Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences' link to latest January 2021 version. Suspended list updated to show licenses that have been terminated/revoked and therefore no longer suspended. 09/02/2023. It will take only 2 minutes to fill in. Updated list of companies in the UK who have had their licence to manufacture or wholesale medicines suspended. 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 recommend that you use a validation tool to check your submission as we Refusal of licence / variation or an existing licence being revoked. We also use cookies set by other sites to help us deliver content from their services. Suspended Driver's License. NOTTINGHAM, Or if you need to cancel a parallel import product licence, complete the cancellation form (PDF, 525 KB, 3 pages). UNITED KINGDOM, VIATRIS UK HEALTHCARE LIMITED, Copy CSV Excel PDF Print Showing 1 to 10 of 325 entries Previous 1 2 3 4 5 33 Next Manufacture of medicinal products in the UK or importation from a third country is subject to the holding of a Manufacturing and Importation Authorisation. 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 . 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). 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. 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. Ilyas ali Updated the list of suspended licences for manufacturers and wholesalers of medicines. Or you can submit the forms to us by email to withdrawcancel@mhra.gov.uk. Updated the Suspended manufacturing and wholesale distribution authorisations list, Added an updated version of the Suspended manufacturing and wholesale distribution authorisations list, Updated Suspended manufacturing and wholesale distribution authorisations csv file, New Suspended manufacturing and wholesale distribution authorisations list uploaded, Updated suspended manufacturing and wholesale distribution authorisations list, Suspended manufacturing and wholesale distribution authorisations updated to include HMS WHOLESALE LIMITED terminated licence, New Suspended manufacturing and wholesale distribution authorisations uploaded, New Suspended manufacturing and wholesale distribution authorisations updated. Updated: list of terminated and cancelled manufacturing and wholesale dealer licences. Updated 'Revoked manufacturing and wholesale distribution authorisations' and 'Suspended manufacturing and wholesale distribution authorisations' lists. EnteroBiotix secures key additional MHRA license and announces regulatory milestones. Updated list of suspended licences added to the page. Please note the site register will be updated on a quarterly basis. Our letter will also tell you how to appeal against our decision. 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. Link to companies GMP and GDP certificates, see EUDRAGMDP link above. 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. REACTA BIOTECH LIMITED T/A REACTA HEALTHCARE, You can find out more in our naming of medicines guidance (PDF, 235 KB, 20 pages). If you think your submission has been wrongly rejected, you should email ris.na@mhra.gov.uk. THANE ROAD, UNITED KINGDOM, THE MENTHOLATUM COMPANY LIMITED, All invoices must be settled upon receipt. Added links to pages providing further information on some of the procedures. Uploaded new Suspended manufacturing and wholesale distribution authorisations list. Since inspections of manufacturers of active substances are based on risk,. posted on Updated the terminated and cancelled manufacturing and wholesale dealer licences for September 2021. "The sector as a whole is expected to grow at pace in the next five years, meaning there is significant potential for Converse Pharma if it can raise the funding it needs," the industry source added. List of terminated and cancelled manufacturers and wholesale dealers licenses updates. 1 REDWOOD AVENUE, . https://mhrainspectorate.blog.gov.uk/2019/10/04/mhra-process-licensing-useful-information/. 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. 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. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. ; Getting multiple traffic violations or speeding tickets. We publish scientific assessment reports called a Public Assessment Report (PAR) available for new marketing authorisations granted after 30 October 2005. Compare over 50 top car insurance quotes and save. Updated: list of suspended manufacturing and wholesale distribution authorisations, Updated: list of revoked manufacturing and wholesale distribution authorisations. View online The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced the licence suspension of ingenol mebutate gel (Picato). Published new suspended manufacturing and wholesale distribution authorisations list. 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. We also use cookies set by other sites to help us deliver content from their services. The list of suspended manufacturing and wholesale distribution authorisations has been updated. 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. Uploaded new Suspended manufacturing and wholesale distribution authorisations spreadsheet. 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 Updated list of terminated and cancelled manufacturing and wholesale Removed link to Excel spreadsheet list of products. POTTERS BAR, 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. Added spreadsheet under "types of application" heading. 783 Bytes. You cannot legally undertake licensable activity while your licence is suspended this includes during an appeal. This includes information of a commercially sensitive or personal nature, that may need to be restricted in the interests of security. When autocomplete results are available use up and down arrows to review and enter to select. 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). 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. Published updated Revoked manufacturing and wholesale distribution authorisations list. If you do not respond to our letter we will revoke your licence automatically after 21 days. We use some essential cookies to make this website work. 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 . 2 NEWTECH SQUARE, Updated suspension list added to the page. We updated the list of suspended manufacturing and wholesale distribution authorisations. ninja foodi digital air fry oven chicken tenders. BEESTON, Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission. You have rejected 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). On the other hand, in Florida, earning 12 points on your license within a year will get your license suspended for 30 days. Latest list of suspended licenses added to the page. Registered users can receive instant email notifications of new alerts, and record their responses to MHRA alerts within their PharmData account. 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. UNITED KINGDOM, Terms and Conditions Opens in new window | Privacy Notice Opens in new window, Click on this link to navigate to www.mhra.gov.uk. UNITED KINGDOM, VIATRIS UK HEALTHCARE LIMITED, It will take only 2 minutes to fill in. If we suspend your licence, the suspension comes into effect immediately. Well send you a link to a feedback form. 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. We also use cookies set by other sites to help us deliver content from their services. Refrain from driving for a period of time. UNITED KINGDOM, CONSILIENT HEALTH (UK) LIMITED, Updated revoked and suspended documents on the page. Updated file 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. This will ensure you are not charged a periodic fee for the period 1 April 2016 to 31 March 2017. IAG are non-statutory multi-disciplinary groups which advise MHRA's Director of IE&S on recommendations for regulatory action. LICENCE TYPE MA Manufacture and Assembly . 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. Updated list of suspended licences and registrations for manufacturers and wholesalers of medicines and ingredients. In August 2018, EnteroBiotix announced that the company had been awarded a manufacturer's specials license . Visit the European Medicines Agency website for more information on the European requirements for cancellations or email the MHRA for UK requirements. We use some essential cookies to make this website work. SR-22 Insurance Certificates. We find an easy way to remember is to set a recurrent reminder in your Outlook calendar or Gmail diary. 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 the list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. (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. Following recent advice from the EMA, the MHRA have suspended all licenses for ranitidine products. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. You have accepted additional cookies. Also is there any process to verify that MIA licence is still valid? 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.