Changes from plenary report to adopted text

Added2. The refusal of a Union marketing authorisation shall constitute a prohibition on the placing on the market of the medicinal product concerned throughout the Union.

RemovedArticle 172 – paragraph 5 – point b c (new): (bc) the intentional or negligent character of the infringement;

Added3. Information about all refusals and the reasons for them shall be made publicly available.

RemovedArticle 172 – paragraph 5 – point b d (new): (bd) any action taken by the infringing party to mitigate the damage caused by the infringement;

AddedArticle 16 Marketing authorisations

RemovedArticle 172 – paragraph 5 – point b e (new): (be) the degree of responsibility of the infringing party taking into account technical and organisational measures implemented to prevent the infringement;

Added1. Without prejudice to Article 1, paragraphs 8 and 9 of [revised Directive 2001/83/EC], a marketing authorisation which has been granted in accordance with this Regulation shall be valid throughout the Union. It shall confer the same rights and obligations in each of the Member States as a marketing authorisation granted by that Member State in accordance with Article 5 of [revised Directive 2001/83/EC].

RemovedArticle 172 – paragraph 5 – point b f (new): (bf) the degree of cooperation with the competent authorities, in order to remedy the infringement and mitigate the possible adverse effects of the infringement;

AddedThe Commission shall ensure that authorised medicinal products for human use are added to the Union Register of Medicinal Products and that they are given a number, which shall appear on the packaging.

RemovedArticle 172 – paragraph 5 – point b g (new): (bg) the manner in which the infringement became known to the competent authorities, in particular whether, and if so to what extent, the infringing party notified the infringement;

Added2. Notification of marketing authorisation shall be published in the Official Journal of the European Union, quoting the date of marketing authorisation and the registration number in the Union Register of Medicinal Products, any International Non-proprietary Name (INN) of the active substance of the medicinal product, its pharmaceutical form, and any Anatomical Therapeutic Chemical Code (ATC).

RemovedArticle 172 – paragraph 5 – point b h (new): (bh) the risk to public health, including in the case of falsification of medicinal products.

Added3. The Agency shall immediately publish the assessment report on the medicinal product for human use and the reasons for its opinion in favour of granting marketing authorisation, after deletion of any information of a commercially confidential nature following a notification to relevant patient organisations. The Agency shall ensure that European public assessment report summaries are readable, clear and comprehensible. [Am. 116]

RemovedRegulation (EC) No 851/2004

AddedThe European public assessment report (EPAR) shall include:

RemovedArticles 11a a (new) and 11a b (new)

Added- a summary of the assessment report written in a manner that is understandable to the public. The summary shall contain in particular a section relating to the conditions of use of the medicinal product;

RemovedArticle 175 a (new) – paragraph 1 – point 1: Article 175a / Amendments to Regulation (EC) No 851/2004 / Regulation (EC) No 851/2004 is amended as follows: / (1) the following articles are inserted: / ‘Article 11aa / European Health Emergency Preparedness and Response Authority / 1. The Health Emergency Preparedness and Response Authority (‘HERA’ or the ‘Authority’) is hereby established as a separate structure under the legal personality of the European Centre for Disease Prevention and Control (‘ECDC’). / 2. The Authority shall be responsible for creating, coordinating and implementing the long-term European portfolio of biomedical research and development agenda for medical countermeasures against current and emerging public health threats as well as the production, procurement, stockpiling and distribution capacity of medical countermeasures and other priority medical products in the Union. / 3. The Authority is represented by the Director of the ECDC. / Article 11ab / Objectives and tasks of the Authority / 1. The Authority shall provide the Member States and the Union institutions, bodies, offices and agencies, with the strategic direction and the resources to develop a robust biomedical R&D capacity to address major public health issues. / The Authority shall carry out the following tasks: / (a) setting out a long-term European portfolio of research and development projects in line with public health priorities set by the Commission in consultation with the World Health Organization (‘WHO’); / (b) setting up and s…

