Uploaded new Suspended manufacturing and wholesale distribution authorisations list. A drug distributor which had its licence suspended earlier this year by Britain's medicines watchdog has hired City advisers to raise tens of millions of pounds of new funding. We use some essential cookies to make this website work. Dont include personal or financial information like your National Insurance number or credit card details. Check benefits and financial support you can get, Find out about the Energy Bills Support Scheme, Marketing authorisations, variations and licensing guidance, Medicines and Healthcare products Regulatory Agency, Decentralised and mutual recognition reliance procedure for marketing authorisations, Medicines: apply for a variation to your marketing authorisation, Electronic Application Form and Cover Letter Tool, a brief description of the major clinical properties of the product, evidence supporting the claimed benefits of the product for the proposed indication(s). You have rejected additional cookies. Updated the terminated and cancelled manufacturing and wholesale dealer licences list. have helped thousands of drivers regain their driving privileges after cancellation, suspension or revocation. Suspension lifted for Metro Pharmacy Limited. . TW9 2QE, Updated the list of cancelled and revoked licenses, Updated list of terminated, cancelled and revoked licenses, Updated list of terminated, cancelled and revoked manufacturing and wholesaler dealer licences, Updated list of terminated, cancelled and revoked manufacturing and wholesale dealer licences. Please note that companies are not required to make payment on submission of both initial and variation application for all wholesale dealer and manufacturing licences invoices are sent via email once the companys application has been processed by the process licensing team. An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees. (INF188/6), Assessing fitness to drive: guide for medical professionals, you applied for it using fraudulent documents and/or using a fraudulent identity, you allow someone else to use your licence to engage in licensable conduct, you do not have the qualifications that you claimed to have on your application, you receive a sentence or disposal for a relevant offence and the date your sentence restrictions end means that you fall into the Automatic Refusal category of our licence criteria, you do not have the right to work in the UK (unless you are a director of a UK-registered company), you breach our licence criteria (as set out in, you break any of the licence conditions - this includes any additional conditions that we have placed on your licence, you do not do the training that we ask you to do, you receive a sentence or disposal for a relevant offence and the date your sentence restrictions end means that you fall into the Consider Additional Factors category of our licence criteria, we decide that you are not a fit and proper person to hold a licence, our decision is found to have been based on information that is factually incorrect, we are instructed to do so by the courts as the result of a legal appeal, we believe that you may be a threat to public safety, we believe that it is in the public interest to do so, you have been charged with a serious relevant offence, the police or another public body are investigating you for a serious relevant offence, lift the suspension and reinstate your licence, require you to take some form of remedial action before we will lift the suspension (for example, we may require you to take additional training). The Medicines and Healthcare products Regulatory Agency (MHRA) first issued a partial suspension of the manufacturer's licence in August 2017, after it "identified non-compliance with good manufacturing practice" during an inspection of its Luton site in July.. Updated the 'When we suspend your licence' section to include reference to open public investigations. Since inspections of manufacturers of active substances are based on risk, some active substance manufacturers may not be in possession of a GMP certificate. UNITED KINGDOM, MYONEX LIMITED, It will take only 2 minutes to fill in. Certificates of Suitability (CEPs) continue to be acceptable in support of UK and GB national authorisations.. The Medicines and Healthcare products Regulatory Agency (MHRA) The MHRA looks at new drugs when pharmaceutical companies want to license medicines outside of the EMA's centralised authorisation procedure. You have accepted additional cookies. List of new manufacturing licences and wholesale distribution authorisations 2015: https://www.gov.uk/government/publications/medicines-new-manufacturing-and-wholesale-dealer-licences, List of manufacturers licences MIA and MANA, MIA(IMP) on EUDRAGMDP link below: http://eudragmdp.ema.europa.eu/inspections/displayHome.do. You will need to register if you havent already. Cancellation of a licence, authorisation or registration is when MHRA makes a decision to cancel the licence, authorisation or registration. updated Suspended and revoked licences for manufacturers and wholesalers of medicines, list of suspended manufacturing and wholesale distribution authorisations updated. CAMBRIDGE, The Medicines and Healthcare products Regulatory Agency (MHRA) is a government body which was set up in 2003 to bring together the