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MHRA
Peace of mind in dispensing unlicensed medicines ... es to patients, pharmacists can feel confident that the product has been through the rigorous inspection and licensing processes controlled by the Medicines and Healthcare products Regulatory Agency (MHRA) to ensure its safety, quality and efficacy. The product will be 'licensed' and will carry an appropriate product licence number. Occasionally, however, a pharmacist will receive a prescription for a ... Date: 30-04-2009 Categories: • Pharmacy Practice
Making the most of Yellow Cards The scheme enables the MHRA to take appropriate action if there is evidence of causal association between a particular medicine and an ADR. If confirmed, the MHRA may require changes to product licences, information leaflets, S ... Date: 11-05-2009 Categories: • OTC
Responsible Pharmacist regulations and the pharmacy refrigerator ... ts had already developed standard operating procedures long before this legislation, covering topics such as stock rotation and the prompt refrigeration of temperature sensitive products in line with MHRA guidelines. However, with the new legislation, all this now has to be available for inspection by law. This is where having a refrigerator specifically designed for the pharmacy can make life much ea ... Date: 13-05-2010 Categories: • Services
Ensuring peace of mind when dispensing unlicensed medicines ... ropean Union (EU): a centralised system encompassing marketing approval in all EU States, or a decentralised system involving individual state assessment and recommendation for approval (e.g. via the MHRA in the UK) to other member states. If there is a special patient need that cannot be met with a licensed medicine, a physician may decide to prescribe an unlicensed alternative. Article 5.1 of Direct ... Date: 13-05-2010 Categories: • Services
Prisym I.D. Ltd PRISYM Pharmacy software is a purpose designed labelling solution for healthcare organisations, specifically developed to meet current compliance requirements including MHRA and CLP. PRISYM Pharmacy is supplied with life-cycle documentation based on the GAMP V Model. It allows you to design, review, approve, print, reprint and reconcile your labels with the peace of mind ... Date: 08-06-2010 Categories: • Company Profiles
The EyeBag Company Ltd ... re-heated about 200 times before efficacy wanes. Patients use it twice a day for the first fortnight then several times each week as required. CE marked and registered as a medical device with the MHRA, the EyeBag usually retails for £20.   Visit www.eyebagcompany.com to find your nearest EyeBag stockist, order an EyeBag on line, or access much more information about MGD. email enquiries should be ... Date: 30-06-2010 Categories: • Company Profiles
IPS Specials ... of the Association of Commercial Specials Manufacturers - the organisation set up to represent Specials as an important sector of the pharmaceutical industry. IPS Specials is a state-of-the-art cGMP, MHRA licensed manufacturer of 'Special' compounded medications and are flexible in meeting the needs of our customers including independent pharmacists, chains, buying groups, wholesalers and hospitals. O ... Date: 22-09-2010 Categories: • Company Profiles
Crescent Pharma Ltd ... cture of high quality pharmaceutical products.Crescent Pharma holds a Wholesale Dealers License, a Manufacturer’s/Importers License and a Certificate of GMP Compliance of a Manufacturer. With its own MHRA approved warehousing (with internal picking and packing facilities) Crescent Pharma is able to provide swift and efficient deliveries to its customers.Crescent Pharma enjoys both directly and indirec ... Date: 30-06-2011 Categories: • Company Profiles
The BNF: a national institution ... JFC) is responsible for the content of the BNF. The JFC includes pharmacists appointed by the Royal Pharmaceutical Society, doctors appointed by the BMJ Publishing Group, and representatives from the MHRA and the UK health departments. The JFC decides on matters of policy and reviews amendments in light of new evidence and expert advice. A similar body, the Paediatric Formulary Committee, is responsib ... Date: 06-10-2011 Categories: • Pharmacy Practice
Herbal help ... with 15 of these being within Europe. Once a registration is gained, the product can carry an indication on the packaging to say: ‘A traditional herbal medicinal product for [the condition/s that the MHRA has agreed to], based on traditional use only’. The manufacturers of registered products can then provide all the technical data needed by healthcare professionals, and can implement proper pharmacov ... Date: 12-10-2011 Categories: • OTC
Problem skin conditions - the alternative profit boost ... that are not recommended by an NHS healthcare professional. However, the majority of ‘alternative’ problem skin products available for stocking on pharmacy shelves fall under strict regulation by the MHRA and cannot make claims unless they are backed up with sufficient clinical evidence. Keeping with the times In recent years, the internet has given everyday people the opportunity to access alternativ ... Date: 12-10-2011 Categories: • Clinical • Dermatology and wound care • OTC
