Changes from plenary report to adopted text

Added4. Where the opinion of the Agency confirms the obligation and unless the Commission returns the opinion to the Agency for further consideration, the marketing authorisation shall be varied accordingly by the Commission in accordance with the procedure set out in Article 13, to:

Added(a) include the obligation as a condition of the marketing authorisation and the risk management system shall be updated accordingly.

Added(b) include the measures to be taken as part of the risk management system as conditions of the marketing authorisation referred to in Article 12(4), point (e).

AddedArticle 100 Safety announcements

AddedThe obligations of marketing authorisation holders laid down in Article 104(1) of [revised Directive 2001/83/EC], and the obligations of the Member States, the Agency and the Commission laid down in paragraphs 2, 3 and 4 of that Article shall apply to the safety announcements referred to in Article 138(1), point (f), of this Regulation concerning medicinal products for human use authorised in accordance with this Regulation.

AddedArticle 101 Eudravigilance database

Added1. The Agency shall, in collaboration with the Member States and the Commission, set up and maintain a database and data processing network (‘Eudravigilance database’) to collate pharmacovigilance information regarding medicinal products authorised in the Union and to allow competent authorities to access that information simultaneously and to share it.

AddedIn justified cases, the Eudravigilance database may include pharmacovigilance information with regard to medicinal products used under compassionate use referred to in Article 26 or early access schemes.

AddedThe Eudravigilance database shall contain information on suspected adverse reactions in human beings arising from use of the medicinal product within the terms of the marketing authorisation as well as from uses outside the terms of the marketing authorisation, including errors in relation to medication, and on those occurring in the course of post-authorisation studies with the medicinal product or associated with occupational exposure. [Am. 223]

Added2. The Agency shall, in collaboration with the Member States and the Commission, draw up the functional specifications for the Eudravigilance database, together with a timeframe for their implementation.

AddedThe Agency shall prepare an annual report on the Eudravigilance database and send it to the European Parliament, the Council and the Commission.

AddedAny substantial change to the Eudravigilance database and the functional specifications shall take into account the recommendations of the Pharmacovigilance Risk Assessment Committee.

AddedThe Eudravigilance database shall be fully accessible to the competent authorities of the Member States and to the Agency and the Commission. It shall also be accessible to marketing authorisation holders to the extent necessary for them to comply with their pharmacovigilance obligations.

AddedThe Agency shall ensure that healthcare professionals and the public have appropriate levels of access to the Eudravigilance database, and that personal data is protected in line with Union data protection and privacy law. The Agency shall work together with all stakeholders, including research institutions, healthcare professionals, and patient and consumer organisations, in order to define the ‘appropriate level of access’ for healthcare professionals and the public to the Eudravigilance database. [Am. 224]

AddedThe data held on the Eudravigilance database shall be made publicly available in an aggregated and anonymised format together with an explanation of how to interpret the data. [Am. 225]

Added3. The Agency shall, in collaboration either with the marketing authorisation holder or with the Member State that submitted an individual suspected adverse reaction report to the Eudravigilance database, be responsible for operating procedures that ensure the quality and integrity of the information collected in the Eudravigilance database.

Added3a. The periodic safety update reports shall, in addition, be made publicly available in the web-portal referred to in Article 138(1), second subparagraph, point (n). [Am. 226]

Added4. Individual suspected adverse reaction reports and follow-ups submitted to the Eudravigilance database by marketing authorisation holders shall be transmitted electronically upon receipt to the competent authority of the Member State where the reaction occurred.

AddedArticle 102 Forms for reporting suspected adverse reactions

AddedThe Agency shall, in collaboration with the Member States, develop standard web-based structured forms for the reporting of suspected adverse reactions by healthcare professionals and patients in accordance with the provisions referred to in Article 106 of [revised Directive 2001/83/EC].

AddedArticle 103 Periodic safety update reports repository

AddedThe Agency shall, in collaboration with the competent authorities of the Member States and the Commission, set up and maintain a repository for periodic safety update reports ( ‘repository’) and the corresponding assessment reports regarding medicinal products authorised in the Union so that they are fully and permanently accessible to the Commission, the competent authorities of the Member States, the Pharmacovigilance Risk Assessment Committee, the Committee for Medicinal Products for Human Use and the coordination group referred to in Article 37 of [revised Directive 2001/83/EC] (‘coordination group’).

