Substitutable medicinal products
2016 interchangeable drug list publication schedule
The Finnish Medicines Agency, Fimea, publishes an interchangeable drug list no less than 45 calendar days before the list comes into effect. It comes both as a list of drugs in PDF format, and as packaging data in ASCII format, which can be downloaded to users’ databases.Compilation of the list starts about five days before it will be published. The marketing authorisations which are granted during the compilation will not be added to the file. The downloadable version is updated following publication of the list, on the basis of data received from the marketing authorisation holders, and is then republished 38 calendar days before the list comes into effect.
|Period of validity||Fimea publishes the list no later than (45 days before list comes into effect):||Availability on the market to be verified and amendments to be made by marketing authorisation holders no later than||Updated downloadable file available (38 days before list becomes valid):|
Fimea requests that marketing authorisation holders check their own products and the availability of their products on the market each time the interchangeable drug list is published, and that they provide notification of any amendments/supplements required by no later than the date indicated in the above table. This notification ought to be made by forms, which can be found on Fimeas website.