Converse Pharma distributes a range of generic drugs, including flu vaccines, employing close to 1,000 people at 11 sites across the country. 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. List of revoked manufacturing sites updated. This information is common to all procedures. The Agency has the power to withdraw a product from the market, and in the case of medicines, to suspend production. On the other hand, in Florida, earning 12 points on your license within a year will get your license suspended for 30 days. posted on We use some essential cookies to make this website work. Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended. LICENCE TYPE MA Manufacture and Assembly . You can change your cookie settings at any time. 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. The list of suspended manufacturing and wholesale distribution authorisations has been updated. The MHRA products website allows you to find: You can look for any word, phrase or Product Licence number (PL) using the search tool. Monthly update to 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. Aventis Pharma Limited . 9-11 HILLHOUSE LANE, You can find out more about the fees we charge in the guidance MHRA fees. You have rejected additional cookies. Suspended Driver's License. Copy CSV Excel PDF Print Showing 1 to 10 of 325 entries Previous 1 2 3 4 5 33 Next 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 also tell us about any factual errors that may have affected our decision. Suspended list updated to show licenses that have been terminated/revoked and therefore no longer suspended. Updated both attachments with newer files. 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. Updated the 'When we revoke your licence' section to: clarify how we will consider new criminality on the licence holder's record; clarify that "licence conditions" includes any additional conditions we have placed on the licence; make explicit that a licence may be revoked if the licence holder breaches our licence criteria. Occupational Licenses. 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. Updated the list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. Added a link to the User Guide for the electronic application form. Updated: list of revoked manufacturing and wholesale distribution authorisations. Added links to pages providing further information on some of the procedures. The Process Licensing Office sits within the Inspectorate and Process Licensing Group of the Inspection, Enforcement and Standards division. 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. 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. This does not replace your right of appeal through the courts. . Updated ist of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked. The Site Number is a specific number allocated to one site. BUILDING 4, 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. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. You can change your cookie settings at any time. Or you can submit the forms to us by email to withdrawcancel@mhra.gov.uk. New version of document has been uploaded. Updated: list of terminated and cancelled manufacturing and wholesale dealer licences. Refusal of licence / variation or an existing licence being revoked. If you have any questions about submitting your application you should email ris.na@mhra.gov.uk. The lenders have hired PricewaterhouseCoopers to advise them, according to one insider. Published updated Revoked manufacturing and wholesale distribution authorisations list. SR-22 Insurance Certificates. LEICESTER, 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. You can print blog posts using the keyboard shortcuts "Control P" or "Command P". To help us improve GOV.UK, wed like to know more about your visit today. All invoices must be settled upon receipt. 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. If you have any questions about the Submissions Portal, you should email submissions@mhra.gov.uk. Your licence remains live during a court appeal. UK Licence No: PL 04425/0697 . 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. 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. CAMBRIDGE, Syri Limited suspension has been lifted. 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. updated Suspended and revoked licences for manufacturers and wholesalers of medicines, list of suspended manufacturing and wholesale distribution authorisations updated. If you do not respond to our letter we will revoke your licence automatically after 21 days. Added new list of terminated and cancelled manufacturing and wholesale dealer licences. 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. Very rare: Agitation, confusion, tremor, ataxia, dysarthria, hallucinations, psychotic symptoms, convulsions, somnolence, encephalopathy, coma. Dont include personal or financial information like your National Insurance number or credit card details. Proposed suspension, variation . Dont worry we wont send you spam or share your email address with anyone. This means that you can still work during your appeal, unless we have also suspended your licence. The pathway that you follow will depend on your intended market and the type of application you are making. You have accepted additional cookies. Updated both 'revoked' and 'Suspended' manufacturing and wholesale distribution authorisations lists. 