Wetgeving


EU-Richtlijnen - SADOC
Het Directoraat-generaal Gezondheid en consumentenbescherming (SANCO) Het. heeft het volgende verhaal opgesteld om ons te informeren over de nieuwe regelingen betreffende de registratie van de traditionele kruidengeneesmiddelen.
Dit directoraat-generaal heeft als taak de Europese burgers gezonder en veiliger te maken en vertrouwen te geven. Het is verantwoordelijk voor de EU-wetgeving op het gebied van voedselveiligheid en veiligheid van producten, volksgezondheid en consumentenbescherming.

Voorbeelden van activiteiten van dit DG zijn:
- volksgezondheid: bestrijding van tabaksgebruik; uitwisseling van kennis op medisch gebied; het voorkomen van besmettelijke ziekten- voedselveiligheid: productie van voedsel, import van veilig voedsel; voorkomen van planten- en dierenziektes- consumentenbescherming: zorgen dat producten (niet alleen voedsel) veilig zijn

EU Richtlijn 2004-24-EG

Vraag & Antwoord: Registratie van traditionele kruidengeneesmiddelen

Wat zijn traditionele kruidengeneesmiddelen?
Sommige planten bevatten stoffen die kunnen worden gebruikt om ziekten te behandelen. Geneesmiddelen die zijn gemaakt van deze stoffen staan bekend als "kruidengeneesmiddelen". Zelfs al zijn ze natuurlijk, kan een aantal van deze producten gevaarlijk zijn voor patiënten. Dit is waarom zij gedekt zijn door de farmaceutische wetgeving, die beoogt de volksgezondheid te beschermen door te zorgen voor de veiligheid, werkzaamheid en kwaliteit van geneesmiddelen.
Binnen de groep van kruidengeneesmiddelen hebben sommige een lange traditie van gebruik.De wetgeving van de Europese Unie classificeert als traditionele kruidengeneesmiddelen: die kruidengeneesmiddelen die gedurende ten minste 30 jaar zijn gebruikt, waarvan ten minste 15 jaar binnen de EU, die zijn bestemd om te worden gebruikt - zonder toezicht van een arts - en niet worden toegediend door middel van injectie .

Enkele voorbeelden van kruiden die worden gebruikt in traditionele kruidengeneesmiddelen zijn:
Calendula officinalis L; Echinacea purpurea L., Moench; Eleutherococcus senticosus (Rupr. et Maxim.) Maxi; Foeniculum vulgare Miller subsp. vulgare var. vulgare; Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung; Hamamelis virginiana L; Mentha x piperita L. en Pimpinella anisum L.

Waarom heeft de EU besluiten om specifieke wetgeving aan te nemen inzake traditionele kruidengeneesmiddelen?
Alle geneesmiddelen, inclusief kruidengeneesmiddelen, moeten een vergunning hebben voordat zij op de Europese markt worden geplaatst.
Echter, traditionele kruidengeneesmiddelen tonen bijzondere kenmerken, met name hun lange traditie in het gebruik. Om daar rekening mee te houden, heeft de EU een lichtere, eenvoudiger en minder kostbare procedure voor registratie voor deze geintroduceerd, met behoud van de nodige garanties inzake kwaliteit, veiligheid en werkzaamheid.
De Herbale-richtlijn (Richtlijn 2004/24/EG) werd aangenomen om de handel, op de Europese markt, van traditionele kruidengeneesmiddelen te vergemakkelijken. De vereenvoudigde procedure staat toe om de registratie van traditionele kruidengeneesmiddelen zonder dat er veiligheid en klinische proeven noodzakelijk zijn, waar toe de aanvrager is verplicht onder de volledige vergunningsprocedure.

De lange traditie van het geneesmiddel maakt het mogelijk om de behoefte aan deze tests en proeven te kunnen vervangen door documentatie die aangeeft dat het product niet schadelijk is om in bepaalde omstandigheden te gebruiken en dat de werkzaamheid aannemelijk is op
basis van het gebruik op lange termijn en de ervaring.
Echter, zelfs een lange traditie in het gebruik sluit bezorgdheid over de veiligheid van het
product niet uit. Daarom hebben de bevoegde autoriteiten van de lidstaten het recht om
aanvullende gegevens te vragen, indien zij dit nodig achten, om de veiligheid van het
geneesmiddel te beoordelen.
Samengevat: de Herbale richtlijn introduceert een vereenvoudigde procedure vergeleken met
de eisen voor een volledige vergunning.

Wat betekent de deadline van 30 april 2011 voor fabrikanten van traditionele kruidengeneesmiddelen?
De Herbale richtlijn werd aangenomen door het Europees Parlement en de Raad op 31 maart
2004. Het gaf een uitzonderlijk lange overgangsperiode van 7 jaar om traditionele
kruidengeneesmiddelen, die al op de markt waren op de datum van inwerkingtreding van de
richtlijn, te registreren. Deze zeven jaar’s overgangsperiode eindigt op 30 april 2011.
Traditionele kruidengeneesmiddelen, die legaal op de markt waren vóór 30 april 2004,
mochten op de markt blijven tot het einde van de overgangsperiode. Dit heeft de aanvragers 7
jaar de tijd gegeven om te registreren. Het is aan de aanvragers om de overeenkomstige
aanvraag voor hun registratie in te dienen bij de bevoegde autoriteiten in de lidstaten waar ze
op de markt willen, op tijd voor het einde van de overgangsperiode.

Legt de Herbale richtlijn nieuwe eisen op voor het op de markt brengen van traditionele kruidengeneesmiddelen? Zouden deze eisen te belastend zijn voor kleine en middelgrote ondernemingen en de toegang voor Chinese en Ayurvedische geneesmiddelen verminderen?
Vóór 2004 vielen kruidengeneesmiddelen onder de dezelfde eisen als andere geneesmiddelen.
De Herbal richtlijn wijzigt deze eisen en voorziet in een vereenvoudigde registratieprocedure
ingevoerd om het op de markt brengen van traditionele kruidengeneesmiddelen voor alle
bedrijven, met inbegrip van kleine en middelgrote ondernemingen (KMO's) te
vergemakkelijken.
De vereenvoudigde procedure kan de registratie van traditionele kruidengeneesmiddelen, met
inbegrip van Chinese of Ayurvedische kruiden geneesmiddelen of kruidengeneesmiddelen
vanuit enige andere traditie, zonder testen en proeven betreffende de veiligheid en de
werkzaamheid, die de aanvrager normaal verplicht is te verstrekken. In plaats daarvan is het
voor de registratie van traditionele kruidengeneesmiddelen voldoende en moet de aanvrager
alleen voldoende bewijs van het medicinaal gebruik van het product gedurende een periode
van ten minste 30 jaar, waarvan ten minste 15 jaar in de Europese Unie, overleggen.
Deze procedure is minder belastend dan de volledige vergunningprocedure en
vergemakkelijkt daardoor de toegang van deze producten op de markt in de EU. Bijgevolg
wordt de toegang tot Chinese of Indiase Ayurvedische geneesmiddelen of de producten van
bedrijven met beperkte financiële middelen niet verminderd.

