What changed between the plenary report and the adopted text

Added:Article 122 Implementing measures related to pharmacovigilance activities

Added:1. In order to harmonise the performance of the pharmacovigilance activities provided for in this Directive, the Commission shall adopt implementing measures in the following areas for which pharmacovigilance activities are provided for in Annex I, Articles 96, 99, 100, 105 to 107, 113, 118 and 120 by setting out:

Added:(a) the content and the rules on the maintenance of the pharmacovigilance system master file kept by the marketing authorisation holder;

Added:(b) minimum requirements for the quality system for the performance of pharmacovigilance activities by the competent authorities of the Member States and the marketing authorisation holder;

Added:(c) rules on the use of internationally agreed terminology, formats and standards for the performance of pharmacovigilance activities;

Added:(d) minimum requirements for the monitoring of data in the Eudravigilance database to determine whether there are new risks or whether risks have changed;

Added:(e) the format and content of the electronic transmission of suspected adverse reactions by Member States and the marketing authorisation holder;

Added:(f) the format and content of electronic periodic safety update reports and risk management plans;

Added:(g) the format of protocols, abstracts and final study reports for the post-authorisation safety studies.

Added:2. Those measures shall take account of the work on international harmonisation carried out in the area of pharmacovigilance. Those measures shall be adopted in accordance with the regulatory procedure referred to in Article 214(2).

Added:Article 123 Guidance to facilitate the performance of pharmacovigilance activities

Added:The Agency shall, in cooperation with competent authorities of the Member States and other interested parties, including those referred to in Article 162 of [revised Regulation (EC) No 726/2004], draw up: [Am. 234]

Added:(a) guidance on good pharmacovigilance practices for both competent authorities and marketing authorisation holders;

Added:(aa) guidance for national competent authorities on the effective inclusion of patients and healthcare professionals in the data collection and communication of the risks of medicinal products within the pharmacovigilance activities; [Am. 235]

Added:(b) scientific guidance on post-authorisation efficacy studies.

Added:Article 124 Reporting on pharmacovigilance tasks

Added:The Agency shall make public a report on the performance of pharmacovigilance tasks by the Member States and the Agency every three years. The first report shall be made public by [three years after application date of [revised Regulation (EC) No 726/2004].

Added:Chapter X Homeopathic medicinal products and traditional herbal medicinal products [Am. 236]

Added:Section 1 Specific provisions applicable to homeopathic medicinal products

Added:Article 125 Registration or authorisation of homeopathic medicinal products [Am. 237]

Added:1. Member States shall ensure that homeopathic medicinal 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 medicinal 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. [Am. 238]

Added:2. Member States shall establish a simplified registration procedure referred to in Article 126 for the homeopathic medicinal products. [Am. 239]

Added:Article 126 Simplified registration procedure for homeopathic medicinal products [Am. 240]

Added:1. Homeopathic medicinal products that satisfy all of the following conditions may be subject to a simplified registration procedure: [Am. 241]

Added:(a) they are administered orally or externally;

Added:(b) no specific therapeutic indication appears on the labelling of the medicinalhomeopathic product or in any information relating thereto; [Am. 242]

Added:(c) there is a sufficient degree of dilution to guarantee the safety of the medicinalhomeopathic product. [Am. 243]

Added:For the purposes of point (c), the medicinalhomeopathic 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 medicinal product results in the obligation to submit a doctor’s prescription. [Am. 244]

Added:The Commission is empowered to adopt delegated acts in accordance with Article 215 to amend the first subparagraph, point (c), in order to take account of scientific progress.

Added:At the time of registration, Member States shall determine the prescription status for the dispensing of the homeopathic medicinal product. [Am. 245]

Added: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 medicinal products, with the exception of the proof of therapeutic efficacy. [Am. 246]

Added:Article 127 Application requirements for simplified registration

Added:An application a simplified registration may cover a series of homeopathic medicinal 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 medicinal products concerned: [Am. 247]

Added:(a) the scientific name or other name given in a pharmacopoeia of the homeopathic stock or stocks, together with a statement of the various routes of administration, pharmaceutical forms and degree of dilution to be registered;

Added:(b) a dossier describing how the homeopathic stock or stocks are obtained and controlled, and justifying their homeopathic use, on the basis of an adequate bibliography;

Added:(c) the manufacturing and control file for each pharmaceutical form and a description of the method of dilution and potentisation;

Added:(d) the manufacturing authorisation for the homeopathic medicinal product concerned; [Am. 248]

Added:(e) the copies of any registrations or authorisations obtained for the same homeopathic medicinal product in other Member States; [Am. 249]

Added:(f) one or more mock-ups of the outer packaging and the immediate packaging of the homeopathic medicinal products to be registered; [Am. 250]

Added:(g) the data concerning the stability of the homeopathic medicinal product. [Am. 251]

Added:Article 128 Application of decentralised and mutual recognition procedures to homeopathic medicinal products [Am. 252]

Added:1. Article 38, paragraphs 4 and 6, Articles 39 to 42 and 95 shall not apply to the homeopathic medicinal products referred to in Article 126. [Am. 253]

Added:2. Chapter III, Sections 3 to 5, shall not apply to the homeopathic medicinal products referred to in Article 133(2). [Am. 254]

Added:Article 129 Labelling of homeopathic medicinal products [Am. 255]

Added:Homeopathic medicinal 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. [Am. 256]

Added:Article 130 Specific requirements for labelling of certain homeopathic medicinal products [Am. 257]

Added:1. The labelling and, where appropriate, the package insert for homeopathic medicinal products referred to in Article 126(1) in addition to the clear mention of the words ‘homeopathic medicinal product’, shall bear the following, and no other, information: [Am. 258]

Added:(a) the scientific name of the stock or stocks followed by the degree of dilution, making use of the symbols of the pharmacopoeia used in accordance with Article 4(62);

Added:(b) name and address of the registration holder and, where appropriate, of the manufacturer;

Added:(c) method of administration and, if necessary, route of administration;

Added:(d) pharmaceutical form;

Added:(e) expiry date, in clear terms (month, year);

Added:(f) contents of the sales presentation;

Added:(g) special storage precautions, if any;

Added:(h) a special warning if necessary for the medicinal product;

Added:(i) manufacturer's batch number;

Added:(j) registration number;

Added:(k) ‘homeopathic medicinal product without approved therapeutic indications’; [Am. 259]

Added:(l) a warning advising the user to consult a doctor if the symptoms persist.

Added:As regards the first subparagraph, point (a), if the homeopathic medicinal product is composed of two or more stocks, the scientific names of the stocks on the labelling may be supplemented by an invented name. [Am. 260]