Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. varied or suspended by the Medicines and Healthcare products Regulatory Agency (MHRA). have helped thousands of drivers regain their driving privileges after cancellation, suspension or revocation. List of terminated and cancelled manufacturers and wholesale dealers licenses updates. 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. We use some essential cookies to make this website work. Suspended list updated to show licenses that have been terminated/revoked and therefore no longer suspended. 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. 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. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. New document added to page for September 2017. Updated suspension list for manufacturing and wholesale distribution authorisations. https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-manufacturing-sites. You have rejected additional cookies. either alone or jointly. To cancel a marketing authorisation for a medicine or a traditional herbal remedy so it can be removed from the market, you need to: Follow the European requirements on the European Medicines Agency (EMA) website completing and submitting their cover letter template and notification report table. We use some essential cookies to make this website work. You can go to the MHRA-GMDP website to view the lists of: Updated the suspended and revoked licenses list. Uploaded updated Suspended manufacturing and wholesale distribution authorisations list. An industry source said on Wednesday that Converse Pharma had intended to explore a sale process as part of a planned exit for its shareholders shortly before the MHRA suspension was implemented. MHRA reserves the right. ASMFs holders must submit their dossier to the MHRA. Published 4 February 2015 Last updated 5 January. City editor Updated suspended manufacturing and wholesale distribution authorisations. For 1 company the licence was terminated. Well send you a link to a feedback form. (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). Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. July update to Terminated, Revoked, Cancelled licences file. Download CSV Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Updated list of terminated and cancelled manufacturing and wholesale dealer licences up to May 2019 added to the page. Occupational Licenses. New version of Revocation list has been uploaded. 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: . 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. The suspension period varies by the customer's number of convictions and age while holding a provisional driver's license: 2nd conviction over 18 years - 30 days; 2nd conviction under 18 years - 30 days suspension and employment and education restriction for 90 days effective at the removal of the suspension Monthly update to 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences' link to latest January 2021 version. UNITED KINGDOM, BCM LIMITED, Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. The MHRA Suspended and Revoked page states; "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" Terminated Licence: We find an easy way to remember is to set a recurrent reminder in your Outlook calendar or Gmail diary. Full document as sent to the MHRA on 21st July 2020: AL10 9UL, BEESTON, Replaced the PDF with a more accessible file. WELBECK PHARMACEUTICALS & HOSPITAL SUPPLIES LIMITED , 35 DEVONSHIRE STREET, LONDON, W1G 6PZ, UNITED KINGDOM. This will ensure you are not charged a periodic fee for the period 1 April 2016 to 31 March 2017. Check benefits and financial support you can get, Find out about the Energy Bills Support Scheme, Medicines and Healthcare products Regulatory Agency, application to withdraw a pending application, Renewal form: human medicine marketing authorisation, Renew: marketing authorisation for a human medicine, Traditional herbal medicines: registration form and guidance, Herbal medicines granted a traditional herbal registration (THR), List of banned or restricted herbal ingredients for medicinal use, Marketing authorisations, variations and licensing guidance. Fees vary depending on the type and route of application. All Rights Reserved. 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. List of API manufacturers, importers and distributors, see EUDRAGMDP link above. Drug wholesaler hit by MHRA suspension hires advisers to find funding injection, Converse Pharma distributes a range of generic drugs. UNITED KINGDOM, THE MENTHOLATUM COMPANY LIMITED, Updated list of terminated, revoked and cancelled licences. 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. Published updated Revoked manufacturing and wholesale distribution authorisations list. We aim to respond to queries within 18 working days, however, where expert advice is required from other parties this may take longer. This means that you can still work during your appeal, unless we have also suspended your licence. You must cancel your marketing authorisation or other licence by 31 December if you want it to be cancelled by 31 March 2016. Well send you a link to a feedback form. View online https://mhrainspectorate.blog.gov.uk/2019/10/04/mhra-process-licensing-useful-information/. The Agency has the power to withdraw a product from the market, and in the case of medicines, to suspend production. Suspended manufacturing and wholesale distribution authorisations list updated. Published updated list of Suspended manufacturing and wholesale distribution authorisations. Subscribe to our News and Updates to stay in the loop and on the road! HUDDERSFIELD, You must do so within 21 days of the suspension coming into effect. We publish scientific assessment reports called a Public Assessment Report (PAR) available for new marketing authorisations granted after 30 October 2005. Healthcare products Regulatory Agency (MHRA) inspectorate as soon as possible. IAG are non-statutory multi-disciplinary groups which advise MHRA's Director of IE&S on recommendations for regulatory action. List of suspended manufacturing and wholesale distribution authorisations updated. 