Explanatory Memorandum to COM(2002)1 - Amendment of the Directive 2001/83/EC as regards traditional herbal medicinal products - Main contents
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| dossier | COM(2002)1 - Amendment of the Directive 2001/83/EC as regards traditional herbal medicinal products. |
|---|---|
| source | COM(2002)1  |
| date | 17-01-2002 |
The fundamental objectives of the Community's pharmaceutical legislation are to ensure the protection of public health while completing the Single Market in pharmaceuticals. To this end, Directive 2001/83/EC i prescribes that no medicinal product may be placed on the market without having obtained a marketing authorisation on the basis of harmonised requirements. In principle, the application for such a marketing authorisation has to contain the results of tests and trials on quality, safety and efficacy of the product. There are however some exceptions. The particulars relating to safety and efficacy need not be presented, e.g. where it is demonstrated by detailed references to published scientific literature that the product has a well-established medicinal use in the sense of Article 10(1)(a)(ii) of Directive 2001/83/EC and as defined in Part 3 of Annex I to that Directive.
This legal framework is suitable for certain herbal medicinal products. However, for many herbal medicinal products, which are being used for a long period, sufficient published scientific literature is not available so that a well-established medicinal use cannot be demonstrated. New tests and trials are in theory possible, but lead to significant financial burdens for the companies concerned, often small or medium-sized enterprises, and entail also inevitable disadvantages of such trials for animals and human beings. These consequences are difficult to justify where the traditional use of the medicinal product is of such a nature as to allow sound conclusions on its safety and efficacy. As a consequence, the legal and practical situation of traditional herbal medicinal products in the Member States varies significantly with negative impacts on the protection of public health as well as on the free movement of these goods within Europe.
The Council and the European Parliament have, on several occasions, addressed the specific situation of herbal medicinal products. In its resolutions of 20 December 1995 i and of 23 April 1996 i, the Council called on the Commission to study the existing situation of these products in close co-operation with the Member States. On demand of the Commission, the Association of the European Self-Medication Industry investigated the situation of herbal medicinal products in Europe and presented a report in 1998 i. In its resolution of 16 April 1996 i, the European Parliament pointed to the growing demand for herbal medicinal products and the importance of this sector of pharmaceutical industry for employment opportunities especially in small and medium-sized enterprises. The European Parliament explicitly called for specific provisions on herbal medicinal products to provide optimum health protection for European citizens, to facilitate the marketing of these products in Europe as well as to ensure an appropriate involvement of experts in this field.
Against this background, the new Directive provides for a special registration procedure allowing the registration and, hence, the marketing of certain traditional herbal medicinal products without requiring particulars and documents on tests and trials on safety and efficacy. However, the same requirements apply to the manufacturing of these products and their quality. In order to further improve the protection of public health, the Directive provides a special legal framework for traditional herbal medicinal products, thus removing the differences and uncertainties about the status of these products currently existing in the Member States. Furthermore, the Directive harmonises the rules applicable to traditional herbal medicinal products in Europe and thereby contributes to facilitate the free movement of these goods in the Single Market.
For reasons of coherence and legibility of the regulatory framework, the specific provisions on traditional herbal medicinal products shall be introduced in the new Community code relating to medicinal products for human use, as contained in Directive 2001/83/EC.
The main objective of the draft Directive is to establish a harmonised legislative framework for traditional herbal medicinal products and hence is based on Article 95 of the EC Treaty. Since the differences currently existing between the situation in the Member States constitute an obstacle to the free movement of these goods within the Community, a certain harmonisation on the European level appears necessary and is consistent with the principle of subsidiarity. The draft Directive is limited to those provisions considered indispensable to attain a sufficient degree of harmonisation while ensuring the full protection of public health and therefore respects also the principle of proportionality.
Contents
The scope of the new provisions is limited to traditional herbal medicinal products (Article 16a). Those herbal medicinal products, which can be authorised under chapter 1 of title III of Directive 2001/83/EC either on the basis of the results of new tests and trials on safety and efficacy or on the basis of reference to published scientific literature, shall not be eligible for the simplified registration. If either of these cases is given, especially where sufficient scientific literature is published for a given herbal medicinal product to prove its well-established medicinal use in the sense of Article 10(1)(a)(ii) of Directive 2001/83/EC, an exception from the general requirements of chapter 1 of title III of Directive 2001/83/EC is not necessary and should therefore not be allowed. With regard to particularities of homeopathic medicinal products, the new provisions shall not apply either to homeopathic medicinal products.