Added- the complete environmental risk assessment submitted to the Agency by the marketing authorisation applicant as well as a summary of environmental risk assessment studies and their results as submitted by the marketing authorisation holder and the assessment of the environmental risk assessment and the information referred to in Article 22(5) of [revised Directive 2001/83/EC] by the Agency. [Am. 117]

RemovedRegulation (EC) No 851/2004

Added- for antimicrobials, all information referred to in Article 17 of and Annex I to [revised Directive 2001/83/EC] as well as any other obligations imposed on the marketing authorisation holder. [Am. 118]

RemovedArticle 175 a (new) – paragraph 1 – point 2, Article 13 – paragraph 1 – point b a (new): (2) in Article 13, the following point is inserted: / ‘(ba) the HERA Board;’

Added4. After a marketing authorisation has been granted, the marketing authorisation holder shall inform the Agency of the dates of actual marketing of the medicinal product for human use in the Member States, taking into account the various presentations authorised.

RemovedRegulation (EC) No 851/2004

AddedThe marketing authorisation holder shall notify the Agency and the competent authority of the Member State concerned of the following:

RemovedArticle 175 a (new) – paragraph 1 – point 3, Article 16 – paragraph 2 – point d a (new): (3) in Article 16(2), the following point is inserted: / ‘(da) ensuring that appropriate scientific, technical and administrative support are provided to the HERA Board;’

Added(a) its intention to permanently cease the marketing of a medicinal product in that Member State in accordance with Article 116(1), point (a); or

RemovedRegulation (EC) No 851/2004

Added(b) its intention to temporarily suspend the marketing of a medicinal product in that Member State in accordance with Article 116(1), point (c); or

RemovedArticles 17 a (new) and 17 b (new)

Added(c) a potential or actual shortage in that Member State in accordance with Article 116(1), point (d); and its reasons for such action under points (a) and (b) in accordance with Article 24, as well as any other reason relating to precautionary actions with regard to quality, safety, efficacy and the environment.

RemovedArticle 175 a (new) – paragraph 1 – point 4: (4) the following articles are inserted: / ‘Article 17a / HERA Board / 1. The HERA Board shall be composed of one representative from each Member State, two representatives of the Commission and two representatives of the European Parliament, all with voting rights. All HERA Board members shall be appointed for a two-year term, renewable once. / 2. In addition, two public health experts shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission. The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents. As quickly as possible, and at the latest within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint those representatives to the HERA Board. / 3. The HERA Board shall be co-chaired by the director and an elected representative of a Member State. The members of the HERA Board shall be appointed in such a way as to guarantee the highest levels of specialist qualifications, a broad spectrum of relevant expertise, and an absence of direct or indirect conflict of interest. / 4. The term of office for members and their alternates shall be four years. That term may be extendable once consecutively. / 5. A representative of the Health Security Committee and a representative of the EMA shall attend the meetings of the HERA Board, as permanent observers. Other rele…

AddedUpon request by the Agency, particularly in the context of pharmacovigilance, the marketing authorisation holder shall provide the Agency with all data relating to the volume of sales of the medicinal product at Union level, broken down by Member State, and any data in the marketing authorisation holder's possession relating to the volume of prescriptions in the Union and its Member States.

RemovedRegulation (EC) No 851/2004

AddedArticle 17 Validity and renewal of marketing authorisations

RemovedArticle 175 a (new) – paragraph 1 – point 5, Article 19: (5) Article 19 is replaced by the following: / ‘Article 19 / Transparency and conflicts of interest / 1. Members of the Management Board, members of the HERA Board, members of the scientific panels, members of the Advisory Forum, the director and the staff shall undertake to act in the public interest and in an independent manner. They shall not have any direct or indirect financial or other interests in the pharmaceutical or other medical industry which could affect their impartiality. They shall make an annual declaration of their financial interests and update them annually and whenever necessary. The declaration shall be made available upon request. / 2. The ECDC's and Authority’s code of conduct shall provide for the implementation of this Article. / 3. The ECDC and the Authority shall make available the rules of procedure, meeting agendas and minutes, and the members of the structures referred to in paragraph 1 and their declarations of interest on their website. / 4. Stakeholders invited to meetings at the ECDC and the Authority shall declare their interests ahead of the meeting’.

