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News: 2021
Price revision 2021
The Icelandic Medicines Agency will in 2021 review the maximum wholesale prices in Iceland, according to regulation no. 1414/2020, article 8.
Minimum service from July 19th to July 30th
Due to summer holidays minimum service will be at the Icelandic Medicines Agency from July 19th to July 30th, both days included.
To MAHs: Important to report medicine shortage to IMA
Medicines shortage shall be reported with at least two months‘ notice, unless there are exceptional circumstances.
Guidelines on Icelandic Translations in MRPs/DCPs
The new protocol was announced in December 2020 and now guidelines have been published on the IMA's website .
Pilot project on e-PILs - deadline extended
The project is solely intended for medicines restricted for hospital use (“H” categorised) in accordance with the Icelandic marketing authorisation. A request for participation for medicinal products that are currently on the Icelandic market, shall be submitted no later than February 5th 2021. Requests for participation for new medicines can be submitted during the lifespan of the project.
Reminder – Pilot project on e-PILs
The project is solely intended for medicines restricted for hospital use (“H” categorised) in accordance with the Icelandic marketing authorisation. A request for participation for medicinal products that are currently on the Icelandic market, shall be submitted before February 1st 2021. Requests for participation for new medicines can be submitted during the lifespan of the project.
New role for the IMA in 2021
With the new Medicinal Products Act No. 100/2020 coming into force the IMA has taken on new roles which include pricing and reimbursement decisions for medicinal products.