52002PC0001

Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending the Directive 2001/83/EC as regards traditional herbal medicinal products

(presented by the Commission)

EXPLANATORY MEMORANDUM

1. General background and objectives

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 [1] 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.

[1] OJ L 311, 28.11.2001, p.67...

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 [2] and of 23 April 1996 [3], 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 [4]. In its resolution of 16 April 1996 [5], 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.

[2] OJ C 350, 30.12.1995, p. 6.

[3] OJ C 136, 8.5.1996, p. 4.

[4] ,Pflanzliche Arzneimittel in der Europäischen Union", ETD/97/501336, Abschlußbericht, November 1998.

[5] OJ C 141, 13.5.1996, p. 63.

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.

2. Specific comments

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(1) and (2) 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(4) 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(1) 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(1) and (3) 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(2) 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(2) 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.

2002/0008 (COD)

Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending the Directive 2001/83/EC as regards traditional herbal medicinal products

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission [6],

[6] OJ ....

Having regard to the opinion of the Economic and Social Committee [7],

[7] OJ ....

Acting in accordance with the procedure laid down in Article 251 of the Treaty [8],

[8] OJ C 95, 30.3.1998, p. 1.

Whereas:

(1) 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 [9] requires that applications for the authorisation to place a medicinal product on the market have to be accompanied by a dossier containing particulars and documents relating in particular to the results of physico-chemical, biological or microbiological as well as pharmacological and toxicological tests and clinical trials carried out on the product and thus proving its quality, safety and efficacy.

[9] OJ L 311, 28.11.2001,p.67 [As amended by directive ....(OJ,L...)]

(2) Where the applicant can demonstrate by detailed references to published scientific literature that the constituent or the constituents of the medicinal product have a well established medicinal use with recognised efficacy and an acceptable level of safety in the sense of Directive 2001/83/EC, he should not be required to provide the results of pre-clinical tests or the results of clinical trials.

(3) A significant number of medicinal products, despite their long tradition, do not fulfil the requirements of a well established medicinal use with recognised efficacy and an acceptable level of safety and are not eligible for a marketing authorisation. To maintain these products on the market, the Member States have enacted different procedures and provisions. These differences currently existing between the provisions laid down in the Member States may hinder trade in traditional medicinal products within the Community and lead to discrimination and distortion of competition between manufacturers of these products. They may also have impact on the protection of public health since the necessary guarantees of quality, safety and efficacy are not always given at present.

(4) Having regard to the particular characteristics of these medicinal products, especially their long tradition, it is desirable to provide a special, simplified registration procedure for certain traditional medicinal products. However, this simplified procedure should be eligible only where no marketing authorisation under Directive 2001/83/EC, in particular due to lack of sufficient scientific literature demonstrating a well established medicinal use with recognised efficacy and an acceptable level of safety, can be obtained. It should likewise not apply to homeopathic medicinal product eligible for a marketing authorisation or for a registration under Directive 2001/83/EC.

(5) The long tradition of the medicinal product enables to renounce clinical trials, insofar as the efficacy of the medicinal product is plausible on the basis of long-term use and experience. Pre-clinical tests do not seem necessary, where the medicinal product on the basis of the information on its traditional use proves not to be harmful in specified conditions of use. However, even the long tradition does not exclude that there may be concerns with regard to the product's safety, so that the competent authorities should be entitled to ask for all data necessary for assessing the safety. The quality aspect of the medicinal product is independent of its traditional use so that no derogation should be made with regard to the necessary physico-chemical, biological and microbiological tests.

(6) The vast majority of medicinal products with a sufficiently long and coherent tradition are based on herbal substances. It therefore seems appropriate to limit the scope of the simplified registration in a first step to traditional herbal medicinal products.

(7) The facilitated registration should be acceptable only where the herbal medicinal product may rely on a sufficiently long medicinal use in the Community. Medicinal use outside the Community should be taken into account only, if the medicinal product has been used within the Community for a certain time.