Wat is de rol van het Europees Geneesmiddelenbureau voor de registratie van traditionele kruidengeneesmiddelen na 30 april 2011?
De European Medicines Agency (EMA) heeft geen rol in de registratie van traditionele
kruidengeneesmiddelen. De vereenvoudigde procedure is een nationale. Dit betekent dat
aanvragen voor de registratie moeten worden ingediend in elke lidstaat waar het product
wordt gebracht. Deze aanvragen worden behandeld door de bevoegde autoriteit in elke
lidstaat.
Er is echter een Comité voor kruidengeneesmiddelen (HMPC) opgericht binnen de European
Medicines Agency in september 2004 met het oog op het opzetten van een EU-lijst van
kruidenpreparaten of kruidenmengsels door de Europese Commissie. Dit betekent dat de
lidstaten de registratie van traditionele kruidengeneesmiddelen, verleend door een andere
lidstaat te erkennen wanneer het gebaseerd is op de EU-lijst.
De taken van de HMPC zijn niet gekoppeld aan het bestaan van de overgangsperiode.
Aanvragen voor de registratie van traditionele kruidengeneesmiddelen kunnen worden
ingediend, zelfs indien de stof of preparaat niet is opgenomen in de EU-lijst.

Worden kruidenproducten toegestaan om op de markt blijven als voedsel of voedingssupplementen na 30 april 2011?
Kruidensubstanties kunnen worden gebruikt om geneesmiddelen of voedsel te produceren.
Een kruidenproduct zal worden beschouwd als een geneesmiddel indien wordt aangeduid dat
het eigenschappen bezit voor de behandeling of preventie van ziekten bij de mens of wanneer
het een farmacologisch, immunologisch of metabolisch effect kan bewerkstelligen. Het is de
bevoegdheid en verantwoordelijkheid van de nationale autoriteiten om te beslissen, op een
geval per gevalbasis, of een kruidenproduct voldoet aan de definitie van geneesmiddel.
Wanneer een kruidengeneesmiddel niet is geregistreerd of toegelaten op 1 mei 2011, mag het
product niet op de EU-markt.
Echter plantaardige producten kunnen worden ingedeeld en op de markt worden gebracht als
levensmiddel, mits zij niet aan de definitie van geneesmiddelen voldoen en dat zij voldoen
aan de geldende levensmiddelenwetgeving. In het bijzonder, plantaardige producten verkocht
in de vorm van voedingssupplementen dienen te voldoen Richtlijn 2002/46/EG inzake
voedingssupplementen en Verordening (EG) nr. 1924/2006 inzake voedings-en
gezondheidsclaims voor levensmiddelen.

Zullen alle alternatieve therapieën, planten en boeken over planten in de Europese Unie worden verboden na 30 april 2011?
Nee, de Herbale richtlijn regelt traditionele kruidengeneesmiddelen door een eenvoudige en lichte registratieprocedure toe te staan. Het geldt niet voor alternatieve therapieën en verbiedt geen specifieke stoffen, beoefenaars, boeken of de planten als zodanig.

Commentaar Maurice Godefridi: Nu natuurlijk alert blijven hoe die richtlijnen in de praktijk zullen worden toegepast.



http://www.fyto.nl/Nieuws%20implementatie%20THMPD.pdf


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

CHAPTER 2a Specific provisions applicable to traditional herbal medicinal products 

Article 16a 
1. A simplified registration procedure (hereinafter “traditional- use registration”) is hereby established for herbal medicinal products which fulfil all of the following criteria: (a) they have indications exclusively appropriate to traditional herbal medicinal products which, by virtue of their composition and purpose, are intended and designed for use without the supervision 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 and posology; 
(c) they are an oral, external and/or inhalation preparation; 
(d) the period of traditional use as laid down in Article 16c(1)(c) has elapsed; 
(e) the data on the traditional use of the medicinal product are 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-standing use and experience. 

2. Notwithstanding Article 1(30), the presence in the herbal medicinal product of vitamins or minerals for the safety of which there is welldocumented evidence shall not prevent the product from being eligible for registration in accordance with paragraph 1, provided that the action of the vitamins or minerals is ancillary to that of the herbal active ingredients regarding the specified claimed indication(s). 
3. However, in cases where the competent authorities judge that a traditional herbal medicinal product fulfils the criteria for authorisation in accordance with Article 6 or registration pursuant to Article 14, the provisions of this chapter shall 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 the pharmaceutical tests referred to in the second indent of Article 8(3)(i); 
(iii) the summary of product characteristics, without the data specified in Article 11(4); 
(iv) in case of combinations, as referred to in Article 1(30) or Article 16a(2), the information referred to in Article 16a(1)(e) relating to the combination as such; if the individual active ingredients are not sufficiently known, the data shall 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 any such decision; 

(c) bibliographical or expert evidence to the effect that the medicinal product in question, or a corresponding product has been in medicinal use throughout a period of at least 30 years preceding the date of the application, including at least 15 years within the Community. At the request of the Member State where the application for traditional-use registration has been submitted, the Committee for Herbal Medicinal Products shall draw up an opinion on the adequacy of the evidence of the longstanding use of the product, or of the corresponding product. The Member State shall submit relevant documentation supporting the referral; 
(d) a bibliographic review of safety data together with an expert report, and where required by the competent authority, upon additional 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 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 posology 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 30 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. Where the product has been used in the Community for less than 15 years, but is otherwise eligible for simplified registration, the Member State where the application for traditional-use registration has been submitted shall refer the product to the Committee for Herbal Medicinal Products. The Member State shall submit relevant documentation supporting the referral. The Committee shall consider whether the other criteria for a simplified registration as referred to Committee considers it possible, it shall establish a Community herbal monograph as referred to in Article 16h(3) which shall be taken into account by the Member State when taking its final decision. 