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. Well send you a link to a feedback form. Name and address of the site: NISA RETAIL LIMITED , BLOOM LANE, NORMANBY ENTERPRISE PARK, SCUNTHORPE, DN15 9YA, UNITED KINGDOM. MHRA alerts & recalls PharmData maintains a list of all MHRA alerts and recalls relevant to community pharmacy. POTTERS BAR, Updates and Changes to the August 2014 published guidance The process of publication of a list of inspected GMP QC laboratories by MHRA has been removed. Updated list of terminated and cancelled manufacturing and wholesale dealer licences up to May 2019 added to the page. 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 Well send you a link to a feedback form. If your organisation operates a PO system, please make sure that the relevant PO is provided to the MHRA before the invoice is issued. The MHRA-GMDP database contains the following information issued by the MHRA relating to manufacturing and wholesale authorisations and certificates. We also use cookies set by other sites to help us deliver content from their services. Updated list of suspended licences and registrations for manufacturers and wholesalers of medicines and ingredients. 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. The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated. TW9 2QE, Updated list of terminated and cancelled manufacturing and wholesale 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. In August 2018, EnteroBiotix announced that the company had been awarded a manufacturer's specials license . mhra licence suspensionhow to calculate solow residual mhra licence suspension. Updated Suspended manufacturing and wholesale distribution authorisations CSV file. You can find out more about how to pay your fees in our guidance on making a payment to MHRA. 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. We will write to you when we suspend your licence, telling you what we have done and why. 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. Failure to Appear. Details of the penalties are explained in ourFees Regulations. You have accepted additional cookies. 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. 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 Actavis, Forley Generics, and Goldshield Group also . List of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. If we intend to revoke or suspend your licence we will write to you to tell you why. 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. 09 October 2019. Anyone in the pharmaceutical or medicinal supply chain should use this list to ensure they are dealing with a valid licence or authorisation holder. MHRA considers each application for a product name to ensure that the proposed name will allow the medicine to be taken safely and correctly. 10 October 2019, MIA holders can be checked on the Eudra GMDP webpage for validity. If you do not include the correct information your application will not be validated. mhra licence suspension mhra licence suspension vo 9 Thng Su, 2022 vo 9 Thng Su, 2022 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. We can also suspend your licence if we believe that you are a threat to public safety or that it is in the public interest to do so. You cannot legally undertake licensable activity while your licence is suspended this includes during an appeal. DEESIDE INDUSTRIAL PARK, 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. You have accepted additional cookies. PEEL PARK CAMPUS, EAST KILBRIDE, Updated Suspended manufacturing and wholesale distribution authorisations List, Updated the list of Suspended manufacturing and wholesale distribution authorisations. MHRA reserves the right. Find out more about the different national and international procedures. 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 list of suspended and revoked licences and registrations. Published updated list of Suspended manufacturing and wholesale distribution authorisations. 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). You have accepted additional cookies. . 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). NISA RETAIL LIMITED. We also use cookies set by other sites to help us deliver content from their services. BEESTON, Report a side effect with a medicine or medical device. The MHRA announces recall of paracetamol tablets, after certain products were found to be discoloured due to the presence of fungi. Ranitidine 50mg/2ml injection is anticipated to be unavailable from the end of May 2020 until further notice. The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated to include May 2015. If you do not use this template your submission will be rejected. Since inspections of manufacturers of active substances are based on risk, some active substance manufacturers may not be in possession of a GMP certificate. Once your application has been validated you will receive an invoice so that you can make a payment for the outstanding amount. 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. 3.85 KB, View online 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. All UK and Great Britain (England, Scotland and Wales) national applications should be submitted through the MHRA Submissions Portal. 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/. 