Changes from plenary report to adopted text

RemovedArticle 207 – paragraph 1 b (new): 1b. Member States shall submit the national plans to the Commission.

Added(53) ‘micro, small and medium-sized enterprises’ means micro, small and medium-sized enterprises as defined in Article 2 of Commission Recommendation 2003/361/EC;

RemovedArticle 208 – paragraph 1: 1. In order to guarantee independence and transparency, the Member States shall ensure that members of staff of the competent authority responsible for granting authorisations, rapporteurs and experts concerned with the authorisation and surveillance of medicinal products have no direct or indirect financial or other interests in the pharmaceutical industry that could affect their impartiality and their independence. These persons shall make an annual declaration of their financial interests and update them annually and whenever necessary. The declaration shall be made available upon request.

Added(54) ‘variation’ or ‘variation of the terms of a marketing authorisation’ means any amendment to:

RemovedArticle 208 – paragraph 2: 2. In addition, the Member States shall ensure that the competent authority makes publicly available its rules of procedure and those of its committees, including their working groups and expert groups, agendas for its meetings and records of its meetings, accompanied by decisions taken, details of votes and explanations of votes, including minority opinions.

Added(a) the contents of the particulars and documents referred to in Article 6(2), Articles 9 to 14 and Article 62, Annex I and Annex II thereto and Article 6 of the [revised Regulation (EC) No 726/2004]; or

RemovedArticle 214 – paragraph 4: 4. The rules of procedure, lists of participating entities of its meetings, agendas for its meetings and records of its meetings, accompanied by decisions taken, and, where applicable, details of votes and explanations of votes, including minority opinions, of the Standing Committee on Medicinal Products shall be made publicly available.

Added(b) the terms of the decision granting the marketing authorisation for a medicinal product, including the summary of product characteristics and any conditions, obligations, or restrictions affecting the marketing authorisation, or changes to the labelling or the package leaflet related to changes to the summary of product characteristics;

RemovedArticle 216 – paragraph 1: By [OP please insert the date = 10 years following 18 months after the date of entering into force of this Directive], the Commission shall present a report to the European Parliament and the Council on the application of this Directive, including an assessment of the fulfilment of its objectives and the resources required to implement it, including regarding the revised framework for regulatory data protection periods.

Added(55) ‘post-authorisation safety study’ means any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures;

RemovedArticle 216 – paragraph 1 a (new): 1a. By ...[2 years from the date of entry into force of this Directive], the Commission shall submit a report to the European Parliament and Council evaluating the appropriateness of the framework of homeopathic products, in particular aspects of public health and patient protection. The report shall, where appropriate, be accompanied by a legislative proposal.

Added(56) ‘pharmacovigilance system’ means a system used by the marketing authorisation holder and by Member States to fulfil the tasks and responsibilities set out in Chapter IX and designed to monitor the safety of authorised medicinal products and detect any change to their benefit-risk balance;

RemovedArticle 216 a (new): Article 216a / Fostering research on, and innovation and production of, medicinal products in the Union / 1. The Commission shall establish a strategy on fostering research on, and innovation and production of, medicinal products in the Union, based on the results published in the report provided for paragraph 2. Member States shall be encouraged to participate in that strategy. / 2. By... [two years from the date of entry into force of this Directive] the Commission shall present an impact assessment evaluating potential measures to be implemented at Union level and at a Member State level to foster research on, and innovation and production of, critical medicinal products in the Union. That report shall evaluate the effect of measures such as: / (a) funding and push and pull incentives directed to foster research and innovation in the Union, including public and private funding for preclinical and clinical research and innovation; / (b) public-private partnerships in research and innovation; / (c) regulatory support for public research and innovation entities; / (d) incentives for production of critical medicinal products within the Union. / Any proposed measures shall be in line with the development of the strategic autonomy of the Union regarding medicinal products.

Added(57) ‘pharmacovigilance system master file’ means a detailed description of the pharmacovigilance system used by the marketing authorisation holder with respect to one or more authorised medicinal products;

RemovedAnnex I – point 21 – point a – introductory part: a) an antimicrobial stewardship and access plan which shall in particular outline:

Added(58) ‘risk management system’ means a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to a medicinal product, including the assessment of the effectiveness of those activities and interventions;

RemovedAnnex I – point 21 – point a – point ii a (new): (iia) information about measures for a strategy to promote access, including proposed production chain capacity;

Added(59) ‘adverse reaction’ means a response to a medicinal product that is noxious and unintended;

RemovedAnnex I – point 21 – point a – point ii b (new): (iib) information about measures to ensure marketing approvals are received for key territories in a timely manner; and

Added(60) ‘serious adverse reaction’ means an adverse reaction that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or a birth defect;

RemovedAnnex I – point 21 – point a – point ii c (new): (iic) information about measures to monitor effectiveness of stewardship and access.

Added(61) ‘unexpected adverse reaction’ means an adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics;

RemovedAnnex IV – paragraph 1 – point a: (a) the name of the medicinal product, including in Braille, followed by its strength and pharmaceutical form, and, if appropriate, whether it is intended for babies, children or adults; where the medicinal product contains up to three active substances, the international non-proprietary name (INN) shall be included, unless it is already part of the name of the medicinal product, or, if one does not exist, the common name;

Added(62) ‘homeopathic medicinal product’ means a medicinal product prepared from homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in the Member States; [Am. 109]

RemovedAnnex IV – paragraph 1 – point g a (new): (ga) for antimicrobials, a warning that improper use and unsafe disposal of the medicinal product contributes to antimicrobial resistance;

Added(63) ‘traditional herbal medicinal product’ means a herbal medicinal product that fulfils the conditions laid down in Article 134(1);

RemovedAnnex IV – paragraph 1 – point j: (j) specific precautions relating to the disposal of unused medicinal products or waste derived from medicinal products as well as reference to any appropriate collection system in place;

Added(64) ‘herbal medicinal product’ means 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 herbal preparations;

RemovedAnnex V – paragraph 1 – point 6 – point f: (f) special precautions for disposal of a medicinal product or waste materials derived from such medicinal product as well as any designated collection system in place. In case of antimicrobial medicinal products in addition to the precautions a warning that inappropriate disposal of the medicinal product contributes to antimicrobial resistance;

Added(65) ‘herbal substances’ means all mainly whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed, usually dried or fresh form, and 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);

RemovedAnnex VI – paragraph 1 – point 2 a (new): (2a) a key information section reflecting the results of consultations with patients’ organisations to ensure that the leaflet is legible, clear and easy to use;

Added(66) ‘herbal preparations’ means preparations obtained by subjecting herbal substances to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation including comminuted or powdered herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates;

RemovedAnnex VI – paragraph 1 – point 4 – point b: (b) the method and, if necessary, route of administration, and where relevant a description of the measuring or delivery device, as well as the relevant individual steps of medicine preparation and administration;

Added(67) ‘corresponding traditional herbal medicinal product’ means a traditional herbal medicinal product with the same active substances, 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 traditional herbal medicinal product applied for;

RemovedAnnex VI – paragraph 2 a (new): The package leaflet may also contain information on the importance of therapeutic adherence and available support for adherence in the Member State.

Added(68) ‘wholesale distribution of medicinal products’ means all activities, consisting of procuring, holding, supplying or exporting medicinal products, whether for profit or not, apart from supplying medicinal products to the public. Such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorised or entitled to supply medicinal products to the public in the Member State concerned;