Article 16d 
1. Without prejudice to Article 16h(1), Chapter 4 of Title III shall apply by analogy to registrations granted in accordance with Article 16a, provided that: 
(a) a Community herbal monograph has been established in accordance with Article 16h(3), or 
(b) the herbal medicinal product consists of herbal substances, preparations or combinations thereof contained in the list referred to in Article 16f. 

2. For other herbal medicinal products as referred to in Article 16a, each Member State shall, when evaluating an application for traditional-use registration, take due account of registrations granted by another Member State in accordance with this chapter. 

Article 16e 
1. Traditional-use registration shall be refused if the application does not comply with Articles 16a, 16b 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 indications do not comply with the conditions laid down in Article 16a; 
(c) the product could be harmful under normal conditions of use; 
(d) the data on traditional use are insufficient, especially if pharmacological effects or efficacy are not plausible on the basis of long-standing use and experience; 
(e) the pharmaceutical quality is not satisfactorily demonstrated. 

2. The competent authorities of the Member States shall notify the applicant, the Commission and any competent authority that requests it, of any decision they take to refuse traditional-use registration and the reasons for the refusal. 

Article 16f 
1. A list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products shall be established in accordance with the procedure referred to in Article 121(2). The list shall contain, with regard to each herbal substance, the indication, the specified strength and the posology, the route of administration and any other information necessary for the safe use of the herbal substance as a traditional medicinal product. 

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

3. If a herbal substance, preparation or a combination thereof 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), 6(1), 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 subparagraph, and 127 of this Directive as well as Commission Directive 91/356/EEC29 shall apply, by analogy, to traditional-use registration granted under this chapter. 

2. In addition to the requirements of Articles 54 to 65, any labelling and user package leaflet shall contain a statement to the effect that: 
(a) the product is a traditional herbal medicinal product for use in specified indication(s) exclusively based upon long-standing use; and 
(b) the user should consult a doctor or a qualified health care practitioner if the symptoms persist during the use of the medicinal product or if adverse effects not mentioned in the package leaflet occur. A Member State may require that the labelling and the user package leaflet shall also state the nature of the tradition in question. 

3. In addition to the requirements of 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(s) exclusively based upon longstanding use. 

Article 16h 

1. A Committee for Herbal Medicinal Products is hereby established. That Committee shall be part of the Agency and shall have the following competence: 
(a) as regards simplified registrations, to: 29 OJ L 193, 17.7.1991, p. 30. 
- perform the tasks arising from Article 16c(1) and (4), 
- perform the tasks arising from Article 16d, 
- prepare a draft list of herbal substances, preparations and combinations thereof, as referred to in Article 16f(1), and 
- establish Community monographs for traditional herbal medicinal products, as referred to in paragraph 3 of this Article; 

(b) as regards authorisations of herbal medicinal products, to establish Community herbal monographs for herbal medicinal products, as referred to in paragraph 3 of this Article; 
(c) as regards referrals to the Agency under Chapter 4 of Title III, in relation to herbal medicinal products as referred to in Article 16a, to perform the tasks set out in Article 32; 
(d) where other medicinal products containing herbal substances are referred to the Agency under Chapter 4 of Title III, to give an opinion on the herbal substance where appropriate. 

Finally, the Committee for Herbal Medicinal Products shall perform any other task conferred upon it by Community law. The appropriate coordination with the Committee for Human Medicinal Products shall be ensured by a procedure to be determined by the Executive Director of the Agency in 
accordance with Article 57(2) of Regulation (EEC) No 2309/93. 

2. Each Member State shall appoint, for a threeyear term which may be renewed, one member and one alternate to the Committee for Herbal Medicinal Products. The alternates shall represent and vote for the members in their absence. Members and alternates shall be chosen for their role and experience in the evaluation of herbal medicinal products and shall represent the competent national authorities. 
The said Committee may co-opt a maximum of five additional members chosen on the basis of their specific scientific competence. These members shall be appointed for a term of three years, which may be renewed, and shall not have alternates. 
With a view to the co-opting of such members, the said Committee shall identify the specific complementary scientific competence of the additional member(s). Co-opted members shall be chosen among experts nominated by Member States or the Agency. 
The members of the said Committee may be accompanied by experts in specific scientific or technical fields. 

3. The Committee for Herbal Medicinal Products shall establish Community herbal monographs for herbal medicinal products with regard to theapplication of Article 10(1)(a)(ii) as well as traditional herbal medicinal products. The said Committee shall fulfil further responsibilities conferred upon it by provisions of this chapter and other Community law. 
When Community herbal monographs within the meaning of this paragraph have been established, they shall be taken into account by the Member States when examining an application. Where no such Community herbal monograph has yet been established, other appropriate monographs, publications or data may be referred to. 
When new Community herbal monographs are established, the registration holder shall consider whether it is necessary to modify the registration dossier accordingly. The registration holder shall notify any such modification to the competent authority of the Member State concerned. The herbal monographs shall be published. 

4. The general provisions of Regulation (EEC)No 2309/93 relating to the Committee for Human Medicinal Products shall apply by analogy to the Committee for Herbal Medicinal Products. 

Article 16i 
Before 30 April 2007, the Commission shall submit a report to the European Parliament and to 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.



Aanpassing
Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use

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(1),
Having regard to the opinion of the European Economic and Social Committee(2),
Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),

