What changed between the plenary report and the adopted text

Added:3. Each Member State shall designate a competent authority for the performance of pharmacovigilance tasks.

Added:4. The Commission may request the Member States to participate, under the coordination of the Agency, in international harmonisation and standardisation of technical measures in relation to pharmacovigilance.

Added:Article 97 Member State responsibilities for pharmacovigilance activities

Added:1. The Member States shall:

Added:(a) take all appropriate measures to encourage patients, doctors, pharmacists and other healthcare professionals to report suspected adverse reactions to the competent authority of the Member State and may involve organisations representing consumers, patients and healthcare professionals for those tasks where appropriate;

Added:(b) facilitate patient reporting through the provision of alternative reporting formats in addition to web-based formats;

Added:(c) take all appropriate measures to obtain accurate and verifiable data for the scientific evaluation of suspected adverse reaction reports;

Added:(d) ensure that the public is given important information on pharmacovigilance concerns relating to the use of a medicinal product in a timely manner through publication on the web-portal and through other means of publicly available information as necessary;

Added:(e) ensure, through the methods for collecting information and where necessary through the follow-up of suspected adverse reaction reports, that all appropriate measures are taken to identify clearly any biological medicinal product prescribed, dispensed, or sold in their territory that is the subject of a suspected adverse reaction report, with due regard to the name of the medicinal product, and the batch number.

Added:(ea) facilitate the protection of patients in relation to adverse events through the development and implementation of plans for safe administration and handling of medicinal products, which may include the use of digital medication safety systems in hospitals and ambulatory care settings. [Am. 223]

Added:2. For the purposes of paragraph 1, points (a) and (e), the Member States may impose specific obligations on doctors, pharmacists and other healthcare professionals.

Added:Article 98 Member State delegation of pharmacovigilance tasks

Added:1. A Member State may delegate any of the tasks entrusted to it under this Chapter to another Member State subject to a written agreement of the latter. Each Member State may represent no more than one other Member State.

Added:2. The delegating Member State shall inform the Commission, the Agency and all other Member States of the delegation in writing. The delegating Member State and the Agency shall make that information publicly available.

Added:Article 99 Marketing authorisation holder pharmacovigilance system

Added:1. Marketing authorisation holders shall operate a pharmacovigilance system for the fulfilment of their pharmacovigilance tasks equivalent to the relevant Member State’s pharmacovigilance system referred to in Article 96(1).

Added:2. Marketing authorisation holders shall by means of the pharmacovigilance system referred to in Article 96(1) evaluate all information scientifically, consider options for risk minimisation and prevention and take appropriate measures as necessary.

Added:3. Marketing authorisation holders shall perform a regular audit of their pharmacovigilance system. They shall place a note concerning the main findings of the audit on the pharmacovigilance system master file and, based on the audit findings, ensure that an appropriate corrective action plan is prepared and implemented. Once the corrective actions have been fully implemented, the note may be removed.

Added:4. As part of the pharmacovigilance system, marketing authorisation holders shall:

Added:(a) have permanently and continuously at their disposal an appropriately qualified person responsible for pharmacovigilance;

Added:(b) maintain and make available on request by a competent authority a pharmacovigilance system master file;

Added:(c) operate a risk management system for each medicinal product;

Added:(d) monitor the outcome of risk minimisation measures that are contained in the risk management plan pursuant to Article 21 or that are laid down as conditions of the marketing authorisation pursuant to Articles 44, 45 and any obligations imposed in accordance with Article 87;

Added:(e) update the risk management system and monitor pharmacovigilance data to determine whether there are new risks or whether risks have changed or whether there are changes to the benefit-risk balance of medicinal products.

Added:5. The qualified person referred to in paragraph 4, point (a), shall reside and operate in the Union and shall be responsible for the establishment and maintenance of the pharmacovigilance system. The marketing authorisation holder shall submit the name and contact details of the qualified person to the competent authority of the Member State and the Agency.

Added:6. The marketing authorisation holder shall, on request from the competent authority of a Member State, nominate a contact person for pharmacovigilance issues in that Member State who shall report to the qualified person referred to in paragraph 4, point (a).

Added:Article 100 Risk management system

Added:1. Holders of marketing authorisations granted before 21 July 2012 shall, by way of derogation from Article 99(4), point (c), not be required to operate a risk management system for each medicinal product.

Added:2. The competent authority of a Member State may impose an obligation on a marketing authorisation holder of a national marketing authorisation to operate a risk management system, as referred to in Article 99(4), point (c), if there are concerns about the risks affecting the benefit-risk balance of an authorised medicinal product. In that context, the competent authority of a Member State shall also oblige the marketing authorisation holder to submit a risk management plan for the risk management system that they intend to introduce for the medicinal product concerned.

