An authorities documents are public unless other specifically provided by legislation. Everyone has the right to access information on public documents.
Document publicity descriptions list Fimea’s key information systems and their key data content: Document publicity descriptions.
The information listed in the data content section can usually be used as search criteria. The most common search criteria include the case record number, the names of parties, the task category of the case as well as the name of the medicinal product. Before submitting a more extensive data request, we recommend that you are in contact with Fimea to determine search criteria that are as appropriate and specific as possible.
Do the following
A data request can be submitted in the manner you wish.
As a rule, we recommend the use of our
- contact form, which is sent from the Fimea website to the registry office: Contact.
A data request may also be submitted
- by email to: firstname.lastname@example.org,
- by letter to Fimea, P.O. Box 55, 00032 Fimea
- by telephone to the Fimea registry office, tel. +358 29 522 3602.
If the information request is submitted verbally and it applies to numerous documents, Fimea may where necessary require the person submitting the request to submit a written data request. This is especially the case when the requesting party is required to pay a fee for the document request.
Access to data
The content of a document is provided either verbally or by allowing the requestor to view and copy the document in Fimea’s facilities and giving them the copy or printout.
Copies or printouts or data in electronic format containing personal data will only be provided from Fimea’s personal data register if the person requesting the data has a legal right the process such personal data.
If Fimea refuses to provide the requested data entirely or in part, the requestor will be notified of the reason for the refusal. In this case, if the person who submitted the data request so desires they will be sent the grounds for the decision and an appealable decision that they can appeal to the Administrative Court.
The requested data from public documents must be provided no more than two weeks after the request has arrived. If the requested documents are numerous or they contain parts which must be kept confidential or the request otherwise requires special measures or a large amount of work, the matter must be resolved within a month of receiving the request.
A fee can be charged for the disclosure of data, which is based on Fimea performances price list.
However, no fee will be charged for individual decisions statements or other similar documents, searching for which will not require a great deal of work and which are provided electronically.
Even so, a fee can be also be charged for documents that are provided electronically, if the information is not easy to find for example in electronic registers using a search function. In this case, the agency will charge according to the working time spent on the task. Fimean liiketaloudellisesti hinnoiteltujen suoritteiden hinnasto (in Finnish).