Whereas:
(1) Directive 2001/83/EC(4) requires that applications for 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 tests as well as pharmacological and toxicological tests and clinical trials carried out on the product and thus proving its quality, safety and efficacy.
(2) Where the applicant can demonstrate by detailed references to published scientific literature that the constituent or the constituents of the medicinal product has or have a well-established medicinal use with recognised efficacy and an acceptable level of safety within the meaning of Directive 2001/83/EC, he/she 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 differing procedures and provisions. The differences that currently exist 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 an impact on the protection of public health since the necessary guarantees of quality, safety and efficacy are not always provided 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 used only where no marketing authorisation can be obtained pursuant to Directive 2001/83/EC, in particular because of a lack of sufficient scientific literature demonstrating a well-established medicinal use with recognised efficacy and an acceptable level of safety. It should likewise not apply to homeopathic medicinal products eligible for marketing authorisation or for registration under Directive 2001/83/EC.
(5) The long tradition of the medicinal product makes it possible to reduce the need for clinical trials, in so far as the efficacy of the medicinal product is plausible on the basis of long-standing 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 a long tradition does not exclude the possibility that there may be concerns with regard to the product's safety, and therefore 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. Products should comply with quality standards in relevant European Pharmacopoeia monographs or those in the pharmacopoeia of a Member State.
(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 simplified 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. Where there is limited evidence of use within the Community, it is necessary to assess carefully the validity and relevance of use outside the Community.
(8) With the objective of further facilitating the registration of certain traditional herbal medicinal products and of further enhancing harmonisation, there should be the possibility of establishing a Community list of herbal substances that fulfil certain criteria, such as having been in medicinal use for a sufficiently long time, and hence are considered not to be harmful under normal conditions of use.
(9) Having regard to the particularities of herbal medicinal products, a Committee for Herbal Medicinal Products should be established within the European Agency for the Evaluation of Medicinal Products (hereinafter "the Agency") set up by Council Regulation (EEC) No 2309/93(5). The Committee should carry out tasks concerning the simplified registration and authorisation of medicinal products as provided for in this Directive. Its tasks should relate in particular to establishing Community herbal monographs relevant for the registration as well as the authorisation of herbal medicinal products. It should be composed of experts in the field of herbal medicinal products.
(10) It is important to ensure full consistency between the new Committee and the Committee for Human Medicinal Products already existing within the Agency.
(11) In order to promote harmonisation, Member States should recognise registrations of traditional herbal medicinal products granted by another Member State based on Community herbal monographs or consisting of substances, preparations or combinations thereof contained in a list to be established. For other products, Member States should take due account of such registrations.
(12) This Directive allows non-medicinal herbal products, fulfilling the criteria of food legislation, to be regulated under food legislation in the Community.
(13) 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.
(14) It is therefore appropriate to amend Directive 2001/83/EC accordingly,

HAVE ADOPTED THIS DIRECTIVE:

Article 1
Directive 2001/83/EC is hereby amended as follows:

1. in Article 1 the following is added:
"29. Traditional herbal medicinal product: a herbal medicinal product that fulfils the conditions laid down in Article 16a(1);
30. Herbal medicinal product: any medicinal product, exclusively 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 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 or fermentation. These include comminuted or powdered herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates."

2. The following chapter is inserted in Title III:

"CHAPTER 2a
Specific provisions applicable to traditional herbal medicinal products

Article 16a
1. A simplified registration procedure (hereinafter 'traditional-use registration') is hereby established for herbal medicinal products which fulfil all of the following criteria:
(a) they have indications exclusively appropriate to traditional herbal medicinal products which, by virtue of their composition and purpose, are intended and designed for use without the supervision 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 and posology;
(c) they are an oral, external and/or inhalation preparation;
(d) the period of traditional use as laid down in Article 16c(1)(c) has elapsed;
(e) the data on the traditional use of the medicinal product are 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-standing use and experience.

2. Notwithstanding Article 1(30), the presence in the herbal medicinal product of vitamins or minerals for the safety of which there is well-documented evidence shall not prevent the product from being eligible for registration in accordance with paragraph 1, provided that the action of the vitamins or minerals is ancillary to that of the herbal active ingredients regarding the specified claimed indication(s).

3. However, in cases where the competent authorities judge that a traditional herbal medicinal product fulfils the criteria for authorisation in accordance with Article 6 or registration pursuant to Article 14, the provisions of this chapter shall 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 the pharmaceutical tests referred to in the second indent of Article 8(3)(i);
(iii) the summary of product characteristics, without the data specified in Article 11(4);
(iv) in case of combinations, as referred to in Article 1(30) or Article 16a(2), the information referred to in Article 16a(1)(e) relating to the combination as such; if the individual active ingredients are not sufficiently known, the data shall 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 any such decision;
(c) bibliographical or expert evidence to the effect that the medicinal product in question, or a corresponding product has been in medicinal use throughout a period of at least 30 years preceding the date of the application, including at least 15 years within the Community. At the request of the Member State where the application for traditional-use registration has been submitted, the Committee for Herbal Medicinal Products shall draw up an opinion on the adequacy of the evidence of the long-standing use of the product, or of the corresponding product. The Member State shall submit relevant documentation supporting the referral;
(d) a bibliographic review of safety data together with an expert report, and where required by the competent authority, upon additional 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 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 posology 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 30 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. Where the product has been used in the Community for less than 15 years, but is otherwise eligible for simplified registration, the Member State where the application for traditional-use registration has been submitted shall refer the product to the Committee for Herbal Medicinal Products. The Member State shall submit relevant documentation supporting the referral.

The Committee shall consider whether the other criteria for a simplified registration as referred to in Article 16a are fully complied with. If the Committee considers it possible, it shall establish a Community herbal monograph as referred to in Article 16h(3) which shall be taken into account by the Member State when taking its final decision.

Article 16d
1. Without prejudice to Article 16h(1), Chapter 4 of Title III shall apply by analogy to registrations granted in accordance with Article 16a, provided that:
(a) a Community herbal monograph has been established in accordance with Article 16h(3), or
(b) the herbal medicinal product consists of herbal substances, preparations or combinations thereof contained in the list referred to in Article 16f.
2. For other herbal medicinal products as referred to in Article 16a, each Member State shall, when evaluating an application for traditional-use registration, take due account of registrations granted by another Member State in accordance with this chapter.

Article 16e
1. Traditional-use registration shall be refused if the application does not comply with Articles 16a, 16b 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 indications do not comply with the conditions laid down in Article 16a;
(c) the product could be harmful under normal conditions of use;
(d) the data on traditional use are insufficient, especially if pharmacological effects or efficacy are not plausible on the basis of long-standing use and experience;
(e) the pharmaceutical quality is not satisfactorily demonstrated.

2. The competent authorities of the Member States shall notify the applicant, the Commission and any competent authority that requests it, of any decision they take to refuse traditional-use registration and the reasons for the refusal.

Article 16f
1. A list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products shall be established in accordance with the procedure referred to in Article 121(2). The list shall contain, with regard to each herbal substance, the indication, the specified strength and the posology, the route of administration and any other information necessary for the safe use of the herbal substance as a traditional medicinal product.

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

3. If a herbal substance, preparation or a combination thereof 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), 6(1), 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 subparagraph, and 127 of this Directive as well as Commission Directive 91/356/EEC(6) shall apply, by analogy, to traditional-use registration granted under this chapter.

