Supply Notice: Unlicensed Jext 300 microgram adrenaline auto-injectors in Austrian packaging

Supply Notice: Unlicensed Jext 300 microgram adrenaline auto-injectors in Austrian packaging

November 1, 2019

Ref: MSN/2019/001
Tier 2 – medium impact
Date of issue 1 November 2019

The Department of Health and Social Care (DHSC) have today advised that UK licensed Jext 300 microgram devices are currently unavailable, the manufacturers ALK-Abello Ltd have obtained acceptance from the Medicines and Healthcare Products Regulatory Agency (MHRA) to import a quantity of Jext 300 microgram from Austria.

The stock has an Austrian German language pack, label and patient information leaflet. Although not licensed in the UK, it is equivalent to the UK licensed product.

Each device will be supplied in a clear envelope which will also contain a UK Patient Information Leaflet.

UK licensed supplies of Epipen 300 microgram and Emerade 300 microgram remain available.

  • For patients who require Jext® 300 microgram, prescribers may consider prescribing an unlicensed device.
  • When prescribing a product that is not licensed in the UK prescribers must indicate on the FP10 prescription that an unlicensed product is required. This can be done by annotating the prescription with the following wording: “special order”.
  • Pharmacies can place orders for unlicensed Jext® 300 microgram via Alliance Healthcare using the PIP code: 801-6941.

Further information can be located in the letter to healthcare professionals from ALK.

Ensure that where a prescriber wishes you to dispense an import, prescriptions are annotated ‘specials/unlicensed’ in the prescribing line and are endorsed as follows:

  • Amount dispensed over pack size used;
  • Invoice price per pack size from which the order was supplied less any discount or rebate;
  • Manufacturers’/importers’ MHRA licence number;
  • Batch number of the product supplied;
  • SP

If you have any queries, please contact DHSCmedicinesupplyteam@dhsc.gov.uk



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