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 [email protected], 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.