2. In addition to the requirements of Articles 54 to 65, any labelling and user package leaflet shall contain a statement to the effect that:
(a) the product is a traditional herbal medicinal product for use in specified indication(s) exclusively based upon long-standing use; and
(b) the user should consult a doctor or a qualified health care practitioner if the symptoms persist during the use of the medicinal product or if adverse effects not mentioned in the package leaflet occur.
A Member State may require that the labelling and the user package leaflet shall also state the nature of the tradition in question.

3. In addition to the requirements of 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(s) exclusively based upon long-standing use.

Article 16h
1. A Committee for Herbal Medicinal Products is hereby established. That Committee shall be part of the Agency and shall have the following competence:
(a) as regards simplified registrations, to:
- perform the tasks arising from Article 16c(1) and (4),
- perform the tasks arising from Article 16d,
- prepare a draft list of herbal substances, preparations and combinations thereof, as referred to in Article 16f(1), and
- establish Community monographs for traditional herbal medicinal products, as referred to in paragraph 3 of this Article;
(b) as regards authorisations of herbal medicinal products, to establish Community herbal monographs for herbal medicinal products, as referred to in paragraph 3 of this Article;
(c) as regards referrals to the Agency under Chapter 4 of Title III, in relation to herbal medicinal products as referred to in Article 16a, to perform the tasks set out in Article 32;
(d) where other medicinal products containing herbal substances are referred to the Agency under Chapter 4 of Title III, to give an opinion on the herbal substance where appropriate.
Finally, the Committee for Herbal Medicinal Products shall perform any other task conferred upon it by Community law.
The appropriate coordination with the Committee for Human Medicinal Products shall be ensured by a procedure to be determined by the Executive Director of the Agency in accordance with Article 57(2) of Regulation (EEC) No 2309/93.

2. Each Member State shall appoint, for a three-year term which may be renewed, one member and one alternate to the Committee for Herbal Medicinal Products.
The alternates shall represent and vote for the members in their absence. Members and alternates shall be chosen for their role and experience in the evaluation of herbal medicinal products and shall represent the competent national authorities.
The said Committee may coopt a maximum of five additional members chosen on the basis of their specific scientific competence. These members shall be appointed for a term of three years, which may be renewed, and shall not have alternates.
With a view to the coopting of such members, the said Committee shall identify the specific complementary scientific competence of the additional member(s). Coopted members shall be chosen among experts nominated by Member States or the Agency.
The members of the said Committee may be accompanied by experts in specific scientific or technical fields.

3. The Committee for Herbal Medicinal Products shall establish Community herbal monographs for herbal medicinal products with regard to the application of Article 10(1)(a)(ii) as well as traditional herbal medicinal products. The said Committee shall fulfil further responsibilities conferred upon it by provisions of this chapter and other Community law.
When Community herbal monographs within the meaning of this paragraph have been established, they shall be taken into account by the Member States when examining an application. Where no such Community herbal monograph has yet been established, other appropriate monographs, publications or data may be referred to.
When new Community herbal monographs are established, the registration holder shall consider whether it is necessary to modify the registration dossier accordingly. The registration holder shall notify any such modification to the competent authority of the Member State concerned.
The herbal monographs shall be published.

4. The general provisions of Regulation (EEC) No 2309/93 relating to the Committee for Human Medicinal Products shall apply by analogy to the Committee for Herbal Medicinal Products.

Article 16i
Before 30 April 2007, the Commission shall submit a report to the European Parliament and to 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 necessary measures to comply with this Directive by 30 October 2005. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.

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

Article 4
This Directive is addressed to the Member States.

Done at Strasbourg, 31 March 2004.

For the European Parliament The President P. Cox
For the Council
The President
D. Roche

(1) OJ C 126 E, 28.5.2002, p. 263.
(2) OJ C 61, 14.3.2003, p. 9.
(3) Opinion of the European Parliament of 21 November 2002 (OJ C 25 E, 29.1.2004, p. 222), Council Common Position of 4 November 2003 (OJ C 305 E, 16.12.2003, p. 52), Position of the European Parliament of 17 December 2003 (not yet published in the Official Journal) and Council Decision of 11 March 2004.
(4) OJ L 311, 28.11.2001, p. 67; Directive as last amended by Commission Directive 2003/63/EC (OJ L 159, 27.6.2003, p. 46).
(5) OJ L 214, 24.8.1993, p. 1; Regulation as last amended by Regulation (EC) No 1647/2003 (OJ L 245, 29.9.2003, p. 19).
(6) OJ L 193, 17.7.1991, p. 30.


Commentaar en vragen in verband met 
COMMUNICATION FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLAMENT 
concerning theReport 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
Document on the basis of Article 16i of Directive 2001/83/EC 

1. Introduction 

1.1. Background to the report 
In order to overcome the difficulties encountered by Member States in applying the pharmaceutical legislation to herbal medicinal products in a uniform manner, specific provisions for traditional herbal medicinal products have been introduced in the Community code relating to medicinal products for human use (Directive 2001/83/EC). 

Under Articles 16a to 16i of Directive 2001/83/EC, introduced by Directive 2004/24/EC, a specific registration procedure is to be used by the Member States for herbal medicinal products that meet the criteria for a traditional herbal medicinal product. Herbal medicinal products are defined as any medicinal product exclusively containing as active ingredients one or more herbal substances, one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations. 

Article 16i requires the Commission to submit a report to the European Parliament and to the Council concerning the application of the simplified registration procedure and including an assessment of the possible extension of traditional-use registration to other categories of medicinal products. This document was prepared in consultation with the European Medicines Agency and the Committee on Herbal Medicinal Products (HMPC) and was submitted for consultation to the Member States and interested parties. As a major source of information, the Commission welcomed the HMPC report of 31 October 2006 (Doc.Ref.EMEA/HMPC/187219/2006) presenting the views of the EMEA and the HMPC. 

1.2. Current situation 
The simplified registration procedure is intended for herbal medicinal products that have a long tradition, but do not fulfil the requirements for a marketing authorisation, in particular the requirement for applicants to demonstrate by detailed references to published scientific literature that the constituent or constituents of the medicinal products has or have a well-established medicinal use with recognised efficacy and an acceptable level of safety (‘well established use’). 

