Commission Implementing Regulation (EU) No 520/2012Dangos y teitl llawn

[F1 CHAPTER VII U.K. Periodic safety update reports

Article 34 U.K. Content of periodic safety update reports

1. The periodic safety update report shall be based on all available data and shall focus on new information which has emerged since the data lock point of the last periodic safety update report.

2. The periodic safety update report shall provide an accurate estimate of the population exposed to the medicinal product, including all data relating to the volume of sales and volume of prescriptions. This estimate of exposure shall be accompanied by a qualitative and quantitative analysis of actual use, which shall indicate, where appropriate, how actual use differs from the indicated use based on all data available to the marketing authorisation holder, including the results of observational or drug utilisation studies.

3. The periodic safety update report shall contain the results of assessments of the effectiveness of risk minimisation activities relevant to the risk–benefit assessment.

4. Marketing authorisation holders shall not be required to include systematically detailed listings of individual cases, including case narratives, in the periodic safety update report. However, they shall provide case narratives in the relevant risk evaluation section of the periodic safety update report where integral to the scientific analysis of a signal or safety concern in the relevant risk evaluation section.

5. Based on the evaluation of the cumulative safety data and the risk-benefit analysis, the marketing authorisation holder shall draw conclusions in the periodic safety update report as to the need for changes and/or actions, including implications for the approved summary of product characteristics for the product(s) for which the periodic safety update report is submitted.

6. Unless otherwise specified in the list of Union reference dates and frequency of submission referred to in Article 107c of Directive 2001/83/EC or agreed with the national competent authorities or the Agency, as appropriate, a single periodic safety update report shall be prepared for all medicinal products containing the same active substance and authorised for one marketing authorisation holder. The periodic safety update report shall cover all indications, routes of administration, dosage forms and dosing regimens, irrespective of whether authorised under different names and through separate procedures. Where relevant, data relating to a particular indication, dosage form, route of administration or dosing regimen shall be presented in a separate section of the periodic safety update report and any safety concerns shall be addressed accordingly.

7. Unless otherwise specified in the list of Union reference dates and frequency of submission referred to in Article 107c of Directive 2001/83/EC, if the substance that is the subject of the periodic safety update report is also authorised as a component of a fixed combination medicinal product, the marketing authorisation holder shall either submit a separate periodic safety update report for the combination of active substances authorised for the same marketing authorisation holder, with cross-references to the single-substance periodic safety update report(s), or provide the combination data within one of the single-substance periodic safety update reports.

Article 35 U.K. Format of periodic safety update reports

1. Electronic periodic safety update reports shall be submitted in the format set out in Annex II.

2. The Agency may publish templates for the modules set out in Annex II.]

Textual Amendments

F1 Regulation revoked in part (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 9 para. 1(t) (subject to transitional provisions in S.I. 2012/1916, Sch. 33A); 2020 c. 1, Sch. 5 para. 1(1)