Contents of the register
Information registered in the NorADRR can also be made available for management, planning and quality improvement of medicinal products and medicinal use and for research.
NorADRR contains reports of suspected ADRS of medicinal products (including vaccines) received from from healthcare personnel and residents in Norway.
NorADRR contains relevant health information related to ADRs or suspected side ADRs when using a medicinal product (including vaccine):
- The patient's social security number or other direct personal identifier
- Information about the ADR
- Information about the medicinal product in question and any other medicinal products the patient is using
- Other important relevant health information
The information can be registered and processed without the consent of the data subject.
Data collection period
Data from 1971 and onwards
Collection of social security numbers started in April 2020 (not mandatory)
Sensitivity level
Person identifiable
Variables
Go to the variable overview to create variable lists and to see detailed information about the variables in this data source.
Open data
Basic statistics from the NorADRR are published annually (in Norwegian) by the Norwegian Medicines Agency, normally in April/May.
Criteria for data access
The data sources have different purposes and are regulated by different laws and regulations. In order to access information from the data sources, what you plan to use the information for must be in accordance with the purpose of the data source.
The types of approvals and documents you must submit to access information depend on what you are applying for, what you are going to use the information for and how you are going to process it. We therefore recommend that you take the time to familiarize yourself with the application guides before starting the application process:
Application guide for anonymous, aggregated data (statistical data)
Application guide for personally identifiable data
Purpose
The NorADR-registry shall contribute to the safe and effective use of medicinal products through ongoing and systematic collection, processing and analysis of information on suspected ADRs of medicinal products (including vaccines).
In order to obtain data from NorADRR, the purpose of the data processing must be in line with the purpose of the NorADR-registry as described in § 1-1 of the registry’s regulation:
- Information in the register must be used for the good of the individual and society in a way that is ethically sound and safeguards the individual's privacy
- The register shall contribute to the safe and efficient use of medicinal products, by continuously and systematically registering, processing and analysing reports of suspected adverse drug reactions (ADRs) and capturing information about ADRs as early as possible
- Information registered in the NorADRR can be made available for management, planning, quality improvement of medicinal products and use of medicinal products, and for research.
Legal authority
The register is a national health registry. It is authorized in Section 11 of the Norwegian Health Register Act (lovdata.no) and regulated by the Norwegian Adverse Drug Reaction Registry regulation (lovdata.no).
Apply for access to data
You can apply for access to data from the registry via the application forms at helsedata.no.
Data processor and data processing manager
Norwegian Products Agency (NOMA) is the data processor and data processing manager for NorADRR and processes applications for access to data.
Cost and time spent
- 30 working days for making information available from a data source
- 60 working days for making available compiled information (from several sources/registers)
The deadlines apply from when the register has received a complete application. The application is only considered complete when it contains all the information, approvals and attachments that are necessary to assess and make decisions about making health data available.
For complicated statistics that take time to prepare, there may in some cases be a longer processing time. Aggregated statistics based on compiled data will in most cases have a longer processing time than 30 days.
Prices for access to data
Helsedataservice charges for the processing of applications submitted via helsedata.no, while the data custodians charge for data preparation and making the data material available. Helsedataservice and the data custodians will issue separate invoices.