The simplified procedure allows the registration of herbal medicinal products without requiring particulars and documents on tests and trials of safety and efficacy, provided that there is sufficient evidence of the medicinal use of the product throughout a period of at least 30 years, including at least 15 years in the Community. 
The application for a simplified registration procedure should thus be accompanied by bibliographical or expert evidence to the effect that the medicinal product in question or a corresponding product has been in medicinal use the relevant period. With regard to the manufacturing of these products and their quality, applications have to fulfil the same requirements as applications for a marketing authorisation. However, a long tradition of use may remove the need for clinical data, if the efficacy of the medicinal product is plausible on the basis of its long-standing use and experience as testified by bibliographic or expert evidence. 

Applicants must substantiate the safety of the medicinal product by means of a bibliographic review of safety data together with an expert report, complemented by any necessary data that the Member State’s competent authority may request. 

Claimed indications must be exclusively appropriate to traditional herbal medicinal products that, by virtue of their composition and purpose, are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes, for prescription or for the monitoring of treatment. 
In view of the particularities of herbal medicinal products, a Committee for Herbal Medicinal Products (HMPC) has been established at the EMEA. 
With a view to further facilitating the registration of certain traditional herbal medicinal products in the EU, a list of herbal substances, preparations and combinations of these for use in traditional herbal medicinal products will be established by the Commission following a proposal by the HMPC. In order to promote harmonisation, Member States will recognise the registration of traditional herbal medicinal products based on Community monographs. 

For the application of both the traditional-use and the well-established use provisions, Community herbal monographs will also be established by the HMPC to serve as a basis for simplified registration or bibliographical marketing authorisation applications. 

When this new simplified registration procedure was introduced, it seemed appropriate to limit its scope in a first step to traditional herbal medicinal products. It also seemed appropriate to evaluate in due course the application of this new procedure, together with an assessment of the possible extension of the scope of traditional-use registration to other categories of medicinal products. 

2. Experience acquired with the simplified registration procedure 

2.1. Transposition of Directive 2001/83/EC 
Directive 2004/24/EC had to be transposed by 30 October 2005. By 10 March 2008, it had been fully transposed in 25 Member States. Two Member States have still not transposed Directive 2004/24/EC and infringement procedures have been initiated by the European Commission. 

2.2. Applications in Member States 
On 30 June 2007, 110 applications had been introduced in 17 Member States. The number of applications is very unevenly distributed, with more than 20 applications having been made in some Member States. In most Member States, however, no or very few applications have so far been introduced. A total of 23 applications have been finalised. 

2.3. Referrals to the HMPC 
Directive 2004/24/EC amending Directive 2001/83/EC introduced several provisions allowing referral to the HMPC for an opinion on certain matters relating to herbal medicinal products. Up to March 2008, one referral had been made to the HMPC under Article 16c(1)(c). 

2.4. Herbal Medicinal Products Committee (HMPC) 
The HMPC was established in 2004 and has held regular meetings. It has also established temporary working parties and developed a number of guidance documents. 
22 monographs have been adopted and published and another 17 are in public consultation. According to the HMPC, the full application of the Directive would require the publication of approximately 200-300 monographs. 
Two draft entries for the list have been proposed by the HMPC to the Commission so far. 

In its contribution to the European Commission for the preparation of this report, the HMPC stated that drafting proposals for entries in the Community list or Community monographs required significant resources. Moreover, the monographs adopted by the HMPC need to be periodically updated. The HMPC has stated that it does not have sufficient resources to carry out these tasks. 

2.5. Genotoxicity data issue 
Under Article 16c(1)(d) of Directive 2001/83/EC, an application for simplified registration must be accompanied by a bibliographic review of safety data together with an expert report. In addition, the competent authority may ask for any further data necessary to assess the safety of the medicinal products. 
The introduction of the simplified registration procedure was based on the assumption that safety and efficacy could be adequately substantiated by long-standing use without requiring additional testing and systematic documentation on all points of Annex I of Directive 2001/83/EC regarding safety. If an application relates to a herbal substance, preparation or combination contained in the list, the safety data do not need to be provided and the competent authority cannot ask for additional data. 

In its guideline on non-clinical documentation for herbal medicinal products in applications for a marketing authorisation (bibliographical and mixed applications) and in applications for simplified registrations, the HMPC is of the view that the genotoxic potential of herbal preparations should always be assessed. The guideline further states that genotoxic data are available for many active substances, but their quality is often inadequate for a safety assessment. When such an assessment cannot be made, further genotoxicity testing is thus required. 

Similarly, in its report, the HMPC identified major issues concerning the availability and quality of genotoxicity data for herbal substances when developing the first series of draft list entries. The HMPC is of the view that if relevant questions regarding genotoxicity data remain unanswered, even after a comprehensive literature search has been performed, a positive opinion on a Community list entry cannot be given. In order to obtain these data, further genotoxicity testing would have to be conducted. 

In order to ensure the successful application of the Directive, the issues relating to genotoxicity demand careful scientific and legal consideration. As stated in the HMPC report, the systematic request for genotoxicity data has made the proposal of list entries difficult since these data are generally not available. It has probably also contributed to the small number of applications received so far. Consequently, a request for genotoxicity data to assess traditional herbal medicinal products should be made on a case-by-case basis when there is a specific concern for safety, as required by the relevant provisions in the legislation. This ensures the protection of public health while allowing the registration of traditional herbal medicinal products. A more restrictive approach would create the risk that the products concerned will end up being marketed under another classification (and not as medicinal products), without the necessary quality, safety and efficacy controls applicable under pharmaceutical legislation. 

3. Extending traditional-use registration to other categories of medicinal products 

3.1. Current situation 
Directive 2004/24/EC was intended to address the specific situation of traditional herbal medicinal products. In order to gain experience, the scope of the Directive was deliberately limited to these products. However, other products may face a similar situation and have a long tradition as medicinal products but do not fulfil the requirements for a full marketing authorisation or a well-established use authorisation. This applies to several traditional forms of medicine, which include, for example, the following: 

Anthroposophic medicine has been established in Europe since 1920. It is practised in Germany, the Netherlands, the UK, Italy, Spain, Poland and France, among others. It follows a global therapeutic approach that embraces the individual as a whole taking into consideration both the personality and the body. Anthroposophic products are designed to stimulate the patient’s powers of self-healing and use mineral, vegetable, metal and animal-based raw materials. They can be used in every form of dosage and administration, including the external, internal and parenteral routes.1 
Traditional medicines from other parts of the world include Ayurveda (traditional Indian medicine) and Chinese traditional medicine. These systems of medicine have existed for centuries in other parts of the world and have their own specific remedies. Some of these remedies could qualify as traditional herbal medicinal products, but other traditional medicinal products do not qualify for the simplified registration procedure. 

