APPENDIX
Letter to the Committee Chairman from Baroness
Hayman, Minister of State, Ministry of Agriculture, Fisheries
and Food (B25)
I was interested to read your Committee's report
on how the Government's decision temporarily to withdraw OP sheep
dips was handled. The Government will respond in due course but
the purpose of this letter is to clear up an issue with which
I was not able to deal in full when I gave evidence to your Committee
on 11 April.
The issue, which was raised by Lembit Öpik,
concerned the development of improved containers by one of the
marketing authorisations, Vericore Limited. I had to be circumspect
because, although Vericore had been bought by Novartis, the marketing
authorisations for OP sheep dips had not been acquired and they
remained with Grampian Pharmaceuticals Limited. That company wrote
to the Veterinary Medicines Directorate (VMD) on 6 April and asked
for the marketing authorisations in question to be terminated.
Once that action had been completed, VMD sought the permission
of Grampian Pharmaceuticals to disclose it to your Committee in
advance of it being made public through Gazetting the expiry of
the authorisations. Permission has now been granted and I can,
therefore, confirm that this is the reason why changes in container
design for the products Ectomort Centenary and Paradip 8% and
Flyte 1250, Seraphos, Downland Seraphos and Paradip 40% will not,
now, take place.
This is disappointing because the plans submitted
by Vericore and considered by the Veterinary Products Committee
in November were acceptable to the Committee. Had the developments
gone ahead, Vericore had estimated that an interim solution could
have been on the market by this summer at latest and that completely
developed closed delivery systems might have been available before
the end of the year.
This, I think, demonstrates that, with the necessary
will, marketing authorisation holders could have developed plans
which would have ensured that containers which met the objective
of minimising the risk of operator exposure to OP concentrate
were brought rapidly to the market. Unfortunately, the plans originally
submitted by the other companies involved were not acceptable.
The Veterinary Products Committee has now considered
revised plans and we expect to receive the Committee's advice
shortly. Naturally, we will ensure that reference to this advice
is included in the Government's response to your Committee's report.
22 June 2000
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