Changes from plenary report to adopted text

AddedWhere a marketing authorisation holder or another person intending to submit information, has confidential data relevant to the subject matter of the procedure, they may request permission to present that data to the Pharmacovigilance Risk Assessment Committee in a non-public hearing.

Added3. Within 60 days of the submission of the information, the Pharmacovigilance Risk Assessment Committee shall make a recommendation, stating the reasons on which it is based, having due regard to the therapeutic effect of the medicinal product. The recommendation shall mention any divergent positions and the grounds on which they are based. In the case of urgency, and on the basis of a proposal by its chairperson, the Pharmacovigilance Risk Assessment Committee may agree to a shorter deadline. The recommendation shall include any or a combination of the following conclusions:

Added(a) no further evaluation or action is required at Union level;

Added(b) the marketing authorisation holder should conduct further evaluation of data and carry out a follow-up of the results of that evaluation;

Added(c) the marketing authorisation holder should sponsor a post-authorisation safety study and carry out a follow up evaluation of the results of that study;

Added(d) the Member States or marketing authorisation holder should implement risk minimisation measures;

Added(e) the marketing authorisation should be suspended, revoked or not renewed;

Added(f) the marketing authorisation should be varied.

Added4. For the purposes of paragraph 3, point (d), the recommendation shall specify the risk minimisation measures recommended and any conditions or restrictions to which the marketing authorisation should be made subject, including the timeline for implementation.

Added5. For the purposes of paragraph 3, point (f), where it is recommended to change or add information in the summary of product characteristics or the labelling or package leaflet, the recommendation shall suggest the wording of such changed or added information and shall indicate where in the summary of product characteristics, the labelling or package leaflet such wording should be placed.

AddedArticle 116 Follow-up of recommendation made in the framework of the urgent Union procedure

Added1. Where the scope of the urgent Union procedure, as determined in accordance with Article 114(6), does not include any centralised marketing authorisation, the coordination group shall, within 30 days of receipt of the recommendation of the Pharmacovigilance Risk Assessment Committee, consider the recommendation and reach a position on the maintenance, variation, suspension, revocation or refusal of the renewal of the marketing authorisation concerned, including a timetable for the implementation of the agreed position. Where an urgent adoption of the position is necessary, the coordination group may, on the basis of a proposal by its chairperson, agree to a shorter deadline.

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, revoke or refuse renewal of the marketing authorisation concerned in accordance with the implementation timetable determined in the agreement.

AddedIn the event that a variation is agreed upon, the marketing authorisation holder shall submit to the competent authorities of the Member States an appropriate application for a variation, 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 the Member States represented within the coordination group differs from the recommendation of the Pharmacovigilance Risk Assessment Committee, the coordination group shall attach to the agreement or majority position a detailed explanation of the scientific grounds for the differences together with the recommendation.

Added3. Where the scope of the procedure, as determined in accordance with Article 114(6), includes at least one centralised marketing authorisation, the Committee for Medicinal Products for Human Use shall, within 30 days of receipt of the recommendation of the Pharmacovigilance Risk Assessment Committee, consider the recommendation and adopt an opinion on the maintenance, variation, suspension, revocation or refusal of the renewal of the marketing authorisations concerned. Where an urgent adoption of the opinion is necessary, the Committee for Medicinal Products for Human Use may, on the basis of a proposal by its chairperson, agree to a shorter deadline.

AddedWhere the 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.

Added4. 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 that are granted by the Member States and that are subject to the urgent Union procedure;

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

Added5. Article 42 shall apply to the adoption of the decision referred to in paragraph 4, point (a), and to its implementation by the Member States.

Added6. Article 13 of [revised Regulation (EC) No 726/2004] shall apply to the decision referred to in paragraph 4, 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 7 Supervision of post-authorisation safety studies

AddedArticle 117 Non-interventional post-authorisation safety studies

Added1. This Section applies to non-interventional post-authorisation safety studies that are initiated, managed or financed by the marketing authorisation holder voluntarily or pursuant to obligations imposed in accordance with Articles 44 or 87, and that involve the collection of safety data from patients or healthcare professionals.

Added2. This Section is without prejudice to Member States and Union requirements for ensuring the well-being and rights of participants in non-interventional post-authorisation safety studies.

Added3. The studies shall not be performed where the act of conducting the study promotes the use of a medicinal product.

Added4. Payments to healthcare professionals for participating in non-interventional post-authorisation safety studies shall be restricted to the compensation for time and expenses incurred.

Added5. The competent authority of the Member State may require the marketing authorisation holder to submit the protocol and the progress reports to the competent authorities of the Member States in which the study is conducted.

