The antigens are donated by a range of companies and have been manufactured as commercial influenza vaccines for human use under the terms of EU product licences, in accordance with GMP.

They are freeze dried whole virus preparations grown in hens' eggs and inactivated by the manufacturer using either ß-propiolactone or Formalin. The reagent 'Instructions for Use' (IFU), which will accompany the shipment and which is also available on our website will indicate the inactivation method used.

The details of the inactivation processes and confirmation testing are commercially confidential and NIBSC does not receive any of the data. NIBSC accepts confirmation from the vaccine manufacturer of the inactivation step, prior to freeze drying the product.

Consequently NIBSC cannot confirm that the products have been inactivated according to any particular procedure specified in an import permit.

NIBSC does not perform any inactivation testing of these materials as they are certified as inactive by the manufacturer. Consequently NIBSC cannot confirm that the products have been tested for inactivation according to any particular procedure specified in an import permit.

The viruses from which the antigens have been derived were grown in hen's eggs of EU origin. However we cannot confirm the area of the EU from which they were obtained.

As NIBSC does not have details of the manufacturing processes used, we cannot confirm that any animal derived nutrients or similar materials have been sourced only from specified countries. However, as the reagents have been manufactured under GMP for human medical use, they will have complied with the normal conditions applied to these types of pharmaceutical products to minimise risk of contamination with TSE's and other animal derived diseases.

Gamma irradiation will destroy these products and should not be used.

It is not possible to label each reagent ampoule or vial with a statement similar to "For in vitro use or use in laboratory animals only". However, where required and appropriate, such a statement can be applied to the shipping container.