Cold and temperate chain compliance – who’s ‘responsible’? ... especially true for antibiotics like cefalexin, but even substances like aspirin are similarly affected. It is therefore no surprise that the safe storage of medicines is such an important issue. The MHRA has reported that in the month of October 2010 in the fifty inspections it carried out in wholesale pharmacies, 24 per cent had temperature control and monitoring deficiencies, 50 per cent of which w ... Date: 13-10-2011 Categories: • Services
Patient safety in your hands ... role in the decision making process, but it is ultimately the pharmacist’s decision as they are the ones risking their professional livelihood. By using a specials manufacturer who is licensed by the MHRA specifi cally to manufacture specials in their Good Manufacturing Practice labs, the pharmacist passes any responsibility for faulty medicines on to the manufacturer. The likelihood of faulty medicin ... Date: 14-10-2011 Categories: • Specials
What’s so special about specials? ... spoke prescriptions on demand. Of course, to produce special medicines in the UK a manufacturer must hold a manufacturer’s (specials) licence showing their compliance with the criteria set out by the MHRA. Yet the more reputable specials manufacturers go a lot further. They have a team of highly trained pharmacy technicians and pharmacists who run every product they supply through a series of stringen ... Date: 14-10-2011 Categories: • Specials
Over the counter drug recalled Pharmacists must clear their shelves of diclofenac tablets as the product is being recalled over health fears. According to an alert by the Medicines and Healthcare Products Regulatory Agency (MHRA) on Wednesday 14 January, diclofenac is associated with a “small but increased” risk of serious cardiac side effects in some patients, if used at high does and for long-term treatment. Diclofenac ... Date: 19-01-2015 Categories: • News • Pharmacy Practice
Epilepsy drug linked to development disorders ... lproate medicines have been found to cause developmental disorders in up to 40% of children born to woman taking the drug during pregnancy. The Medicines and Healthcare products Regulatory Agency (MHRA) has urged healthcare professionals to better inform those taking the drug of risks associated with it. Information booklets are now available for patients and practitioners as well as stronger ... Date: 26-01-2015 Categories: • News • News in Brief • Pharmacy Practice
The future of e-cigarettes ... have the scope for medicines regulation but there will also be the option of Tobacco Product Directive (TPD) regulated. Would TPD regulated products be sufficient? AS: No, devices will have to be MHRA regulated. MR: Just to add to Ash’s point there, to able to make a medical claim that says that you are a product that helps smoking cessation, you need to have an MHRA licence and you need to be ... Date: 19-02-2015 Categories: • Roundtable
NEWS IN BRIEF: I Love My Pharmacist; Dry eye disease; Alzheimer's; Complaints ... tients and healthcare professionals alike." Packaging overhaul for Alzheimer’s medication The pharmaceutical industry has teamed up with the Medicines and Healthcare products Regulatory Agency (MHRA) to redesign Alzheimer’s medication packaging. The new design will include days of the week on the blister packs in an effort to help patients retain their independence in taking their medicines. ... Date: 04-11-2015 Categories: • News • News in Brief
NEWS IN BRIEF: Alcohol Poisoning; Superbugs; Diabetes; Parking ... e GlucoMen LX Sensor test strips to monitor their blood glucose levels must ensure they immediately close the vials properly after using them, the Medicines and Healthcare Products Regulatory Agency (MHRA) has warned. Failure to do so could expose the test strips distributed by Menarini Diagnostics UK to high humidity, which could lead to a reading that is higher than it should be. People are ad ... Date: 22-12-2015 Categories: • News • News in Brief
NEWS IN BRIEF: Cuts Crisis; Calorie Counts; Pharmacy Proposal; Diet Pills; Bestway Boss; Sugar App; Junior Docs ... eters warned about danger pills Dieters looking to lose weight in the New Year need to be aware of the dangers of buying diet pills online, the Medicines and Healthcare products Regulatory Agency (MHRA) have warned. During 2015 MHRA enforcement officers seized more than 240,000 doses of pills claiming to be for weight loss or slimming. A number of the products seized were marketed as ‘all her ... Date: 04-01-2016 Categories: • News • News in Brief