functions of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). If you use assistive technology (such as a screen reader) and need a You can also use the A-Z list to find the active substance. Common: Headache, dizziness. The Agency has the power to withdraw a product from the market, and in the case of medicines, to suspend production. It is your responsibility to make sure the invoices for your submissions are paid on time. Suspended Driver's License. LEICESTER, Please ensure that you limit bulk cancellations to a maximum of 10 product licenses showing per application form. You can change your cookie settings at any time. Its licence was "largely reinstated" following a re-investigation in April, says Sky. 10 October 2019, MIA holders can be checked on the Eudra GMDP webpage for validity. You can get a suspended license for reasons including: If you have a suspended drivers license, your state will likely require you to: Our suspended license pages for your state will help you: Click your state below for suspended license and reinstatement requirements at your states DMV, SOS, DOR, or MVD. (MHRA) on safety, quality and efficacy of vaccines; MHRA responsible for Yellow Card Adverse Drug Reaction reporting system; Yellow Card reports can signal possibility that a product may be associated with certain risks. If you think your submission has been wrongly rejected, you should email ris.na@mhra.gov.uk. We will also tell you what you can do that might stop us from revoking your licence. To help us improve GOV.UK, wed like to know more about your visit today. dealer licences. The MHRA announces recall of paracetamol tablets, after certain products were found to be discoloured due to the presence of fungi. Non-payment may also result in suspension of any licence or authorisation, followed by legal proceedings for any unpaid amounts, as a debt due to the Crown. WD18 7JJ, News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. NG90 2PR, The Licence Number is a specific number allocated to one company. We can also suspend your licence if we believe that you are a threat to public safety or that it is in the public interest to do so. Converse Pharma distributes a range of generic drugs, including flu vaccines, employing close to 1,000 people at 11 sites across the country. UNITED KINGDOM, DENDRON BRANDS LIMITED, Updated list of suspended and revoked licences and registrations. https://mhrainspectorate.blog.gov.uk/2019/10/04/mhra-process-licensing-useful-information/. Termination of a licence, authorisation or registration takes place at the request of the holder of the licence, authorisation or registrant, for example, the business decides they no longer wish to perform an activity that requires a licence, authorisation or registration. Terminated and cancelled manufacturing and wholesale dealer licences for January through to February 2016. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced the licence suspension of ingenol mebutate gel (Picato). The MHRA has been assured that acceptable standards of Good Manufacturing Practice are in place for . An application is made to the Medicines and Healthcare Products Regulatory Agency (MHRA), which examines the licence given to the product in other jurisdictions and decides whether a parallel import licence should be granted. Your licence remains live during a court appeal. Occupational Licenses. version of this document in a more accessible format, please email, Check benefits and financial support you can get, Find out about the Energy Bills Support Scheme, Medicines and Healthcare products Regulatory Agency, Medicines: notes for applicants and holders of a wholesale dealer licence or broker registration, Veterinary Medicines Registers: manufacturing and distribution, Licences to manufacture or wholesale medicines, Medicines: variation forms for a manufacturer's licence. It will take only 2 minutes to fill in. Published Medicines: terminated and cancelled manufacturing and wholesale dealer licences for August 2019. The Site Number is a specific number allocated to one site. Refusal to pay outstanding fees on the grounds that the PO is not provided on the invoice will not be accepted. NOTTINGHAM, Suspended list updated to show licenses that have been terminated/revoked and therefore no longer suspended. Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission. You should also use our eAF and cover letter tool to determine what information you need to include in your application. We use some essential cookies to make this website work. Updated list of suspended manufacturing and wholesale distribution authorisations. Dont worry we wont send you spam or share your email address with anyone. Alpha Release This is a new service - your feedback will help improve it. "The sector as a whole is expected to grow at pace in the next five years, meaning there is significant potential for Converse Pharma if it can raise the funding it needs," the industry source added. Following the end of the transition period, published information on new procedures for obtaining a marketing authorisation in the UK, Great Britain (England, Scotland and Wales) or Northern Ireland. Updated the list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. This does not replace your right of appeal through the courts. There is no additional fee for fast-tracking applications. