What changed between the plenary report and the adopted text

Added:2. Notwithstanding paragraph 1, Member States may require the use of certain types of labelling in order to show:

Added:(a) the price of the homeopathic medicinal product; [Am. 261]

Added:(b) the conditions for refunds by social security bodies.

Added:Article 131 Advertising of homeopathic medicinal products [Am. 262]

Added:1. Chapter XIII shall apply to homeopathic medicinal products. [Am. 263]

Added:2. By derogation from paragraph 1, Article 176(1) shall not apply to medicinalhomeopathic products referred to in Article 126(1). [Am. 264]

Added:However, only the information specified in Article 130(1) may be used in the advertising of such homeopathic medicinal products. [Am. 265]

Added:Article 132 Exchange of information on homeopathic medicinal products [Am. 266]

Added:Member States shall communicate to each other all the information necessary to guarantee the quality and safety of homeopathic medicinal products manufactured and marketed within the Union, and in particular the information referred to in Articles 202 and 203. [Am. 267]

Added:Article 133 Other requirements for homeopathic medicinal products [Am. 268]

Added:1. Homeopathic medicinal products other than those referred to in Article 126(1) shall be granted a marketing authorisation in accordance with Articles 6 and 9 to 14 and labelled in accordance with Chapter VI. [Am. 269]

Added:2. A Member State may introduce or retain in its territory specific rules for the non-clinical tests and clinical studies of homeopathic medicinal products other than those referred to in Article 126(1), in accordance with the principles and characteristics of homeopathy as practised in that Member State. [Am. 270]

Added:In this case, the Member State concerned shall notify the Commission of the specific rules in force.

Added:3. Chapter IX shall apply to homeopathic medicinal products, with the exception of those referred to in Article 126(1). Chapter XI, Chapter XII, Section 1, and Chapter XIV shall apply to homeopathic medicinal products. [Am. 271]

Added:Section 2 Specific provisions applicable to traditional herbal medicinal products

Added:Article 134 Simplified registration procedure for traditional herbal medicinal products

Added:1. Herbal medicinal products that satisfy all of the following conditions may be subject to a simplified registration procedure (‘traditional-use registration’):

Added:(a) they have therapeutic indications 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 or for prescription or monitoring of treatment;

Added:(b) they are exclusively for administration in accordance with a specified strength and posology;

Added:(c) they are an oral, external or inhalation preparation;

Added:(d) the period of traditional use as laid down in Article 136(1), point (c), has elapsed;

Added:(e) the data on the traditional use of the herbal medicinal product referred to in Article 136(1), point (c), are sufficient.

Added:The data on the use of a medicinal product referred to in the first subparagraph, point (e), shall be considered sufficient where the herbal medicinal product proves not to be harmful in the specified conditions of use and the pharmacological effects or efficacy of the herbal medicinal product are plausible on the basis of long-standing use and experience.

Added:2. Notwithstanding Article 4(1), point (64), 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 herbal medicinal 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 substances regarding the specified claimed therapeutic indication(s).

Added:3. However, in cases where the competent authorities judge that a herbal medicinal product that fulfils the conditions laid down in paragraph 1 (‘traditional herbal medicinal product’) fulfils the criteria for a national marketing authorisation in accordance with Article 5 or for a simplified registration in accordance with Article 126, the provisions of this Section shall not apply.

Added:Article 135 Submission of dossier for traditional herbal medicinal product

Added:1. The applicant and the traditional-use registration holder shall be established in the Union.

