Views on specials manufacturing sought
Specials manufacturing — making unlicensed medicines to order — in the UK is being reviewed by the Medicines and Healthcare products Regulatory Agency because it believes the current rules may no longer be appropriate.
The agency has asked a range of stakeholders, including pharmacists,
for their views in an informal
consultation that closes on 30 June 2008.
After this, the MHRA expects to consult formally on any proposals for
change.
The agency has identified a number of issues that it wants to resolve.
An example is seen in the differences between the treatment of imported
unlicensed medicines and those that are domestically produced. Imports
are pre-vetted and can be blocked by the MHRA on grounds of safety alone,
but the prohibition of a domestic product on safety grounds requires
legislation.
Similarly, because imports are pre-vetted, the MHRA is able
to determine whether there is a genuine special need for the product.
It cannot do this for domestic products, because it does not know when
they are ordered.
The MHRA is also concerned about a lack of clarity over the circumstances
in which it is, or is not, appropriate for the manufacture of a special
to take place. Specifically, it wants to know what healthcare professionals
and patients expect in terms of regulatory and other safeguards in
relation to clinical decisions to use an unlicensed product.
The MHRA wants to achieve four outcomes from the review:
- Clinicians
who are sanctioned to exercise their professional judgement to
order unlicensed
medicines
- Clear responsibility and accountability for protecting
the safety and rights of patients
- Regulatory safeguards that meet
the principles of better regulation
- Arrangements that complement
the
wider system
for licensing medicines
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The
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