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The Medicines and Healthcare products Regulatory Agency's (MHRA) Criminal Enforcement Unit (CEU) has seized a quantity of suspected unlicensed medical products including unlicensed versions of Botox, numbing agents and dermal fillers in Bolton, Greater Manchester. Officers from the MHRA and Greater Manchester Police conducted a raid across nine addresses in Bolton, Westhoughton and Leigh in the early hours of Thursday 13 July 2023, where two women and a man were arrested. Andy Morling, MHRA Deputy Director of Criminal Enforcement said: "Medicines like these are powerful and dangerous in the wrong hands, potentially leading to serious adverse health consequences. The criminals trading in these products are not only breaking the law, they also have no regard for your safety. It is illegal to advertise, sell or supply medicines such as these without the appropriate authorisation. If you see these products, or any other powerful medicines, being sold on social media or elsewhere online, think. It's unlikely to be legitimate. You can help the MHRA take action by reporting concerns to us through our Yellow Card scheme.

The Medicine and Healthcare Product Regulatory Agency (MHRA) has recalled all pholcodine-containing medicines from the UK pharmacy due to concerns of its potential to cause a severe allergic reaction in some people having general anaesthesia for surgery. The decision was made following the conclusion of a review of post-marketing safety data by the MHRA. The Commission on Human Medicines (CHM) has considered the evidence of an increased risk of the very rare event of anaphylaxis when exposed to neuromuscular blocking agents (NMBA) and advised that pholcodine-containing medicines should be withdrawn. MHRA has advised pharmacists to consider recommending appropriate treatment alternatives for patients who present with a new dry cough or who are currently taking pholcodine. Royal Pharmaceutical Society (RPS) President Professor Claire Anderson said: "If you are taking a cough medicine (including tablets and syrups), check the packaging, label or Patient Information Leaflet to see if pholcodine is a listed ingredient - if it is, and you have any questions, you can talk to your pharmacist who can suggest a different medicine suitable for you.

The Medicines and Healthcare products Regulatory Agency (MHRA) has appointed Dekra to certify medical devices in the UK. Dekra Certification UK has joined the three current UK approved bodies, increasing the UK's capacity to process conformity assessments for medical devices to ensure safe and effective devices reach the UK public. An approved body is an organisation that has been designated by the MHRA to assess whether manufacturers and their medical devices meet the requirements set out in  the UK Medical Devices Regulations 2002. Following an appropriate assessment, the new approved body will issue relevant certification allowing manufacturers to place a UKCA marking on their products before putting them on the market. Dr Laura Squire, chief healthcare quality and access officer at the MHRA, said: "This is a major milestone in our mission to ensure patients across the UK have access to the high-quality medical devices they need to protect their health.

The Medicines and Healthcare products Regulatory Agency (MHRA) has introduced a new tool to check the eligibility for marketing authorisation applicants. Applicants are now required to use the online 'Eligibility Checker' tool to determine whether their Marketing Authorisation Application (MAA) is suitable for the Agency's International Recognition procedure (IRP), which will become operational on 1 January 2024. The tool will also help applicants identify which route (A or B) to follow, before submitting their IRP application. Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said that the tool has been tailored to "facilitate a smooth and efficient process for marketing authorisation applicants."

The Medicines and Healthcare products Regulatory Agency (MHRA) has recalled Labetalol 200mg tablets (Tillomed Laboratories Ltd) directed to pharmacies and wholesalers. Manufacturer, Tillomed Laboratories is recalling one batch of Labetalol 200mg tablets due to an error on the foil blister packaging. The incorrect aluminium foil blister packaging states Labetalol 100mg tablets, however it should be labelled as Labetalol 200mg Tablets. This error has occurred at the primary packing operation. Tillomed Laboratories Limited has confirmed the actual tablet contained in the blister is Labetalol 200mg Tablets, which is the strength stated on the outer carton. This error is limited to the packaging of the batch with 100mg aluminium foil blister and does not impact the lot (batch) number or expiry as printed on the outer carton and aluminium foil blister. Healthcare professionals has been advised to stop supplying the batches immediately. Quarantine all remaining stock and return it to supplier using supplier's approved process.