There are several conditions that have to be fulfilled to be eligible for the registration under the new provisions (Article 16a). The entirety of these conditions shall guarantee that only those herbal medicinal products have access to the simplified registration, where it is appropriate and justified to depart from the strict requirements of chapter 1 of title III of Directive 2001/83/EC. Hence, the product must be a herbal medicinal product. Furthermore, the possible indications and ways of administration are limited, while the product must be for administration with a specified strength. Finally, the period of traditional use must have elapsed and the information on the traditional use of the medicinal product must be sufficient. This condition is necessary to ensure that only traditional herbal medicinal products are granted access to the market via the registration procedure, for which the information on the traditional use allows the national authority to conclude on the safety and the efficacy of the product.
In principle, the applicant for a registration under the new provisions has to provide the same particulars and documents as for an application under chapter 1 of title III of Directive 2001/83/EC, including the results of physico-chemical, biological or microbiological tests (Article 16c). Hence, relating to the quality of the medicinal product the same requirements as for an authorisation under chapter 1 of title III of Directive 2001/83/EC apply. However, instead of providing the results of tests and trials on safety and efficacy of the product, the applicant has to present bibliographical or expert evidence on the traditional medicinal use of the product as well as a bibliographic review of safety data together with an expert report. The well established medicinal use in the sense of Article 10(1)(a)(ii) of Directive 2001/83/EC, as defined in Part 3 of Annex I to that Directive, requires at least 10 years from the first systematic and documented use. Bearing in mind that a traditional medicinal use under the new provisions does not require such a systematic and documented use, a period of thirty years seems appropriate. In principle, only medicinal use within the Community is relevant since it is very difficult to verify whether information on use outside the Community provides a reliable basis to conclude on the efficacy and especially the safety of the product. However, if the product has been available within the Community for at least 15 years, it appears acceptable that the evidence of 30 years of medicinal use may fully or partly relate to such use outside the Member States.
Due to the dissimilar situation of herbal medicinal products in the Member States, which cannot immediately be harmonised in its entirety by the new provisions, the mutual recognition procedure as laid down in chapter 4 of title III of Directive 2001/83/EC cannot be applied to registrations of traditional herbal medicinal products. The new provisions oblige the Member States however to take due account of authorisations or registrations granted to the product (Article 16d). In interpreting this obligation, the progressing harmonisation in the field of traditional herbal medicinal products on the basis of monographs established by the new committee has to be considered.
An application for the registration of a medicinal product under the new provisions is to be refused under certain conditions (Article 16e). It is to be refused, if the evaluation shows that the qualitative and/or quantitative composition of the product is not as declared in the application, if the therapeutic indications do not comply with the restrictions laid down in Article 16b, if the product could be harmful in the normal conditions of use, if the data on the traditional use in insufficient or if the pharmaceutical quality is not satisfactorily demonstrated.
With the intention to further facilitate the application for certain traditional herbal medicinal products, a list of herbal substances shall be set up that fulfil the conditions of eligibility for the registration procedure (Article 16f). For each substance, the list shall indicate the therapeutic indication, the specified strength, the route of administration and any other relevant safety information. If an application for traditional use registration refers to a herbal substance contained in that list, the applicant, instead of supplying the respective documents, may refer to the contents of the list. Nevertheless, even in this case, the normal requirements regarding the quality of the product fully apply.