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. CH5 2NT, Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely. Well send you a link to a feedback form. Updated the list of suspended 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'. 1 MEER END, 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. Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. New list of terminated licenses, August 2016 to July 2017 added to the page. You must then resend the entire submission with the errors corrected. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. CDL Disqualifications. Updated list of suspended licences for manufacturers and wholesalers of medicines. Find out more about the different national and international procedures. 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. Updated list of companies in the UK who have had their licence to manufacture or wholesale medicines suspended. Dealer Licences 2016 to October, Updated list of terminated and cancelled licences. Or if you need to cancel a parallel import product licence, complete the cancellation form (PDF, 525 KB, 3 pages). posted on 3.85 KB, View online We will write to you when we suspend your licence, telling you what we have done and why. The list of suspended manufacturing and wholesale distribution authorisations has been updated. Latest list of suspended licenses added to the page. 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. Converse Pharma could not be reached for comment. For example, in Kentucky, it takes an accumulation of 12 points over the course of 2 years in order to receive a suspension. The lists of suspensions and revocations have been updated. The attorneys at The Davis Law Group, P.C. 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. . Updated attachment - March to Feb 2019 edition, Updated list of terminated and cancelled manufacturing and wholesale dealer licences. Removed link to Excel spreadsheet list of products. Submit the relevant forms above to MHRA via the MHRA portal if youre a UK applicant. Dont include personal or financial information like your National Insurance number or credit card details. Failure to Appear. Updated the list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. 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. Updated Suspended manufacturing and wholesale distribution authorisations CSV file. Or you can submit the forms to us by email to withdrawcancel@mhra.gov.uk. Refrain from driving for a period of time. We will also tell you what you can do that might stop us from revoking your licence. 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. Proposed suspension, variation . 783 Bytes. UNITED KINGDOM, DENDRON BRANDS LIMITED, 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. 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. If you use assistive technology (such as a screen reader) and need a 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: list of terminated and cancelled manufacturing and wholesale dealer licences. CB4 0GW, 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. Depending on the state you live in, you may incur a suspension for a different amount of points. 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). 1 CHURCH ROAD, 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. List of manufacturer specials (human) (MS) and manufacturer specials authorisation (veterinary): https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-manufacturing-sites, List of licensed wholesale distribution sites (human and veterinary): https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-wholesale-distribution-sites, List of brokers: https://www.gov.uk/government/publications/register-of-brokers-authorised-to-deal-in-human-medicines, List of suspended and revoked licences and authorisations: https://www.gov.uk/government/publications/suspended-licences-for-manufacturers-and-wholesalers-of-medicines, Export certificates: https://www.gov.uk/export-a-human-medicine, Terminated and cancelled manufacturing and wholesale dealer licences: https://www.gov.uk/government/publications/medicines-terminated-and-cancelled-manufacturing-and-wholesale-dealer-licences. 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. 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). New list of suspended manufacturing and wholesale distribution authorisations added to the page. Added spreadsheet under "types of application" heading. MHRA Suspended Licence checks are a critical part of your Quality Management System and Risk Management processes, so keep on top of them. You can find out more in our naming of medicines guidance (PDF, 235 KB, 20 pages). LICENCE TYPE MA Manufacture and Assembly . We also use cookies set by other sites to help us deliver content from their services. The above events are generally reversible and are usually reported in patients with renal impairment, or with other predisposing factors (see 4.4 Special Warnings . The clarifying remark section of individual GMP and GDP certificates will indicate any exceptions. Updated the list of suspended manufacturing and wholesale distribution authorisations. 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. It will take only 2 minutes to fill in. 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. UNITED KINGDOM, CONSILIENT HEALTH (UK) LIMITED, If your organisation operates a PO system, please make sure that the relevant PO is provided to the MHRA before the invoice is issued. Read More Contract Manufacture Once we revoke your licence we cannot change our decision unless it is for one of the following reasons: You can appeal our decision to revoke your licence in a Magistrates or Sheriff Court. 