The MHRA's Criminal Enforcement Unit (CEU), working with other law enforcement partners, has seized more than two million "illegally traded medicines" this year, with a total value of £5 million. The products confiscated in the UK were prescription-only medicines including anti-depressants, pain medication and human growth hormones. The MHRA launched an initiative, Operation Pangea, 15 years ago to combat "illegal internet trade in medical" products. Andy Morling, the Deputy Director of Criminal Enforcement of MHRA, spoke about Operation Pangea's 15-year anniversary. "Fifteen years ago, the MHRA started Operation Pangea, combining our knowledge and resources with those of international partners to disrupt and bring to justice the criminal gangs responsible for selling medicines illegally and causing harm around the world.

The Medicines and Healthcare products Regulatory (MHRA) and Genomics England to launch a brand-new genetic research resource, known as a 'biobank' on Thursday (June 01) to tackle the issue of Adverse Drug Reactions (ADRs). Biobank will help to better understand how a patient's genetic makeup can impact the safety of their medicines. "The Yellow Card biobank, which will contain genetic data and patient samples, will operate alongside the MHRA's Yellow Card reporting site for suspected side effects and adverse incidents involving medicines and medical devices," said MHRA. The biobank pilot will officially begin on 1 June 2023 with participant recruitment commencing later this year, on 1 September. The sequencing of participants' genetic material will begin in Spring 2024, with initial research findings from the pilot due to be published in 2025. Genomics England will be supporting the MHRA with sequencing and storage of genetic material through use of their well-established and secure infrastructure.

UK regulator has approved a second oral antiviral for early treatment of Covid-19 in high-risk adults, after molnupiravir. The Medicines and Healthcare products Regulatory Agency (MHRA) gave its nod for a new treatment called Paxlovid (PF-07321332 and ritonavir), after finding it safe and effective at reducing the risk of hospitalisation and death in people diagnosed with mild Covid-19 infection. Developed by Pfizer, Paxlovid prevents the multiplying of virus, helping the body to overcome the infection. A clinical trial for the treatment in high risk individuals revealed that a five-days course of Paxlovid reduces the risk of hospitalisation and death by 89 per cent. It further revealed that Paxlovid is most effective when taken in the early stage of infection. Dr June Raine, MHRA chief executive, said: "We now have a further antiviral medicine for the treatment of Covid-19 that can be taken by mouth rather than administered intravenously. This means it can be administered outside a hospital setting, before Covid-19 has progressed to a severe stage."

A couple in Maidenhead, Berkshire has been handed suspended sentence for illegal possession and supply of £1.6m of unlicensed medicines. Following investigations initiated by the MHRA, Karina Filimonova and Andrejs Stolarovs were caught with the unlicensed medicines which included prescription-only medications. Southwark Crown Court sentenced each "to eight months imprisonment suspended for 18 months and 150 hours unpaid work" for possessing and intending to supply medicinal products contrary to the Human Medicines Regulations 2012. "This was a sophisticated operation illegally bringing unlicensed medicines into the UK from Singapore and India, and then distributing them across the country and abroad," said Andy Morling, MHRA Deputy Director of Criminal Enforcement. "Criminals trading in medicines illegally like this are not only breaking the law, but they also have no regard for your safety. These are powerful medicines that can lead to serious adverse health consequences if taken without appropriate medical supervision." In 2020, the Royal Mail Group (RMG) informed the MHRA about parcels containing unlicensed medicines discovered during their investigation into suspicious parcel activity. Following this, the MHRA's Criminal Enforcement Unit, in cooperation with local police, launched an investigation and apprehended the couple at their residence in Kidwells Close, Maidenhead.

