Changes from plenary report to adopted text

AddedArticle 110 Single assessment of periodic safety update reports

Added1. A single assessment of periodic safety update reports shall be performed for medicinal products authorised in more than one Member State and, in the cases referred to in Article 108, paragraphs 4, 5 and 6, for all medicinal products containing the same active substance or the same combination of active substances and for which a Union reference date and a frequency of periodic safety update reports has been established.

AddedThe single assessment shall be conducted by either of the following:

Added(a) a Member State appointed by the coordination group where none of the marketing authorisations concerned has been granted in accordance with the centralised procedure provided for in Article 3 of [revised Regulation (EC) No 726/2004];

Added(b) a rapporteur appointed by the Pharmacovigilance Risk Assessment Committee, where at least one of the marketing authorisations concerned has been granted in accordance with the centralised procedure provided for in Article 3 of [revised Regulation (EC) No 726/2004].

AddedWhen selecting the Member State in accordance with the second subparagraph, point (a), the coordination group shall take into account whether any Member State is acting as a reference Member State, in accordance with Chapter III, Sections 3 and 4.

Added2. The Member State or rapporteur, as appropriate, 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 Member States concerned. The Agency shall send the report to the marketing authorisation holder.

AddedWithin 30 days of receipt of the assessment report, the Member States and the marketing authorisation holder may submit comments to the Agency and to the rapporteur or Member State.

Added3. Following the receipt of the comments referred to in paragraph 2, the rapporteur or Member State 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 any 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 of [revised Regulation (EC) No 726/2004] and forward them to the marketing authorisation holder.

AddedArticle 111 Regulatory action on periodic safety update reports

AddedFollowing the assessment of periodic safety update reports referred to in Article 107, the competent authorities of the Member States shall consider whether any action concerning the marketing authorisation for the medicinal product concerned is necessary and shall maintain, vary, suspend or revoke the marketing authorisation as appropriate.

AddedArticle 112 Procedure for regulatory action on periodic safety update reports

Added1. In the case of a single assessment of periodic safety update reports in accordance with Article 110(1) which recommends action concerning more than one marketing authorisation that does not include any centralised marketing authorisation, the coordination group shall, within 30 days of receipt of the assessment report of the Pharmacovigilance Risk Assessment Committee, consider the assessment report and reach a position on the maintenance, variation, suspension or revocation of the marketing authorisations concerned, including a timetable for the implementation of the agreed position.

Added2. If, within the coordination group, the Member States represented reach an agreement on the action to be taken by consensus, the chairperson shall record the agreement and send it to the marketing authorisation holder and the Member States. The Member States shall adopt necessary measures to maintain, vary, suspend or revoke the marketing authorisations concerned in accordance with the timetable for implementation determined in the agreement.

AddedIn the event of a variation, the marketing authorisation holder shall submit to the competent authorities of the Member States an appropriate application for a modification, including an updated summary of product characteristics and an updated package leaflet within the determined timetable for implementation.

AddedIf an agreement by consensus cannot be reached, the position of the majority of the Member States represented within the coordination group shall be forwarded to the Commission which shall apply the procedure laid down in Article 42.

AddedWhere the agreement reached by the Member States represented within the coordination group or the position of the majority of Member States differs from the recommendation of the Pharmacovigilance Risk Assessment Committee, the coordination group shall attach to the agreement or the majority position a detailed explanation of the scientific grounds for the differences together with the recommendation.

Added3. In the case of a single assessment of periodic safety update reports in accordance with Article 110(1) that recommends action concerning more than one marketing authorisation that includes at least one centralised marketing authorisation, the Committee for Medicinal Products for Human Use shall, within 30 days of receipt of the report of the Pharmacovigilance Risk Assessment Committee, consider the report and adopt an opinion on the maintenance, variation, suspension or revocation of the marketing authorisations concerned, including a timetable for the implementation of the opinion.

Added4. Where the opinion of the Committee for Medicinal Products for Human Use referred to in paragraph 3 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.

Added5. On the basis of the opinion of the Committee for Medicinal Products for Human Use referred to in paragraph 3, the Commission shall, by means of implementing acts:

Added(a) adopt a decision addressed to the Member States concerning the measures to be taken in respect of marketing authorisations granted by the Member States and concerned by the procedure provided for in this section; and

Added(b) where the opinion states that regulatory action concerning the marketing authorisation is necessary, adopt a decision to vary, suspend or revoke the centralised marketing authorisations and concerned by the procedure provided for in this section.

Added6. Article 42 shall apply to the adoption of the decision referred to in paragraph 5, point (a), and to its implementation by the Member States.

Added7. Article 13 of [revised Regulation (EC) No 726/2004] shall apply to the decision referred to in paragraph 5, point (b). Where the Commission adopts such decision, it may also adopt a decision addressed to the Member States pursuant to Article 55 of [revised Regulation (EC) No 726/2004].

AddedSection 5 Signal detection

AddedArticle 113 Signal monitoring and detection

Added1. Regarding medicinal products authorised in accordance with Chapter III, competent authorities of the Member States shall in collaboration with the Agency, take the following measures:

Added(a) monitor the outcome of risk minimisation measures contained in risk management plans and of the conditions referred to in Articles 44, 45 and any obligations imposed in accordance with Article 87;

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

Added(c) monitor the data in the Eudravigilance database to determine whether there are new risks or whether risks have changed and whether those risks impact on the benefit-risk balance.

Added2. The Pharmacovigilance Risk Assessment Committee shall perform the initial analysis and prioritisation of signals of new risks or risks that have changed or changes to the benefit-risk balance. Where it considers that follow-up action may be necessary, the assessment of those signals and agreement on any subsequent action concerning the marketing authorisation shall be conducted in a timescale commensurate with the extent and seriousness of the issue.

