Following the fourth meeting of the Ireland/Northern Ireland
Specialised Committee, the UK and the EU have
agreed a phased process for implementing medicines regulation
in Northern Ireland up to 31 December 2021.
This will provide additional time for
businesses to prepare in relation to batch testing, importation,
and Falsified Medicines Directive
requirements.
In a joint statement, six
bodies* representing the EU and UK pharmaceutical
industry said:
“This is good news for patients in Northern
Ireland. We are pleased the UK Government and EU Commission have
responded to the concerns raised by industry and removed the
immediate threat of a cliff-edge in the way medicines are
distributed to Northern Ireland from the end of this
year.
“We await the detail of how this will work
in practice and there is much work to do. But this is a pragmatic
step in the right direction. Both sides must now use the next 8
weeks to clarify the rules which will apply in Northern Ireland
from 2022, so that companies can make full use of this extra time
to prepare for the long-term.”
Under the Northern Ireland Protocol, medicines
in Northern Ireland will be governed by EU rules and
regulations.
However, these rules are to be enforced by the
UK’s medicines regulator, the MHRA. Both sides need to agree how
the regulations will be interpreted and implemented come December
2021.
While this joint decision addresses one of the
immediate priorities of the UK and EU pharmaceutical industry, we
continue to call on the UK Government and EU Commission to
negotiate a Mutual Recognition Agreement for medicines
manufacturing.
Read more about why this
is important for patients and the
economic case.
*Signatories
Richard Torbett, Chief
Executive, The Association of the British Pharmaceutical Industry
(ABPI)
Nathalie Moll,
Director-General, European Federation of Pharmaceutical
Industries and Associations (EFPIA)
Jurate Svarcaite, Director
General, Association of the European Self-Medication Industry
(AESGP)
Adrian van den Hoven, Director
General, Medicines for Europe
Warwick Smith, Director
General, British Generic Manufacturers Association
(BGMA)
Michelle Riddalls, Chief
Executive Officer, PAGB, the consumer healthcare
association
