Information for pharmaceutical companies

Reporting to EudraVigilance

National authorities and marketing authorisation holders (MAH) in the EEA must send all suspected adverse reaction reports directly to EudraVigilance (EV). Reporting to EV can be done both in the national language and in English.

EudraVigilance, suspected adverse reaction reports and E2B

The Swedish Medical Products Agency (Swedish MPA) sends suspected adverse reaction reports to EV in ICH E2B (R2) format. Any transition to ICH E2B (R3) format will be notified by the Swedish MPA. Downloading these suspected adverse reaction reports from EV does not provide direct access to the narrative of the reports; this depends on the user’s access. Access to the narrative ‘ICSR data set level 2B’ can be requested in accordance with EudraVigilance access policy (ICSR being the individual case safety report).

Information from EMA regarding Level 2B access: ‘can be assigned to users in support of signal management or where the review of ICSR data is warranted in the context of a pharmacovigilance assessment procedure by the MAH’.

Film showing how to request Level 2B access:

MAH’s request for follow‍-‍up information

Requests from the MAH for further information may be sought in special cases from the Swedish MPA. In order to request further information, the request must be relevant, have medical grounds and be justified by the MAH. Examples of this may be where a product as further routine pharmacovigilance activities in its risk management plan (RMP) describes the use of a follow‍-‍up questionnaire for an adverse reaction. The Swedish MPA does not pass on routine follow‍-‍up from the MAH to the reporter.

Recommendations to the MAH when a request for follow‍-‍up are considered

• The MAH must contact the company’s QPPV before making an enquiry to the Swedish MPA. This is in order to gain access to a full report, including the narrative of the report. After getting access to the full report the MAH should assess if important information is missing and should be requested for example according to the follow‍-‍up questionnaire in the current RMP. Information that is documented in the report should not be requested.
• Justification for the request should be described. For example, if the request concerns an event for a medicinal product with a follow‍-‍up questionnaire described in its Risk Management Plan (RMP), selected and relevant text from RMP specific to the request must be attached.
• Questions and questionnaires addressed to the reporter should be in Swedish. It is recommended that you only should translate the questions for which the information is not already provided in the initial report.
• No name nor logotypes for companies such as the MAH should be stated in the document with the questions to the reporter.
• Each request for follow-up of an ICSR should be submitted individually.
• Please use the wwc-number for reference when contacting us regarding a report.
• MAH's with a Swedish representative must enclose a signed and dated PoA (Power of Attorney) from the MAH’s authorised signatory for the product with each request where the representative is not registered with the Swedish MPA.
• Send the request by email to: adr-report@lakemedelsverket.se

COVID-19 Vaccines and follow‍-‍up

The Swedish MPA assess the need for requesting further information from the reporter for each ICSR with COVID‍-‍19 Vaccines we receive due to the ongoing Pharmacovigilance Activities. The assessment includes reactions which are considered as AESI (adverse events of special interest), lack of effect or disease progression but also a medical review.

Handling of requests for follow‍-‍up at the Swedish MPA

The Swedish MPA handles the request for follow‍-‍up as follows:

• Only questions regarding important information that is missing in the report will be forwarded to the reporter. The Swedish MPA does not pass on routine follow‍-‍ups from the MAH to the reporter.
• If a response is received from the reporter, the report is updated with new information in EV.

The Swedish MPA rejects requests for follow‍-‍up if:

• They are not justified, are not considered relevant or there is no medical ground.
• The attached documentation does not confirm the need for follow‍-‍up, e.g., relevant attached documents from the current RMP.
• It concerns already known adverse reactions in the Summary of Product Characteristics (SmPC) (exceptions to this may occur).

Language of the Swedish MPA’s suspected adverse reaction reports

• Narratives are written in Swedish.
• The English version of MedDRA is used for coding. The data fields are in English in EudraVigilance with the following exceptions given in Swedish:
  • the product name of the medicinal product reported.
  • the adverse reaction term reported (linked to English MedDRA term in coding).

EVWEB or gateway system failure

EMA has instructions describing management:

Management of duplicates in EudraVigilance

• In cases where it is suspected that there is a duplicate in EV, EMA must be notified via the EMA Service Desk with information on the cases that are suspected to be duplicate. If EMA’s investigation shows that the case involves a duplicate, what is known as a ‘master case’ will be created that merges all duplicates according to the latest available information.
• If the MAH suspects that the EV report downloaded from the Swedish MPA may be the same as that received by the MAH, the MAH must nevertheless complete its reporting to EV. In this case, EMA should be informed via the EMA Service Desk that they must initiate the duplicate management process.

See GVP Module VI Addendum I – ‘Duplicate management of suspected adverse reaction reports’:

Suspected adverse reaction reports from the literature

There are no requirements in Sweden for suspected adverse reaction reports based on published literature articles to be submitted as an annex to the suspected adverse reaction report. However, a reference to the article must be indicated in the report (Vancouver style). The article need only be submitted if requested.

Suspected adverse reaction reports that the MAH wishes to upgrade from non‍-‍serious to serious

An suspected adverse reaction report downloaded by the MAH from EV and originating from the Swedish MPA must not be resubmitted by the MAH unless new information has been received from the reporter. For example, this should not be sent to EV if the MAH chooses to assess the severity of the report differently.