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Published updated Revoked manufacturing and wholesale distribution authorisations list. BUILDING 4, The Process Licensing Office sits within the Inspectorate and Process Licensing Group of the Inspection, Enforcement and Standards division. Healthcare products Regulatory Agency (MHRA) inspectorate as soon as possible. You can find out more in our naming of medicines guidance (PDF, 235 KB, 20 pages). Dont worry we wont send you spam or share your email address with anyone. https://www.gov.uk/government/publications/medicines-application-forms-for-a-manufacturer-licence, https://www.gov.uk/government/publications/medicines-variation-forms-for-a-manufacturer-licence, https://www.gov.uk/government/publications/mhra-fees, https://www.gov.uk/government/publications/medicines-new-manufacturing-and-wholesale-dealer-licences, http://eudragmdp.ema.europa.eu/inspections/displayHome.do, https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-manufacturing-sites, https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-wholesale-distribution-sites, https://www.gov.uk/government/publications/register-of-brokers-authorised-to-deal-in-human-medicines, https://www.gov.uk/government/publications/suspended-licences-for-manufacturers-and-wholesalers-of-medicines, https://www.gov.uk/export-a-human-medicine, https://www.gov.uk/government/publications/medicines-terminated-and-cancelled-manufacturing-and-wholesale-dealer-licences, Supply chain security: part 1 - introduction, Round Table: The impact of Electronic Health Records on UK Clinical Trials, Manufacture of Investigational Medicinal Products Frequently Asked Questions, MHRA Process for approving Manufacturing Authorisations or API Registrations in relation to unlicensed Cannabis-Based Products for Medicinal Use, Innovation, Quality & Transparency a Compliance Team 1 Perspective, licences for the manufacture/importation of licensed medicinal products for human use, commonly abbreviated to MIA, 'specials' licences for the manufacture/importation of unlicensed medicinal products for human use, commonly abbreviated to MS, authorisations for the manufacture/importation of investigational medicinal products for human use, commonly abbreviated to MIA(IMP), authorisations for the manufacture/importation of licensed medicinal products for veterinary use (ManA), 'specials' licences for the manufacture of unlicensed medicinal products for veterinary use, (ManSA), manufacturer's licences for exempt advanced therapy medicinal products (MeAT), licences for the wholesale distribution of medicinal products for human use, commonly abbreviated to WDA (H) (including those covering unlicensed medicines obtained from another EEA member state), licences for the wholesale distribution/importation of medicinal products for veterinary use - WDA (V), active substance manufacturer, importer or distributor registrations, certificates of Good Manufacturing Practice (GMP), certificates of Good Distribution Practice (GDP), new applications typically take 90 working days to process, variations where no inspection is required: 30 working days - variations where an inspection is required: 90 working days, new applications for registration as Active Substance manufacturers, importers and distributors take 60 working days - if an inspection is required: 90 working days. If you have any questions about the Submissions Portal, you should email submissions@mhra.gov.uk. Healthcare. You should also use this form if you want to withdraw a variation application or amendment for an existing MA. LICENCE TYPE MA Manufacture and Assembly . The List of Terminated and Cancelled Licences has been updated. Truancy. Following recent advice from the EMA, the MHRA have suspended all licenses for ranitidine products. We will revoke (take away) your licence if: We will write to you before we revoke your licence, telling you what we intend to do and why. Ilyas ali M&A Pharmachem, a UK-based producer of complex molecules and OTC products, is recalling two batches of paracetamol 500mg tablets, each containing 12 pots of 1,000 tablets. posted on If you do not use this template your submission will be rejected. Updated the 'When we revoke your licence' section to: clarify how we will consider new criminality on the licence holder's record; clarify that "licence conditions" includes any additional conditions we have placed on the licence; make explicit that a licence may be revoked if the licence holder breaches our licence criteria. Well send you a link to a feedback form. MHRA is the Government body set up to discharge the responsibilities of the Licensing Authority, under powers delegated by those Ministers. Updated: list of terminated and cancelled manufacturing and wholesale dealer licences. The portal should be used for wholesale distribution authorisations [WDA(H)] and active substance manufacturers, importers and distributors new applications, variation applications and annual compliance reports (active substance manufacturers, importers or distributors only). You have rejected additional cookies. Updated both attachments - Revoked manufacturing and wholesale distribution authorisations and Suspended manufacturing and wholesale distribution authorisations, New list of Suspended manufacturing and wholesale distribution authorisations uploaded, Updated 