Added6. The marketing authorisation holder shall send the final report of the study to the competent authorities of the Member States in which the study was conducted within 12 months of the end of data collection.

Added7. While a study is being conducted, the marketing authorisation holder shall monitor the data generated and consider its implications for the benefit-risk balance of the medicinal product concerned.

AddedAny new information that might influence the evaluation of the benefit-risk balance of the medicinal product shall be communicated to the competent authorities of the Member State in which the medicinal product has been authorised in accordance with Article 90.

AddedThe obligation laid down in the second subparagraph is without prejudice to the information on the results of studies that the marketing authorisation holder shall make available by means of the periodic safety update reports as laid down in Article 107.

Added8. Articles 118 to 121 shall apply exclusively to studies referred to in paragraph 1 that are conducted pursuant to an obligation imposed in accordance with Articles 44 or 87.

AddedArticle 118 Agreement of a protocol for a non-interventional post-authorisation safety study

Added1. Before a study is conducted, the marketing authorisation holder shall submit a draft protocol to the Pharmacovigilance Risk Assessment Committee, except for studies to be conducted in only one Member State that requests the study in accordance with Article 87. For such studies, the marketing authorisation holder shall submit a draft protocol to the competent authority of the Member State in which the study is conducted.

Added2. Within 60 days of the submission of the draft protocol referred to in paragraph 1 the competent authority of the Member State or the Pharmacovigilance Risk Assessment Committee, as appropriate, shall issue:

Added(a) a letter endorsing the draft protocol;

Added(b) a letter of objection, which shall set out in detail the grounds for the objection, where:

Added(i) it considers that the conduct of the study promotes the use of a medicinal product;

Added(ii) it considers that the design of the study does not fulfil the study objectives; or

Added(c) a letter notifying the marketing authorisation holder that the study is a clinical trial falling under the scope of Regulation (EU) No 536/2014.

Added3. The study may commence only when the written endorsement from the competent authority of the Member State or the Pharmacovigilance Risk Assessment Committee, as appropriate, has been issued.

AddedWhere a letter of endorsement of the draft protocol as referred to in paragraph 2, point (a), has been issued, the marketing authorisation holder shall forward the protocol to the competent authorities of the Member States in which the study is to be conducted and may thereafter commence the study according to the endorsed protocol.

AddedArticle 119 Update of a protocol for a non-interventional post-authorisation safety study

AddedAfter a study has been commenced, any substantial amendments to the protocol shall be submitted, before their implementation, to the competent authority of the Member State or to the Pharmacovigilance Risk Assessment Committee, as appropriate. The competent authority of the Member State or the Pharmacovigilance Risk Assessment Committee, as appropriate, shall assess the amendments and inform the marketing authorisation holder of its endorsement or objection. Where applicable, the marketing authorisation holder shall inform the Member States in which the study is conducted.

AddedArticle 120 Final study report on a non-interventional post-authorisation safety study

Added1. Upon completion of the study, a final study report shall be submitted to the competent authority of the Member State or the Pharmacovigilance Risk Assessment Committee within 12 months of the end of data collection unless a written waiver has been granted by the competent authority of the Member State or the Pharmacovigilance Risk Assessment Committee, as appropriate.

Added2. The marketing authorisation holder shall evaluate whether the results of the study have an impact on the marketing authorisation and shall, if necessary, submit to the competent authorities of the Member States an application to vary the marketing authorisation.

Added3. Together with the final study report, the marketing authorisation holder shall electronically submit an abstract of the study results to the competent authority of the Member State or the Pharmacovigilance Risk Assessment Committee.

AddedArticle 121 Recommendations following the submission of a final study report on non-interventional post-authorisation safety studies

Added1. Based on the results of the study and after consultation of the marketing authorisation holder, the Pharmacovigilance Risk Assessment Committee may make recommendations concerning the marketing authorisation, stating the reasons on which they are based. The recommendations shall mention any divergent positions and the grounds on which they are based.

Added2. When recommendations for the variation, suspension or revocation of a national marketing authorisation are made, the Member States represented within the coordination group shall agree on a position on the matter taking into account the recommendation referred to in paragraph 1 and shall include a timetable for the implementation of the agreed position.

AddedIf, 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 vary, suspend or revoke the marketing authorisation concerned in accordance with the implementation timetable determined in the agreement.

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

AddedThe agreement shall be made publicly available on the European medicines web-portal established in accordance with Article 104 of [revised Regulation (EC) No 726/2004].

Added3. If 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.

Added4. Where 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 majority position a detailed explanation of the scientific grounds for the differences together with the recommendation.

AddedSection 8 Implementation, guidance and reporting