NEWS IN BRIEF: St John's Wort; Named and Shamed; Jailed Brothers; Tampons; ENT; Community Care; NHS Dissatisfaction ... ticular St John’s Wort Tablets since September 2013 should check the batch numbers on the label to see if they have the affected product, says the Medicines and Healthcare products Regulatory Agency (MHRA). St John's Wort - liver disease fears https://t.co/CIu2KIlDzd @MHRAgovuk recommend to check the batch number against those being recalled — British Liver Trust (@LiverTrust) February 9, 2016 Ph ... Date: 09-02-2016 Categories: • News • News in Brief
NEWS IN BRIEF: Erectile Drug Seizure; Illegal Supply of Lyrica; Superdrug; Hull GP; Valeant; Sanofi; E-cigarettes Thousands of illegal erectile dysfunction drugs seized in Scunthorpe Enforcement officers from the Medicines and Healthcare products Regulatory Agency (MHRA) have seized more than 62,000 doses of unlicensed erectile dysfunction medicines during raids at addresses in Scunthorpe. The illegal and potentially dangerous unlicensed medicines have an estimat ... Date: 28-04-2016 Categories: • News • News in Brief
NEWS IN BRIEF: Embezzled Cash; Asthma Clinics; Fake Viagra; Day Lewis; Pharmacy Cuts; Statins Glitch ... uter system used by someGPs to determine a patient’s risk, meaning some people have had their risk of cardiovascular disease miscalculated. The Medicines and Healthcare products Regulatory Agency (MHRA) has contacted GPs to let them know there has been an error in the SystmOne clinical IT software since 2009. But the regulator said that only a limited number of patients may have been affected by ... Date: 12-05-2016 Categories: • News • News in Brief
NEWS IN BRIEF: NHS Taxation; Large-scale Inspections; MHRA; Flu ... uld also force the European Medicines Agency – the largest EU body in Britain – out of London, said Medicines and Healthcare products Regulatory Agency chair Sir Michael Rawlins. Asked whether the MHRA would be able to take on all the extra work registering new drugs and medical devices carried out by the EMA, Sir Michael replied: “Certainly not.” MHRA would need to recruit hundreds of new staff ... Date: 24-05-2016 Categories: • News • News in Brief
MHRA warns against homeopathic teething products The MHRA has warned parents against using unlicensed homeopathic teething products due to a risk of seizures and other serious side effects. The agency’s advice comes after the US Food and Drug Administrat ... Date: 11-10-2016 Categories: • Latest News • More News • News
Pharmacists arrested in Yorkshire linked to criminal prescription drug supply chain ... the result of the UK drug regulator's large-scale investigation into the diversion of prescription drug supplies into the criminal market. The Medicines and Healthcare Products Regulatory Agency (MHRA) said that, uncommonly, the drugs involved were legitimate UK products. It said the investigation has found an "extensive network of criminality involving businesses such as wholesale dealers and ... Date: 16-12-2016 Categories: • Latest News • News
Online pharmacies illegally selling antibiotics could derail anti-resistance efforts ... ce. The researchers analysed 20 pharmacies that UK residents can buy medicine from online, and found three quarters are not registered with the Medicines and Healthcare products Regulatory Agency (MHRA) and the General Pharmaceutical Council, as required by law. And less than a third of the websites asked customers to complete a health questionnaire prior to dispensing drugs, it was found. Pr ... Date: 20-02-2017 Categories: • Clinical • Latest News • News • Practice and policy • Vaccinations and infections
How to help patients quit smoking ... in the absence of a formal regulatory framework, the contents and performance of e-cigarettes cannot be guaranteed. In my opinion, it is for this reason that pharmacists should not sell e-cigarettes. MHRA had promised regulation by the end of 2016 but this was not delivered. A large cross-sectional study13 showed that e-cigarettes were more successful than licensed NRT or unaided cessation attempts ... Date: 23-03-2017 Categories: • Clinical • Latest News • News • Smoking cessation
Two sentenced for selling illegal weight loss tablets online ... from Hong Kong and declared as 'vitamins'. More than 30,000 of the pills, with a value of over £15,700, were then found at the couple's home by Medicines & Healthcare products Regulatory Agency (MHRA) investigators. In the latest in a string of online pharmacy scandals, it was discovered that the Donegans had made in access of £215,000 from their illegal sale of the slimming pills online. 'Real ... Date: 31-03-2017 Categories: • Latest News • News
Analysis: Why is the MHRA considering making sildenafil available OTC ? ... without prescription, according to the medicines regulator. Pfizer Consumer Healthcare, which holds the license for sildenafil, applied to the Medicines and Healthcare products Regulatory Agency (MHRA) to sell a maximum of eight of the 50mg tablets as a pharmacy medicine. The MHRA, which regulates UK medicines on behalf of the Government, is now holding a public consultation on whether this cha ... Date: 07-04-2017 Categories: • Latest News • More News • News