Added1. Without prejudice to paragraph 2, a marketing authorisation for a medicinal product shall be valid for an unlimited period.

RemovedArticle 181 – paragraph 3 a (new): The provisions in Chapter III shall apply from ... [the date of entry into force of this Regulation].

Added2. By way of derogation from paragraph 1, the Commission may decide when granting an authorisation, on the basis of a scientific opinion by the Agency concerning the safety of the medicinal product, to limit the validity of the marketing authorisation to five years.

RemovedAnnex II – point 16: (16) the obligation to conduct post-marketing studies, including post-authorisation safety studies, post-authorisation efficacy studies and post-authorisation environmental risk assessment studies, and to submit them for review, as provided for in Article 20;

AddedWhere the validity of the marketing authorisation is limited to five years, the marketing authorisation holder shall apply to the Agency for a renewal of the marketing authorisation at least nine months before the marketing authorisation ceases to be valid.

RemovedAnnex II – point 25 a (new): (25a) the obligations related to the availability and supply of medicinal products as laid down in Chapter X;

AddedWhere a renewal application has been submitted in accordance with the second subparagraph, the marketing authorisation shall remain valid until a decision is adopted by the Commission in accordance with Article 13.

RemovedAnnex II – point 25 b (new): (25b) the obligations to report on financial support and research and development costs as laid down in Article 57 of [revised Directive 2001/83/EC].

AddedThe marketing authorisation may be renewed on the basis of a re-evaluation by the Agency of the benefit-risk balance. Once renewed, the marketing authorisation shall be valid for an unlimited period.

RemovedAnnex IV – Part III – paragraph 1 – point 2 – point e: (e) Reason for shortage providing, where applicable, information on: / (i) raw material disruption; / (ii ) API disruption; / (iii) excipient disruption; / (iv) production problems; / (v) quality problems; / (vi) production capacity; / (vii) logistics problems; / (viii) distribution problems; / (ix) inventory and storage practices; / (x) increase in demand; / (xi) commercial reasons; and / (xii) any other reasons;

AddedArticle 18 Marketing authorisation granted in exceptional circumstances

RemovedAnnex IV – Part V – paragraph 1 – point 2 – point d a (new): (da) methodology for establishing the demand forecast;

Added1. In exceptional circumstances where, in an application under Article 6 of [revised Directive 2001/83/EC] for a marketing authorisation of a medicinal product or a new therapeutic indication, of an existing marketing authorisation under this Regulation, an applicant is unable to provide comprehensive data on the efficacy and safety of, and, where missing, on the environmental risk posed by, the medicinal product under normal conditions of use, the Commission may, by derogation to Article 6, grant an authorisation under Article 13, subject to specific conditions, where the following requirements are met: [Am. 119]

RemovedAnnex IV – Part V a (new): Part Va / For the purposes of reporting in accordance with Article 118(1) and for the early detection of supply shortages, wholesalers shall provide the following information in a timely manner: / 1. Product availability information: / Product availabilities shall be reported per warehouse and shall be indexed as yes/no. / 2. Service level information: / Service level information which captures the level of fulfilment of wholesale orders by marketing authorisation holders and suppliers shall be reported. Such information involves comparing the quantity ordered with the quantity actually received at the product level. The resulting difference describes the service level.

Added(a) the applicant has demonstrated, in the application file, that there are objective and verifiable reasons not to be able to submit comprehensive data on the efficacy and safety of the medicinal product under normal conditions of use based on one of the grounds set out in Annex II to [revised Directive 2001/83/EC];