'Suspended manufacturing and wholesale distribution authorisations' csv file, Added NECESSITY SUPPLIES LIMITED and their suspension till Feb 2020, We have updated the current suspended list, Suspended manufacturing and wholesale distribution authorisations update, We have updated the Suspended manufacturing and wholesale distribution authorisations data, We have updated the suspended manufacturing and wholesale distribution authorisations list, Published updated lists of suspended and revoked licences. We may lift the suspension if you are found not guilty or the charges are dropped. Use the pre-submission checklist (PDF, 129 KB, 7 pages) to help you with your application. All other specific services or enquiries contact can be found via the following link: https://www.gov.uk/guidance/contact-mhra#contents, Medicines and Healthcare products Regulatory Agency, Inspection, Enforcement & Standards Division Inspectorate and Process licensing, 10 South Colonnade, Canary Wharf, London E14 4PU, Dont miss the next post, sign up to be notified by email when a new post comes out, Comment by Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely. Please note, you are required as a company to ensure that all personal details provided to the MHRA are up to date and the MHRA needs to be notified within any application if any changes in personal details need to be updated, including email addresses and telephone numbers. What the data show Since September 2020, 15 Companies were affected. You can print blog posts using the keyboard shortcuts "Control P" or "Command P". Compare over 50 top car insurance quotes and save. Updated Suspended licences for manufacturers and wholesalers of medicines, Updated list of suspended manufacturing and wholesale distribution authorisation, Updated list of Suspended manufacturing and wholesale distribution authorisations, Updated list of suspended and revoked manufacturing and wholesale distribution authorisations, Updates list of suspended manufacturing and wholesale distribution authorisations. We use some essential cookies to make this website work. This is based on the MHRA assessment report with any commercially or personally confidential information removed. Added links to pages providing further information on some of the procedures. On the other hand, in Florida, earning 12 points on your license within a year will get your license suspended for 30 days. Added updated list of suspended manufacturing and wholesale distribution authorisations. Added August file for - Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences. To help us improve GOV.UK, wed like to know more about your visit today. New document added to page for September 2017. People are at the heart of Good Distribution Practice (GDP) and the RP is the central person within a Licence Holder's operations ensuring compliance with the conditions of the licence and ensuring the quality of the medicinal products handled. We aim to respond to queries within 18 working days, however, where expert advice is required from other parties this may take longer. UNITED KINGDOM, BCM LIMITED, Failure to Appear. Any questions on the content of this database should be addressed to IE&S-IMT@mhra.gov.uk. The marketing license for ingenol mebutate gel (Picato) has been suspended by the MHRA due to studies showing an increased risk of skin malignancies from the drug. Uploaded updated Suspended manufacturing and wholesale distribution authorisations list. Submission of a new ASMF and any update to an ASMF should be made by the ASMF holder using MHRA Submissions . Yesterday MHRA released an update on suspended manufacturing and wholesale distribution authorization. Company name,Licence revoked,Date of revocation,Reason PRESTFORD LIMITED,WDA(H) 43010,04-Apr-22,Regulatory Action ACCENDO PHARMA LIMITED,WDA(H) 43391,16-Dec-21,Regulatory Action CHOPRAS PHARMACY LIMITED,WDA(H) 39745,17-Nov-21,Regulatory Action CELTICPHARM LIMITED,WDA(H) 44336,11-Nov-21,Regulatory Action WISE PHARMACIES LIMITED,WDA(H) 41881,11-Oct-21,Regulatory Action GIS MEDICAL & SURGICAL . Added spreadsheet under "types of application" heading. You have accepted additional cookies. Updated the list of terminated, cancelled and revoked manufacturing and wholesale dealer licences, Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences' attachment to December 2021, Updated list of medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences. If we suspend your licence, the suspension comes into effect immediately. REACTA BIOTECH LIMITED T/A REACTA HEALTHCARE, Updated list of suspended and revoked licences for manufacturers and wholesalers of medicines. We recommend that you use a validation tool to check your submission as we The information published in this Register was that held by the MHRA on the date of publication. 94 RICKMANSWORTH ROAD, WATFORD, Updated lists of suspended and revoked licences. You can also submit the forms via the Central European System Platform (CESP). Suspended vs. Revoked License: The Differences, Driving with a Suspended License: What You Need to Know. At 1936 per MHRA inspection or re-inspection, you want as few visits as possible. Updated attachment - March to Feb 2019 edition, Updated list of terminated and cancelled manufacturing and wholesale dealer licences. Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences' link to latest January 2021 version. All UK and Great Britain (England, Scotland and Wales) national applications should be submitted through the MHRA Submissions Portal. Updated suspension list for manufacturing and wholesale distribution authorisations. ASMFs holders must submit their dossier to the MHRA. NJ MVC | Suspensions and Restorations Suspensions and Restorations Information about restoring your license or registration Restoring Your License or Registration If your license has expired, you will need to renew it in-person. Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended. It is the MA applicants responsibility to make sure that the ASMF is submitted either before you submit your application or at the same time, as your application will not be valid without it. Uploaded new Suspended manufacturing and wholesale distribution authorisations spreadsheet. Uploaded updated suspended and revoked licences lists. Updated Suspended manufacturing and wholesale distribution authorisations list. We also use cookies set by other sites to help us deliver content from their services. UNITED KINGDOM, CONSILIENT HEALTH (UK) LIMITED, We have updated the list of suspended and revoked licenses and registrations, updated Suspended manufacturing and wholesale distribution authorisations, New version of Suspended manufacturing and wholesale distribution authorisations list has been uploded. An example of when we might do this is if you are under police investigation for a serious offence. EnteroBiotix secures key additional MHRA license and announces regulatory milestones. Updated 'Revoked manufacturing and wholesale distribution authorisations' and 'Suspended manufacturing and wholesale distribution authorisations' lists. Complete the application to withdraw a pending application (MS Word Document, 35 KB) for and email it to us with withdrawal as your subject line. Do not send the corrected deficiencies by email. PILs are based on the Summaries of Product Characteristics (SPCs) which are a description of a medicinal products properties and the conditions attached to its use. Well send you a link to a feedback form. An updated list of suspended authorisations was attached. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. PL 04425/0697 . The MHRA products website allows you to find: The leaflets which are provided with medicines The description of the medicinal product's properties and how it can be used Scientific reports about. Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. Dont include personal or financial information like your National Insurance number or credit card details. Updated list of suspended licences added to the page. You can use the A-Z list to find an active substance, or search for a medicine. We can maintain the suspension until we are in a position to make one of the following decisions: We will usually suspend your licence if you have been charged with a relevant offence. Drug wholesaler hit by MHRA suspension hires advisers to find funding injection, Converse Pharma distributes a range of generic drugs. 1 MEER END, Report a side effect with a medicine or medical device. ; Getting multiple traffic violations or speeding tickets. Updated lists of suspended and revoked licenses. Updated 'Suspended manufacturing and wholesale distribution authorisations' link. You must do so within 21 days of the revocation coming into effect. Updated both 'revoked' and 'Suspended' manufacturing and wholesale distribution authorisations lists. Updated list of suspended licences and registrations for manufacturers and wholesalers of medicines and ingredients. Proposed suspension, variation . Dont include personal or financial information like your National Insurance number or credit card details. If your application for these types of licences is pending and you no longer wish to proceed, you need to withdraw it. Suspended manufacturing and wholesale distribution authorisations list updated. This will ensure you are not charged a periodic fee for the period 1 April 2016 to 31 March 2017. Published a new version of the 'Get Licensed' document. Updated list of suspended licences and registrations, Suspended manufacturing and wholesale distribution authorisations has been updated, Updated document - Revoked manufacturing and wholesale distribution authorisations, Updated list of suspended manufacturing and wholesale distribution authorisations. Comment by In August 2018, EnteroBiotix announced that the company had been awarded a manufacturer's specials license . @MarkKleinmanSky. London, UK, 23 December 2021 Today Novartis announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved the marketing authorisation to extend the licence in Great Britain for Piqray (alpelisib) for use in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor 2 NEWTECH SQUARE, The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated to include May 2015. Updated: list of terminated and cancelled manufacturing and wholesale dealer licences, Updated: list of terminated revoked and cancelled licences, Updated: List of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. All applications or queries regarding applications can be sent to the PCL team via email: pcl@mhra.gov.uk - stating in the subject box: Initial/Variation/Query type of licence held - company name/number (for example: Initial MIA 12345).