Z-classification revoked for S-classified medicinal products, which are foreseen to maintain their S-classified status
The Icelandic Medicines Agency has reviewed Z-classification of medicinal products, which are exclusively used in hospitals and healthcare institutions, in accordance with Article 74 of Regulation No. 141/2011 on marketing authorisations of proprietary medicinal products, their labelling and package leaflets. The Agency intends to revoke Z-classification of those S-classified medicinal products, which are foreseen to maintain their S-classified status. In this regard, reference is made to previously announced plans of the Agency to revoke the S-labelling of certain medicinal products.
In case a marketing authorisation holder has any comments on the Agency´s planned action, such comments must be submitted before 16 April 2018 to lyfjastofnun@lyfjastofnun.is, accompanied by reference to the relevant V-number in the Agency’s letter.
In case of no comments being received by that date the Agency will revoke the Z-classified status of the medicinal products, but they will continue to be S-classified. The amendment comes into effect 1 May 2018.