NG90 2PR, Dont include personal or financial information like your National Insurance number or credit card details. Published updated list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. Published new list of Suspended manufacturing and wholesale distribution authorisations. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. We publish the most up-to-date information for a medicine according to its licence history. Dont worry we wont send you spam or share your email address with anyone. Under 'Ways to make your submission', Updated email address and naming to Department of Health and Social Care. Your licence remains live during a court appeal. 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). (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. Download CSV We recommend that you use a validation tool to check your submission as we dealer licences. 9-11 HILLHOUSE LANE, 94 RICKMANSWORTH ROAD, You can read our guidance about the submission of ASMFs. A certificate of Good Distribution Practice (GDP) is issued to a wholesale distributor if the outcome of the inspection confirms that the wholesale distributor complies with Good Distribution Practice. New terminated and cancelled manufacturing and wholesale dealer licences list uploaded, Updated link 'Medicines terminated and cancelled manufacturing and wholesale dealer licences', Updated list of medicines terminated and cancelled manufacturing and wholesale dealer licences. All invoices must be settled upon receipt. MHRA considers each application for a product name to ensure that the proposed name will allow the medicine to be taken safely and correctly. Latest list of suspended licenses added to the page. Updated both attachments with newer files. IAG are non-statutory multi-disciplinary groups which advise MHRA's Director of IE&S on recommendations for regulatory action. Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended. An example of when we might do this is if you are convicted of a relevant criminal offence. Replaced the PDF with a more accessible file. Complete the cancellation form (MS Word Document, 33.5 KB) if you're a UK applicant as well as following the European process at step 1. 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 This portal allows registered users to submit WDA (H) Wholesale Distribution Authorisation applications and variations API Active Pharmaceutical. A licence suspension is not a punishment: it is a temporary measure that gives us time to look into your case and/or await the outcome of investigations being carried out by the police or other public bodies. 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. We also use cookies set by other sites to help us deliver content from their services. An example of when we might do this is if you are under police. Suspended vs. Revoked License: The Differences, Driving with a Suspended License: What You Need to Know. 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. Following the MHRA's confirmation of "more than 40 arrests" and the suspension of five pharmacists, the BBC - which claimed to have seen a full copy of the watchdog's intelligence report - said 19 wholesalers are still "under suspicion as investigations into the criminal network continue". You will need to register if you havent already. You have accepted additional cookies. Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission. WD18 7JJ, Published new version of the suspended manufacturing and wholesale distribution authorisations list. Syri Limited suspension has been lifted. Welcome to the MHRA Process Licensing Portal. Maalox oral suspension - Magnesium hydroxide; Aluminium hydroxide gel dried Magnesium hydroxide; . Melatonin 4mg/5ml oral suspension STD, SF, LF, AF, NSF 150ml 20620 8 Menadiol 5mg/5ml oral suspension STD, SF, LF, CF . 1 REDWOOD AVENUE, 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. New September 2020 version of 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. Updated list of suspended and revoked licences for manufacturers and wholesalers of medicines. Energy bill support to be extended as price rise looms, Arm snubs London to float on the New York Stock Exchange despite PM's efforts but announces new Bristol site, Body blow for Downing Street and govt promise to turn UK into 'new Silicon Valley'. Negligent failures of senior UK dermatologists, and senior MHRA doctors, are such that the MHRA should immediately suspend isotretinoin's licence for the treatment of under-18s, and introduce a substantive consent form for all other patients. Converse Pharma could not be reached for comment. You have accepted additional cookies. The list of suspended manufacturing and wholesale distribution authorisations has been updated. Published Medicines: terminated and cancelled manufacturing and wholesale dealer licences for August 2019. SR-22 Insurance Certificates. Published a new version of the Suspended manufacturing and wholesale distribution authorisations list. Updated list of suspended licences added to the page. You can change your cookie settings at any time. Updated 'Suspended manufacturing and wholesale distribution authorisations' attachment, Updated 'Suspended and revoked licences and registrations for manufacturers and wholesalers of medicines and ingredients', New Suspended manufacturing and wholesale distribution authorisations published, New list of suspended manufacturing and wholesale distribution authorisations, Addition of new revocation and suspension. PL 04425/0697 . The Medicines and Healthcare products Regulatory Agency (MHRA) may suspend a licence to wholesale or manufacture medicines and medical products if it: In certain circumstances MHRA will permanently revoke a licence. UNITED KINGDOM, BCM LIMITED, updated suspended and revoked lists added to the page. You have rejected additional cookies. You can appeal our decision to suspend your licence in a Magistrates or Sheriff Court. Updated list of suspended licences and registrations for manufacturers and wholesalers of medicines and ingredients. LE4 3EH, GLASGOW, You must then resend the entire submission with the errors corrected. Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences' link to latest January 2021 version. You have rejected additional cookies. Published new list of terminated and cancelled manufacturing and wholesale dealer licences, Publish list of terminated and cancelled licenses from August 2017 to July 2018. . Updated list of terminated and cancelled manufacturing and wholesale dealer licences. Updated the 'When we suspend your licence' section to include reference to open public investigations. UNIT 191, CAMBRIDGE SCIENCE PARK, Updated list of suspended manufacturing and wholesale distribution authorisations added to the page. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. 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. Updated list of terminated and cancelled manufacturing and wholesale Healthcare products Regulatory Agency (MHRA) inspectorate as soon as possible. You can change your cookie settings at any time. 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. Aventis Pharma Limited . Uploaded new version of Suspended and revoked licences list. Phase 4 studies. View online Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. On-site inspections will resume as soon as travel restrictions permit. Any questions on the content of this database should be addressed to IE&S-IMT@mhra.gov.uk. . UNITED KINGDOM, VIATRIS UK HEALTHCARE LIMITED, Penalty fees may be incurred for non-payment. mhra licence suspensionhow to calculate solow residual mhra licence suspension. The absence of a GMP certificate should not be understood as meaning that the active substance manufacturer in question does not comply with GMP. You cannot legally undertake licensable activity while your licence is suspended this includes during an appeal. The MHRA-GMDP database contains the following information issued by the MHRA relating to manufacturing and wholesale authorisations and certificates. Revocation List updated with a new addition. An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees. Reinstating Your License. Levothyroxine 100 mcg tablets in Numark packaging are the same product as the Teva branded version and are also affected by suspension of the license. Comment by If you have submitted an application for a new MA, traditional herbal remedy and/or a parallel import product licence and you no longer want to proceed with application, you need to submit a withdrawal form. Updated list of suspended licenses added to the page. If your application for these types of licences is pending and you no longer wish to proceed, you need to withdraw it. This blog shares the work of the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate, by inspectors and those the Inspectorate works with. Uploaded new version of Suspended manufacturing and wholesale distribution authorisations. 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. The agency advised healthcare professionals to immediately stop supplying the batches and to quarantine and remove all remaining stock. Published 4 February 2015 Last updated 5 January. Applications can be fast tracked if there is compelling evidence of benefit in a public health emergency or if there is a shortage of supply of an essential medicine that has been verified by the Department of Health and Social Care (DHSC). It is an additional route of appeal that we offer so that you can appeal in a way that does not incur court costs. UK WDA (H) 12426. ; Getting multiple traffic violations or speeding tickets. Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. Added links to pages providing further information on some of the procedures. Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. Copy CSV Excel PDF Print Showing 1 to 10 of 325 entries Previous 1 2 3 4 5 33 Next 10 October 2019, MIA holders can be checked on the Eudra GMDP webpage for validity. 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. You can find out more about how to pay your fees in our guidance on making a payment to MHRA. ninja foodi digital air fry oven chicken tenders. Or you can submit the forms to us by email to withdrawcancel@mhra.gov.uk. This does not replace your right of appeal through the courts. 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. Uploaded new Suspended manufacturing and wholesale distribution authorisations spreadsheet. Co-Amoxiclav DST Grunenthal 300/42.75mg Granules for Oral Suspension; Co-Amoxiclav DST Grunenthal 400/57mg Granules for Oral Suspension; Co-amoxiclav for Injection 1000/20mg; Co-amoxiclav for Injection 500/100mg; Co-Amoxiclav Injection 500/100; Co-Amoxiclav Oral Suspension 125mg/31.25mg/5ml Amoxi-Co 125/31 You can change your cookie settings at any time. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced the licence suspension of ingenol mebutate gel (Picato). 1999 - 2023 DMV.ORG. 09/02/2023. You can find out more about the fees we charge in the guidance MHRA fees. 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. It will take only 2 minutes to fill in. posted on Sky News has learnt that Converse Pharma Group, which is one of the biggest suppliers to community pharmacies across the UK, is working with Teneo Restructuring on a hunt for additional capital. If you respond to our letter we will take what you tell us into consideration. Please note the site register will be updated on a quarterly basis. 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. Full document as sent to the MHRA on 21st July 2020: Marketing. 2 "Manufacturer's Licence" and "import from a third country" 2.1 A Manufacturer's Licence (MIA) may be granted for the manufacture and assembly of You should also use this form if you want to withdraw a variation application or amendment for an existing MA. Suspensions & Reinstatements. What the data show Since September 2020, 15 Companies were affected. