Procedure for testing exchange of E2B files with the Danish Medicines Agency

Claus Iversen
Dokumentation
This paper presents the procedure for testing the exchange of E2B files between the Danish Medicines Agency and the Pharmaceutical Industry.

Preparations

  • It is a prerequisite that your company has a profile on the EMEA EudraVigilance gateway. If you don't already have one, please contact the EMEA.
  • The IT system of the Danish Medicines Agency only supports ICH ICSR DTD Version 2.1. Please make sure that your testfiles match this standard.

    Contact the Danish Medicines Agency

  • Contact Marie Gomard (tel +45 44 88 92 06) from the Medicines Control Division in order to make an appointment regarding the test. Information must be provided on the following points:
  • Who is our contact at your company?
  • Does your company want to test sending E2B files, receiving E2B files or both?
  • What is your profile id on the EMEA EudraVigilance gateway?
  • A suitable time for the test will be agreed on. Any alterations from this plan from any of the parties should be communicated instantly.

    Testing

  • If you are sending E2B files to the Danish Medicines Agency please tell us the report number as stated in the field A.1.0.1 Sender’s (case) safety report unique identifier and A.1.10.2 Other sender’s case report number before sending the file. Furthermore it must be obvious from the contents of the sec-tion B.5 Narrative case summary and further information that it is a testfile. Please send your E2B files to DKMAEUDRA on the EMEA EudraVigilance gateway.
  • If you are receiving an E2B file from the Danish Medicines Agency it will have the number DK-DKMA-20021027 in the field A.1.10.1 Regulatory authority’s case report number. The data in the report is fictitious. It is stated in the section B.5 Narrative case summary and further information that it is a testfile.

    Evaluation

  • Both parties should evaluate the contents of the acknowledgement messages within 2 business days after the test was performed.
  • Please contact the Danish Medicines Agency 2 business days after the test was performed to compare notes. If retest is desired this can be arranged.

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