The pathway that you follow will depend on your intended market and the type of application you are making. Updated 'Suspended manufacturing and wholesale distribution authorisations' list, Updated 'Revoked manufacturing and wholesale distribution authorisations' list. dealer licences. We updated the list of suspended manufacturing and wholesale distribution authorisations. UNITED KINGDOM, VIATRIS UK HEALTHCARE LIMITED, We can suspend your licence for one or both of the following reasons: For example, we will suspend your licence if: Examples of what we mean by serious relevant offence are: terrorism, murder, manslaughter, rape, assault occasioning bodily harm (actual or grievous), battery, kidnapping, possession of indecent photographs of children, restriction of production and supply of controlled drugs. New September 2020 version of 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. Added August file for - Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences. Compare over 50 top car insurance quotes and save. MHRA considers each application for a product name to ensure that the proposed name will allow the medicine to be taken safely and correctly. An example of when we might do this is if you are convicted of a relevant criminal offence. 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. Ranitidine 50mg/2ml injection is anticipated to be unavailable from the end of May 2020 until further notice. BUILDING 4, either alone or jointly. It will take only 2 minutes to fill in. AstraZeneca's Evusheld (tixagevimab co-packaged with cilgavimab) is authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) and is the first antibody combination for pre-exposure prophylaxis (PrEP) against COVID-19 licensed in Great Britain. Updated list of terminated, revoked and cancelled licences. You can appeal our decision to suspend your licence in a Magistrates or Sheriff Court. 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. The List of Terminated, Revoked and Cancelled Licences has been updated. 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). Updated list of suspensions. At 1936 per MHRA inspection or re-inspection, you want as few visits as possible. List of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. Learn more about the circumstances that can lead to a licence holder losing their licence, either permanently or temporarily. UK WDA (H) 12426. July update to Terminated, Revoked, Cancelled licences file. An example of when we might do this is if you are under police. Marketing. UNIT 191, CAMBRIDGE SCIENCE PARK, G74 5PE, Well send you a link to a feedback form. 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. Converse Pharma could not be reached for comment. Actavis, Forley Generics, and Goldshield Group also . Updated lists of suspended and revoked licences. Published 4 February 2015 Last updated 5 January. UNITED KINGDOM, DENDRON BRANDS LIMITED, Suspended manufacturing and wholesale distribution authorisations list updated. Healthcare. Some information may have been excluded from public view. Well send you a link to a feedback form. Updated list of suspended licenses added to the page. Updated Suspended manufacturing and wholesale distribution authorisations CSV file. Please ensure that you limit bulk cancellations to a maximum of 10 product licenses showing per application form. When autocomplete results are available use up and down arrows to review and enter to select. An example of when we might do this is if you are under police investigation for a serious offence. Well send you a link to a feedback form. 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. Updated: list of suspended manufacturing and wholesale distribution authorisations, Updated: list of revoked manufacturing and wholesale distribution authorisations. In April 2018, C+D reported that the suspension had been extended due to remaining "non-compliance issues". It will take only 2 minutes to fill in. 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. You should also use our eAF and cover letter tool to determine what information you need to include in your application. 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. Accumulating too many driving record points. Once your application has been validated you will receive an invoice so that you can make a payment for the outstanding amount. mhra licence suspensionhow to calculate solow residual mhra licence suspension. We may still revoke your licence. You should read the guidance for your specific pathway for any extra information or steps that might be required. Updated Suspended manufacturing and wholesale distribution authorisations list. 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. Updated ist of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked. This portal allows registered users to submit WDA (H) Wholesale Distribution Authorisation applications and variations API Active Pharmaceutical. the mentholatum company limited, 1 redwood avenue, peel park campus, east kilbride, glasgow, g74 5pe, united kingdom 09 October 2019. 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. Monthly update to 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. . PEEL PARK CAMPUS, EAST KILBRIDE, Well send you a link to a feedback form. 