Update on Modafinil (Provigil) produced by Teva UK Ltd

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30 September 2016

As we outlined at our recent Annual Conference, we contacted both Teva UK Limited and the Medicines and Healthcare Regulation Agency (MHRA) following a dramatic increase in the number of people with narcolepsy who have been unable to obtain the above medication.

On August 9th, we contacted Teva and were told that it was likely to be out of stock until Q1, 2017 as the packaging has been re-designed and requires MHRA approval.

We were led to believe its the MHRA approval element that takes 3 months and when we offered to contact MHRA directly, Teva explained that they were unable to provide details of who to contact due to confidentiality.

Nevertheless, we contacted the MHRA the same day and received the following response on September 15th, after several chasers.

MHRA Response 15/09/16

"Two self-certification applications affecting the label and/or PIL were approved for Provigil 100 & 200mg tablets on 01/07/2016 (leaflet) and 26/08/2016 (label and leaflet). Both submissions were approved within the required 14 day timeline. Once approved, the Marketing Authorisation Holder (MAH) has between 3-6 months to implement the updated artwork and therefore the updated packs should be in the market-place by February 2017. The MAH can continue to utilise the existing (old) stock within the 6 month implementation period. There is no outstanding action with regard to approving redesigned artwork with us; maintenance of stock within the market-place is a matter for the MAH."

Following this response, we replied requesting further information on the nature of the changes.

MHRA Response 28/09/16

"Both changes were physical changes to packaging components (e.g. dimensions of packs, leaflet folding and position of pharmacodes) to allow use of an alternative packing line. There were no changes to the content of the leaflet or labelling information. The leaflet will be in the public domain, as it will be visible via our website but the cartons do not appear to be in production yet (from the original enquiry), so there is limited information that we can provide. We think that it is up to the MAH to provide the details of the changes."

We have today sent Teva UK Limited a copy of this post and asked them to comment on their ongoing supply issues. When we receive a response, we will, of course, let you all know.