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. You have accepted additional cookies. If a submission is rejected, we will email you the reasons for the rejection. Sara Berry 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. 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. An example of when we might do this is if you are under police. Dont worry we wont send you spam or share your email address with anyone. 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. This includes information of a commercially sensitive or personal nature, that may need to be restricted in the interests of security. An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees. Dont worry we wont send you spam or share your email address with anyone. If you respond to our letter we will take what you tell us into consideration. Andrew Bailey says 'nothing is decided' suggesting interest rates may rise less than thought Ilyas ali Suspended manufacturing and wholesale distribution authorisations list updated. 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. have helped thousands of drivers regain their driving privileges after cancellation, suspension or revocation. This will ensure you are not charged a periodic fee for the period 1 April 2016 to 31 March 2017. Is there any portal where we can check the list of MIA holders? TRIDENT PLACE, MOSQUITO WAY, Syri Limited suspension has been lifted. mhra licence suspension 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. 1 MEER END, MIDLAND MILL, 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. Published 4 February 2015 Last updated 5 January. Maalox oral suspension - Magnesium hydroxide; Aluminium hydroxide gel dried Magnesium hydroxide; . Uploaded new version of Suspended manufacturing and wholesale distribution authorisations. We aim to respond to queries within 18 working days, however, where expert advice is required from other parties this may take longer. 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. 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). Updated Suspended licences for manufacturers and wholesalers of medicines, Updated list of suspended manufacturing and wholesale distribution authorisation, Updated list of Suspended manufacturing and wholesale distribution authorisations, Updated list of suspended and revoked manufacturing and wholesale distribution authorisations, Updates list of suspended manufacturing and wholesale distribution authorisations. We may still revoke your licence. The List of Terminated, Revoked and Cancelled Licences has been updated. Please note, this includes changes to MHRA Guidance Note 6 1. Medical Evaluation Process. SR-22 Insurance Certificates. Dont worry we wont send you spam or share your email address with anyone. 94 RICKMANSWORTH ROAD, Any submission that does not meet the requirements will be rejected. The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated to include May 2015. Alpha Release This is a new service - your feedback will help improve it. 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. REACTA BIOTECH LIMITED T/A REACTA HEALTHCARE, The lenders have hired PricewaterhouseCoopers to advise them, according to one insider. If you have any questions about submitting your application you should email ris.na@mhra.gov.uk. @MarkKleinmanSky. The clarifying remark section of individual GMP and GDP certificates will indicate any exceptions. Healthcare. You can change your cookie settings at any time. If your application for these types of licences is pending and you no longer wish to proceed, you need to withdraw it. 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. Dealer Licences 2016 to October, Updated list of terminated and cancelled licences. 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. This does not replace your right of appeal through the courts. Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission. The Site Number is a specific number allocated to one site. Link to companies GMP and GDP certificates, see EUDRAGMDP link above. UNITED KINGDOM, CONSILIENT HEALTH (UK) LIMITED, Well send you a link to a feedback form. Published new version of the suspended manufacturing and wholesale distribution authorisations list. To help us improve GOV.UK, wed like to know more about your visit today. UK WDA (H) 12426. Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. Updated Suspended manufacturing and wholesale distribution authorisations CSV file. MILTON ROAD, 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. Dont include personal or financial information like your National Insurance number or credit card details. Dont include personal or financial information like your National Insurance number or credit card details. UNITED KINGDOM, BCM LIMITED, You can change your cookie settings at any time. Updated the terminated and cancelled manufacturing and wholesale dealer licences list. Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended. UNIT 191, CAMBRIDGE SCIENCE PARK, Converse Pharma distributes a range of generic drugs, including flu vaccines, employing close to 1,000 people at 11 sites across the country. Melatonin 4mg/5ml oral suspension STD, SF, LF, AF, NSF 150ml 20620 8 Menadiol 5mg/5ml oral suspension STD, SF, LF, CF . M&A Pharmachem, a UK-based producer of complex molecules and OTC products, is recalling two batches of paracetamol 500mg tablets, each containing 12 pots of 1,000 tablets. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. In August 2018, EnteroBiotix announced that the company had been awarded a manufacturer's specials license . Report a side effect with a medicine or medical device. ; Getting multiple traffic violations or speeding tickets. New list of suspended manufacturing and wholesale distribution authorisations added to the page. We also use cookies set by other sites to help us deliver content from their services. Updated list of terminated and cancelled manufacturing and wholesale Copy CSV Excel PDF Print Showing 1 to 10 of 325 entries Previous 1 2 3 4 5 33 Next Apply for new broker registrations and to vary existing broker registrations via https://fmdbroker.hma.eu/, Using link to MHRA fees: https://www.gov.uk/government/publications/mhra-fees. 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. 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. Updated: list of suspended manufacturing and wholesale distribution authorisations, Updated: list of revoked manufacturing and wholesale distribution authorisations. Any company that has an MHRA suspended licence cannot trade, suffers loss of credibility, loss of earnings and a reduced inspection schedule, which adds further costs and regulator interaction. Updated document - Suspended manufacturing and wholesale distribution authorisations. Updated list of suspended and revoked licences for manufacturers and wholesalers of medicines. You have rejected additional cookies. 