In anticipation of the new pharmacovigilance legislation the Medicines Evaluation Board (MEB) decided to simplify the electronic handling of suspected adverse drug reaction reports requiring expedited reporting according to Regulation (EC) No 726/2004 and Directive 2001/83/EC as amended. Marketing Authorisation Holders (MAHs) no longer need to send these reports to the MEB, but should instead report directly to the EMA EudraVigilance database. The direct reporting to the EudraVigilance database may start on the 1st of December 2011 and all MAHs should submit directly to EudraVigilance at the latest by 7 February 2012.
Until the new EU pharmacovigilance legislation comes into force, the expedited reporting requirements only apply to serious cases:
Serious domestic
MAHs no longer need to send reports to the MEB, but should instead report all serious suspected adverse reactions occurring in the Netherlands directly to the EudraVigilance database.
- Lareb and RIVM reports should be regarded as ‘regulatory reports’ and should not be transmitted to EudraVigilance, as this might lead to duplicate reports in the database. ‘Non-serious’ Lareb/RIVM cases which have been upgraded to ‘serious’ by the MAH should not be submitted to EudraVigilance. Cases identified in publications based on analysis from Lareb should not be submitted to EudraVigilance either.
- Reports concerning compassionate use or named patient should also be submitted to EudraVigilance. In addition, the company should submit a CIOMS form of the report to the Healthcare Inspectorate.
- For cases identified in literature, a copy of the relevant published article (in pdf-format) should be sent via e-mail to evlit@ema.europa.eu. The file name of the PDF should match exactly the ‘World-Wide Unique Case Identification Number ‘ (in E2B(R2) format: primary source country-organisation identifier-casenumber, for example NL-CBGMEB-12345) and this number should also be stated in the subject line.
Serious EEA
When the Netherlands act as Reference Member State (RMS) in a decentralised procedure or the mutual recognition procedure, EEA cases will be made available to the MEB through the EV-PM module of the EudraVigilance database, according to current procedures in occurrence countries. To avoid duplicate reports in the EudraVigilance database, MAHs should not submit these EEA cases to EudraVigilance directly.
Serious Non-EEA
According to current legislation MAHs should ensure that all spontaneous suspected serious unexpected adverse reactions occurring in the territory of a third country are reported promptly to the EMA, and no later than 15 days following receipt of the information. MAHs are no longer required to submit non-EEA cases (regardless of authorisation procedure) to the MEB and there is no longer a need to apply for the non-EEA waiver.
The new EU pharmacovigilance legislation also introduces the obligation to report non-serious suspected adverse drug reactions within 90 days. Until the new legislation enters into force, there is no requirement for submission of non-serious reports.
The European Commission is of the opinion that with direct reporting to the EudraVigilance database, the legal demands on the reporting are fulfilled provided that the reports are available within the stipulated 15-day time frame. In case of technical problems with ICH E2B(R2) reporting to EudraVigilance, reports should be sent to the EMA in an alternative way in line with the instructions given by the EMA.
The MEB is now receiving 98% of all Dutch Individual Case Safety Reports (ICSRs) electronically in E2B(R2) format.The electronic reporting of suspected ADRs in line with ICH E2B(R2) format became mandatory in November 2005, based on article 24 of Regulation 726/2004 and article 106 of Directive 2001/83/EC as amended. Those MAHs who are still not able to submit in ICH E2B(R2) format are stretching this deadline extensively and should take appropriate action urgently. MAHs who do not yet have electronic ICH E2B(R2) reporting in place are allowed to send the CIOMS forms to adr15d@cbg-meb.nl until further notice.
Questions related to expedited reporting requirements can be sent to magmb@cbg-meb.nl
Notes:
1. The procedures for MAHs for receiving Lareb cases are not affected
2. Requirements related to SUSARs from interventional clinical trials(Directive 2001/20/EC) are not affected