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Updated: list of terminated and cancelled manufacturing and wholesale dealer licences. Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences' attachment to latest version. Updated attachment - March to Feb 2019 edition, Updated list of terminated and cancelled manufacturing and wholesale dealer licences. The lists of suspensions and revocations have been updated. Common: Headache, dizziness. 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. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Uploaded updated Medicines terminated and cancelled manufacturing and wholesale dealer licences PDF. If you want to fast track your application because of a shortage of supply we recommend you discuss this with DHSC by emailing DHSCmedicinesupplyteam@dhsc.gov.uk. Published new suspended manufacturing and wholesale distribution authorisations list. UNITED KINGDOM, THE MENTHOLATUM COMPANY LIMITED, We also use cookies set by other sites to help us deliver content from their services. The DHSC contact for fast-tracking a licence has changed. Manufacturing and Wholesale At 1936 per MHRA inspection or re-inspection, you want as few visits as possible. Sara Berry "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. If you have any questions about MHRA Submissions , you should email submissions@mhra.gov.uk. The MHRA has been assured that acceptable standards of Good Manufacturing Practice are in place for . We use some essential cookies to make this website work. Uploaded updated suspended and revoked licences lists. Dont include personal or financial information like your National Insurance number or credit card details. New version of document has been uploaded. mhra licence suspension mhra licence suspension vo 9 Thng Su, 2022 vo 9 Thng Su, 2022 POTTERS BAR, Updated list of suspended licences and registrations for manufacturers and wholesalers of medicines and ingredients. It will take only 2 minutes to fill in. Updated content to reflect that the UK cannot act as a Reference Members State (RMS) for approval of marketing authorisations in decentralised and mutual recognition licensing procedures during the transition period. Updated list of terminated and cancelled manufacturing and wholesale dealer licences up to May 2019 added to the page. Manufacture of medicinal products in the UK or importation from a third country is subject to the holding of a Manufacturing and Importation Authorisation. MILTON ROAD, Updated list of suspended and revoked licences and registrations. HATFIELD, 09 October 2019. Terminated and cancelled manufacturing and wholesale dealer licences for January through to February 2016. Post-license. If you have any questions about submitting your application you should email ris.na@mhra.gov.uk. Certificates of Suitability (CEPs) continue to be acceptable in support of UK and GB national authorisations.. Download CSV You must do so within 21 days of the suspension coming into effect. Is there any portal where we can check the list of MIA holders? You should read the guidance for your specific pathway for any extra information or steps that might be required. 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. Alternatively, we can maintain the suspension until we have all of the information we require to make a licensing decision. 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. You can print blog posts using the keyboard shortcuts "Control P" or "Command P". Report a side effect with a medicine or medical device. The Medicines and Healthcare products Regulatory Agency (MHRA) may suspend a licence to wholesale or manufacture medicines and medical products if it: identifies safety issues needs to investigate a licence holder In certain circumstances MHRA will permanently revoke a licence. 1 MEER END, Fees vary depending on the type and route of application. Learn more about the circumstances that can lead to a licence holder losing their licence, either permanently or temporarily. 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. Anyone in the pharmaceutical or medicinal supply chain should use this list to ensure they are dealing with a valid licence or authorisation holder. Subscribe to stay in the loop & on the road! In March, one of Converse Pharma's subsidiaries, DE Group, had its licence suspended by the Medicines and Healthcare products Regulatory Agency (MHRA) for breaches of its terms, forcing it to mothball its operations. The Medicines and Healthcare products Regulatory Agency (MHRA) said that is unlikely that any affected tablets will have reached patients as the discoloration is noticeable on opening the affected packs. Updates and Changes to the August 2014 published guidance The process of publication of a list of inspected GMP QC laboratories by MHRA has been removed. Updated: Suspended manufacturing and wholesale distribution authorisations, Suspended and revoked licences for manufacturers and wholesalers of medicines - August 2015, Updated: suspended and revoked licences for manufacturers and wholesalers of medicines, Updated: List of suspended manufacturing and wholesale distribution authorisations, Updated list of suspended and revoked licences for manufacturers and wholesalers of medicines. The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated to include May 2015. The MHRA announces recall of paracetamol tablets, after certain products were found to be discoloured due to the presence of fungi. DEESIDE, You have rejected 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. To make a request for fast tracking your marketing authorisation you should email a letter of no more than 3 pages to RIS.NA@mhra.gov.uk. Updated Suspended manufacturing and wholesale distribution authorisations List, Updated the list of Suspended manufacturing and wholesale distribution authorisations. We use some essential cookies to make this website work.