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. When autocomplete results are available use up and down arrows to review and enter to select. We publish scientific assessment reports called a Public Assessment Report (PAR) available for new marketing authorisations granted after 30 October 2005. New version of the revocation and suspension lists has been uploaded. The MHRA Process Licensing Portal is part of the government's Digital by Default agenda and is a web application which provides a secure environment and an easy to use platform which allows. BUILDING 4, 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 posted on Updated the Suspended manufacturing and wholesale distribution authorisations list. ALR Program. Monthly update to 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. 09/02/2023. 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 suspension of the license will last until "Teva has completed its investigation and resolved the underlying issues ", the MHRA wrote. Updated list of medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences for February. Uploaded updated Suspended manufacturing and wholesale distribution authorisations list. Cancellation of a licence, authorisation or registration is when MHRA makes a decision to cancel the licence, authorisation or registration. UNITED KINGDOM, BARD PHARMACEUTICALS LIMITED, You should submit your application using the electronic Common Technical Document (eCTD). The current Updated list of suspensions. Revocation List updated with a new addition. You have rejected additional cookies. You can also tell us about any factual errors that may have affected our decision. All Rights Reserved. Since inspections of manufacturers of active substances are based on risk, some active substance manufacturers may not be in possession of a GMP certificate. If we intend to revoke or suspend your licence we will write to you to tell you why. Updated suspension list added to the page. 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. We publish the most up-to-date information for a medicine according to its licence history. Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. View online For 1 company the licence was terminated. Published new 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. 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. Any questions on the content of this database should be addressed to IE&S-IMT@mhra.gov.uk. Actavis, Forley Generics, and Goldshield Group also . Published updated 'Suspended manufacturing and wholesale distribution authorisations' spreadsheet. New version of document has been uploaded. Converse Pharma could not be reached for comment. WATFORD, 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. Download CSV You must do so within 21 days of the suspension coming into effect. If you use assistive technology (such as a screen reader) and need a If you have any questions about MHRA Submissions , you should email submissions@mhra.gov.uk. Or you can submit the forms to us by email to withdrawcancel@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. 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. Suspended Driver's License. Check benefits and financial support you can get, Find out about the Energy Bills Support Scheme, Drug or alcohol misuse or dependence: assessing fitness to drive, Declaration of voluntary surrender for medical reasons, Psychiatric disorders: assessing fitness to drive, Can I drive while my application is with DVLA? It will take only 2 minutes to fill in. 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. If you do not use this template your submission will be rejected. New version of Revocation list has been uploaded. 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. LE4 3EH, Compare over 50 top car insurance quotes and save. EN6 1TL, Welcome to the MHRA Process Licensing Portal. 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. Full document as sent to the MHRA on 21st July 2020: An example of when we might do this is if you are convicted of a relevant criminal offence. Added list of terminated and cancelled licences for April 2019. Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences' attachment to latest version. Updated the list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. 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. 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 Suspended manufacturing and wholesale distribution authorisations list. It will take only 2 minutes to fill in. Learn more about the circumstances that can lead to a licence holder losing their licence, either permanently or temporarily. At 1936 per MHRA inspection or re-inspection, you want as few visits as possible. We use some essential cookies to make this website work. varied or suspended by the Medicines and Healthcare products Regulatory Agency (MHRA). THANE ROAD, Our letter will also tell you how to appeal against our decision. Updated revoked and suspended documents on the page. Updated both attachments with newer files. Penalty fees may be incurred for non-payment. We use some essential cookies to make this website work. 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. You should read the guidance for your specific pathway for any extra information or steps that might be required. Updated the list of suspended licences for manufacturers and wholesalers of medicines. Phase 4 studies. 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. We have updated the list of suspended and revoked licenses and registrations, updated Suspended manufacturing and wholesale distribution authorisations, New version of Suspended manufacturing and wholesale distribution authorisations list has been uploded. 1999 - 2023 DMV.ORG. . Reinstating Your License. PEEL PARK CAMPUS, EAST KILBRIDE, This file may not be suitable for users of assistive technology. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. will check that NeeS and eCTD submissions are technically valid using the Extedo Eurs is Yours (EiY) validation tool. Once your application has been validated you will receive an invoice so that you can make a payment for the outstanding amount. 1 CHURCH ROAD, We may lift the suspension if you are found not guilty or the charges are dropped. The agency advised healthcare professionals to immediately stop supplying the batches and to quarantine and remove all remaining stock. It typically deals with the manufacture, assembly and wholesale distribution of medicinal products under UK and EU legislation, these licences are often called process licences and include: The MHRA Process Licensing Portal is part of the government's Digital by Default agenda and is a web application which provides a secure environment and an easy to use platform which allows customers to submit new applications and variations to existing wholesale distribution authorisations electronically via https://pclportal.mhra.gov.uk/. MHRA Suspended Licence checks are a critical part of your Quality Management System and Risk Management processes, so keep on top of them.