AddedThe Agency shall, in collaboration with the competent authorities of the Member States and the Commission, and after consultation with the Pharmacovigilance Risk Assessment Committee, draw up the functional specifications for the repository.

AddedAny substantial change to the repository and the functional specifications shall always take into account the recommendations of the Pharmacovigilance Risk Assessment Committee.

AddedArticle 104 European medicines web-portal and register of studies for environmental risk assessment

Added1. The Agency shall, in collaboration with the Member States and the Commission, set up and maintain a European medicines web-portal for the dissemination of information on medicinal products authorised or to be authorised in the Union. The dedicated web-portal shall be set up in accordance with Directive (EU) 2016/2102 of the European Parliament and of the Council. By means of that portal, the Agency shall make public the following: [Am. 227]

Added(a) the names of members of the Committees referred to in Article 142, points (d) and (e), and the members of the coordination group, together with their professional qualifications and with the declarations referred to in Article 147(2);

Added(b) agendas and minutes from each meeting of the Committees referred to in Article 142, points (d) and (e), and of the coordination group as regards pharmacovigilance activities;

Added(c) a summary of the risk management plans for medicinal products authorised in accordance with this Regulation and the accompanying summaries of the risk management plans; [Am. 228]

Added(d) a list of the locations in the Union where pharmacovigilance system master files are kept and contact information for pharmacovigilance enquiries, for all medicinal products authorised in the Union;

Added(e) information about how to report to competent authorities of the Member States suspected adverse reactions to medicinal products and the standard structured forms referred to in Article 102 for their web-based reporting by patients and healthcare professionals, including links to national websites;

Added(f) Union reference dates and frequency of submission of periodic safety update reports established in accordance with Article 108 of [revised Directive 2001/83/EC];

Added(g) protocols and public abstracts of results of the post-authorisation safety studies referred to in Articles 108 and 120 of [revised Directive 2001/83/EC];

Added(h) the initiation of the procedure provided for in Article 41(2) of this Regulation, and Articles 114, 115 and 116 of [revised Directive 2001/83/EC], the active substances or medicinal products concerned and the issue being addressed, any public hearings pursuant to that procedure and information on how to submit information and to participate in public hearings; [Am. 229]

Added(i) conclusions of assessments, obligations for post-marketing studies, recommendations, opinions, approvals and decisions taken by the Agency and its Committees under this Regulation and [revised Directive 2001/83/EC], unless it is required that this information is made public by the Agency by other means; [Am. 230]

Added(j) conclusions of assessments, recommendations, opinions, approvals, obligations deriving from the conditional marketing authorisations and decisions taken by the coordination group, the competent authorities of the Member States and the Commission in the framework of the procedures set out in Articles 16, 106, 107 and 108 of this Regulation and of Chapter IX, Sections 3 and 7 of [revised Directive 2001/83/EC]. [Am. 231]

AddedThe summariesrisk management plans referred to in point (c) shall include a description of any additional risk minimisation measures and distribution or implementation plans. [Am. 232]

Added2. In the development and review of the web portal, the Agency shall consult relevant stakeholders, including patient and consumer groups, healthcare professionals, not-for-profit entities and industry representatives. [Am. 233]

Added3. The Agency shall, in collaboration with the Member States and the Commission, set up and maintain a register of environmental risk assessment studies conducted for the purpose of supporting an environmental risk assessment for medicinal products authorised in the Union, unless such information is made public in the Union by different means. [Am. 234]

AddedInformation in such register shall be publicly available and easily accessible on the Agency’s website, and shall include, as a minimum, the information reported in accordance with Section 1.6 of Annex II to [revised Directive 2001/83/EC], unless restrictions are necessary to protect commercially confidential information. For the purpose of setting up such register, the Agency mayshall, where not already received, request marketing authorisation holders and competent authorities to submit results of any such study already completed for products authorised in the Union within [OP please add the date = 24 months after the date of application of this Regulation]. [Am. 235]

AddedArticle 105 Literature monitoring

Added1. The Agency shall monitor selected medical literature for reports of suspected adverse reactions to medicinal products containing certain active substances. It shall publish the list of active substances being monitored and the medical literature subject to this monitoring.

Added2. The Agency shall enter into the Eudravigilance database relevant information from the selected medical literature.