Video: The Pharmacist on changes to OTC medicines ... s and how these could affect your business. For more on this story see: The Government's list of ten 'low value' prescription medicines which are being reviewed to be made OTC products The MHRA's consultation on reclassifying sildenafil, an alternative to Viagra, as a pharmacy medicine Date: 07-04-2017 Categories: • Interviews • Latest News • News • Views
Do online pharmacies pose a threat to independents? ... ning to providers The CQC released a joint statement with the General Pharmaceutical Council (GPhC), the General Medical Council (GMC), and the Medicines and Healthcare products Regulatory Agency (MHRA), warning providers and staff that they must follow professional guidelines to ensure safe and effective care for patients. The statement said: ‘We will continue to work closely together to share ... Date: 13-04-2017 Categories: • Latest News • News • Practice and policy • Services • Uncategorised
MHRA: Patients with serious allergies should carry two adrenaline injectors Following a recent European review, the Medicines and Healthcare products Regulatory Agency (MHRA) has issued a drug safety update on adrenaline auto-injectors. Following a recent European review into the devices, the MHRA makes the following recommendations: Prescribe two adrenaline auto ... Date: 18-08-2017 Categories: • Latest News • News
Manufacturer recalls insulin pens over fears they may be 'structurally compromised' ... tact Novo Nordisk to replace the cartridge holder as some could be damaged or subject to damage in the future. We continue to encourage people to report any issues involving medical devices to the MHRA via our Yellow Card Scheme.’ Dan Howarth, head of care at the charity Diabetes UK, said: ‘Ensuring the correct level on insulin is vitally important in the management of diabetes; so it’s importan ... Date: 24-08-2017 Categories: • Latest News • News
Viagra Connect to be available without prescription Viagra Connect will be available in pharmacies without a prescription, the Medicines and Healthcare Products Regulatory Agency (MHRA) has revealed . Previously classified as a prescription only medicine (POM), the product is now a pharmacy medicine (P), available to men over 18 who have erectile dysfunction (ED). Encouraging ... Date: 28-11-2017 Categories: • Clinical • News • Sexual health
PSNC requested 97 price concessions for November ... ly issue and the drug has remained available to pharmacies and patients. Where the department is aware of supply issues affecting a generic drug, we work closely with the pharmaceutical industry, the MHRA and the NHS in order to mitigate the impact on patient care.' Ongoing shortages Over the past few months, many generic products have been experiencing shortage and pricing issues. PSNC said: ... Date: 30-11-2017 Categories: • Latest News • News
GSK recalls inhalers over manufacturing concerns ... oses in the device’. The Seretide Accuhaler has been recalled as it ‘is used for maintenance treatment as opposed to a reliever treatment’, the Medicines and Healthcare products Regulatory Agency (MHRA) added. The MHRA said pharmacists with stock of the affected batches should: Quarantine any remaining stock and return to the original supplier for credit; Identify patients or carers who ... Date: 22-02-2018 Categories: • News
What do I need to know about the new Viagra regulations? ... re patients for what is a debilitating condition. From spring, pharmacists can sell the male impotence drug Viagra without a prescription. The Medicines and Healthcare Products Regulatory Agency (MHRA) hopes that making this medication more widely available ‘will help direct men who might not otherwise seek help into the healthcare system and away from the risks that come with buying medicines fro ... Date: 15-03-2018 Categories: • News
FMD roll-out will be delayed by 'one to two years', wholesaler predicts  ... FMD) will not be implemented in the UK on 9 February 2019, as mandated by the European Commission (EC), because pharmacists ‘aren’t ready’. The Medicines and Healthcare products Regulatory Agency (MHRA) refuted the claim. It is ‘certainly not looking to delay the roll-out of the delegated regulation for FMD in the UK’ and is ‘still working to the deadline’, it told The Pharmacist. Under the new ... Date: 11-04-2018 Categories: • Analysis • Latest News • News
Everything you need to know about FMD  ... f falsified medicines at EU borders, according to the UK medicines verification organisation SecurMed UK. More recently, medicines watchdog the Medicines and Healthcare products Regulatory Agency (MHRA) seized 6.2 million of medicine doses and medical devices worth £15.8m in 2015. The problem is so widespread that the World Health Organisation (WHO) estimated that 1% of sales in developed countr ... Date: 12-04-2018 Categories: • Analysis • Latest News • News