Ayurveda literally means ‘science of life’ in Sanskrit. It is not only a medical system but a way of life that aims for the holistic management of health and diseases. Ayurvedic medicinal products include ingredients of plant, animal and mineral origin. Most contain only herbal ingredients. The substances included in the products are described in the monographs of the Ayurveda Pharmacopoeia. 2 
A variety of dosage forms and presentations of Ayurvedic formulations are used, ranging from food-like presentations to pharmaceutical forms. There is no significant use of parenteral formulations, with non-invasive techniques predominating. 

Within the Ayurvedic tradition, no particular distinction is made as regards the legal classification (prescription or non-prescription) of products. They are typically prescribed by practitioners following examination and diagnosis of the patient and their administration is followed up throughout use, normally in healthcare settings. 

Traditional Chinese medicine theory asserts that processes of the human body are interrelated and in constant interaction with the environment. It is largely based on the philosophical concept that the human body is a small universe with a set of complete and sophisticated interconnected systems. Traditional Chinese medicinal products, which can also take the form of injections, are often combined products of herbal origin but also may contain animal, mineral and metal ingredients.3 

The major reasons why the above products may not be able to obtain a marketing authorisation or a simplified registration under the current Community legal framework are as follows: 

Composition of the product 
Directive 2001/83/EC requires traditional herbal medicinal products to be composed exclusively of herbal substances or preparations, with the exception of vitamins and minerals having an ancillary action. Some traditional products are mostly but not exclusively composed of herbal substances. They may also include mineral components, animal products, metal products or herbal constituents. 

Route of administration 
Traditional herbal medicinal products must be administrated orally, externally or via inhalation. According to the public statement of the HMPC on the interpretation of the term ‘external use’ for use in the field of traditional herbal medicinal products, the term ‘external’ means mainly application on the skin, but includes topical, oral, nasal, rectal, vaginal, ocular or auricular use. The route of administration for certain medicinal products in other traditions can also be by injection. 

Unsupervised use and indications 
According to Directive 2004/24/EC, traditional herbal medicinal products must be intended and designed for use without the supervision of a medical practitioner. This would cover minor disorders or symptoms that are benign. However, some traditional medicinal products do not fulfil these criteria and are not suitable for administration without the supervision of a qualified practitioner. Traditional medicinal products with therapeutic indications that involve diseases such as cancer, psychiatric diseases, infectious diseases such as hepatitis or influenza, cardiovascular diseases or metabolic diseases such as diabetes are not suitable for administration without the supervision of a medical practitioner. In some traditions, moreover, the therapy is integrated within a global approach as part of a general diagnosis by a duly qualified practitioner. However, this does not necessarily mean that certain of the products used could not be considered, under Community pharmaceutical legislation, as non-prescription products. 

Proof of traditional use in the Community 
The traditional use of traditional herbal medicinal products is demonstrated by bibliographic and expert evidence that the medicinal product in question or a corresponding product has been in medicinal use throughout a period of at least 30 years, including at least 15 years within the Community. The rationale behind this requirement is the difficulty of verifying whether information on use outside the Community provides a reliable basis to assess the efficacy and, especially, safety of a product. However, it is difficult for traditional medicinal products from other parts of the world to meet the requirement of at least 15 years use within the Community. In such cases, the product must be referred to the HMPC for an opinion to assess whether all the other conditions for simplified registration as set out in Article 16a of Directive 2001/83/EC are met. This situation can prevent access to the European market for some traditional herbal medicinal products from third countries. 

3.2. Extending the scope of the simplified registration procedure 
The rationale behind the current simplified registration procedure is to enable products that have been in long-standing traditional medicinal use to be registered under a simplified procedure because their safety and efficacy can be deduced from their long-standing use under the specified conditions of use. The vast majority of medicinal products with a sufficiently long and coherent tradition are based on herbal substances. It therefore seemed appropriate to limit the scope of the simplified registration in a first step to traditional herbal medicinal products. There are several conditions to be met for a product to be eligible for registration. Taken together, these conditions guarantee that only traditional herbal medicinal products have access to the simplified registration procedure, where it is appropriate and justified to depart from the strict requirements of Chapter I of Title III of Directive 2001/83/EC. 

The purpose of this report is to evaluate whether there are other medicinal products that could meet the conditions for simplified registration. In view of the different aspects noted above, the following conclusions can be drawn regarding the extension of scope: 

Composition of the product 
Registration of traditional use could be extended to encompass substances that are not herbal substances or herbal preparations but which also have a long-standing tradition with well-documented safety and plausible evidence of efficacy or pharmacological effects. These substances may be used on their own or in association with herbal products. They may include substances of animal, mineral or metallic origin and micro-organisms. These substances should be assessed under the same conditions and procedures as herbal medicinal products and their long-standing use would be documented under the same conditions as for traditional herbal products. As already provided for in Directive 2004/24/EC, in order to substantiate quality, the applicant would have to provide the same particulars and documents as for an application under Chapter I of Title III of Directive 2001/83/EC, including the results of physico-chemical, biological or microbiological tests. In particular, for products of animal origin, the relevant provisions of Module 3 of Directive 2003/63/EC will apply, including specific measures for the prevention of the transmission of animal spongiform encephalopathy. For starting material of animal origin, the history and origin of the starting material must be described and documented. 

As already provided for in Directive 2004/24/EC, where the safety of the product is concerned, the applicant would have to prove a well-documented traditional use under the existing rules with relevant proof of the product’s safety. In cases of doubt as to the safety of the traditional use, additional data may be required by the competent authority before the simplified registration can be granted. 

As already provided for in Directive 2004/24/EC, where efficacy is concerned, the applicant would have to document the pharmacological effects or the plausibility of efficacy on the basis of long-term use and experience. 

Route of administration 
Traditional-use registration is limited to certain routes of administration because these are the safest ways of administration. In addition, since the simplified registration procedure is intended for products that, by virtue of their purpose, are intended to be used without the supervision of a medical practitioner, it is not appropriate to extend the procedure to include other routes that would generally require the supervision of a practitioner. Injection products should therefore continue to follow the normal marketing authorisation procedure. 

Unsupervised use and indications 
Sice simplified registration does not require clinical trials of safety and efficacy, as a lighter procedure compared with the marketing authorisation procedure, it appears appropriate to limit the scope of simplified registration to products aimed at minor diseases that can be treated without the intervention of a practitioner. 