(8) With the objective to further facilitate the registration of certain traditional herbal medicinal products and to further enhance harmonisation, there should be the possibility to establish a Community list with herbal substances that fulfil certain criteria, such as being in medicinal use for a sufficiently long time, and hence do not seem harmful in the normal conditions of use.

(9) Having regard to the particularities of herbal medicinal products, a specific committee should be established within the European Agency for the Evaluation of Medicinal Products set up by Council Regulation [(EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products] [10] (hereinafter: the Agency). The committee should be composed of experts in the field of herbal medicinal products. Its tasks should relate in particular to establishing Community herbal monographs relevant for the registration as well as the authorisation of herbal medicinal products.

[10] OJ L 214, 24.8.1993, p. 1, Regulation as last amended by Commission Regulation (EC) no 649/1998 (OJ L 88, 24.3.1998, p. 7)

(10) It is important to ensure full consistency between the new committee and the committee for human medicinal products already existing at the Agency, in particular in case of a procedure regarding an application, which concerns a herbal medicinal product and relies on Directive 2001/83/EC, appropriate co-ordination between the two committees should be ensured, relying on the provisions of Article 55(2) of Regulation 2309/93.

(11) When deciding upon an application for registration of a traditional herbal medicinal product, the Member State concerned should be obliged to take due account of authorisations or registrations previously granted by another Member State for that product. In case where the authorisation or registration refers to a herbal medicinal product for which a monograph has been established under this Directive, it should be recognised, unless there are major objections of public health.

(12) The Commission should present a report on the application of the chapter on traditional herbal medicinal products to the European Parliament and to the Council including an assessment on the possible extension of traditional use registration to other categories of medicinal products.

(13) It is therefore appropriate to amend Directive 2001/83/CE accordingly,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Directive 2001/83/EC is amended as follows:

(1) In Article 1 the following points (29) to (32) are added:

«(29) Traditional herbal medicinal product:

a herbal medicinal product that fulfils the conditions laid down in Article 16a;

(30) Herbal medicinal product:

any medicinal product, containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations;

(31) Herbal substances:

all mainly whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed, usually in dried form but sometimes fresh. Certain exudates that have not been subjected to a specific treatment are also considered to be herbal substances. Herbal substances are precisely defined by the plant part used and the botanical name according to the binomial system (genus, species, variety and author);

(32) Herbal preparations:

preparations obtained by subjecting herbal substances to treatments such as extraction, distillation, expression, fractionation, purification, concentration and fermentation. These include comminuted or powdered herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates.»

(2) The following new chapter 2a is inserted in title III.

"Chapter 2a: Specific provisions applicable to traditional herbal medicinal products

Article 16a

A simplified registration procedure (hereinafter "traditional use registration") is hereby installed for herbal medicinal products which fulfil the following criteria:

(a) they are indicated exclusively for indications adapted to a traditional herbal medicinal product, which, by virtue of its composition and purpose, is intended and designed for use without the intervention of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment;

(b) they are exclusively for administration in accordance with a specified strength;

(c) they are an oral, external and/or inhalation preparation;

(d) the period of traditional use as stipulated in Article 16c (1) (c) has elapsed;

(e) the data on the traditional use of the medicinal product is sufficient, in particular the product proves not to be harmful in the specified conditions of use and the pharmacological effects or efficacy of the medicinal product are plausible on the basis of long-term use and experience.

However, in cases where the competent authorities judge that a traditional herbal medicinal product fulfils the criteria for an authorisation in accordance with Article 6 or a registration pursuant to Article 14, the provisions of this chapter do not apply.

Article 16b

1. The applicant and registration holder shall be established in the Community.

2. In order to obtain traditional use registration, the applicant shall submit an application to the competent authority of the Member State concerned.

