The Medicines and Healthcare Products Regulatory Agency (MHRA) is proposing a 31 December 2013 end-date for the sell through of unlicensed herbal products.
Following the ending of the transition period of the Traditional Herbal Medicinal Products Directive (THMPD) in April 2011, stocks placed legally on the market before that date have been allowed to be sold through.
The MHRA now says it wants to “regularise” the position on sell-through and is consulting with industry on its proposal to set a final date.
The Agency says that although the sell through has proceeded well in much of the herbal sector it is concerned at evidence of “abuse” in other parts, specifically herbal products claiming “implausibly long shelf lives”. It also says that its investigations have shown “continuing evidence of poor standards” in some unlicensed herbal products and non-compliance with the voluntary labelling among products being sold through.
The MHRA says it believes its proposal would have “little substantive adverse impact” since operators would have benefited from a sell through period of almost three years.