KEY POINTS OF THE LEGISLATION-Development and Validation of Plant-Derived Medicines for Human Health


The main points of the Directive are the following.

1.    Ensure high-quality standards for traditional herbal medicinal products.

2.    Take into account sufficient long-term use and experience in proof of efficacy.

3.    Labeling and leaflets adjusted to herbal medicinal products.

4.    Establishment of a new committee at the European Medicines Agency (EMA) level on Herbal Medicinal Products (HMPC).

In particular, in order to recognize a product as a traditional herbal medicine, a simplified registration procedure has been established fulfilling the following criteria.

1.    The product should have indications exclusively appropriate for traditional herbal medicinal products that are intended for use without the supervision of a medical practitioner.

2.    It is exclusively for administration in accordance with a specified strength and posology.

3.    It is an oral, external, and/or inhalation preparation.

4.    A certain period of traditional use is required (see below).

5.    The data on its traditional use should be sufficient to prove it in the specified conditions to be safe and efficacious on the basis of long-lasting use and experience.

Concerning the composition of a traditional herbal medicine, the European Parliament advocated possibilities of a range of combinations. In fact, it is possible to add in the traditional herbal products vitamins or minerals, provided that their action is ancillary to that of the herbal active ingredients regarding the specified claimed indications.

Applicants should provide documents that show a high-quality standard of their products and any authorization or registration obtained in another Member State or in a third country to place the medicinal product on the market. A bibliographical or expert evidence is necessary to demonstrate that the medicinal product in question has been used throughout a period of at least 30 years preceding the date of the application, including at least 15 years within the EU. At the request of the Member State, the HMPC at the EMA shall draw an opinion on the adequacy of the evidence of long-lasting use of the product or of a corresponding product. Applicants should also provide a bibliographic review of safety data together with an expert report and where required by the competent authority, data necessary for assessing the safety of the medicinal product.

When the product has been in use in the community for less than 15 years, the Member State where the application for traditional-use registration has been submitted shall refer the product to the European HMPC.

If the committee considers it possible, it shall establish a community herbal monograph which shall be taken into account by the Member State for its final decision.

One of the most important achievements of the European Parliament to improve the traditional herbal medicines Directive was the establishment of the HMPC at the EMA. The role of this Committee involves the following.

1.    Performing the tasks required to ascertain the quality, the composition, and the traditional use of the product.

2.    Preparing Community herbal monographs which allow for the authorization of herbal medicinal products.

3.    Preparing a list of herbal substances, preparations, and combinations.

The Committee consists of one member and one alternate appointed by each Member State chosen for their role and experience in the evaluation of herbal medicinal products. The Committee may also coopt a maximum of five additional members chosen on the basis of their specific scientific competence.

The final text of the Directive gave to the Committee a wider scope of tasks including, in particular, the final decision in an arbitration process in cases where a mutual recognition procedure between EU Member States could not be finalized successfully. This enlarged the responsibility of the Committee and will ensure an appropriate assessment, giving confidence to the manufacturers in the area to submit applications as they can now expect to get the best available expertise in judging their products.

The new HMPC will have to have autonomy in decision-making and tasks from those envisaged for the Committee on Human Medicinal Products in Directive 2001/83/EC. Another aspect considered in the Directive is the obligation to include in package leaflets and other forms of publicity information to the effect that the therapeutic efficacy of traditional medicinal herbs has not been proven in specific clinical trials, as required by Directive 2001/83/EC.

Finally, the Directive lays down a harmonized legislative framework for all EU countries, promoting the free movement of traditional medicinal herbs in the com- munity. Furthermore, the Directive guarantees the highest level of protection for public health on the basis of the documentation required concerning the quality, efficacy, and safety.

In September 2008, the European Commission published its report on the experience acquired as a result of the application of the provisions of Chapter 2a of Directive 2001/83/EC, as amended by Directive 2004/24/EC, on specific provisions applicable to traditional herbal medicinal products. The Commission’s report admittedly has the merit of stressing clearly the fundamental objectives of Directive 2001/83/EC, which indicate that any medicinal product, before being authorized for sale, must be accompanied by a technical scientific dossier, documenting its quality, efficacy, and safety.


The approval of the Directive 2004/24/EC on traditional herbal medicinal products brings recognition to these important compounds as medicines. Nowadays, the progress achieved in the last decades with the use of new advanced therapies (biotechnological products, therapeutic use of stem cells, and gene therapy) will add a new dimension to the therapeutic armamentarium. However, we are conscious that no one can reproduce in laboratory all the complex biotechnological products present in nature (plants and herbals), which besides a natural balance of different active principles will certainly have a safer toxicological profile in comparison to monoclonal antibodies and other biotechnological and cell products.

The approval of the Directive came after more than 10 years of conflicting views and very intense and controversial discussions among the Commission, European Parliament, and all the other stakeholders. It was an honor and privilege for the authors of this chapter to co-ordinate the opinion of the European Parliament and to combine the specific scientific competence, one being professor in Pharmacology and Toxicology at the University of Rome Tor Vergata and the other with a specific and long-lasting professional competence on European legislation. This allowed us to reach a consensus among all the interested parties after the agreement between the Commission and the European Parliament on many amendments through compromise.

We are less satisfied with the slow progress in preparing the relative monographs by the European HMPC and particularly with the reluctance of some national authorities to take fully into account the monographs in the context of national applications.

In addition, we believe the progress which EMA is achieving in the collaboration with the European Food Safety Authority (Parma) is important in order to rapidly classify an herbal product as a medicinal product or instead as food.

We also believe that a new piece of legislation should deal with those traditional herbals not recognized as such within the 7 years after entry into force of the Directive as well as with other aspects such as extension of traditional-use registration to other categories of medicinal products or to the combinations of traditional herbals with amino acids, fatty acids, and so on.

The possibility will remain for herbals to be used in food stuff and as food supplements depending on the national legislation in the EU Member States which may be harmonized in the future by an amendment of the EU food supplement Directive and by the envisaged regulation on food fortification, respectively.

Soure: Giacinto Bagetta, Marco Cosentino, Marie Tiziana Corasaniti, Shinobu Sakurada (2012); Herbal Medicines: Development and Validation of Plant-derived Medicines for Human Health; CRC Press

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