. Any medication that requires
intravenous
Intravenous therapy (abbreviated as IV therapy) is a medical technique that administers fluids, medications and nutrients directly into a person's vein. The intravenous route of administration is commonly used for rehydration or to provide nutrie ...
administration will not be authorised.
* Only herbal medicines that are intended to be used without supervision by a
medical doctor
A physician (American English), medical practitioner (Commonwealth English), medical doctor, or simply doctor, is a health professional who practices medicine, which is concerned with promoting, maintaining or restoring health through th ...
will be authorised by this scheme.
* The intended use of a herbal medicine will only be authorised on the basis of its
traditional
A tradition is a belief or behavior (folk custom) passed down within a group or society with symbolic meaning or special significance with origins in the past. A component of cultural expressions and folklore, common examples include holidays or ...
history and/or the recognised
pharmacological
Pharmacology is a branch of medicine, biology and pharmaceutical sciences concerned with drug or medication action, where a drug may be defined as any artificial, natural, or endogenous (from within the body) molecule which exerts a biochemica ...
properties of the herbal ingredient(s).
*
Vitamin
A vitamin is an organic molecule (or a set of molecules closely related chemically, i.e. vitamers) that is an Nutrient#Essential nutrients, essential micronutrient that an organism needs in small quantities for the proper functioning of its ...
s and minerals may be added to the herbal medicine provided that their use is ancillary to the herbal ingredient(s).
* If the competent EU member judges that the herbal medicine fulfills the criteria for a marketing authorisation, then an authorisation under Traditional Herbal Medicines Product Directive should be granted.
* Herbal medicine products manufactured using isolated active ingredients from plants will not be regarded as herbal medicines and will not receive an authorisation under this scheme.
The Traditional Herbal Medicines Product Directive does allow medicinal claims to be made on the
label
A label (as distinct from signage) is a piece of paper, plastic film, cloth, metal, or other material affixed to a container or product, on which is written or printed information or symbols about the product or item. Information printed dir ...
of the final product, although restrictions do apply on the final wording.
References
{{reflist
External links
Text of the DirectiveText of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human useUK MHRA Traditional Herbal Medicines Registration Scheme
Traditional herbal medicinal products
Medical regulation
2004 in law
2004 in the European Union
Traditional medicine