Article 16c

1. The application shall be accompanied by:

(a) the particulars and documents:

(i) referred to in Article 8(3) (a) to (h), (j) and (k),

(ii) the results of pharmaceutical tests referred to in the first indent of Article 8(3) (i),

(iii) the summary of product characteristics without the data specified in Article 11(4),

(iv) in case of a combination, as referred to in Article 1 (30), the information data referred to in Article 16a (e) relating to the combination as such; if the individual active ingredients are not sufficiently known, the data need also relate to the individual active ingredients;

(b) any authorisation 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 authorisation or registration, whether in the Community or a third country, and the reasons for such a decision;

(c) bibliographical or expert evidence to the effect that the medicinal product in question, or a corresponding medicinal product has been in medicinal use in the Community throughout a period of at least thirty years preceding the date of application;

(d) a bibliographic review of safety data together with an expert report, and where required by the competent authority, upon justified request, data necessary for assessing the safety of the medicinal product.

Annex I shall apply by analogy to the particulars and documents specified in point (a).

2. A corresponding medicinal product, as referred to in paragraph 1 (c), is characterised by having the same active ingredients, irrespective of the excipients used, the same or similar intended purpose, equivalent strength and the same or similar route of administration as the medicinal product applied for.

3. The requirement to show medicinal use throughout the period of thirty years, referred to in paragraph 1 (c), is satisfied even where the marketing of the product has not been based on a specific authorisation. It is likewise satisfied if the number or quantity of ingredients of the medicinal product has been reduced during that period.

4. If the product has been available within the Community for at least 15 years, the applicant may supply evidence of medicinal use throughout a period of time, which completes the period of 30 years in a specified territory or territories outside the Community.

Article 16d

When evaluating an application for traditional use registration, each Member State shall take due account of registrations or authorisations granted by another Member State.

Article 16e

1. Traditional use registration shall be refused if the application does not comply with Articles 16a, 16 b or 16c or if at least one of the following conditions is fulfilled:

(a) the qualitative and/or quantitative composition is not as declared,

(b) the therapeutic indications do not comply with the conditions laid down in Article 16 a,

(c) the product could be harmful in the normal conditions of use,

(d) data on traditional use is insufficient, especially if pharmacological effects or efficacy are not plausible on the basis of long-term use and experience,

(e) the pharmaceutical quality is not satisfactorily demonstrated.

2. The competent authorities of the Member States shall provide the applicant, the Commission and any competent authority requesting this, with any decision it makes to refuse traditional use registration on safety grounds and the reasons for this.

Article 16f

1. The Committee referred to in Article 16h shall set up a list of herbal substances. The list shall contain with regard to each herbal substance the therapeutic indication, the specified strength, the route of administration and any other information necessary for the safe use of the herbal substance.

2. If an application for traditional use registration relates to a herbal substance contained in the list, referred to in paragraph 1, the data specified in Article 16c (1) (b) (c) and (d) does not need to be provided. Article 16e (1) (c) and (d) shall not apply.

3. If a herbal substance ceases to be included in the list, referred to in paragraph 1, registrations pursuant to paragraph 2 for herbal medicinal products containing this substance shall be revoked unless the particulars and documents, referred to in Article 16c (1)are submitted within three months.

Article 16g

1. Articles 3 (1) and (2), 4(4), 12, 17(1), 19, 20, 23, 24, 25, 40 to 52, 70 to 85, 101 to 108, 111(1) and (3), 112, 116 to 118, 122, 123, 125, 126 second indent, 127 of this Directive as well as Commission Directive 91/356/EEC [11] shall apply, by analogy, to traditional use registration granted under this chapter.

[11] OJ L 193, 17.7.1991, p. 30.

2. In addition to the provisions laid down in Articles 54 to 65 any labelling and user package leaflet shall contain a statement to the effect that:

(a) the product is a herbal medicinal product for traditional use in a specified indication and that the efficacy of the product has not been clinically proven but relies exclusively on long-term use and experience; and

(b) the user should consult a doctor or a qualified practitioner if the symptoms persist during the use of the medicinal product.

A Member State may provide that the labelling and the user package leaflet shall also state the nature of the tradition in question.

3. In addition to the provisions laid down in Articles 86 to 99 any advertisement for a medicinal product registered under this chapter shall contain the following statement: "traditional herbal medicinal product for use in [specified indication] for which efficacy has not been proven".