Added:3. The obligation referred to in paragraph 2 shall be duly justified, notified in writing, and shall include the timeframe for submission of the risk management plan.

Added:4. The competent authority of a Member State shall provide the marketing authorisation holder with an opportunity to submit written observations in response to the imposition of the obligation within a time limit which it shall specify, if the marketing authorisation holder so requests within 30 days of receipt of the written notification of the obligation.

Added:5. On the basis of the written observations submitted by the marketing authorisation holder, the competent authority of a Member State shall withdraw or confirm the obligation. Where the competent authority of a Member State confirms the obligation, the marketing authorisation shall be varied accordingly to include the measures to be taken as part of the risk management system as conditions of the marketing authorisation referred to in Article 44, point (a).

Added:Article 101 Funds for pharmacovigilance activities

Added:1. The management of funds intended for activities connected with pharmacovigilance, the operation of communication networks and market surveillance shall be under the permanent control of the competent authorities of the Member States in order to guarantee their independence in the performance of those pharmacovigilance activities.

Added:2. Paragraph 1 shall not preclude the competent authorities of the Member States from charging fees to marketing authorisation holders for performing pharmacovigilance activities on the condition that the independence in the performance of those pharmacovigilance activities is strictly guaranteed.

Added:Section 2 Transparency and communications

Added:Article 102 National web-portal

Added:1. Each Member State shall set up and maintain a national medicines web-portal which shall be linked to the European medicines web-portal established in accordance with Article 104 of [revised Regulation (EC) No 726/2004]. By means of the national medicines web-portals, the Member States shall make publicly available at least the following:

Added:(a) public assessment reports, together with a summary thereof;

Added:(b) summaries of product characteristics and package leaflets;

Added:(ba) the outcome of the assessment of the ERA, including the data submitted by the marketing authorisation holder, in accordance with Article 22(7a) and Article 29(4a); [Am. 224]

Added:(c) summaries of risk management plans for medicinal products covered by a national marketing authorisation in accordance with Chapter III;

Added:(d) information on the different ways of reporting suspected adverse reactions to medicinal products to competent authorities of the Member States by healthcare professionals and patients, including the web-based structured forms referred to in Article 102 of [revised Regulation (EC) No 726/2004].

Added:(da) where relevant, information related to antimicrobials, in accordance with Article 17(2) and Article 29(4a); [Am. 225]

Added:(db) where relevant, the awareness card with information on antimicrobial resistance and the appropriate use and disposal of antimicrobials; [Am. 226]

Added:(dc) periodic safety update reports; [Am. 227]

Added:(dd) information on the shortage status of medicinal products as referred to in Article 121(1), point (b), of [revised Regulation (EC) No 726/2004]. [Am. 228]

Added:2. The summaries referred to in paragraph 2, point (c), shall include, where relevant, a description of additional risk minimisation measures.

Added:Article 103 Publication of assessment

Added:The Agency shall make publicly available the final assessment conclusions, recommendations, opinions and decisions referred to in Articles 107 to 116, by means of the European medicines web-portal.

Added:Article 104 Public announcements

Added:1. As soon as the marketing authorisation holder intends to make a public announcement relating to information on pharmacovigilance concerns in relation to the use of a medicinal product, and in any event at the same time or before the public announcement is made, they shall be required to inform the competent authorities of the Member States, the Agency and the Commission.

Added:2. The marketing authorisation holder shall ensure that information to the public is presented objectively and is not misleading.

Added:3. Unless urgent public announcements are required for the protection of public health, the Member States, the Agency and the Commission shall inform each other not less than 24 hours prior to a public announcement relating to information on pharmacovigilance concerns.

Added:4. For active substances contained in medicinal products authorised in more than one Member State, the Agency shall be responsible for the coordination between competent authorities of the Member States of safety announcements and shall provide timetables for the information being made publicly available.

Added:5. Under the coordination of the Agency, the Member States shall make all reasonable efforts to agree on a common message in relation to the safety of the medicinal product concerned and the timetables for their distribution. The Pharmacovigilance Risk Assessment Committee shall, at the request of the Agency, provide advice on those safety announcements.

Added:6. When the Agency or competent authorities of the Member States make publicly available information referred to in paragraphs 2 and 3, any personal data or data of a commercially confidential nature shall be deleted unless its public disclosure is necessary for the protection of public health.

Added:Section 3 Recording and reporting of suspected adverse reactions

Added:Article 105 Recording and reporting of suspected adverse reactions by the marketing authorisation holder

Added:1. Marketing authorisation holders shall record all suspected adverse reactions in the Union or in third countries that are brought to their attention, whether reported spontaneously by patients or healthcare professionals, or occurring in the context of a post-authorisation study including data relating to off-label use of the product.