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

Added:Article 136 Application requirements for traditional-use registration

Added:1. An application for traditional-use registration shall be accompanied by:

Added:(a) the particulars and documentation:

Added:(i) referred to in points (1), (2), (3), (5) to (9), (16) and (17) of Annex I;

Added:(ii) the results of the pharmaceutical tests referred to in Annex I;

Added:(iii) the summary of product characteristics, without the clinical particulars as specified in Annex V;

Added:(iv) in case of combinations, as referred to in Article 4(1), point (64), or in Article 134(2), the information referred to in Article 134(1), first subparagraph, point (e), relating to the combination as such; if the individual active substances are not sufficiently known, the data shall also relate to the individual active substances;

Added:(b) any national marketing authorisation or registration obtained by the applicant in another Member State, or in a third country, to place the herbal medicinal product on the market, and details of any decision to refuse to grant a national marketing authorisation or registration, whether in the Union or a third country, and the reasons for any such decision;

Added:(c) bibliographical or expert evidence to the effect that the herbal medicinal product in question, or a corresponding medicinal 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 Union;

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

Added:For the purposes of the first subparagraph, point (c), at the request of the Member State where the application for traditional-use registration has been submitted, the herbal medicinal products working group shall draw up an opinion on the adequacy of the evidence of the long-standing use referred to in the first subparagraph, point (c), of the herbal medicinal product, or of the corresponding herbal medicinal product. The Member State shall submit relevant documentation supporting the referral.

Added:For the purposes of the first subparagraph, point (d), if the individual active substances are not sufficiently known, the data referred to in the first subparagraph, point (a)(iv), shall also relate to the individual active substances.

Added:Annex II shall apply by analogy to the particulars and documentations specified in the first subparagraph, point (a).

Added:2. The requirement to show medicinal use throughout the period of at least 30 years, set out in paragraph 1, first subparagraph, point (c), is satisfied even where the marketing of the herbal medicinal product has not been based on a specific marketing authorisation. It is likewise satisfied where the number or quantity of ingredients of the herbal medicinal product has been reduced during that period.

Added:3. Where the herbal medicinal product has been used in the Union for less than 15 years but is otherwise eligible for a traditional-use registration in accordance with paragraph 1, the competent authority of the Member State where the application for traditional-use registration has been submitted shall refer the application for the traditional herbal medicinal product to the herbal medicinal products working group and submit relevant documentation supporting this referral.

Added:The herbal medicinal products working group shall consider whether the criteria other than the period of transitional use for a traditional-use registration as referred to in Article 134 are complied with. If the herbal medicinal products working group considers it possible, it shall establish a Union herbal monograph as referred to in Article 141(3) which shall be taken into account by the competent authority of Member State when taking its final decision on the application for the traditional use registration.

Added:Article 137 Application of mutual recognition to traditional herbal medicinal products

Added:1. Chapter III, Sections 3 to 5, shall apply by analogy to traditional-use registrations granted in accordance with Article 134, provided that:

Added:(a) a Union herbal monograph has been established in accordance with Article 141(3); or

Added:(b) the traditional herbal medicinal product consists of herbal substances, herbal preparations or combinations thereof contained in the list referred to in Article 139.

Added:2. For traditional herbal medicinal products not covered by paragraph 1, the competent authority of each Member State shall, when evaluating an application for traditional-use registration, take due account of registrations granted by the competent authority of another Member State in accordance with this Section.

Added:Article 138 Refusal of registration of traditional herbal medicinal products

Added:1. Traditional-use registration shall be refused if the application does not comply with Articles 134, 135 or 136 or if at least one of the following conditions is fulfilled:

Added:(a) the qualitative or quantitative composition is not as declared;

Added:(b) the therapeutic indications do not comply with the conditions laid down in Article 134;

Added:(c) the traditional herbal medicinal product could be harmful under normal conditions of use;

Added:(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;

Added:(e) the pharmaceutical quality is not satisfactorily demonstrated.

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

Added:Article 139 List of herbal substances, herbal preparations and combinations thereof

Added:1. The Commission shall adopt implementing acts to establish a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products, taking into account the draft list prepared by the herbal medicinal products working group. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2). The list shall contain, with regard to each herbal substance, the therapeutic 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 herbal medicinal product.

Added: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 136(1), points (b), (c) and (d), shall not be required and Article 138(1), points (c) and (d), shall not apply.