Proof of long-standing use in a third country 
In the simplified registration procedure, applicants need to prove that the medicinal product in question or a corresponding product has been in medicinal use throughout a period of at least 30 years preceding the date of application, including at least 15 years within the Community. The requirement for at least 15 years traditional use in the Community was introduced as it was considered more difficult to gather information on the traditional use of a product from other parts of the world, especially data on safety, since pharmacovigilance systems vary widely across the world. However, use in the Community may be accepted for this requirement if evidence can be supplied of the same use for which registration is sought even if this use was without registration or authorisation as a medicinal product. 

More experience with the requirement for at least 15 years use in the Community has to be gathered with a view to assessing its necessity. Pending this assessment the requirement should be maintained. 

Procedure 
The current procedure for assessment of traditional medicinal products would remain unchanged. This means that the assessment would be performed by the national competent authorities, which would have to evaluate whether all the conditions for simplified registration are met, including documented safe use. As already provided for in Article 16c(1)(c) of Directive 2001/83/EC, referral to the HMPC for an opinion on the adequacy of the long-standing use would continue to be an option. Extending the scope of the simplified registration procedure should thus not lead to an unduly high increase in the workload of the HMPC after an initial phase. 

3.3. Results of the public consultation 
A draft of this report was published for consultation on the website of DG Enterprise and Industry’s Pharmaceuticals Unit on 30 May 2007. Comments on the document were invited by 10 August 2007. During the consultation, DG ENTR received 53 contributions. A summary of the responses was published on the pharmaceuticals website4. All the responses were carefully analysed and taken into consideration whenever possible. 

Most of the comments supported extending the scope of Directive 2004/24/EC based on the criterion of composition as proposed in the draft report. However, certain respondents reported obstacles to the registration of products through the simplified registration procedure, linked to the other criteria for registration or to implementation issues. The specificity of certain medical traditions as a whole was also raised as an issue in the consultation. 

4. Summary and Conclusion 

Directive 2004/24/EC was intended to address the specific situation of medicinal products that, despite their long tradition of use, do not fulfil the requirements for a marketing authorisation as set out in the Community pharmaceutical legislation. By introducing a simplified registration procedure with specific requirements, the Directive aimed to allow these products to be marketed under harmonised conditions and to ensure the protection of public health by making such products subject to the necessary guarantees of quality, safety and efficacy. During the public consultation on the draft of this report, numerous supportive views were expressed on the setting of harmonised safety standards for traditional products. 

During the public consultation, some stakeholders referred to the experience with the application of the requirements of the simplified registration procedure. In particular, the issue of genotoxicity data needs careful consideration from a scientific and legal point of view. The requirement for genotoxicity data should be considered on a case by case basis in the framework of the simplified registration, because wrong interpretation of the legal requirements could possibly lead to the marketing of some products under another qualification that would not necessarily offer the same guarantees of quality, safety and efficacy. Such a result would be contrary to the public health and harmonisation objectives of Directive 2001/83/EC and Directive 2004/24/EC. In order to overcome this difficulty, a case-by-case decision, where specific concerns about safety exist, appears to be a proportionate and balanced approach and in line with the objectives of the Directive. 

As regards the possible extension of the scope of the Directive, any such extension should be in line with the objectives of Directive 2004/24/EC, i.e. to have harmonised rules for the placing on the market of certain medicinal products with a long tradition of use but which do not generally satisfy the requirements for marketing authorisation, while ensuring the protection of public health by introducing specific requirements for proof of quality, safety and efficacy. 

In this regard, the European Commission is prepared to consider extending the simplified registration procedure to products other than herbal substances with a long tradition of safe use. This proposal received general support during the public consultation on the draft of this report. On the other hand, the key requirements of the simplified registration procedure, based on public health considerations, such as the limitation to products with 15 years use in the Community, to certain routes of administration and to products that do not need the supervision of a medical practitioner, should be maintained. For certain requirements, more experience is needed before any change to the system can be proposed. 

The proposed extension would enable certain medicinal products from specific European or non-European medicine systems (such as — in alphabetical order — anthroposophic, Ayurvedic, Chinese, Kampo Korean, Mongolian, Thai, Tibetan Unani, or Vietnamese medicine), as well as traditional products with a long-standing tradition in the European Union (such as honey, royal jelly, propolis, fish oils, minerals, micro-organisms and other substances) to be eligible for the simplified registration procedure with a view to placing them on the market as traditional medicinal products. 

Many of these products are present in the Community market, and their inclusion under the simplified registration procedure will introduce harmonisation in a sector where differences currently exist between Member States as regards classification and placing on the market and will increase the protection of public health since the quality, safety and efficacy of the products concerned will be assessed during the simplified registration procedure. 

On the other hand, it should be emphasised that Community legislation on medicinal products, in particular Directive 2001/83/EC laying down the procedures for placing products on the market, follows a product-specific approach and does not attempt to provide a framework for the regulation of traditions of medical practice. 

During the public consultation, proponents of three traditional medical systems using products with a long-standing tradition expressed support for the global regulation of their traditions within the EU: anthroposophic, Ayurvedic and traditional Chinese medicine. It was suggested that proof of the plausibility of efficacy should not be by medicinal product, but by therapeutic approach. 

Medical traditions such as those mentioned above are based on a holistic approach, and the set of requirements for the simplified registration procedure under Directive 2004/24/EC is not appropriate for a global regulation of such medical practices. The regulation of such traditions would demand a different approach from that introduced by Directive 2004/24/EC. Therefore, the Commission does not envisage extending the scope of the simplified registration procedure to cover traditional medical systems as such. Nevertheless, independently of this report, the suitability of a separate legal framework for products of certain traditions should be assessed.

1Anthroposophic Medicines, their origin, production and application, Medical section of the School of Spiritual Science, 4143 Dornach, Switzerland. Anthroposophic Pharmaceutical Codex, APC, The International Association of Anthroposophic Pharmacists, Dornach, Switzerland, 11.2007, available at http://www.iaap.org.uk/downloads/codex.pdf, 4.12.07.

2Mission Report, Fact-Finding Mission of the European Commission to India 15-18 January 2007.

3International traditional Chinese medicine programme for cooperation in science and technology, Ministry of Science and Technology, People’s Republic of China and various contacts with the Chinese delegation and Chinese medicine practitioners.

4http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/new.htm.


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