European Directive on Traditional Herbal Medicinal Products
Encyclopedia
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
on the Community code relating to medicinal products for human use was established by the European Parliament
and Council
on 31 March 2004 to provide a simplified regulatory approval process
for traditional
herbal medicines
in the European Union
(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 medicines must be now manufactured under Good Manufacturing Practice
(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in widespread use, could still be sold but that valid new herbs which cannot meet the 30 year rule may require to be withdrawn from sale.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:
The Traditional Herbal Medicines Product Directive does allow medicinal claims to be made on the label of the final product, although restrictions do apply on the final wording.
The Directive 2004/24/EC amending, as regards traditional herbal medicinal products, Directive 2001/83/EC
Directive 2001/83/EC
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 use...
on the Community code relating to medicinal products for human use was established by the European Parliament
European Parliament
The European Parliament is the directly elected parliamentary institution of the European Union . Together with the Council of the European Union and the Commission, it exercises the legislative function of the EU and it has been described as one of the most powerful legislatures in the world...
and Council
European Council
The European Council is an institution of the European Union. It comprises the heads of state or government of the EU member states, along with the President of the European Commission and the President of the European Council, currently Herman Van Rompuy...
on 31 March 2004 to provide a simplified regulatory approval process
Approved drug
In the United States, the FDA approves drugs. Before a drug can be prescribed, it must undergo an extensive FDA approval process. This process involves first testing the drug on animals or in medical labs. If found to be safe by the FDA and approved for the next phase of study, the drug is then...
for traditional
Traditional medicine
Traditional medicine comprises unscientific knowledge systems that developed over generations within various societies before the era of modern medicine...
herbal medicines
Herbalism
Herbalism is a traditional medicinal or folk medicine practice based on the use of plants and plant extracts. Herbalism is also known as botanical medicine, medical herbalism, herbal medicine, herbology, herblore, and phytotherapy...
in the European Union
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
(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
Herbalist
An herbalist is:#A person whose life is dedicated to the economic or medicinal uses of plants.#One skilled in the harvesting and collection of medicinal plants ....
.
Herbal medicines must be now manufactured under Good Manufacturing Practice
Good Manufacturing Practice
"Good manufacturing practice" or "GMP" are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients, diagnostics, foods,...
(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 administeredRoute of administrationA route of administration in pharmacology and toxicology is the path by which a drug, fluid, poison, or other substance is taken into the body.-Classification:Routes of administration are usually classified by application location...
orally, externally, or by inhalation are suitable. Any medication that requires intravenousIntravenous therapyIntravenous therapy or IV therapy is the infusion of liquid substances directly into a vein. The word intravenous simply means "within a vein". Therapies administered intravenously are often called specialty pharmaceuticals...
administration will not be authorised.
- Only herbal medicines that are intended to be used without supervision by a medical doctorPhysicianA physician is a health care provider who practices the profession of medicine, which is concerned with promoting, maintaining or restoring human health through the study, diagnosis, and treatment of disease, injury and other physical and mental impairments...
will be authorised by this scheme.
- The intended use of a herbal medicines will only be authorised on the basis of its traditionalTraditional medicineTraditional medicine comprises unscientific knowledge systems that developed over generations within various societies before the era of modern medicine...
history and/or the recognised pharmacologicalPharmacologyPharmacology is the branch of medicine and biology concerned with the study of drug action. More specifically, it is the study of the interactions that occur between a living organism and chemicals that affect normal or abnormal biochemical function...
properties of the herbal ingredient(s).
- VitaminVitaminA vitamin is an organic compound required as a nutrient in tiny amounts by an organism. In other words, an organic chemical compound is called a vitamin when it cannot be synthesized in sufficient quantities by an organism, and must be obtained from the diet. Thus, the term is conditional both on...
s and mineralMineralA mineral is a naturally occurring solid chemical substance formed through biogeochemical processes, having characteristic chemical composition, highly ordered atomic structure, and specific physical properties. By comparison, a rock is an aggregate of minerals and/or mineraloids and does not...
s 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 of the final product, although restrictions do apply on the final wording.