Information for Market Authorisation Holders

Since drug safety is a common goal for both market authorization holders (MAH) and Lareb a good cooperation between Lareb and the MAH is highly valued. This page will provide you with the most important information about this. Detailed rules for reporting of ADRs by MAH can be found on the Dutch MEB website.

Mailing address

Whenever Lareb receives a report of serious ADRs an anonymous copy of this report is forwarded to the MAH of the product within 15 days. Mailing of these reports is a fully automated process.

Generic products

When the report mentions a specific generic product, this report will be sent to the MAH of the specific product. If it is not clear which generic product has been used, the report will be sent to the innovative pharmaceutical company. Lareb can also send all non-serious reports to E2B compatible MAH on request. If a pharmaceutical company is not E2B compatible, but wishes to be informed about the non-serious reports concerning their products, a so called line-listing can be offered in most cases.

Reports by patients

Patients have been able to report directly to Lareb since April 2003. Please note that in most cases there is no medical confirmation of the reported adverse drug reaction. If a case is medically confirmed, this will be mentioned in the report.

International cooperation

Anonymous copies of all reports are sent to the Dutch Medicines Evaluation Board (MEB). In addition, these reports are forwarded to the European Medicines Agency (EMA) and to the database of the World Health Organization Collaborating Centre (the Uppsala Monitoring Centre).

Publications

If Lareb is preparing a publication about a specific product, the MAH is offered the opportunity to give scientific feedback about the contents of the final draft. Relevant, scientific remarks are highly valued.

Quarterly reports

Four times a year signals are being forwarded to the MEB in a Quarterly Report. These reports will be published in an unabridged version on the website of Lareb together with a short reaction of the MEB. In the event a topic concerns a specific product, the MAH is offered the opportunity to give feedback. When the message concerns several products at the same time (for instance in the event of class effects) the individual MAH will not be notified in advance. MAH will have the possibility to give feedback within 2 weeks. 

Request for follow-up info (via Lareb) from the reporter

In cases where Lareb receives follow-up information, the MAH will be notified automatically when this information is processed (within 15 days of receipt). There is no need for active inquiry. According to the Health Care Inspectorate in the Netherlands, the MAH is not obliged to ask for follow-up information with respect to reports originating from Lareb. However, in specific cases, it is possible to ask Lareb for follow-up information that requires consultation with the report’s submitter.

A request for follow-up (FU-information) can be taken into account if the following requirements are fulfilled:

  • Only reports from physicians can be taken into account.   
  • The report is of special interest to the MAH for one of the following reasons: the suspect drug is new on the Dutch market, the suspect drug is being used for a new indication, the suspect drug is being followed in a Risk Management Plan and the suspect drug is a possible new signal or the report is incomplete (according to CIOMS V)
  • The MAH uses the standard FU-request form (the form is in Dutch only) and sends it to Lareb by e-mail (or standard mail). 
  • The request for FU information is clearly formulated. The MAH limits the number of questions and explains the relevance of the requested information.

Lareb will deal with a valid FU-request as soon as possible and will get back to the MAH within 8 weeks. The response will be given in one of the following formats:

  • Lareb askes the report’s submitter for FU information, with the following result: 
  • Lareb asked the report’s submitter for FU information, but did not receive an answer.
  • Lareb decided not to ask the report’s submitter for FU information, because...

Lareb never provides a complete discharge letter, but will give the information from the letter that is needed to answer the question. It is not possible for MAH to ask additional questions about the FU information given by Lareb. 

For questions or requests you can email the contact person for the pharmaceutical industry Joep Scholl by sending an e-mail to: j.scholl@lareb.nl