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Description of content: The
Regulations provide that a "UK marketing authorisation" comprises
the following different types of authorisation: UKMA(UK)(Category 1) and
UKMA(Category 2), which permit marketing of a medicinal product in all the
territories of the UK; UKMA(GB) which does not permit marketing of a
medicinal product in Northern Ireland; and UKMA(NI) which does not permit
marketing of a medicinal product in Great Britain. These Regulations make
amendments to the 2012 Regulations ensure that the correct type of
authorisation is referred to.
The Regulations make provision to transition existing marketing
authorisations with an authorisation with a territorial limit of Great
Britain to be converted to authorisations valid across the UK.
The Regulations also make provision for a new requirement, for each
of the above categories of authorisation, for products to be labelled
"UK only"; and provision to disapply the product identification and
anti-tampering device rules contained in Commission Delegated Regulation (EU)
2016/161.
The changes made by the Regulations mean that the same products, in
the same packs with the same labels, will be available across the whole of
the UK
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