Added3. The Agency shall, in consultation with the Commission, Member States and interestedtheir relevant authorities, as well as other relevant parties, including experts from academia, draw up a detailed guide regarding the monitoring of medical literature and the entry of relevant information into the Eudravigilance database. [Am. 236]

AddedArticle 106 Monitoring of safety of medicinal products

Added1. The obligations of marketing authorisation holders and of Member States laid down in Article 105 and Article 106 of [revised Directive 2001/83/EC] shall apply to the recording and reporting of suspected adverse reactions for medicinal products for human use authorised in accordance with this Regulation.

Added2. The obligations of marketing authorisation holders laid down in Article 107 of [revised Directive 2001/83/EC] and the procedures under Articles 107 and 108 of that Directive shall apply to the submission of periodic safety update reports, the establishment of Union reference dates and changes to the frequency of submission of periodic safety update reports for medicinal products for human use authorised in accordance with this Regulation.

AddedThe provisions applicable to the submission of periodic safety update reports laid down in the of Article 108(2), second subparagraph, of that Directive shall apply to marketing authorisation holders of marketing authorisations which were granted before 2 July 2012 and for which the frequency and dates of submission of the periodic safety update reports are not laid down as a condition to the marketing authorisation until such time as another frequency or other dates of submission of the reports are laid down in the marketing authorisation or are determined in accordance with Article 108 of that Directive.

Added3. The assessment of the periodic safety update reports shall be conducted by a rapporteur appointed by the Pharmacovigilance Risk Assessment Committee. The rapporteur shall closely collaborate with the rapporteur appointed by the Committee for Medicinal Products for Human Use or the Reference Member State for the medicinal products concerned.

AddedThe rapporteur shall prepare an assessment report within 60 days of receipt of the periodic safety update report and send it to the Agency and to the members of the Pharmacovigilance Risk Assessment Committee. The Agency shall send the report to the marketing authorisation holder.

AddedWithin 30 days of receipt of the assessment report, the marketing authorisation holder and the members of the Pharmacovigilance Risk Assessment Committee may submit comments to the Agency and to the rapporteur.

AddedFollowing the receipt of the comments referred to in the third subparagraph, the rapporteur shall within 15 days update the assessment report taking into account any comments submitted, and forward it to the Pharmacovigilance Risk Assessment Committee. The Pharmacovigilance Risk Assessment Committee shall adopt the assessment report with or without further changes at its next meeting and issue a recommendation. The recommendation shall mention the divergent positions with the grounds on which they are based. The Agency shall include the adopted assessment report and the recommendation in the repository set up under Article 103, and forward both to the marketing authorisation holder.

Added4. In the case of an assessment report that recommends any action concerning the marketing authorisation, the Committee for Medicinal Products for Human Use shall, within 30 days of receipt of the report by the Pharmacovigilance Risk Assessment Committee, consider the report and adopt an opinion on the maintenance, variation, suspension or revocation of the marketing authorisation concerned, including a timetable for the implementation of the opinion. Where this opinion of the Committee for Medicinal Products for Human Use differs from the recommendation of the Pharmacovigilance Risk Assessment Committee, the Committee for Medicinal Products for Human Use shall attach to its opinion a detailed explanation of the scientific grounds for the differences together with the recommendation.

AddedWhere the opinion states that regulatory action concerning the marketing authorisation is necessary, the Commission shall adopt a decision, by means of implementing acts, to vary, suspend or revoke the marketing authorisation in accordance with Article 13. Where the Commission adopts such a decision, it may also adopt a decision addressed to the Member States pursuant to Article 57.

Added5. In the case of a single assessment of periodic safety update reports concerning more than one marketing authorisation in accordance with Article 110(1) of [revised Directive 2001/83/EC] which includes at least one marketing authorisation granted in accordance with this Regulation, the procedure laid down in Article 107 and Article 109 of that Directive shall apply.

Added6. The final recommendations, opinions and decisions referred to in paragraphs 3, 4 and 5 shall be made public by means of the European medicines web-portal referred to in Article 104.

AddedArticle 107 Agency pharmacovigilance related activities

Added1. Regarding medicinal products for human use authorised in accordance with this Regulation, the Agency shall, in collaboration with the Member States, take the following measures:

Added(a) monitor the outcome of risk minimisation measures contained in risk management plans and of conditions referred to in Article 12, paragraph 4, points (d) to (g), or in Article 20, paragraph 1, points (a) and (b), and in Articles 18(1) and 19;

Added(b) assess updates to the risk management system;