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. 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. Under 'Ways to make your submission', Updated email address and naming to Department of Health and Social Care. 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. 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. Updated the terminated and cancelled manufacturing and wholesale dealer licences list. You should submit your application using the electronic Common Technical Document (eCTD). Comment by 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. Updated lists of suspended and revoked licenses. You should read the guidance for your specific pathway for any extra information or steps that might be required. 2. . Updated document - Suspended manufacturing and wholesale distribution authorisations. If you are applying for a UK, Great Britain or Northern Ireland licence, you must get a PL number from the MHRA Portal or by emailing PLNumberAllocation@mhra.gov.uk before you submit your application. It will take only 2 minutes to fill in. 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. WATFORD, 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. Visit the European Medicines Agency website for more information on the European requirements for cancellations or email the MHRA for UK requirements. All UK and Great Britain (England, Scotland and Wales) national applications should be submitted through the MHRA Submissions Portal. Department of Health and Social Care (DHSC) has issued a medicine supply notification for Ranitidine (all formulations) . The list of suspensions and revocations is updated on the same day that the suspension or revocation takes place. Updated Suspended manufacturing and wholesale distribution authorisations list. You can also submit the forms via the Central European System Platform (CESP). MHRA is the Government body set up to discharge the responsibilities of the Licensing Authority, under powers delegated by those Ministers. Published updated 'Suspended manufacturing and wholesale distribution authorisations' spreadsheet. CAMBRIDGE, The Licence Number is a specific number allocated to one company. List of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. Sunset-clause monitoring This page lists questions relating to the notification of marketing and cessation, suspension, withdrawal of a medicinal product from the market and withdrawal of a marketing authorisation. To help us improve GOV.UK, wed like to know more about your visit today. Wholesale dealer licences/API/broker licences: GDP.Inspectorate@mhra.gov.uk, Manufacturing licences: gmpinspectorate@mhra.gov.uk. 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. You can change your cookie settings at any time. Updated list for terminated, revoked and cancelled, We have updated the Medicines: terminated and cancelled manufacturing and wholesale dealer licences, We have updated the Medicines terminated and cancelled manufacturing and wholesale dealer licences attachments. Updated list of terminated and cancelled manufacturing and wholesale dealer licences. SR-22 Insurance Certificates. MHRA alerts & recalls PharmData maintains a list of all MHRA alerts and recalls relevant to community pharmacy. NOTTINGHAM, The wholesale distribution of medicinal products and importation of medicines certified by a Qualified Person in accordance with Article 51 of Directive 2001/83/EC from listed countries is subject to the holding of a Wholesale Distribution Authorisation. 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. 94 RICKMANSWORTH ROAD, 09/02/2023. Updated both 'revoked' and 'Suspended' manufacturing and wholesale distribution authorisations lists. Published a new version of the Suspended manufacturing and wholesale distribution authorisations list. Suspensions & Reinstatements. Also is there any process to verify that MIA licence is still valid? Updated list of medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences for February. You have accepted additional cookies. Alpha Release This is a new service - your feedback will help improve it. Marketing. 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. You can print blog posts using the keyboard shortcuts "Control P" or "Command P". The suspension of the license will last until "Teva has completed its investigation and resolved the underlying issues ", the MHRA wrote. The list of suspended licences has been updated. You will not be charged if your submission is rejected for technical reasons. Added August file for - Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences. Details of the penalties are explained in ourFees Regulations. Anyone in the pharmaceutical or medicinal supply chain should use this list to ensure they are dealing with a valid licence or authorisation holder. We can revoke (take away) your licence if you no longer meet our licensing criteria. Updated list of terminated and cancelled manufacturing and wholesale dealer licences, List of terminated and cancelled licences updated, Updated list of terminated and cancelled licenses, Updated List of Terminated and Cancelled Manufacturing and Wholesale Dealer Licences, Updated List of Terminated and Cancelled Syri Limited suspension has been lifted. 29.3 KB. TRIDENT PLACE, MOSQUITO WAY, When autocomplete results are available use up and down arrows to review and enter to select. And it ensures the safety and effectiveness of medicines in the UK. An updated list of suspended licenses has been uploaded. Added links to pages providing further information on some of the procedures. Medical Evaluation Process. If you think your submission has been wrongly rejected, you should email ris.na@mhra.gov.uk. Sara Berry Updated 'Suspended manufacturing and wholesale distribution authorisations' list, Updated 'Revoked manufacturing and wholesale distribution authorisations' list.