Added3. The Agency and competent authorities of the Member States and the marketing authorisation holder shall inform each other in the event of new risks or risks that have changed or changes to the benefit-risk balance being detected.

Added4. Member States shall ensure that marketing authorisation holders inform the Agency and competent authorities of the Member State in the event of new risks or risks that have changed or when changes to the benefit-risk balance have been detected.

AddedSection 6 Urgent Union procedure

AddedArticle 114 Initiation of an urgent Union procedure

Added1. A Member State or the Commission, as appropriate, shall, on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities, initiate the procedure provided for in this Section (the ‘urgent Union procedure’) by informing the other Member States, the Agency and the Commission where:

Added(a) it considers suspending or revoking a marketing authorisation;

Added(b) it considers prohibiting the supply of a medicinal product;

Added(c) it considers refusing the renewal of a marketing authorisation; or

Added(d) it is informed by the marketing authorisation holder that, on the basis of safety concerns, the marketing authorisation holder has interrupted the placing on the market of a medicinal product or has taken action to have a marketing authorisation withdrawn, or intends to take such action or has not applied for the renewal of a marketing authorisation.

Added2. A Member State or the Commission, as appropriate, shall, on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities, inform the other Member States, the Agency and the Commission where it considers that a new contraindication, a reduction in the recommended dose or a restriction to the therapeutic indications of a medicinal product is necessary. The information shall outline the action considered and the reasons therefore.

AddedAny Member State or the Commission, as appropriate, shall, when urgent action is considered necessary in any of the cases referred to in the first subparagraph, initiate the urgent Union procedure.

AddedWhere the urgent Union procedure is not initiated, for medicinal products authorised in accordance with Chapter III, Sections 3 and 4, the case shall be brought to the attention of the coordination group.

AddedArticle 95 shall apply where the interests of the Union are involved.

Added3. Where the urgent Union procedure is initiated, the Agency shall verify whether the safety concern relates to medicinal products other than the one covered by the information, or whether the safety concern is common to all medicinal products belonging to the same range or therapeutic class.

AddedWhere the medicinal product involved is authorised in more than one Member State, the Agency shall without undue delay inform the initiator of the urgent Union procedure of the outcome of the verification, and the procedures laid down in Articles 115 and 116 shall apply. Otherwise, the safety concern shall be addressed by the Member State concerned. The Agency or the Member State, as applicable, shall make the information that the urgent Union procedure has been initiated available to marketing authorisation holders.

Added4. Without prejudice to paragraphs 1 and 2, and Articles 115 and 116, a Member State may, where urgent action is necessary to protect public health, suspend the marketing authorisation and prohibit the use of the medicinal product concerned on its territory until a definitive decision is adopted in the urgent Union procedure. It shall inform the Commission, the Agency and the other Member States no later than the following working day of the reasons for its action.

Added5. At any stage of the procedure laid down in Articles 115 and 116, the Commission may request a Member State in which the medicinal product is authorised to take temporary measures immediately.

AddedWhere the scope of the procedure, as determined in accordance with paragraphs 1 and 2, includes medicinal products covered by centralised marketing authorisations, the Commission may, at any stage of the urgent Union procedure, take temporary measures immediately in relation to those marketing authorisations.

Added6. The information referred to in this Article may relate to individual medicinal products or to a range of medicinal products or a therapeutic class.

AddedIf the Agency identifies that the safety concern relates to more medicinal products than those that are covered by the information or that the safety concern is common to all medicinal products belonging to the same range or therapeutic class, it shall extend the scope of the procedure accordingly.

AddedWhere the scope of the urgent Union procedure concerns a range of medicinal products or therapeutic class, medicinal products covered by the centralised marketing authorisation, that belong to that range or class shall also be included in the procedure.

Added7. At the time the information referred to in paragraphs 1 and 2 is provided, the Member State shall make available to the Agency all relevant scientific information that it has at its disposal and any assessment by the Member State.

AddedArticle 115 Urgent Union procedure scientific assessment

Added1. Following receipt of the information referred to in Article 114, paragraphs 1 and 2, the Agency shall publicly announce the initiation of the urgent Union procedure by means of the European medicines web-portal. In parallel, Member States may publicly announce the initiation of the procedure on their national medicines web-portals.

AddedThe announcement shall specify the matter submitted to the Agency in accordance with Article 114, and the medicinal products and, where applicable, the active substances concerned. It shall contain information on the right of the marketing authorisation holders, healthcare professionals and the public to submit to the Agency information relevant to the procedure and it shall state how such information may be submitted.

Added2. The Pharmacovigilance Risk Assessment Committee shall assess the matter that has been submitted to the Agency in accordance with Article 114. The rapporteur, as referred to in Article 152 of [revised Regulation (EC) No 726/2004], shall closely collaborate with the rapporteur appointed by the Committee for Medicinal Products for Human Use and with the reference Member State for the medicinal products concerned.

AddedFor the purposes of the assessment referred to in the first subparagraph, the marketing authorisation holder may submit comments in writing.

AddedWhere the urgency of the matter permits, the Pharmacovigilance Risk Assessment Committee may hold public hearings, where it considers that this is appropriate on justified grounds particularly with regard to the extent and seriousness of the safety concern. The hearings shall be held in accordance with the modalities specified by the Agency and shall be announced by means of the European medicines web-portal. The announcement shall specify the modalities of participation.

AddedThe Agency shall, in consultation with the parties concerned, draw up Rules of Procedure on the organisation and conduct of public hearings, in accordance with Article 163 of [revised Regulation (EC) No 726/2004].