The Criminal Enforcement Unit (CEU) of the Medicines and Healthcare products Regulatory Agency (MHRA) seized a large quantity of suspected illegally traded medicines, including powerful prescription-only medicines, during raids conducted at two residential and two business premises across North Manchester. Officers from the MHRA and Greater Manchester Police carried out searches across two residential addresses in Oldham and Cheetham in the early hours of Wednesday (29 November), and arrested a man in his 20s on "suspicion of conspiracy to supply controlled drugs, breaches of the Human Medicines Regulations 2012 and money laundering." They also seized thousands of illegal medicines from two business addresses in Bury and Miles Platting, including powerful opioid painkillers and antidepressants, as well as unlicensed versions of erectile dysfunction drugs.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 3 medicines recall for Sildenafil 100mg Film-coated Tablets (Strandhaven Limited T/A Somex Pharma). Manufacturer of drug, Strandhaven Limited T/A Somex Pharma has informed the MHRA that the pack size on some cartons of the batch state 8 tablets instead of 4 tablets. This is an error due to cartons being mixed at the printers. All cartons with batch number ET22028 contain one blister strip of 4 tablets regardless of whether it states 8 tablets or 4 tablets on the pack. Only the batch number ET22028 is affected. Due to the low number of complaints received, only the packs labelled as containing 8 tablets are being recalled at this time. The batch is comprised of 60340 packs, to date 195 packs have been found to be mislabelled.

The Medicines and Healthcare Products Regulatory Agency (MHRA) confirmed that Ozempic has been found at two UK wholesalers on 18 October. The pre-filled falsely labelled pens have been purchased from legitimate suppliers in Austria and Germany. However, there has been no evidence that fake Ozempic has been supplied to UK patients. Dr Alison Cave, MHRA Chief Safety Officer spoke about closely with regulatory partners to ensure patients' safety. He said: "Buying semaglutide from illegally trading online suppliers significantly increases the risk of getting a product either falsified or not licensed for use in the UK. "Products purchased in this way will not meet our strict quality and safety standards, and taking such medicines may put your health at risk," he added.

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched new guidance to highlight the latest safety advice on the steps to take during anaphylaxis. On the start of World Allergy Week (19 June), an annual initiative led by the World Allergy Organization, aiming to raise awareness of allergies, their management and prevention, the MHRA has collaborated with allergy awareness advocates to share an easy step-by-step infographic guide and video outlining the latest advice from the CHM's working group on the safe and effective use of AAIs. Steve Barclay, Secretary of State for Health and Social Care said: "A severe allergic reaction can be life-threatening. One in five people in the UK suffer with at least one allergy, so it's vital people are equipped with the knowledge to keep themselves safe. Adrenaline auto-injectors - also known as AAIs or by their brand names such as EpiPen - are highly effective and convenient for the immediate treatment of anaphylaxis. If you have been prescribed one, please carry it with you at all times and make sure you are up to date on the latest safety guidance - it could save your life."

Medicines and Healthcare products Regulatory Agency (MHRA) has reminded healthcare professionals that use of systemic (oral and injectable) Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, and diclofenac is contraindicated in the last trimester of pregnancy (after 28 weeks of pregnancy). It has advised that patients who are unsure whether pain relief medicine they are taking is an anti-inflammatory (NSAID), to speak to doctor, midwife, or pharmacist. Some non-prescription pain relief medicines may contain more than one active drug, therefore it is important to read the box or the leaflet provided with the medicine to see if it contains an NSAID like ibuprofen. The use of any non-prescription medicine for the management of pain during pregnancy should be for the shortest possible time at the lowest possible dose, suggested MHRA.

The Medicines and Healthcare products Regulatory Agency (MHRA) made its new International Recognition procedure (IRP) fully operational from 1 January 2024, inviting developers of new medicines to submit their applications for marketing authorisation. Beginning this year, the EC Decision Reliance Procedure (ECDRP) has been replaced by IRP, and the Mutual Recognition/Decentralised Reliance Procedure (MRDCRP) has come under its umbrella. The move is expected to further improve access to life-saving medicines for UK patients following the UK's departure from the European Union.