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. Updated list of medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences for February. You can go to the MHRA-GMDP website to view the lists of: Updated the suspended and revoked licenses list. Updated suspended manufacturing and wholesale distribution authorisations. Updated list of suspended licences added to the page. Dont include personal or financial information like your National Insurance number or credit card details. Its licence was "largely reinstated" following a re-investigation in April, says Sky. We will also tell you what you can do that might stop us from revoking your licence. 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). Uploaded new Suspended manufacturing and Revoked spreadsheets. The MHRA has been assured that acceptable standards of Good Manufacturing Practice are in place for . UNITED KINGDOM, WOODLEY BIOREG LIMITED, Registered users can receive instant email notifications of new alerts, and record their responses to MHRA alerts within their PharmData account. Submit the relevant forms above to MHRA via the MHRA portal if youre a UK applicant. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Removed link to Excel spreadsheet list of products. You can change your cookie settings at any time. 09/02/2023. 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. Updated list of companies in the UK who have had their licence to manufacture or wholesale medicines suspended. An updated list of suspended licenses has been uploaded. Published new list of Suspended manufacturing and wholesale distribution authorisations. Updated document - Suspended manufacturing and wholesale distribution authorisations. Updated lists of suspended and revoked licenses. 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. Replaced the PDF with a more accessible file. Uploaded updated suspended and revoked licences lists. You have rejected additional cookies. Published Medicines: terminated and cancelled manufacturing and wholesale dealer licences for August 2019. RICHMOND, the mentholatum company limited, 1 redwood avenue, peel park campus, east kilbride, glasgow, g74 5pe, united kingdom WD18 7JJ, The List of Terminated and Cancelled Licences has been updated. Visit the European Medicines Agency website for more information on the European requirements for cancellations or email the MHRA for UK requirements. Read More Contract Manufacture 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. Published 4 February 2015 Last updated 5 January. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences' link to latest January 2021 version. UNITED KINGDOM, THE MENTHOLATUM COMPANY LIMITED, Uploaded new version of Suspended and revoked licences list. We may still revoke your licence. Our legal power to do this is explained in Get Licensed (PDF, 3.03 MB, 90 pages). REACTA BIOTECH LIMITED T/A REACTA HEALTHCARE, UNITED KINGDOM, BARD PHARMACEUTICALS LIMITED, Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. Alpha Release This is a new service - your feedback will help improve it. 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). Dont worry we wont send you spam or share your email address with anyone. We also use cookies set by other sites to help us deliver content from their services. You have rejected additional cookies. Published updated versions of the Revoked manufacturing and wholesale distribution authorisations list and the Suspended manufacturing and wholesale distribution authorisations list. 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. ALR Program. 783 Bytes. Maalox oral suspension - Magnesium hydroxide; Aluminium hydroxide gel dried Magnesium hydroxide; . (MHRA) on safety, quality and efficacy of vaccines; MHRA responsible for Yellow Card Adverse Drug Reaction reporting system; Yellow Card reports can signal possibility that a product may be associated with certain risks. Uploaded new version of Suspended manufacturing and wholesale distribution authorisations. 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. (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). Published a new version of the 'Get Licensed' document. You will not be charged if your submission is rejected for technical reasons. Is there any portal where we can check the list of MIA holders? Updated the Suspended manufacturing and wholesale distribution authorisations list. Yesterday MHRA released an update on suspended manufacturing and wholesale distribution authorization. New list of suspended licenses added to the page. Medical Evaluation Process. 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). New September 2020 version of 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees. An example of when we might do this is if you are convicted of a relevant criminal offence. Suspended manufacturing and wholesale distribution authorisations list updated. Maalox 175mg/200mg Oral Suspension . Call us at (847) 390-8500 or submit your information via our contact form to arrange a free consultation. Updated the list of suspended licences for manufacturers and wholesalers of medicines. Well send you a link to a feedback form. View online Company name,Licence revoked,Date of revocation,Reason PRESTFORD LIMITED,WDA(H) 43010,04-Apr-22,Regulatory Action ACCENDO PHARMA LIMITED,WDA(H) 43391,16-Dec-21,Regulatory Action CHOPRAS PHARMACY LIMITED,WDA(H) 39745,17-Nov-21,Regulatory Action CELTICPHARM LIMITED,WDA(H) 44336,11-Nov-21,Regulatory Action WISE PHARMACIES LIMITED,WDA(H) 41881,11-Oct-21,Regulatory Action GIS MEDICAL & SURGICAL . 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.