Below is an update concerning the licensing status of bevacizumab if intended to be placed on the market for intravitreal administration.
This publication clarifies the MHRA’s position on the licensing regime that governs the placing of medicines on the market. It replaces the guidance published in 2009 and 2011 concerning the licensing status of bevacizumab when it is intended to be placed on the market for intravitreal administration.
This follows a request by the High Court to review whether the process of compounding bevacizumab (the manipulation of an authorised medicine, to produce multiple aliquots, usually in plastic syringes) exceeds what is permissible for ‘off-label’ use-the result being an unlicensed medicine which would require a Marketing Authorisation (MA) if placed on the market.
The Agency accepts that when prescribed and/or used by a healthcare professional, this does not create an unlicensed medicine and falls under the scope of ‘off-label’ use. However, if placed on the market, the product would require a new or extended MA, or an exemption from the need for one.
In reaching this conclusion, MHRA considers that a distinction needs to be drawn between the functions regulated in the European scheme of medicines regulation, and the clinical use of products within that marketplace.
The medicines regulatory regime legislates for the placing on the market of industrially produced medicinal products. The regime does not legislate how medicines are to be prescribed and used by healthcare professionals once they have been placed on the market.
A prescriber may use a medicine outside the conditions of its marketing authorisation, this is commonly referred to as ‘off-label’ use.
The prescriber should be aware of their additional responsibility when prescribing ‘off-label’.
Professional governance bodies have published advice to prescribers that should be taken into account.
The MHRA has also published prescribing guidance in the context of medicines supplied as ‘specials’ and this should also be considered.