Analysis of the impact of new EU laws on the UK by the European
Scrutiny Committee includes the impact of EU rule changes in
veterinary medicines, human medicines and fertilisers on Northern
Ireland under the Northern Ireland Protocol.
Veterinary Medicines
More than half of the veterinary medicines in NI could be in
danger of becoming unavailable when the grace period for
veterinary medicines ends in December if the Northern Ireland
Protocol is strictly applied. The Government are challenging
whether NI has to follow EU rules for such drugs under the
Protocol. The Committee have called the EU’s readiness to amend
rules on human medicines but not for animal medicines
‘frustrating’ and backed the Government’s search for a ‘more
sustainable solution’.
Fertiliser products
New EU rules governing fertilisers came into effect on 16 July
and have to be applied to NI under the Protocol, causing a
divergence between British regulations and those in Northern
Ireland. The Committee is seeking clarity from the Government
over why it thinks movements of fertilisers from Britain to
Northern Ireland will not face increased friction as a result and
stresses the need for engagement with the devolved governments
since this is a devolved matter.
Supply of medicines from Great Britain to Northern
Ireland
The Government highlights in a reply to the Committee two
concerns over the easements for medicine movements between GB and
NI tabled by the EU following industry engagement.
These are that new medicines approved in the GB would still need
EU-authorised packaging to be sent to NI and the continued
application of the Falsified Medicines Directive. To address
this, the Government is using the NI MHRA Authorised Route so NI
patients can continue to have access to prescription drugs
available in GB.