Changes from report parliamentary committee draft to plenary report

AddedChapter X – title: Homeopathic products and traditional herbal medicinal products

AddedArticle 125 – title: Registration or authorisation of homeopathic products

AddedArticle 125 – paragraph 1: 1. Member States shall ensure that homeopathic products manufactured and placed on the market in the Union are registered in accordance with Articles 126 and 127 or authorised in accordance with Article 133(1), except where such homeopathic products are covered by a registration or authorisation granted in accordance with national legislation on or before 31 December 1993. In case of registrations, Chapter III, Sections 3 and 4, and Article 38, paragraphs 1, 2 and 3 shall apply.

AddedArticle 125 – paragraph 2: 2. Member States shall establish a simplified registration procedure referred to in Article 126 for the homeopathic products.

AddedArticle 126 – title: Simplified registration procedure for homeopathic products

AddedArticle 126 – paragraph 1 – subparagraph 1 – introductory part: Homeopathic products that satisfy all of the following conditions may be subject to a simplified registration procedure:

AddedArticle 126 – paragraph 1 – subparagraph 1 – point b: (b) no specific therapeutic indication appears on the labelling of the homeopathic product or in any information relating thereto;

AddedArticle 126 – paragraph 1 – subparagraph 1 – point c: (c) there is a sufficient degree of dilution to guarantee the safety of the homeopathic product

AddedArticle 126 – paragraph 1 – subparagraph 2: For the purposes of point (c), the homeopathic product may not contain either more than one part per 10000 of the mother tincture or more than 1/100th of the smallest dose used in allopathy with regard to active substances whose presence in an allopathic homeopathic product results in the obligation to submit a doctor’s prescription.

AddedArticle 126 – paragraph 1 – subparagraph 4: At the time of registration, Member States shall determine the prescription status for the dispensing of the homeopathic product.

AddedArticle 126 – paragraph 2: 2. The criteria and rules of procedure provided for in Article 1(10), point (c), Article 30, Chapter III, Section 6, Articles 191, 195 and 204 shall apply by analogy to the simplified registration procedure for homeopathic products, with the exception of the proof of therapeutic efficacy.

AddedArticle 127 – paragraph 1 – introductory part: An application a simplified registration may cover a series of homeopathic products derived from the same homeopathic stock or stocks. The following shall be included with the application in order to demonstrate, in particular, the pharmaceutical quality and the batch-to-batch homogeneity of the homeopathic products concerned:

AddedArticle 127 – paragraph 1 – point d: (d) the manufacturing authorisation for the homeopathic product concerned;

AddedArticle 127 – paragraph 1 – point e: (e) the copies of any registrations or authorisations obtained for the same homeopathic product in other Member States;

AddedArticle 127 – paragraph 1 – point f: (f) one or more mock-ups of the outer packaging and the immediate packaging of the homeopathic products to be registered;

AddedArticle 127 – paragraph 1 – point g: (g) the data concerning the stability of the homeopathic product.

AddedArticle 128 – title: Application of decentralised and mutual recognition procedures to homeopathic products

AddedArticle 128 – paragraph 1: 1. Article 38, paragraphs 4 and 6, Articles 39 to 42 and 95 shall not apply to the homeopathic products referred to in Article 126.

AddedArticle 128 – paragraph 2: 2. Chapter III, Sections 3 to 5, shall not apply to the homeopathic products referred to in Article 133(2).

AddedArticle 129 – title: Labelling of homeopathic products

AddedArticle 129 – paragraph 1: Homeopathic products, with the exception those referred to in Article 126(1), shall be labelled in accordance with the provisions of Chapter VI and shall be identified by a reference on their labels, in clear and legible form, to their homeopathic nature.

AddedArticle 130 – title: Specific requirements for labelling of certain homeopathic products

AddedArticle 130 – paragraph 1 – subparagraph 1 – introductory part: The labelling and, where appropriate, the package insert for homeopathic products referred to in Article 126(1) in addition to the clear mention of the words ‘homeopathic product’, shall bear the following, and no other, information:

AddedArticle 130 – paragraph 1 – subparagraph 1 – point k: (k) ‘homeopathic product without approved therapeutic indications’;

AddedArticle 130 – paragraph 1 – subparagraph 2: As regards the first subparagraph, point (a), if the homeopathic product is composed of two or more stocks, the scientific names of the stocks on the labelling may be supplemented by an invented name.

AddedArticle 130 – paragraph 2 – point a: (a) the price of the homeopathic product;

AddedArticle 131 – title: Advertising of homeopathic products

AddedArticle 131 – paragraph 1: 1. Chapter XIII shall apply to homeopathic products.

AddedArticle 131 – paragraph 2 – subparagraph 1: By derogation from paragraph 1, Article 176(1) shall not apply to homeopathic products referred to in Article 126(1).

AddedArticle 131 – paragraph 2 – subparagraph 2: However, only the information specified in Article 130(1) may be used in the advertising of such homeopathic products.

AddedArticle 132 – title: Exchange of information on homeopathic products

AddedArticle 132 – paragraph 1: Member States shall communicate to each other all the information necessary to guarantee the quality and safety of homeopathic products manufactured and marketed within the Union, and in particular the information referred to in Articles 202 and 203.

AddedArticle 133 – title: Other requirements for homeopathic products

AddedArticle 133 – paragraph 1: 1. Homeopathic 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.

