GRS Blog

End of unlicensed herbal remedies on UK market - deadline 30 April 2014

21/11/2013

The UK's MHRA has announced today that "from 30 April 2014, all manufactured herbal medicines will have to be authorised in order to be sold and supplied lawfully in the UK."

"This means that after this date herbal retailers will no longer be able to sell unlicensed herbal medicines that are not registered under the Traditional Herbal Registration (THR) scheme in the UK."

It has taken this long to get to this point because herbal retailers who had products on the market before April 2011 were allowed to "sell through" their stock.  Originally, it was anticipated that this stock would be sold within an 18-24 month period which is the average shelf-life for these products.  This transitional period also allowed for manufacturers to get their production processes up to the required standards.  However, unlicensed herbal medicines are still readily available in the UK so, after consultation, the MHRA has reached this decision.

So will May 2014 be the time when we really see what the impact of the Traditional Herbal Medicine Registration Scheme has on the herbal industry?  Will it just push it all 'underground' and operate in the murky depths of the Black Market?  Will hundreds of products disappear overnight and deny the consumer choice?  Will we see the herbal market dominated by just a few companies?  Or will it be a combination of all these? 

And what happened to the UK's announcement that it was going to regulate herbal practitioners?  GRS has made several enquiries about this and we've had nothing but silence.  Would anyone like to enlighten us?

And will there be a flurry of activity by manufacturers trying to get their 'house in order' before May 2014 or will they not bother?  Will it be a case of 'head in the sand and hope it all goes away' or will they simply wind up their companies? 

It'll be interesting to see if the number of herbal enquiries GRS receives increases in the run up to this deadline: we were inundated when the new Directive came into full force at the end of April 2011.  May be all we can say right now is:

"Watch this space!"

Author: Greer Deal, Director of Global Regulatory Services