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 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). This will ensure you are not charged a periodic fee for the period 1 April 2016 to 31 March 2017. Updated list of terminated and cancelled manufacturing and wholesale dealer licences up to May 2019 added to the page. Publish list of terminated and cancelled licenses from July 2017 to June 2018. Updated the list of suspended manufacturing and wholesale distribution authorisations. Reinstating Your License. All Rights Reserved. You can find out more about how to pay your fees in our guidance on making a payment to MHRA. Updated suspension list added to the page. 2. . The attorneys at The Davis Law Group, P.C. 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). You have accepted additional cookies. Welcome to the MHRA Process Licensing Portal. Maalox oral suspension - Magnesium hydroxide; Aluminium hydroxide gel dried Magnesium hydroxide; . Name and address of the site: NISA RETAIL LIMITED , BLOOM LANE, NORMANBY ENTERPRISE PARK, SCUNTHORPE, DN15 9YA, UNITED KINGDOM. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. The DHSC contact for fast-tracking a licence has changed. Published updated Revoked manufacturing and wholesale distribution authorisations list. 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. Published new suspended manufacturing and wholesale distribution authorisations list. Alpha Release This is a new service - your feedback will help improve it. In this situation the licence holder who is performing the testing and acts as the contract acceptor should be named as a contract laboratory on the contract giver's licence. Updated lists of suspended and revoked licenses. Download CSV Find out more about the different national and international procedures. 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. You should also use this form if you want to withdraw a variation application or amendment for an existing MA. 1999 - 2023 DMV.ORG. Download CSV 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. MILTON ROAD, 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. You can also use the A-Z list to find the active substance. Updated list of terminated and cancelled manufacturing and wholesale dealer licences. Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. UNITED KINGDOM, VIATRIS UK HEALTHCARE LIMITED, Uploaded updated Medicines terminated and cancelled manufacturing and wholesale dealer licences PDF. The MHRA products website allows you to find: You can look for any word, phrase or Product Licence number (PL) using the search tool. Suspended vs. Revoked License: The Differences, Driving with a Suspended License: What You Need to Know. Under 'Ways to make your submission', Updated email address and naming to Department of Health and Social Care. MHRA Suspended Licence checks are a critical part of your Quality Management System and Risk Management processes, so keep on top of them. 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. Uploaded new version of Suspended and revoked licences list. 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 We find an easy way to remember is to set a recurrent reminder in your Outlook calendar or Gmail diary. Updated Suspended manufacturing and wholesale distribution authorisations List, Updated the list of Suspended manufacturing and wholesale distribution authorisations. 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. Occupational Licenses. 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. Report a side effect with a medicine or medical device. The MHRA-GMDP database contains the following information issued by the MHRA relating to manufacturing and wholesale authorisations and certificates. 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. 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. If the outcome of the inspection is that the manufacturer does not comply, a statement of non-compliance may be issued and entered into MHRA-GMDP. HATFIELD, If you do not respond to our letter we will revoke your licence automatically after 21 days. MHRA reserves the right. The list of suspensions and revocations is updated on the same day that the suspension or revocation takes place. If you have any questions about the Submissions Portal, you should email submissions@mhra.gov.uk. LICENCE TYPE MA Manufacture and Assembly . Terms and Conditions Opens in new window | Privacy Notice Opens in new window, Click on this link to navigate to www.mhra.gov.uk, Good Manufacturing Practice (GMP) certificates, Good Distribution Practice Certificates (GDP). 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 Updated document - Suspended manufacturing and wholesale distribution authorisations. Published new list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. 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. Updated the list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. Updated suspended manufacturing and wholesale distribution authorisations. mhra licence suspension mhra licence suspension vo 9 Thng Su, 2022 vo 9 Thng Su, 2022 Alternatively, we can maintain the suspension until we have all of the information we require to make a licensing decision. Link to companies GMP and GDP certificates, see EUDRAGMDP link above. New version of the revocation and suspension lists has been uploaded. If your application for these types of licences is pending and you no longer wish to proceed, you need to withdraw it. Refusal of licence / variation or an existing licence being revoked. You should submit your application using the electronic Common Technical Document (eCTD). Updated: list of terminated and cancelled manufacturing and wholesale dealer licences. 