Aim of the website
Pharmacovigilance Centre Lareb is the Dutch knowledge centre for adverse reactions to drugs and other health products. Adverse drug reactions (ADRs) can be reported using the reporting form on this website. Each report of an ADR is carefully analyzed and recorded in a central database. Reports are anonymously displayed on this website. In addition, knowledge about ADRs and Lareb is distributed via this website
Personal information that is asked for on the reporting form is handled according to the General Data Protection Regulation (GDPR) and the general privacy regulation of Pharmacovigilance Centre Lareb. The general privacy regulation of Pharmacovigilance Centre Lareb is only available in Dutch. Personal information that is asked for is used for the registration of the ADR report and communication with the reporter. In order to detect duplicate reports, Pharmacovigilance Centre Lareb checks if the case already has been reported by using the patient’s date of birth and gender. Reporters may be approached for extra information about the case. In addition, reporters may be asked to fill in a questionnaire about the quality of the service of Pharmacovigilance Centre Lareb. The results of this questionnaire are exclusively shared with the management of Pharmacovigilance Centre Lareb.
The following personal information is collected:
From the reporter:
- E-mail address (for registration and correspondence between reporter and Pharmacovigilance Centre Lareb)
- 4 digits postal code (for mapping of distribution of reporting of vaccines within the Netherlands; reporting of postal code is not mandatory)
From the patient who experienced the ADR:
- Date of birth
- Drug use and indication
- Medical information
- Experienced adverse drug reaction(s)
- BSN number (citizen service number, no mandatory and only requested for reports concerning a corona vaccine)
Sharing with third parties
Reported ADRs are shared, without personal information of the reporter and patient, (with the exception of the patient’s age and gender) to the Netherlands Medicine Evaluation Board (CBG), the European Medicines Agency (EMA), the World Health Organization (WHO) and the marketing authorization holders (MAHs) of the suspected drug. The aim of forwarding the reports to these third parties is to monitor the safety of drugs nationally as well as internationally.
In addition, anonymised reports are incidentally shared with the Federation of Dutch Thrombosis Services (FNT), the Health and Youth Care Inspectorate (IGJ), the Netherlands Food and Consumer Product Safety Authority (NVWA), Dutch Pharmacy Association (KNMP), the National Institute for Public Health and the Environment (RIVM), the Dutch Institute for Rational Use of Medicine (IVM) and Eurocat (researchgroups of the University Medical Centre of Groningen).
Description of automatized data collection
All data collected on the reporting form is automatically processed and stored in the database of Pharmacovigilance Centre Lareb. This is a shielded database; only authorised staff members of the Pharmacovigilance Centre Lareb have access to this database.
The Pharmacovigilance Centre Lareb has been authorized by the National Institute for Public Health and the Environment (RIVM), to request the citizen service number (BSN) in the case of an unknown corona vaccine and/or unknown batch number of a corona vaccine. By using the citizen service number (BSN), information on the administered vaccine can be retrieved from the vaccine register at the National Institute for Public Health and the Environment (RIVM). This retrieval of information is done via a secure setting. As soon as the information on the vaccine and the batch number are known, the citizen service number (BSN) is removed from the database.
Right to access, correction and erasure
At any time, reporters can make a request to withdraw their consent, or to access, correct or erase their personal data. Requests can be sent by e-mail to email@example.com . Lareb will follow up your request within four weeks.
Pharmacovigilance Centre Lareb has undertaken technical security measures to protect personal data. All data collected by the form on the website, is secured by a Transport Layer Security (TLS) certificate. This secures the connection between your computer and the website and ensures that all data is shielded during transport and cannot be read by third parties. You can check this in the browser bar, which shows that the website address begins with https://
All information in the reports are only accessible to staff members of Pharmacovigilance Centre Lareb and specifically those staff members who have specific login codes.
The IP address of the reporter will be checked if it has been blacklisted. The IP address will not be saved or transferred. If the IP address being used to send a report is found on a blacklist, the reporter will be requested to do a captcha test. This is a check to determine whether the reporter is a human user.
An invisible field has been built into the reporting form. As soon as this field is filled, a captcha test will be shown. This is done to deter possible bots. If more than ten report forms are filled in within 5 minutes from the same IP address, this ‘reporter’ will also be shown a captcha test.
A cookie is a small file that is sent by web servers and to your browser and stored on the hard drive of your computer. These cookies help improve the website’s usability and your experience when you visit our website Pharmacovigilance Centre Lareb uses functional and analytical cookies on its website. Functional cookies (cookies that are necessary to make the website operate) and analytical cookies, that have little or no impact on privacy, are always placed when you visit our website. The purpose of a functional cookie is to save the current scroll position. This expires after a session.
On this website, Pharmacovigilance Centre Lareb uses Google Analytics, a web analytics service provided by Google Inc. (Google). We use this service to track how visitors use the website, with the aim of improving the website. The Netherlands Pharmacovigilance Centre Lareb has signed a data processing agreement with Google and selected ‘masking the last octet of your IP address’. The 'data sharing' is off and the Netherlands Pharmacovigilance Centre Lareb does not use other Google services in conjunction with Google Analytics cookies on this website.
The collected data are processed by:
Netherlands Pharmacovigilance Centre Lareb
5237 MH 's-Hertogenbosch
Phone: +31 73 64 69 700
Release date: 06-10-2021