What changed between the plenary report and the adopted text

Change 3

Removed:Article 106 – paragraph 5: 5. Member States shall ensure that reports of suspected adverse reactions arising from an error, including those associated with the use, administration, and dispensation of a medicinal product, by professionals, that are brought to their attention are made available to the Eudravigilance database and to any authorities, bodies, organisations or institutions, responsible for patient safety within that Member State concerned. They shall also ensure that the authorities responsible for medicinal products within that Member State are informed of any suspected adverse reactions brought to the attention of any other authority within that Member State. These reports shall be appropriately identified in the forms referred to in Article 102 of [revised Regulation (EC) No 726/2004]

Added:For allergen medicinal products supplied in accordance with this paragraph, the competent authorities of the Member State may request the submission of relevant information in accordance with Annex II.

Removed:Article 106 – paragraph 5 a (new): 5a. Reports of adverse reactions arising from incorrect administration or dispensation of a medicinal product shall be available in the Eudravigilance database and shall be included in periodic safety update reports. Where relevant, Member States shall take corrective action to achieve high standards of medication safety in healthcare settings after consultation of healthcare professionals and other relevant stakeholders.

Added:2. Without prejudice to Article 30 of [revised Regulation (EC) No 726/2004], Member States may temporarily authorise the use and distribution of an unauthorised medicinal product in response to a suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm.

Removed:Article 107 – paragraph 3 a (new): 3a. The Agency or the national competent authorities, as appropriate, shall make publicly available the reports referred to in paragraph 1, points (a) and (b).

Added:3. Member States shall ensure that marketing authorisation holders, manufacturers and healthcare professionals are not subject to civil or administrative liability for any consequences resulting from the use of a medicinal product otherwise than for the authorised therapeutic indications or from the use of an unauthorised medicinal product, where such use is recommended or required by a competent authority in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm. Such provisions shall apply whether or not a national or a centralised marketing authorisation has been granted.

Removed:Article 123 – paragraph 1 – introductory part: 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:

Added:4. Liability for defective products, as provided for by [Council Directive 85/374/EEC – OP please replace reference by new instrument COM(2022) 495 when adopted], shall not be affected by paragraph 3.

Removed:Article 123 – paragraph 1 – point a a (new): (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;

Added:Article 4 Definitions

Removed:Chapter X – title: Homeopathic products and traditional herbal medicinal products

Added:1. For the purposes of this Directive, the following definitions apply:

Removed:Article 125 – title: Registration or authorisation of homeopathic products

Added:(1) ‘medicinal product’ means any substance or combination of substances that fulfils at least one of the following conditions:

Removed:Article 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.

Added:(a) any substance or combination of substances that is presented as having properties for treating or preventing disease in human beings; or

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

Added:(b) any substance or combination of substances that may be used in or administered to human beings with a view to either restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis;

Removed:Article 126 – title: Simplified registration procedure for homeopathic products

Added:(2) ‘substance’ means any matter irrespective of origin, which may be:

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

Added:(a) human, e.g. tissues and cells, human blood, human secretions and human blood products;

Removed:Article 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;

Added:(b) animal, e.g. whole animals, animal organs and parts thereof, animal tissues and cells, animal secretions, toxins, extracts, animal blood and animal blood products;

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

Added:(c) vegetal, e.g. plants, including algae, parts of plants, plant secretions and exudates, extracts;

Removed:Article 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.

Added:(d) chemical, e.g. elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis;

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

Added:(e) micro-organisms, e.g. bacteria, viruses and protozoa;

Removed:Article 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.

Added:(f) fungi, including micro-fungi (yeast);

Removed:Article 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:

Added:(3) ‘active substance’ means any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis;

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

Added:(4) ‘starting material’ means any material from which an active substance is manufactured or extracted;

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

Added:(5) ‘excipient’ means any ingredient of a medicinal product other than the active substance;

Removed:Article 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;

Added:(6) ‘functional excipient’ means an excipient that contributes to or enhances the performance of a medicinal product or performs an action ancillary to that of the active substance but does not have a therapeutic contribution on its own;

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

Added:(7) ‘advanced therapy medicinal product’ means advanced therapy medicinal product as defined in Article 2(1), point (a), of Regulation (EC) No 1394/2007;

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

Added:(8) ‘allergen product’ means any medicinal product that is intended to identify or induce a specific acquired alteration in the immunological response to an allergen;

Removed:Article 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.

Added:(9) ‘competent authorities’ means the Agency and the competent authorities of the Members States;

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

Added:(10) ‘Agency’ means the European Medicines Agency;

Removed:Article 129 – title: Labelling of homeopathic products

Added:(11) ‘non-clinical’ means a study or a test conducted in vitro, ex vivo, in silico, or in chemico, or a non-human in vivo test related to the investigation of the safety and efficacy of a medicinal product. Such test may include simple and complex human cell-based assays, microphysiological systems including organ-on-chip, computer modelling and other in silico methods, other non-human or human biology-based test methods, including aquatic egg models as well as invertebrate species, and animal-based tests; [Am. 98]

Removed:Article 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.

Added:(12) ‘reference medicinal product’ means a medicinal product that is or has been authorised in the Union under Article 5, in accordance with Article 6;

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

Added:(13) ‘generic medicinal product’ means a medicinal product that has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product;

Removed:Article 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:

Added:(14) ‘biological medicinal product’ means a medicinal product, the active substance of which is produced by or extracted from a biological source and which due to its complexity, its characterisation and the determination of its quality may require a combination of physico-chemical-biological testing, together with its control strategy;

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

Added:(15) ‘letter of access’ means an original document, signed by the owner of the data or its representative, that states that the data may be used for the benefit of a third party by a competent authority or the Commission for the purposes of this Directive;

Removed:Article 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.

Added:(16) ‘fixed dose combination medicinal product’ means a medicinal product consisting of a combination of active substances intended to be placed on the market as a single pharmaceutical form;