The Agency has the power to withdraw a product from the market, and in the case of medicines, to suspend production. If we intend to revoke or suspend your licence we will write to you to tell you why. You must cancel your marketing authorisation (MA), parallel import product licence and/or traditional herbal remedy registration, before a product can be removed from the market. The company is now said to be exploring raising equity or debt - or a combination of the two - as it seeks to exploit growth opportunities, particularly through expansion in the south of England. List of suspended licences for manufacturers and wholesalers of medicines updated, Updated the suspended list with two new suspensions and corrected suspension date for St Helen's Millennium Centre Services Limited. UNITED KINGDOM, Terms and Conditions Opens in new window | Privacy Notice Opens in new window, Click on this link to navigate to www.mhra.gov.uk. Dont include personal or financial information like your National Insurance number or credit card details. There should be a procedure that ensures there are documented checks made at least twice a month of MHRA's list of suspended licence holders and regular checks on EudraGMDP website for issued. Added new list of terminated and cancelled manufacturing and wholesale dealer licences. Updated the Suspended manufacturing and wholesale distribution authorisations list, Added an updated version of the Suspended manufacturing and wholesale distribution authorisations list, Updated Suspended manufacturing and wholesale distribution authorisations csv file, New Suspended manufacturing and wholesale distribution authorisations list uploaded, Updated suspended manufacturing and wholesale distribution authorisations list, Suspended manufacturing and wholesale distribution authorisations updated to include HMS WHOLESALE LIMITED terminated licence, New Suspended manufacturing and wholesale distribution authorisations uploaded, New Suspended manufacturing and wholesale distribution authorisations updated. You can change your cookie settings at any time. Updated the terminated and cancelled manufacturing and wholesale dealer licences list. MILTON ROAD, Dont worry we wont send you spam or share your email address with anyone. 1999 - 2023 DMV.ORG. UNITED KINGDOM, VIATRIS UK HEALTHCARE LIMITED, Download CSV You can change your cookie settings at any time. CB4 0GW, Marketing. The revelation of investment talks follows a challenging period during which the DE Group had its licence suspended by the MHRA for multiple breaches of its terms. If you do not use this template your submission will be rejected. 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. Phase 4 studies. 09 October 2019. New document added to page for September 2017. 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). Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission. 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 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. New version of suspended list has been uploaded. 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. An example of when we might do this is if you are under police. . News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. mhra licence suspension mhra licence suspension vo 9 Thng Su, 2022 vo 9 Thng Su, 2022 Published updated list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. 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.. Your driver license may be suspended by your local Department of Motor Vehicles (DMV), Secretary of State (SOS), Department of Revenue (DOR), or Motor Vehicle Division (MVD).. You can get a suspended license for reasons including: . updated suspended and revoked lists added to the page. The summary of product characteristics (SmPC) should be submitted to the MHRA in the correct format using the SPC template (MS Word Document, 36 KB). We also use cookies set by other sites to help us deliver content from their services. 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. New version of the revocation and suspension lists has been uploaded. This is based on the MHRA assessment report with any commercially or personally confidential information removed. An example of when we might do this is if you are convicted of a relevant criminal offence. UK WDA (H) 12426. 2. . Added list of terminated and cancelled licences for April 2019. posted on Updated list of medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences for February. 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. Added updated list of suspended manufacturing and wholesale distribution authorisations. 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. . Any submission that does not meet the requirements will be rejected. Terminated and cancelled manufacturing and wholesale dealer licences for January through to February 2016. You can find out more about the fees we charge in the guidance MHRA fees. G74 5PE, Updated Suspended manufacturing and wholesale distribution authorisations List, Updated the list of Suspended manufacturing and wholesale distribution authorisations. HATFIELD, You have accepted additional cookies. CDL Disqualifications. If you do not respond to our letter we will revoke your licence automatically after 21 days. . Since inspections of manufacturers of active substances are based on risk, some active substance manufacturers may not be in possession of a GMP certificate. To help us improve GOV.UK, wed like to know more about your visit today. Our legal power to do this is explained in Get Licensed (PDF, 3.03 MB, 90 pages). The lists of suspensions and revocations have been updated. 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. UK Licence No: PL 04425/0697 . MHRA's primary role is to protect public health and the IAG process forms a regulatory tool to manage this. 1 REDWOOD AVENUE, Updated lists of suspended and revoked licenses. Updated list of terminated and cancelled manufacturing and wholesale dealer licences up to May 2019 added to the page. Subscribe to our News and Updates to stay in the loop and on the road! GLASGOW, EMA is recommending that patients stop using Picato (ingenol mebutate), a gel for treating the skin condition actinic keratosis, while it continues its review of the medicine's safety. have helped thousands of drivers regain their driving privileges after cancellation, suspension or revocation. POTTERS BAR, Get free quotes from the nation's biggest auto insurance providers. 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. Fees vary depending on the type and route of application. CH5 2NT, If a submission is rejected, we will email you the reasons for the rejection. You can go to the MHRA-GMDP website to view the lists of: Updated the suspended and revoked licenses list. (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). Complete the cancellation form (MS Word Document, 33.5 KB) if youre a UK applicant as well as following the European process at step 1. Uploaded new Suspended manufacturing and wholesale distribution authorisations list. Revocation List updated with a new addition. Uploaded updated suspended and revoked licences lists. "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. 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. Cancellation of a licence, authorisation or registration is when MHRA makes a decision to cancel the licence, authorisation or registration. Suspensions & Reinstatements. Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences' attachment to latest version. 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. Depending on the state you live in, you may incur a suspension for a different amount of points. Uploaded new version of Suspended manufacturing and wholesale distribution authorisations. Submission of a new ASMF and any update to an ASMF should be made by the ASMF holder using MHRA Submissions . Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. If you use assistive technology (such as a screen reader) and need a 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 Subscribe to stay in the loop & on the road! It also covers 'sunset-clause' monitoring. 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). UNITED KINGDOM, THE MENTHOLATUM COMPANY LIMITED, Published 4 February 2015 Last updated 5 January. Refusal to pay outstanding fees on the grounds that the PO is not provided on the invoice will not be accepted. dealer licences. Ilyas ali News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Our letter will also tell you how to appeal against our decision. 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. Updated list of terminated and cancelled manufacturing and wholesale Published a new version of the Suspended manufacturing and wholesale distribution authorisations list. Healthcare products Regulatory Agency (MHRA) inspectorate as soon as possible. Converse Pharma Group, which supplies thousands of community pharmacies across the UK, wants to raise money after having its licence temporarily suspended by the MHRA, Sky News learns. Maalox oral suspension - Magnesium hydroxide; Aluminium hydroxide gel dried Magnesium hydroxide; . The Process Licensing Office sits within the Inspectorate and Process Licensing Group of the Inspection, Enforcement and Standards division. New September 2020 version of 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. Proposed suspension, variation . 94 RICKMANSWORTH ROAD, If you have any questions about submitting your application you should email ris.na@mhra.gov.uk. 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. Well send you a link to a feedback form. https://mhrainspectorate.blog.gov.uk/2019/10/04/mhra-process-licensing-useful-information/. Copy CSV Excel PDF Print Showing 1 to 10 of 325 entries Previous 1 2 3 4 5 33 Next Updated list of suspended licences and registrations for manufacturers and wholesalers of medicines and ingredients. @MarkKleinmanSky. Updated 'Suspended manufacturing and wholesale distribution authorisations' list, Updated 'Revoked manufacturing and wholesale distribution authorisations' list. The lenders have hired PricewaterhouseCoopers to advise them, according to one insider. Updated file 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. posted on 29.3 KB. You can read our guidance about the submission of ASMFs. And it ensures the safety and effectiveness of medicines in the UK. You must do so within 21 days of the suspension coming into effect. THANE ROAD, Updated list of suspended and revoked licences for manufacturers and wholesalers of medicines. Converse Pharma distributes a range of generic drugs, including flu vaccines, employing close to 1,000 people at 11 sites across the country. Manufacturing and Wholesale 7 companies were further suspended (46% of the total), hence they were not able to overcome the reason for suspension, and only 1 had suspension lifted. We may lift the suspension if you are found not guilty or the charges are dropped. You must cancel your marketing authorisation or other licence by 31 December if you want it to be cancelled by 31 March 2016. 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. City sources said the company, which was formed from a management buyout in 2013, was in talks with its lenders at the state-backed NatWest Group and Secure Trust Bank about the process. NISA RETAIL LIMITED. 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. SR-22 Insurance Certificates. latest Suspended manufacturing and wholesale distribution authorisations, Updated Suspended manufacturing and wholesale distribution authorisations, Updated suspended manufacturing and wholesale distribution authorisations. You can use the A-Z list to find an active substance, or search for a medicine. Published new suspended manufacturing and wholesale distribution authorisations list. A certificate of Good Manufacturing Practice (GMP) is issued to a manufacturer if the outcome of the inspection confirms that the manufacturer complies with the principles of Good Manufacturing Practice. 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. The information published in this Register was that held by the MHRA on the date of publication. If you have any questions about MHRA Submissions , you should email submissions@mhra.gov.uk. AL10 9UL, You have rejected additional cookies. 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. 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 EN6 1TL, Accumulating too many driving record points. HUDDERSFIELD, You can change your cookie settings at any time. UNIT 191, CAMBRIDGE SCIENCE PARK, 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. If you have any questions about the Submissions Portal, you should email submissions@mhra.gov.uk. View online The Licence Number is a specific number allocated to one company. Alpha Release This is a new service - your feedback will help improve it. Updated document - Suspended manufacturing and wholesale distribution authorisations. Suspended manufacturing and wholesale distribution authorisations list updated. Updated list of terminated and cancelled manufacturing and wholesale dealer licences. An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees. Healthcare. Sara Berry The list of suspended licences has been updated. Full document as sent to the MHRA on 21st July 2020: The use of POs is an internal control process and cannot be used as a reason to withhold payment of legitimate invoices. 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. You will not be charged if your submission is rejected for technical reasons. Failure to Appear. Updated both 'revoked' and 'Suspended' manufacturing and wholesale distribution authorisations lists. BUILDING 20, STATION CLOSE, Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. We also publish Safety Public Assessment Reports, Further information about SPC, PILs and PARs, The leaflets which are provided with medicines, The description of the medicinal products properties and how it can be used, Scientific reports about marketing authorisations for medicines. 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. Publish list of terminated and cancelled licenses from July 2017 to June 2018. LICENCE TYPE MA Manufacture and Assembly . 09/02/2023. Its licence was "largely reinstated" following a re-investigation in April, says Sky. Updated ist of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked. Updated: list of terminated and cancelled manufacturing and wholesale dealer licences. Join 1,972,984 Americans who searched for Car Insurance Rates: Please enter your ZIP Code to access Suspended License specific to your state: Your driver license may be suspended by your local Department of Motor Vehicles (DMV), Secretary of State (SOS), Department of Revenue (DOR), or Motor Vehicle Division (MVD).