Where appropriate, the existing pharmaceutical legislation applies to the new registration procedure (Article 16g). This concerns:
- the exclusion of medicinal products prepared in a pharmacy in accordance with the magistral or the official formula (Article 3 i and i of Directive 2001/83/EC);
- the right of Member States to apply national legislation on the sale, supply or use of medicinal products as contraceptives or abortifacients (Article 4 i of Directive 2001/83/EC);
- the obligation that the necessary documents and particulars must be drawn up by experts (Article 12 of Directive 2001/83/EC);
- the time limit of 210 days for the decision on a valid application (Article 17 i of Directive 2001/83/EC);
- the analysis of particulars submitted by the competent national authorities (Article 19 of Directive 2001/83/EC);
- the control of manufacturers and importers coming from third countries (Article 20 of Directive 2001/83/EC);
- the obligation of the marketing authorisation holder to take account of scientific and technical progress (Article 23 of Directive 2001/83/EC);
- the validity of a marketing authorisation for 5 years (Article 24 of Directive 2001/83/EC);
- the civil and criminal liability of the manufacturer and the marketing authorisation holder (Article 25 of Directive 2001/83/EC);
- the general provisions on manufacture and importation (Articles 40 to 52 of Directive 2001/83/EC);
- the provisions on classification of medicinal products (Articles 70 to 75 of Directive 2001/83/EC);
- the provisions on wholesale distribution of medicinal products (Articles 76 to 85 of Directive 2001/83/EC);
- the provisions on pharmacovigilance (Articles 101 to 108 of Directive 2001/83/EC);
- the obligation of Member States for repeated inspections (Article 111 i and i of Directive 2001/83/EC);
- the obligation to furnish proof of controls carried out (Article 112 of Directive 2001/83/EC);
- the provisions on suspension etc. of a marketing authorisation (Articles 116, 118 and 126 second indent of Directive 2001/83/EC);
- the prohibition of supply of medicinal products (Article 117 of Directive 2001/83/EC);
- certain information obligations (Articles 122 to 123 of Directive 2001/83/EC);
- certain obligations regarding administrative decisions (Article 125 of Directive 2001/83/EC);
- the certificate on manufacturing authorisation (Article 127 of Directive 2001/83/EC);
- the Directive 91/356/EEC on the principles and guidelines of good manufacturing practice.
In principle also the general provisions on labelling and package leaflet (Articles 54 to 65 of Directive 2001/83/EC) as well as on advertising (Articles 86 to 99 of Directive 2001/83/EC) apply. However, it appears necessary to ensure a full information to the public, especially the patients, about the particularities of traditional herbal medicinal products, registered under this Directive. It contains therefore, inter alia, the obligation to include in the labelling, the package leaflet and in any advertising the information that the product is a traditional herbal medicinal product and that the efficacy has not been clinically proven (Articles 16g i and (3)).
To ensure full participation and involvement of experts in the field of herbal medicinal products, a new Committee for Herbal Medicinal Products is set up within the European Agency for the Evaluation of Medicinal Products established by Council Regulation (EEC) No 2309/93 (Article 16h). The committee's tasks will relate to the scientific issues with regard to herbal medicinal products and herbal substances. The committee will be composed of one member nominated by each Member State with regard to their special role and experience for 3 years renewable.
One of the major tasks of the new committee will be to establish Community herbal monographs (Article 16h(3)). These monographs contain relevant information for herbal medicinal products, such as a definition, the constituents, clinical particulars, pharmacological properties and bibliographical references. Such monographs are relevant for the assessment of an application for a marketing authorisation based on well established medicinal use as well as of an application for registration under the new provisions. With the intention to continuously improve the harmonisation of the situation of herbal medicinal products in Europe, whenever such monographs have been adopted they must be used as basis for any application for registration under the new provisions. Furthermore, when new monographs are adopted, the registration holder is obliged to introduce a modification to the registration dossier so as to comply with the new monograph.
It is important to ensure full consistency between the Committee for Proprietary Medicinal Products and the Committee for Herbal Medicinal Products. The two committees should consult each other and, where possible, reach agreement on the position to take in case of a referral regarding an application, which relies on Article 10(1)(a)(ii) of Directive 2001/83/EC and which makes use of a Community herbal monograph. The obligation of the Executive Director of the Agency to ensure appropriate co-ordination between the scientific committees of the Agency as contained in Article 55 i of Regulation 2309/93 should be extended to the new committee (Article 16g(3)). As far as legislative amendments are necessary, they will be considered during the discussions on the procedural provisions on the mutual recognition procedure.