Regulatory in brief | Northern Ireland, UK

Regulatory in brief | Northern Ireland, UK

11 November 2020 - Deborah Wilkes

The European Union and the UK have reached an agreement on medicines regulation in Northern Ireland, while the Proprietary Association of Great Britain (PAGB) is calling on the National Health service (NHS) to harness online resources to boost self care.

Phased implementation in Northern Ireland

Pharmaceutical industry associations have welcomed an agreement between the European Union and the UK which allows new regulations governing medicines in Northern Ireland to be phased in by 31 December 2021.

In a joint statement, the industry associations said the move would provide additional time for businesses to prepare for batch testing, importation and requirements of the Falsified Medicines Directive.

The associations described the agreement as a “pragmatic step in the right direction”. “Both sides must now use the next eight 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,” they commented.

Under the Northern Ireland Protocol agreed as part of the UK’s withdrawal from the European Union, medicines in Northern Ireland will be governed by European Union rules and regulations but those rules will be enforced by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

The six industry associations include the Association of the European Self-Care Industry (AESGP) and the Proprietary Association of Great Britain (PAGB).

Harness online resources to boost self care

“The National Health Service (NHS) should do more to help people self care by offering a clear online gateway to quality-assured information about minor health conditions,” according to the Proprietary Association of Great Britain (PAGB).

The PAGB wants policymakers to develop a self care section in the NHS App and on the NHS website to which people can be referred for trustworthy advice.

The consumer healthcare industry association points out that the NHS worked with Google, Twitter and Facebook on a range of measures to ensure people who search online for “coronavirus” are directed towards the NHS website and away from fake news.

The PAGB is also calling for NHSX – the body driving digital innovation in the NHS – to explore apps that could support self care, encourage the use of pharmacies and help manage demand on general practitioners.

Furthermore, the PAGB says online NHS systems which help people decide what to do about their symptoms should signpost people towards local pharmacies for self-treatable conditions where appropriate rather than connecting them to a general practitioner.

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