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. 2022 Jan 31;36(1):33–46. doi: 10.1007/s40290-021-00414-8

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© The Author(s) 2022

Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.

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Fig. 4 — The influence of PASS on the removal and reclassification of SCs. Figure shows the absolute number of European Risk Management Plans (EU-RMPs) SCs (i.e., IIR, IPR and MI) with additional (a) Pharmacovigilance (PV) activities, such as PASS, for Products A, B, C, D, E, F, and G any time point between 2006 and 2020, and the number of SCs (i.e., IIR, IPR and MI) whose removal or reclassification were associated with results from an aPV activity. a The absolute number of SCs that were removed or reclassified based on results from at least one aPV activity compared to the total number of SCs with at least one aPV activity b The absolute number of SCs that were removed or reclassified based on results from completed aPV activities before or after the implementation of GVP Module V Revision 2 in 2017, respectively. aPV additional pharmacovigilance, EU-RMP European Risk Management Plan, GVP Guidelines on Good Pharmacovigilance Practices, HA health authority, IIR important identified risk, IPR important potential risk, MI missing information, PASS Post-authorisation Safety Studies, PV pharmacovigilance, RM risk minimisation, SCs safety concerns