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 find an easy way to remember is to set a recurrent reminder in your Outlook calendar or Gmail diary. List of terminated and cancelled manufacturers and wholesale dealers licenses updates. 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. These templates should not be altered in any way, other than inserting the relevant information. You can change your cookie settings at any time. the mentholatum company limited, 1 redwood avenue, peel park campus, east kilbride, glasgow, g74 5pe, united kingdom Copy CSV Excel PDF Print Showing 1 to 10 of 325 entries Previous 1 2 3 4 5 33 Next 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. The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated to include May 2015. Updated the terminated and cancelled manufacturing and wholesale dealer licences list. Dont worry we wont send you spam or share your email address with anyone. Published a new version of the Suspended manufacturing and wholesale distribution authorisations list. HATFIELD, Report a side effect with a medicine or medical device. UNITED KINGDOM, THE MENTHOLATUM COMPANY LIMITED, Dealer Licences 2016 to October, Updated list of terminated and cancelled licences. An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees. 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. Updated the list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. MHRA Suspended Licence checks are a critical part of your Quality Management System and Risk Management processes, so keep on top of them. Refusal to pay outstanding fees on the grounds that the PO is not provided on the invoice will not be accepted. 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. either alone or jointly. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Updated list of suspended licences added to the page. Very rare: Agitation, confusion, tremor, ataxia, dysarthria, hallucinations, psychotic symptoms, convulsions, somnolence, encephalopathy, coma. MILTON ROAD, 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. 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. Published updated version of Suspended manufacturing and wholesale distribution authorisations list. Or if you need to cancel a parallel import product licence, complete the cancellation form (PDF, 525 KB, 3 pages). Truancy. . Department of Health and Social Care (DHSC) has issued a medicine supply notification for Ranitidine (all formulations) . https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-manufacturing-sites. Call us at (847) 390-8500 or submit your information via our contact form to arrange a free consultation. Well send you a link to a feedback form. If you do not respond to our letter we will revoke your licence automatically after 21 days. Suspended Driver's License. July update to Terminated, Revoked, Cancelled licences file. 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. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Please note, this includes changes to MHRA Guidance Note 6 1. Updated the list of suspended licences for manufacturers and wholesalers of medicines. Dont worry we wont send you spam or share your email address with anyone. 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. Please ensure that you limit bulk cancellations to a maximum of 10 product licenses showing per application form. 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. Updated the list of suspended manufacturing and wholesale distribution authorisations. 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). IAG are non-statutory multi-disciplinary groups which advise MHRA's Director of IE&S on recommendations for regulatory action. NOTTINGHAM, Join 1,972,984 Americans who searched for Car Insurance Rates: Please enter your ZIP Code to access Suspended License specific to your state: Your driver license may be suspended by your local Department of Motor Vehicles (DMV), Secretary of State (SOS), Department of Revenue (DOR), or Motor Vehicle Division (MVD). Added spreadsheet under "types of application" heading. In April 2018, C+D reported that the suspension had been extended due to remaining "non-compliance issues". Refusal of licence / variation or an existing licence being revoked. 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. Added updated list of suspended manufacturing and wholesale distribution authorisations. Added a link to the User Guide for the electronic application form. The list of suspended manufacturing and wholesale distribution authorisations has been updated. UNITED KINGDOM, VIATRIS UK HEALTHCARE LIMITED, DEESIDE INDUSTRIAL PARK, Submission of a new ASMF and any update to an ASMF should be made by the ASMF holder using MHRA Submissions . Use the pre-submission checklist (PDF, 129 KB, 7 pages) to help you with your application. 09 October 2019. If you have any questions about the Submissions Portal, you should email submissions@mhra.gov.uk. 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. MIDLAND MILL, 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. Anyone in the pharmaceutical or medicinal supply chain should use this list to ensure they are dealing with a valid licence or authorisation holder. 