The future strategy for
batch testing of medicinal products in Great Britain: government
response
Detail of outcome
Batch testing is the process of confirming every batch of
medicine has the correct composition through laboratory tests by
the manufacturer. The government consulted on 4 proposals for a
future batch testing policy for Great Britain where medicines are
imported from a country with which the UK does not have a mutual
recognition agreement on batch testing.
The majority of the responses were in favour of no import testing
or UK Qualified Person (QP) certification for medicines imported
from countries on the approved list (option A). Responses to
the consultation highlighted the benefits of this option for the
safety and availability of medicines, as well as avoiding adding
additional cost and complexity that could disrupt medicine supply
chains.
After careful consideration of all the responses to consultation,
alongside other relevant information and evidence, the government
has decided to make permanent the approach of maintaining a list
of approved countries for import which require no import testing
or UK QP certification. This policy protects patient
safety, supports the aims set out by this government in
the Life Sciences
Vision to stimulate a thriving UK life sciences sector
and avoids adding unnecessary regulation to an already highly
regulated sector. As this policy is currently in operation and in
legislation, there is no need for a 2-year period to allow
industry to prepare for implementation.
Original consultation Summary
We want your views on 4 proposed options for a future policy on
batch testing of medicines for Great Britain.
This consultation ran from
11am on 31 May 2022 to 11:45pm on 26 July 2022
Consultation description
Batch testing is the process of confirming every batch of
medicine has the correct composition through laboratory tests by
the manufacturer.
The UK’s independence from the EU now means the UK can set its
own regulatory policy in Great Britain on how, when and if to
accept batch testing results from third countries or choose to
require batch testing in the UK of products intended for the UK
market.
We’re seeking views on the 4 policy options outlined in the
attached consultation document, along with the practicalities of
implementing them, in relation to medicines imported into Great
Britain from a third country with which the UK does not have a
mutual recognition agreement (MRA) on batch testing.
Documents
The future strategy for
batch testing of medicinal products in Great Britain –
consultation document
