What regulations apply for safety surveillance in Sweden?
In Sweden reference is made to LVFS 2007:2. Current guideline is Volume 9A.
What should be sent to the EVHUMAN for MPA?
All spontaneous serious reports originating in Sweden.
The request to also report “All spontaneous serious reports originating within the EEA if Sweden is RMS” and “All spontaneous serious unexpected reports originating outside the EEA” is withdrawn.
To other Nordic countries you do not have to send serious, unexpected reports originating outside the EU. Do you have to send these to the MPA?
No.
Is it acceptable to send all serious spontaneous reports occurring outside the EU, i.e. also expected cases?
Follow EMA/EVHUMANs guidelines.
Should consumer reports be sent to the EVHUMAN for MPA?
No, not as individual case reports. Consumer reports received during current PSUR period should be listed separately and be attached to the PSUR.
Do you have to attach the article if you send reports from the literature?
No, a reference is sufficient.
What are the time limits?
A spontaneous report must be sent within 15 days after the receipt by the company.
How do you send electronically?
Either you send the reports via the EMEA Gateway which in turn communicates with the MPA Gateway, or in the case where you do not have a Gateway of your own, the EVWEB tool of EMEA (the Webtrader) could be used. For information on the testing procedure requested to be able to communicate with EMEA, please see the Eudravigilance web-site.
When is the reporting obligation fulfilled?
The received MDN (Message Disposition Notification) verifies the sending date.
However, it is only when the company has received an approval by means of an ICHCSR acknowledgment message that the reporting obligation is fulfilled.
Do you get an MDN if you are using the Webtrader?
The EVWEB will provide you with an MDN. Please, see the Eudravigilance web-site for more information.
What is the procedure if the ’Ack’ is delayed?
If there are operational incidents at the EVHUMAN/EMA, information will be posted at their web-site. The EMEA and Eudravigilance web-sites should be consulted with regard to technical problems with the Cyclone gateway or with Eudravigilance. If you have not received an ‘ack’ within two days, try re-seding the report. The company must ensure that the agency has received the report (confirmed with an ’ack’) within 15 calendar days following receipt date or complied with back-up-routine.
If electronic dispatch does not work – which steps must the company take?
The company must send the report (preferably in the CIOMS format) by e-mail or by fax. E-mail record or fax receipt will show that the company has met reporting time limits. The head of the CIOMS form should be marked ’ELECTRONIC FAILURE + company name’. As soon as electronic connections is re-established the company must send the report electronically. It is the responsibility of the MAH that all back-log cases reaches the EV-PM.
What is the MPA address in the Eudravigilance system?
All adverse reactions, occuring in Sweden, should be reported directly to the Eudravigilance database (Id = EVHUMAN)
Can you send PDF files via the EMEA gateway?
No, the report itself must be in XML format. If you cannot convert the PDF file to XML you must enter the report manually by means of the EVWEB. If you have additional information (e.g. an electrocardiogram sheet), and you have noted this in the E2B section ’Additional Document’, this could preferably be sent as a PDF file to biv.central@mpa.se with an e-mail heading comprising Company number, world wide case number, and receipt date.
How can small companies cope with electronic reporting?
Small companies with very scarce reporting may contract a consultant specializing in this are to do the reporting for them.