Article 16h

1. A Committee for Herbal Medicinal Products is hereby established. That Committee shall be part of the Agency.

2. The Committee for Herbal Medicinal Products shall consist of one member nominated by each Member State for a term of 3 years, which shall be renewable. They shall, as appropriate, be chosen by reason of their role and experience in the evaluation of herbal medicinal products and shall represent their competent authorities.

3. The Committee shall establish Community herbal monographs for herbal medicinal products with regard to the application of Article [10a] [10(1)(a)(ii)] as well as traditional herbal medicinal products. The appropriate co-ordination with the committee for human medicinal products shall be ensured by the Executive Directive of the Agency according to Article 55(2) of Regulation 2309/93. The Committee shall fulfil further responsibilities conferred upon it by provisions of this chapter and other Community law.

When Community herbal monographs in the sense of this paragraph have been established they shall be used as the basis for any application.

When new Community herbal monographs are established, the registration holder shall within one year after the date of establishment of such monograph, introduce a modification to the registration dossier in order to comply with that monograph. The registration holder shall notify that modification to the competent authority of the Member State concerned.

4. The Committee shall adopt its own rules of procedure.

Article 16i

Until ... [date], the Commission shall present a report to the European Parliament and the Council concerning the application of the provisions of this chapter.

The report shall include an assessment on the possible extension of traditional use registration to other categories of medicinal products."

Article 2

1. The Member States shall take the measures necessary to comply with this Directive by 31 December 2004. They shall forthwith inform the Commission thereof. When Member States adopt the said measures, they shall contain a reference to this Directive or be accompanied by such a reference when officially published.

2. For the traditional herbal medicinal products as referred to in Article 1 of this Directive, which are already on the market on the entry into force of this Directive, the competent authorities shall apply the provisions of the present Directive within five years after its entry into force.

Article 3

This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.

Article 4

This Directive is addressed to the Member States.

Done at Brussels,

For the European Parliament For the Council

The President The President

IMPACT ASSESSMENT FORM THE IMPACT OF THE PROPOSAL ON BUSINESS WITH SPECIAL REFERENCE TO SMALL AND MEDIUM-SIZED ENTERPRISES (SMEs)

Title of proposal

Proposal for a Directive of the European Parliament and of the Council amending the Directive 2001/83/EC as regards traditional herbal medicinal products.

The Proposal

1. Taking account of the principle of subsidiarity, why is Community legislation necessary in this area and what are its main aims-

The purpose of the proposed Directive is to lay down specific provisions traditional herbal medicinal products in the Community. It brings together the European experience and understanding in the field of traditional herbal medicines with the essential aim of safeguarding public health and satisfying the consumer choice. Trade in traditional herbal medicinal products within the Community is, at present, hindered by disparities between the national requirements and differences in basic traditional use concepts in EU. Specific legislation will contribute to a free circulation of these products within the Community while ensuring their quality, safety and efficacy.

The impact on business

2. Who will be affected by the proposal-

- which sectors of business-

The majority of the concerned companies belongs to the pharmaceutical sector and is manufacturing medicinal products for which the conditions of market access are modified by the present proposal. It will also have an impact on certain companies belonging either to the pharmaceutical or to the food industry since it aims at allowing the marketing as medicinal products of products which so far do not have a defined status.

- which sizes of business- (what is the concentration of small and medium-sized firms)

Apart from some multinational players involved in marketing herbal medicines, the vast majority of the businesses within the Community in this sector are small and medium size enterprises.

- are there particular geographical areas of the Community where these businesses are found-

According to different sources, France and Germany cover more than 50 % of the EU market.

