Medicines Control Agency consults on herbal and children’s medicines
The Medicines Control Agency is seeking comments on implementing the
European Commission’s proposals for a directive on traditional herbal
medicinal products. The MCA is also seeking comments on EC consultations
about medicines for children.
The MCA says, in consultation letter MLX 283, that the proposed herbal
medicines directive would require it to introduce a simplified registration
procedure. Manufacturers would have to provide evidence of traditional
use (for at least 30 years) of a product but there would be no requirement
to present data on tests or trials relating to efficacy. Instead, the
wording “the efficacy of the product has not been clinically proven
but relies exclusively on long-term use and experience” would be
used. A bibliographic review of safety data would be needed and registration
could be refused if this was inadequate or the product was found harmful
in normal conditions of use.
An agreed positive list of herbal substances with therapeutic indications,
specified strength, route of administration and relevant safety information
would be drawn up by a proposed Committee for Herbal Medicinal Products.
Applicants seeking licences would be able to refer to this list rather
than provide data on traditional use and safety. Quality of manufacture
would still need to be demonstrated.
The European directive could be in force by the end of 2004. The MCA says
that the current regulation of herbal medicines within the United Kingdom
“fails to provide an adequate balance between protecting the consumer
and providing consumer choice”. Most herbal medicines reach the market
through an exemption to the Medicines Act 1968 and the Government, the
MCA and the Committee on Safety of Medicines have concerns about the low
quality and safety standards of some unlicensed preparations.
The MCA is minded to transpose the directive into UK law and repeal the
existing exemption, saying that a scheme that officially recognises traditional
medicines would increase consumer confidence, leading to increased sales.
Comments on the proposals can be sent to Alison Daykin, 16-132 Market
Towers, 1 Nine Elms Lane, London SW8 5NQ (tel 020 7273 0404, e-mail alison.daykin@mca.gsi.gov.uk)
by 21 June. A more detailed question and answer briefing on the directive
is available on the MCA’s
website (www.mca.gov.uk/ourwork/licensingmeds/herbal meds/qanda.pdf).
The MCA is also drawing attention to a recent European Commission document
on medicines for children (PJ, 16 March, p349). The MCA is co-ordinating
the UK Government’s response to this and says that it would like
to see copies of any comments sent to the EC. These can be sent to Chris
Bantock, European support unit manager, at the MCA (tel 020 7273 0395,
e-mail chris.bantock@mca.gsi.gov.uk).
Back to Top
|