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. If we intend to revoke or suspend your licence we will write to you to tell you why. . Uploaded new version of Suspended manufacturing and wholesale distribution authorisations. Department of Health and Social Care (DHSC) has issued a medicine supply notification for Ranitidine (all formulations) . An updated list of suspended authorisations was attached. Submit the relevant forms above to MHRA via the MHRA portal if youre a UK applicant. MIDLAND MILL, In total, it sells more than 6,000 products to 4,000 customers, the bulk of which are community pharmacies, giving the company an important role in UK healthcare provision. If the unlicensed medicine is obtained from a supplier holding a MHRA Manufacturer 'Specials' Licence or Wholesale Dealer Licence, the contractor shall endorse the prescription with the initials 'SP' to claim the . Updated suspension list for manufacturing and wholesale distribution authorisations. The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated to include May 2015. Visit the European Medicines Agency website for more information on the European requirements for cancellations or email the MHRA for UK requirements. Revocation List updated with a new addition. Alpha Release This is a new service - your feedback will help improve it. CDL Disqualifications. Added new list of terminated and cancelled manufacturing and wholesale dealer licences. 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: . The lenders have hired PricewaterhouseCoopers to advise them, according to one insider. https://mhrainspectorate.blog.gov.uk/2019/10/04/mhra-process-licensing-useful-information/. Maalox 175mg/200mg Oral Suspension . Cancellation of a licence, authorisation or registration is when MHRA makes a decision to cancel the licence, authorisation or registration. The agency advised healthcare professionals to immediately stop supplying the batches and to quarantine and remove all remaining stock. An updated list of suspended licenses has been uploaded. Syri Limited suspension has been lifted. Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences' attachment to latest version. 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. Updated list of suspended manufacturing and wholesale distribution authorisations. ASMFs holders must submit their dossier to the MHRA. 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. 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. Updated both 'revoked' and 'Suspended' manufacturing and wholesale distribution authorisations lists. HD1 6EF, News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. 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. You can change your cookie settings at any time. The Agency has the power to withdraw a product from the market, and in the case of medicines, to suspend production. What the data show Since September 2020, 15 Companies were affected. Updated list of suspended manufacturing and wholesale distribution authorisations added to the page. 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 suspended and revoked licences for manufacturers and wholesalers of medicines. Dont worry we wont send you spam or share your email address with anyone. 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). We look forward to hearing from you to discuss your case. Please note, this includes changes to MHRA Guidance Note 6 1. If your organisation operates a PO system, please make sure that the relevant PO is provided to the MHRA before the invoice is issued. 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. 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 publish scientific assessment reports called a Public Assessment Report (PAR) available for new marketing authorisations granted after 30 October 2005. Updated the 'When we suspend your licence' section to include reference to open public investigations. Replaced suspended list document with new updated version (suspended_list040518.csv), New list of suspended manufacturers and wholesalers, Updated list of suspended licences for manufacturers and wholesalers of medicines. 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. We aim to respond to queries within 18 working days, however, where expert advice is required from other parties this may take longer. WELBECK PHARMACEUTICALS & HOSPITAL SUPPLIES LIMITED , 35 DEVONSHIRE STREET, LONDON, W1G 6PZ, UNITED KINGDOM. Updated both attachments with newer files. 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. We may lift the suspension if you are found not guilty or the charges are dropped. View online Suspensions & Reinstatements. You can find out more in our naming of medicines guidance (PDF, 235 KB, 20 pages). 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. 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. Updated contact information for Department of Health for advice when seeking to fast-track an application due to a shortage of supply of essential medicines. (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). WATFORD, You have rejected additional cookies. UNITED KINGDOM, BCM LIMITED, 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 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. UNITED KINGDOM, BARD PHARMACEUTICALS LIMITED, 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.