AddedArticle 133 – paragraph 2 – subparagraph 1: A Member State may introduce or retain in its territory specific rules for the non-clinical tests and clinical studies of homeopathic 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.

AddedArticle 133 – paragraph 3: 3. Chapter IX shall apply to homeopathic 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 products.

AddedArticle 140 – paragraph 2 – subparagraph 1 – point b: (b) the user should consult a doctor or a qualified healthcare practitioner if the symptoms persist during the use of the traditional herbal medicinal product or if adverse effects occur; and

AddedArticle 140 – paragraph 2 – subparagraph 1 – point b a (new): (ba) the user consult a doctor or a qualified healthcare practitioner for information about possible contraindications or pharmacological interactions with other medications.

AddedArticle 140 – paragraph 3: 3. In addition to the requirements set out in Chapter XIII, any advertisement for a traditional herbal medicinal product registered under this Section shall contain the following statement: Traditional herbal medicinal product for use in specified therapeutic indication(s) exclusively based upon long-standing use. For more information, consult a healthcare professional.

AddedArticle 142 – paragraph 3 – point a: (a) preparation, dividing up, changes in packaging or presentation where these processes are carried out, solely for retail and hospital supply, by pharmacists in dispensing pharmacies or by persons legally authorised in the Member States to carry out such processes; or

AddedArticle 147 – paragraph 1 – subparagraph 1 – point j a (new): (ja) use an appropriate wastewater treatment system;

AddedArticle 147 – paragraph 1 – subparagraph 1 – point j b (new): (jb) comply with relevant risk mitigation measures identified in accordance with Article 22.

AddedArticle 148 – paragraph 9: 9. Where relevant, competent authorities of the Member State supervising the central and decentralised sites shall liaise with the competent authority of the Member State responsible for the supervision of the marketing authorisation.

AddedArticle 160 – paragraph 1 – introductory part: The Commission is empowered to adopt delegated acts in accordance with Article 215 to supplement this Directive by specifying:

AddedArticle 160 – paragraph 1 – point b a (new): (ba) measures to reduce the negative impact on the environment posed by the manufacturing of medicinal products.

Article 163 – paragraph 1: 1. The competent authority of the Member State concerned shall take all appropriate measures to ensure that the wholesale distribution of medicinal products is subject to an authorisation to engage in activity as a wholesaler in medicinal products (“wholesale distribution authorisation”). The wholesale distribution authorisation shall indicate the premises, the categories of medicinal products and the wholesale distribution operations for which it is valid.

Change 45

RemovedArticle 166 – paragraph 1 – point l: deleted

RemovedSee amendment to Article 166 – paragraph 1 a (new).

Article 166 – paragraph 1 – point m: (m) cooperate with all relevant stakeholders, including marketing authorisation holders and competent authorities of the Member States on the security of supply.

Change 46

ChangedArticle 166168 – paragraph 1 a (new): 1a.– Memberintroductory Statespart: shall1. designateFor wholesaleall distributionsupplies authorisationof holdersmedicinal whoproducts shallto continuouslya guaranteeperson theauthorised appropriateor andentitled continuedto supply of an adequate range of medicinal products to meet the requirements of apublic specificin geographicalthe area,Member andState deliverconcerned, the suppliesauthorised requestedwholesaler overshall theprovide wholea ofdocument, thewhich areamay inbe question,submitted withinin aelectronic reasonableformat, timeframe,that whichmakes shallit bepossible definedto inascertain nationalthe legislation.following:

Change 47

AddedArticle 172 – paragraph 1 – point a: (a) the natural or legal person offering the medicinal products is authorised or entitled to supply medicinal products to the public, also at a distance, in accordance with national legislation of the Member State in which that person is established and complies, where applicable, with the conditions referred to in paragraph 2 of this Article;

AddedArticle 175 – paragraph 1 – subparagraph 2 – point e: (e) the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind;

AddedArticle 176 – paragraph 3 – point b a (new): (ba) shall not induce to an excessive or abusive use of the medicinal product.

AddedArticle 176 – paragraph 4: 4. Any form of advertising that aims to highlight negatively another medicinal product shall be prohibited. Advertising that suggests that a medicinal product is safer or more effective than another medicinal product shall also be prohibited, unless demonstrated and supported by the summary of product characteristics for the relevant indications and patient population.

AddedArticle 177 – paragraph 1 – point b a (new): (ba) are antibiotics or antimicrobials for which there is an identified risk of antimicrobial resistance as referred to in Article 51(1a).

AddedArticle 177 – paragraph 2: 2. Medicinal products may be advertised to the general public where, by virtue of their composition and purpose, they are intended and designed for use without the intervention of a healthcare professional for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist, if necessary.

Article 177 – paragraph 4: 4. The prohibition contained in paragraph 1 shall not apply to vaccination campaigns approved by the competent authorities of the Member States.

Change 48

RemovedArticle 185 – paragraph 1 – point b: (b) any supply of samples shall be in response to a written or electronic request, signed and dated, from the persons qualified to prescribe or supply medicinal products;

AddedArticle 178 – paragraph 1 – point b – point ii: (ii) the information necessary for correct use and disposal of the medicinal product;

RemovedArticle 188 – paragraph 15 a (new): 15a. The Agency shall draw up guidelines on the use of the Union database.