New medicines licensing offence planned
A new criminal offence of providing false or misleading information in relation to applications for, and renewals of, marketing authorisations for medicines is likely to be created.
Consultation on the plan, set out in consultation letter MLX 311 (PDF 230K), started on 24 December 2004 and runs until 25 March.
It is already an offence to provide false information to the Medicines
and Healthcare products Regulatory Agency in relation to applications
for the grant, renewal and variation of manufacturer’s and wholesale
dealer’s licences, but not to product licences. This discrepancy
is described in the consultation document as “a significant weakness
in medicines regulation”.
The consultation paper makes it clear that the proposed law change was
prompted by the withdrawal of oral polio vaccine in 2000 (PJ, 28 October
2000, p638). The vaccine was withdrawn after its maker, Medeva, misled
the then Medicines Control Agency about adherence to European guidelines
that prohibit the use of bovine materials from countries in which there
are known case of bovine spongiform encephalopathy. |
The
Pharmaceutical Journal
Acrobat
Reader