The latest formulation of XGEVA (denosumab) is now available to patients in the UK, offering a more convenient treatment option for bone metastasis. It is the first product to be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) via the new International Recognition Procedure (IRP). Denosumab (XGEVA) is used to prevent serious bone-related complications resulting from bone metastasis in adults and to treat giant cell tumour of bone in both adults and adolescents. The medicine was authorised on 29 February 2024 as a 120 mg solution for injection in a prefilled syringe. In contrast to the current vial presentation, this simplifies the administration process, reducing the volume of liquid injected and lowering the risk of dosing errors. The product was authorised in 30 days by the MHRA, thanks to the new IRP that facilitated a rapid approval process.

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on plans to reclassify a locally-applied hormone replacement therapy product to treat the cause and relieve the symptoms of vaginal atrophy. The MHRA is proposing that Gina 10 microgram vaginal tablets, containing oestradiol, be made available over the counter as a "self care" product, under the supervision of a pharmacist. The Commission on Human Medicines too has advised that the application by Novo Nordisk, which is used to treat vaginal dryness, caused by oestrogen deficiency in postmenopausal women, can be made available as a pharmacy (P) medicine. The MHRA has been asking GPs, pharmacists and members of the public for their opinions on whether the tablets can be made available to women aged 50 and over who have not had a period for at least a year. If the reclassification goes ahead, pharmacists will be given training materials and a checklist to help them supply the medicine safely.

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a second "bivalent" vaccine as a Covid-19 booster. The updated booster vaccine made by Pfizer/BioNTech, targeting two coronavirus variants, has been approved for use in individuals aged 12 years and above. In each dose of the booster vaccine, 'Comirnaty bivalent Original/Omicron', half of the vaccine (15 micrograms) targets the original virus strain and the other half (15 micrograms) targets Omicron (BA.1). Dr June Raine, MHRA chief executive said: "I am pleased to announce that we now have a second approved vaccine for the UK Autumn booster programme. The clinical trial of the Pfizer/BioNTech bivalent vaccine showed a strong immune response against the Omicron BA.1 variant as well as the original strain. Bivalent vaccines are helping us to meet the challenge of an ever-evolving virus, to help protect people against Covid-19 variants. We have in place a comprehensive safety surveillance strategy for all UK-approved Covid-19 vaccines, and this will include the updated booster we approved today."

The Medicines and Healthcare products Regulatory Agency (MHRA) has warned the public to avoid buying pre-filled weight loss pens without a prescription. The warning came after 369 fake Ozempic injections have been seized since January 2023. However, Saxenda pens were obtained by members of the public in the UK through "non-legitimate routes". The health regulator has urged the public to buy the pens after consulting a healthcare professional and with a prescription. Dr Alison Cave, MHRA Chief Safety Officer shared her opinion on the matter, she said: "Buying products such as Ozempic or Saxenda without a prescription, from illegally trading suppliers, significantly increases the risk of receiving something which is either fake or not licensed for use in the UK.

The Medicines and Healthcare products Regulatory Agency (MHRA) has reminded healthcare professionals prescribing aripiprazole to alert patients about its possible side effects, following a rise in the number of reports of gambling disorder associated with the drug. Patients taking aripiprazole, which is used for the treatment of schizophrenia and bipolar disorder, are at risk of developing unusual urges or cravings that they cannot resist, including behaviours such as addictive gambling, excessive eating or spending, or an abnormally high sex drive. The regulator has received 69 reports of gambling or gambling disorder suspected to be caused by aripiprazole in the last 14 years via the Yellow Card Scheme, out of which 32 were received between 1 January and 31 August this year. Alison Cave, MHRA Chief Safety Officer, said: "The number of reports for suspected gambling and other impulsive behaviours associated with aripiprazole are small in comparison to the frequency with which it is prescribed, but the consequences for any patient developing these conditions can be significant."