Today, the Department of Health and Social has published the outcome from the ‘Future strategy for batch testing of medicinal products in Great Britain’ consultation [i]. The Government has accepted calls from PAGB and other trade associations to make permanent the approach of maintaining a list of approved countries for import which require no import testing or UK Qualified Person (QP) certification.
The Government consulted on a number of 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 QP certification for medicines imported from countries on the approved list.
PAGB has been leading calls for a number of years for this outcome and has consistently worked with members and officials, to provide evidence to highlight the need for both a permanent and non-duplicative solution to ensure patients would have access to their medicines in the future.
Today’s announcement fits with the objectives guiding the review: to protect patient safety, support the aims set out by government in the Life Sciences Vision to stimulate a thriving UK life sciences sector, and avoid adding unnecessary regulatory burdens.
Michelle Riddalls, Chief Executive of PAGB, the consumer healthcare association, said:
‘PAGB has been working tirelessly over the past few years to inform this decision by showing the potential negative impact that introducing the repeat testing and batch release would bring to both access and patients. So, we are delighted with the outcome of this consultation and pleased the Government has listened to the voice of the consumer healthcare industry. Our members can and will continue to supply safe medicines with fewer challenges that could disrupt medicines supplies.
‘This is a win for patients who will have access to the medicines and treatments they need to effectively manage the symptoms of self-treatable conditions. The knock-on effect this has on alleviating pressure from NHS shouldn’t be underestimated either.
‘We are really pleased that this pragmatic and reasonable approach has been taken and would like to thank our members who worked with us to collect the data and evidence to support this outcome.’
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PAGB, the consumer healthcare association, represents the manufacturers of branded OTC medicines, self-care medical devices and food supplements in the UK.
 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 presented an opportunity for the Government to 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.
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