Policy responses and statements
Background: The MHRA has written to the College to consult on proposals to prohibit the sale, supply or importation of unlicensed medicinal products for internal use which contain Senecio species. This is a follow-up to an earlier consultation that took place in January 2004 (MLX 296), which set out the background, the risks posed by Senecio species, the options considered and the proposals to prohibit Senecio species in unlicensed medicinal products for internal use. At the time of that agreement, there was a voluntary with the herbal sector to withdraw products containing Senecio species, an agreement that remains in place. The MHRA's earlier consultation referred to concerns that the MHRA continued to receive reports of the supply of products purportedly containing Senecio. Such reports died back and the MHRA has received no further reports since January 2005. In view of this, and of the creation of the Herbal Medicines Advisory Committee, with a specific remit to advise on the safety of unlicensed herbal medicines, the MHRA has recently sought the views of the Committee for up to date advice on whether regulatory action should be taken. A range of options was considered including proceeding with the original proposals for a prohibition in unlicensed medicines or continuing to rely on a voluntary agreement. The Herbal Medicines Advisory Committee has advised that there is a clear risk to the public if they took unlicensed products containing Senecio species. They advised that the voluntary agreement should be reinforced with a statutory prohibition. Proposals to amend existing Orders SI 1977/670 (Bal Jivan Chamco), 2001/841 (Aristolochia) and 2002/3170 (Kava-Kava) made under Section 62 of the Medicines Act 1968 - Amendments are required following the accession of Bulgaria and Romania to the EU to ensure that the exemption for goods in transit in those Orders applies also to goods from Bulgaria and Romania. Other minor changes are also proposed. COMMENTS ON
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