Follow-up information on adverse reaction reports

23 November 2017, Updated 27 February 2019

The Danish Medicines Agency has introduced a new practice for the processing of pharmaceutical companies’ requests for follow-up information on reports of suspected adverse reactions. We need to strengthen the practice to ensure that we only receive follow-up requests that are relevant and necessary for pharmacovigilance reasons.

When we receive a follow-up request from a pharmaceutical company, we assess whether the request for the follow-up information is relevant and necessary.

  • In order to request follow-up information from the Danish Medicines Agency, the pharmaceutical company must have full access (level 2B) to the case report via EudraVigilance (narrative included)
  • The companies must give a specific reason for each follow-up request
  • The request must be relevant, necessary and well-founded in each case
  • The criteria for submitting a follow-up request must always be met before a written well-founded follow-up request is submitted to the Danish Medicines Agency

Specific reason

  • A written request is sent to the Danish Medicines Agency containing a specific reason for the requested information and why the information is relevant and necessary for pharmacovigilance and patient safety
  • All questions in a follow-up request must be formulated as specific questions that are understandable to the recipient (experience shows that imprecise questions will result in imprecise answers; consider the use of open and closed questions)
  • Follow-up questions should be formulated so that they can be forwarded to the recipient without any editing or explanations
  • Questions to citizens should be in Danish

Recommendations

  • Questions to healthcare professionals should preferably be in Danish
  • Write your statement of reasons to the recipient and explain briefly why the requested information is relevant and necessary
  • Consider how to present questions in a clear and precise manner, for example in a table
  • Consider whether the follow-up reply can be coded in structured fields

Submission of request for follow-up information

The written request and questions should be sent via DKMAnet. See the guideline under Related content.

Rejection

The Danish Medicines Agency will reject follow-up requests from pharmaceutical companies in the following situations:

  • A request that does not include a specific reason for each question will be returned, and the pharmaceutical company will be asked to submit a new reasoned request that meets the above criteria.
  • A request that does not include precise questions will be returned, and the company will be asked to submit a new request with questions that meet the above criteria.
  • In the opinion of the Danish Medicines Agency, the collection of additional information is not relevant and necessary for monitoring the safety of the medicinal product (signal detection and assessment of the medicinal product’s risk-benefit balance)
  • A follow-up request on known adverse reactions described in the summary of product characteristics is generally rejected. In exceptional cases, a follow-up may be relevant, for example a strong suspicion that a known adverse reaction occurs more frequently than expected, and a signal has been reported
  • Non-serious reports (unless a signal has been reported and the information is relevant in relation to the reported signal)

Examples of situations where it may be relevant and necessary to request follow-up information

  • PSUR pharmacovigilance assessment procedure
  • Pharmacovigilance assessment procedure required by the PRAC
  • Pharmacovigilance referral assessment procedure
  • Pharmacovigilance signal assessment procedure
  • RMP obligation

Forwarding of follow-up requests

If the follow-up request is considered relevant and necessary for patient safety, the Danish Medicines Agency will forward the follow-up request and update the case report if or when the Danish Medicines Agency receives new relevant information.

Previous follow-up requests

Previously submitted follow-up requests that have not been answered will be assessed with increased focus on pharmacovigilance and patient safety. Requests that do not meet the above criteria will be rejected. We will send a reply to the companies as soon as possible. We cannot give a date for when we will send a reply to each company.

See the Guideline for follow-up via DKMAnet, which gives a detailed description of the practice as well as the Q&A document.

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