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. THANE ROAD, To help us improve GOV.UK, wed like to know more about your visit today. You can find out more about how to pay your fees in our guidance on making a payment to MHRA. mhra licence suspensionhow to calculate solow residual mhra licence suspension. 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. Updated both 'revoked' and 'Suspended' manufacturing and wholesale distribution authorisations lists. DEESIDE, We also use cookies set by other sites to help us deliver content from their services. 1 REDWOOD AVENUE, We also use cookies set by other sites to help us deliver content from their services. 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. Get free quotes from the nation's biggest auto insurance providers. Syri Limited suspension has been lifted. Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. MHRA's primary role is to protect public health and the IAG process forms a regulatory tool to manage this. You can appeal our decision to suspend your licence in a Magistrates or Sheriff Court. New version of Revocation list has been uploaded. NG90 2PR, Updated list of suspended licences and registrations for manufacturers and wholesalers of medicines and ingredients. Healthcare. LE4 3EH, Updated list of suspended licences and registrations for manufacturers and wholesalers of medicines and ingredients. City editor You have accepted additional cookies. You cannot legally undertake licensable activity while your licence is suspended this includes during an appeal. 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. 94 RICKMANSWORTH ROAD, You will not be charged if your submission is rejected for technical reasons. UNITED KINGDOM, CONSILIENT HEALTH (UK) LIMITED, New list of terminated licenses, August 2016 to July 2017 added to the page. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Suspension lifted for Metro Pharmacy Limited. We can maintain the suspension until we are in a position to make one of the following decisions: We will usually suspend your licence if you have been charged with a relevant offence. Melatonin 4mg/5ml oral suspension STD, SF, LF, AF, NSF 150ml 20620 8 Menadiol 5mg/5ml oral suspension STD, SF, LF, CF . If you have any questions about submitting your application you should email ris.na@mhra.gov.uk. Updated file 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. 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. Your driver license may be suspended by your local Department of Motor Vehicles (DMV), Secretary of State (SOS), Department of Revenue (DOR), or Motor Vehicle Division (MVD).. You can get a suspended license for reasons including: . Updated Suspended manufacturing and wholesale distribution authorisations List, Updated the list of Suspended manufacturing and wholesale distribution authorisations. 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. 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 BUILDING 4, Updated the terminated and cancelled manufacturing and wholesale dealer licences for September 2021. We recommend that you use a validation tool to check your submission as we You can change your cookie settings at any time. Learn more about the circumstances that can lead to a licence holder losing their licence, either permanently or temporarily. Updated Suspended manufacturing and wholesale distribution authorisations CSV file. Uploaded updated Suspended manufacturing and wholesale distribution authorisations list. Following recent advice from the EMA, the MHRA have suspended all licenses for ranitidine products. 2 NEWTECH SQUARE, You must do so within 21 days of the suspension coming into effect. 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 . REACTA BIOTECH LIMITED T/A REACTA HEALTHCARE, This will ensure you are not charged a periodic fee for the period 1 April 2016 to 31 March 2017. You can use the A-Z list to find an active substance, or search for a medicine. The MHRA products website allows you to find: You can look for any word, phrase or Product Licence number (PL) using the search tool. It will take only 2 minutes to fill in. Do not send the corrected deficiencies by email. If you do not use this template your submission will be rejected. We may lift the suspension if you are found not guilty or the charges are dropped. Updated: list of revoked manufacturing and wholesale distribution authorisations. Post-license. 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. Manufacturing and Wholesale UNITED KINGDOM, BARD PHARMACEUTICALS LIMITED, Ilyas ali You should also use this form if you want to withdraw a variation application or amendment for an existing MA. The MHRA announces recall of paracetamol tablets, after certain products were found to be discoloured due to the presence of fungi. 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. Updated the Suspended manufacturing and wholesale distribution authorisations list. Submit the relevant forms above to MHRA via the MHRA portal if youre a UK applicant. If you do not include the correct information your application will not be validated. Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission. New version of the revocation and suspension lists has been uploaded. 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.