EXCLUSIVE: FMD could cost pharmacists thousands, major wholesaler predicts ... d ‘without fail’, as it will be an extra process ‘they are not doing now’. He added: ‘This is an extra thing they [pharmacists] would be obliged to do. But in which way, we don’t know yet.’ The MHRA recently told The Pharmacist that a public consultation, which includes an impact assessment looking at the various costs associated with the implementation of FMD in the UK, will be published ‘in th ... Date: 17-04-2018 Categories: • Latest News • News • Pharma Financial
EXCLUSIVE: Don’t believe ‘rumours’ about FMD delay, urges NPA ... code scanning system will be delayed, the National Pharmacy Association (NPA) has said. NPA board member Raj Patel stressed that the EU and the Medicines and Healthcare products Regulatory Agency (MHRA) have both been ‘clear’ that the UK must be compliant with the Falsified Medicines Directive (FMD) by February 2019. The ‘deeply frustrating silence’ from the Government on the details of the FMD ... Date: 19-04-2018 Categories: • News
MHRA bans valproate prescription in women of childbearing age The MHRA has announced a ban on the prescribing of valproate to women and girls of childbearing age, unless they are on a pregnancy prevention programme. The regulatory authority announced today that the l ... Date: 24-04-2018 Categories: • News
Are we really ready for the Falsified Medicines Directive? ... ching an agreement that suits pharmacy as much as it suits the Government's coffers will be found. Perhaps I'm being overly pessimistic and the Medicines and Healthcare products Regulatory Agency (MHRA) – the Government's medicines watchdog leading on the directive – will pull something out the bag. Perhaps the whole operation will be far less complex and far quicker to implement than we've previou ... Date: 24-04-2018 Categories: • Views
Is the MHRA's hardline stance on valporate really justified? ... therefore any fiddling about with the prescribing process risks provoking in us a major flounce. And so it is with valproate. Suddenly, the Medicines and Healthcare products Healthcare Authority (MHRA) has come over all draconian about this drug. Apparently, GPs have got to identify and refer for specialist assessment all women of childbearing age taking it. We must stop prescribing it for bipolar ... Date: 02-05-2018 Categories: • Views
Are you ready for the Falsified Medicines Directive? ... s were seized at EU borders, according to the UK’s medicines verification organisation SecurMed UK, a non-profit legal entity. More recently, the Medicines and Healthcare products Regulatory Agency (MHRA) seized 6.2 million of medicine doses and medical devices in the UK worth £15.8m in 2015.   A costly measure?   The regulation stipulates that pharmacists will have to pay for any ‘phys ... Date: 25-05-2018 Categories: • News
Pharmacy minister acknowledges ‘issues’ with reimbursement for specials not in drug tariff ... als, which will be subject to consultation with relevant stakeholders.’ Specials prices are based on information submitted by manufacturers with Medicine and Healthcare products Regulatory Agency (MHRA) specials licenses. According to the Pharmaceutical Negotiating Committee (PSNC), prices are determined as below: If an unlicensed special or import listed in the drug tariff is prescribed, t ... Date: 03-07-2018 Categories: • Latest News • News
EXCLUSIVE: ‘No intention at this time’ to assess FMD impact on community pharmacy, says MHRA ... medication before they are dispensed to verify their authenticity. It will come into force on 9 February in the UK. The comments come after the Medicines and Healthcare products Regulatory Agency (MHRA) published an FMD impact assessment consultation for what are known as Article 23 providers on Monday (16 July). The document looked at who should scan the products as well as the costs the differ ... Date: 20-07-2018 Categories: • Latest News • News
Cannabis-derived medicines to be available on prescription from autumn ... definition’ of what constitutes a cannabis-derived medicinal product will now be developed by the Department of Health and Social Care (DHSC) and the Medicines and Health products Regulatory Agency (MHRA). Medicines that fit this definition will then be reclassified to Schedule 2 of the Misuse of Drugs Regulation 2001, allowing them to be prescribed.   Currently, cannabis oil, cannabis, ca ... Date: 29-07-2018 Categories: • Clinical • News
Brexit uncertainties: Contractors need to carefully choose FMD system, NPA urges ... possible, in the remote possibility there is no workable UK FMD repository.’   ‘Regulatory inspections’   Earlier this month, the Medicines and Healthcare products Regulatory Agency (MHRA) published an FMD impact assessment consultation for what are known as Article 23 providers. These include those authorised or entitled to supply medicinal products to the public who do not operate w ... Date: 02-08-2018 Categories: • News

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