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Exemptions from Icelandic package labelling requirements

The Icelandic Medicines Agency has updated guidelines on applications for exemptions from package labelling requirements. In most cases an exemption is only granted on a temporary basis with the aim of protecting human or animal health

Opening hours during holidays 2022

Minimum service from July 18th to July 29th

The e-PIL pilot project – Changes in admission criteria

Marketing authorisation holders can apply for a medicinal product to be exempt from the annual fee until 25 February 2022

New Tariff for fees collected by the IMA

Opening hours during holidays 2021

Price revision 2021

Minimum service from July 19th to July 30th

To MAHs: Important to report medicine shortage to IMA

Pilot project on e-PILs has started

Guidelines on Icelandic Translations in MRPs/DCPs

Pilot project on e-PILs – deadline extended

Reminder – Pilot project on e-PILs

New role for the IMA in 2021

Upcoming changes to Icelandic translations of Product Information

IMA services during the COVID-19 outbreak

Opening hours during holidays 2020

To MAHs and their representatives – Pilot project on e-PILs

Minimum service from 20 July to 31 July 2020

Changed procedure for nationally approved products in worksharing procedures where EMA is the reference authority

Encouragement to pharmaceutical companies to register medicines commonly used in Named Patient Programmes

IMA services during the COVID-19 outbreak

Correction in the Icelandic translation of the Annex to the guideline on excipients in the labelling and package leaflet of medicinal products for human use – Sodium

To Marketing Authorisation Holders and their agents

Minimum service from July 22nd – 2nd of August

Happy holiday season !

The IMA over Christmas and New Year

Marketing authorisation holders to report shortage to IMA

Vacant position at IMA’s Quality Assessment Team

Minimum service during 23 July – 3 August

Revocation of S-classification status for certain medicinal products: lists

New Tariff for fees collected by the Icelandic Medicines Agency

Z-classification revoked for S-classified medicinal products from May 1st 2018

Z-classification revoked for S-classified medicinal products, which are foreseen to maintain their S-classified status

RMS slots available with Iceland as RMS