The use of confidential data for purposes such as scientific research or for planning and reports by authorities will require data access authorisation. Confidential data include trade secrets and personal health data.
Do the following
If your application only concerns Fimea’s own data, apply for data access authorisation from Fimea according to the instructions on this page.
The exception is Fimea’s research projects such as the Medicines Barometer. There is a separate set of instructions for accessing this data for research use. The instructions are available on the following website: Medicines Barometer (in Finnish)
If you want to combine personal data contained in Fimea's registers with personal data of other parties, apply for data access authorisation from Social and Health Data Permit Authority Findata, in accordance with the instructions provided by them. Findata’s instructions are available on the following site: Data permits
Data access authorisation requests are submitted to Fimea by form
Use this form to apply for data access authorisation: Data Permit Application (docx)
Complete the form carefully and ensure that the necessary attachments are included. Mandatory attachments are specified on the form with an asterisk*.
Non-disclosure commitments are to be submitted by form: Confidentiality argeement (docx)
You can use this template when drafting a privacy statement: Privacy Notice for Scientific Research (docx)
You can use this template when drafting a data utilisation plan: Data Utilisation Plan (docx)
When preparing the data protection impact assessment, either the applicant organisation's own form template or the template available on the website of the Office of the Data Protection Ombudsman can be used. An impact assessment must always be completed if personal data is processed.
A data access authorisation application must include information on the basis of which the decision for access can be made.
The applicant must include the intended use of the data and give grounds for why the data should be provided in the requested scope in their data access authorisation application. In addition, they must provide information on how the information security of confidential data will be ensured appropriately.
Supplying all the necessary information will speed up the processing of the data access authorisation application. Please pay particular attention to the providing the information requested by Fimea in as much detail as possible. Data descriptions of the registers can be found in the Data resources catalogue. You can obtain more information about the register content from the contact persons for the registers. Please pay attention to the comments about the registers presented in the data descriptions and Haittavaikutusrekisterin tietojen käytössä huomioitavaa (pdf, in Finnish). If additional information is needed for the processing of a data access authorisation application, Fimea will contact the applicant.
Submit the application to the registry office
A signed data access authorisation application form and its attachments must be submitted to the Fimea registry office to kirjaamo(@)fimea.fi. An application can be submitted to Fimea via secure email: Secure Mail. Use secure email if your data access authorisation application contains the personal data of research subjects or other confidential data.
Alternatively, application documents can be sent by post. If an application is sent by post, the papers should not be stapled to one another. Postal address: Fimea, P.O. Box 55, 00032 Fimea.
Data access authorisation decision
If a data access authorisation application contains confidential data, the applicant must pay a fee for a decision on the matter. The applicant commits to complying with the conditions set out in the decision. In other situations, an agreement will be concluded on the conditions for use of data. The Ministry of Social Affairs and Health Decree on fees chargeable by Fimea contains provisions on fees: Decree on fees chargeable by Fimea (pdf).
Currently valid fees include:
- Decision on data access authorisations concerning new scientific research or extension of data materials 350 euros
- Decision on data access authorisation or data extension related to an individual dissertation 200 euros
- Continuation of a previously granted data access authorisation or its review, or a decision on the supplementing of the research team 50 euros
Provision of data
Fimea and the data access authorisation holder will together agree on how data will be provided. Fimea charges the applicant for the extraction and delivery of the data at an hourly rate in accordance with Fimea's price list for services priced according to commercial criteria (pdf). The applicant can request a cost estimate for the implementation of the extraction in advance.
When data is disclosed under the Act on the Secondary Use of Health and Social Data, it will only be disclosed to a secure operating environment. The applicant is responsible for obtaining a secure operating environment and its related costs. For example, the data can be processed in Findata's secure remote operating environment, the detailed information and price list for which are available on the Findata website.
Advisory service under the Act on the Secondary Use of Health and Social Data
We provide information on the secondary use of data stored in our registers from: kirjaamo(@)fimea.fi. When combining data from several different registers, contact Findata.