3. What will business have to do to comply with the proposal (in terms of regulatory efforts)-

In the Community, there is likely to be little impact for larger pharmaceutical companies as these businesses usually manufacture all products to pharmaceutical standards and hold marketing authorisations and manufacturing authorisation. For the small and medium-sized enterprises the impact also has to be considered generally positive, even if there will be a certain impact in terms of fees and administration. The proposal's objective is not to strengthen the already existing technical-regulatory requirements. To the contrary it envisages establishing a derogatory regime in order to allow the market access of a large category of medicinal products for which certain of the existing requirements, in particular with regard to the efficacy, will not be needed any more. Those small and medium-sized enterprises which for the moment do not market these products as pharmaceuticals, will need to invest in the equipment and personnel necessary to achieve a licence for the manufacturing of medicines and to carry out the necessary quality assurance work to adequately comply with standards relating to the quality and safety of these products. Only some of these enterprises have such facilities at present. However, it needs to be taken into consideration that the conditions for marketing these herbal medicinal products will be identical in the fifteen Member States and therefore will allow an easier access to non-national markets in contrast to what is the case today.

4. What economic effects is the proposal likely to have-

- on employment

Only a limited category of companies will have to do certain investments. For these companies, the Directive's effect on the employment will certainly be positive. As mentioned above, for those companies already belonging to the pharmaceutical sector, the access to an enlarged market on the basis of harmonised conditions should increase their potential sales volumes and hence their competitiveness leading again to a positive effect on the employment.

- on investment and the creation of new businesses

For larger pharmaceutical businesses, there will probably be an increase in investment in the sector as it will increase marketability of these products. There is likely to be little impact on costs as these enterprises already manufacture all products to pharmaceutical standards.

On the other hand, certain new investments in equipment and personnel could become necessary for that category of companies marketing products, which do not possess a defined status at present. This could lead to certain activities of merger or of a transfer to other areas of business.

Overall, the effect of this Directive on the companies producing traditional medicines which is the vast majority of the concerned companies, is likely to be very positive considering the fact that the Directive offers possibilities to extend their market into other Member States and lays down new technical-regulatory conditions for this market access.

- on the competitiveness of businesses (within EU/world/wide)

Bearing in mind the heterogeneous character of the companies, it is difficult to predict the further evolution of their competitiveness as a result of adopting the Directive. However, enlarging the potential market (from national to Community), modifying the technical requirements (above mentioned derogatory regime), better information of the public and increased confidence in the security of these products should allow to improve the overall competitiveness of this sector and to outweigh the investments which will be necessary in certain companies.

5. Does the proposal contain measures to take account of the specific situation of small and medium-sized firms (reduced or different requirements etc)-

The implementation of this Directive will define standards on a European level for the group of traditional herbal medicines and will allow these products to maintain their status as medicinal products in their country of origin and to obtain it in the other Member States, permitting thus a de-partitioning of the market in this sector. Bearing in mind the increasing interest in this kind of medicinal product in the majority of the Member States, it can be expected that the overall effect on the business performance of producers of traditional herbal medicines, most of which are small and medium-sized enterprises, will be positive.

The proposed Directive will ease the burden of proof in the area of safety and efficacy, thereby reducing the requirements which apply to this kind of product at the moment.

Consultation

6. List the organisations which have been consulted about the proposal and outline their main views.

The contents of the proposed Directive have been discussed intensely with the Member States and other stakeholders. Everybody supported the underlying principle of this initiative. A questionnaire on the need and possible contents of the envisaged legislation, prepared by the Commission and sent to the Member States, was discussed during the Pharmaceutical Committee in September 2000. An ad hoc working group, composed of representatives of the Commission and interested Member States, was set up and prepared a first draft. This draft was sent to the Member States for comments. At the same time, the envisaged legislation was discussed with other stakeholders. Among the various conferences where the draft Directive was addressed, especially a workshop held on the 26 January 2001 in Brussels on the review of the pharmaceutical legislation has to be mentioned. Participants to this workshop represented the major associations of patients, consumers, pharmaceutical industry, distributors, doctors, and pharmacists. On the basis of the comments received by the Member States as well as the feed back from other parties, the Commission revised the draft. This modified version was once again discussed with the Member States during the Pharmaceutical Committee in April 2001 where the Member States' representatives declared their accord. Following these discussions, the draft was a last time amended in order to take into consideration certain technical remarks.