Converse Pharma distributes a range of generic drugs, including flu vaccines, employing close to 1,000 people at 11 sites across the country. 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. Details of the penalties are explained in ourFees Regulations. Healthcare products Regulatory Agency (MHRA) inspectorate as soon as possible. Occupational Licenses. Added new list of terminated and cancelled manufacturing and wholesale dealer licences. Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences' link to latest January 2021 version. You should also use our eAF and cover letter tool to determine what information you need to include in your application. We also use cookies set by other sites to help us deliver content from their services. Any submission that does not meet the requirements will be rejected. 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. latest Suspended manufacturing and wholesale distribution authorisations, Updated Suspended manufacturing and wholesale distribution authorisations, Updated suspended manufacturing and wholesale distribution authorisations. This does not replace your right of appeal through the courts. WELBECK PHARMACEUTICALS & HOSPITAL SUPPLIES LIMITED , 35 DEVONSHIRE STREET, LONDON, W1G 6PZ, UNITED KINGDOM. You can print blog posts using the keyboard shortcuts "Control P" or "Command P". Some information may have been excluded from public view. The MHRA announces recall of paracetamol tablets, after certain products were found to be discoloured due to the presence of fungi. Updated suspension list added to the page. You can find out more about how to pay your fees in our guidance on making a payment to MHRA. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. The lenders have hired PricewaterhouseCoopers to advise them, according to one insider. . Removed link to Excel spreadsheet list of products. Published a new version of the Suspended manufacturing and wholesale distribution authorisations list. MHRA considers each application for a product name to ensure that the proposed name will allow the medicine to be taken safely and correctly. Welcome to the MHRA Process Licensing Portal. Alternatively, we can maintain the suspension until we have all of the information we require to make a licensing decision. HATFIELD, 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. The Medicines and Healthcare products Regulatory Agency (MHRA) The MHRA looks at new drugs when pharmaceutical companies want to license medicines outside of the EMA's centralised authorisation procedure. TRIDENT PLACE, MOSQUITO WAY, WD18 7JJ, Updated list of suspended manufacturing and wholesale distribution authorisations. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. UK WDA (H) 12426. 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. Publish list of terminated and cancelled licenses from July 2017 to June 2018. It will take only 2 minutes to fill in. Yesterday MHRA released an update on suspended manufacturing and wholesale distribution authorization. It is your responsibility to make sure the invoices for your submissions are paid on time. If you do not respond to our letter we will revoke your licence automatically after 21 days. 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. You can find out more in our naming of medicines guidance (PDF, 235 KB, 20 pages). Updated 'Suspended manufacturing and wholesale distribution authorisations' link. Please note the site register will be updated on a quarterly basis. (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. Published updated 'Suspended manufacturing and wholesale distribution authorisations' spreadsheet. If you have any questions about MHRA Submissions , you should email submissions@mhra.gov.uk. Updated list of suspended licences and registrations for manufacturers and wholesalers of medicines and ingredients. Following the MHRA's confirmation of "more than 40 arrests" and the suspension of five pharmacists, the BBC - which claimed to have seen a full copy of the watchdog's intelligence report - said 19 wholesalers are still "under suspicion as investigations into the criminal network continue". We also use cookies set by other sites to help us deliver content from their services. Published new list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. Published new suspended manufacturing and wholesale distribution authorisations list. Learn more about the circumstances that can lead to a licence holder losing their licence, either permanently or temporarily. version of this document in a more accessible format, please email, Check benefits and financial support you can get, Find out about the Energy Bills Support Scheme, Medicines and Healthcare products Regulatory Agency, Medicines: notes for applicants and holders of a wholesale dealer licence or broker registration, Veterinary Medicines Registers: manufacturing and distribution, Licences to manufacture or wholesale medicines, Medicines: variation forms for a manufacturer's licence. 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. You have accepted additional cookies. 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. The MHRA-GMDP database contains the following information issued by the MHRA relating to manufacturing and wholesale authorisations and certificates. You must cancel your marketing authorisation or other licence by 31 December if you want it to be cancelled by 31 March 2016. 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. You have accepted additional cookies. UNITED KINGDOM, VIATRIS UK HEALTHCARE LIMITED, 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. 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). Updated lists of suspended and revoked licenses. The information published in this Register was that held by the MHRA on the date of publication. Updated lists of suspended and revoked licences. Published new version of the suspended manufacturing and wholesale distribution authorisations list. 1 MEER END, 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. MHRA Suspended Licence checks are a critical part of your Quality Management System and Risk Management processes, so keep on top of them. If you respond to our letter we will take what you tell us into consideration. The marketing license for ingenol mebutate gel (Picato) has been suspended by the MHRA due to studies showing an increased risk of skin malignancies from the drug. At 1936 per MHRA inspection or re-inspection, you want as few visits as possible. We also use cookies set by other sites to help us deliver content from their services. 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. List of API manufacturers, importers and distributors, see EUDRAGMDP link above. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. 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. This is based on the MHRA assessment report with any commercially or personally confidential information removed. Updated 'Suspended manufacturing and wholesale distribution authorisations' list, Updated 'Revoked manufacturing and wholesale distribution authorisations' list. Updated list of companies in the UK who have had their licence to manufacture or wholesale medicines suspended. 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. You can change your cookie settings at any time. The List of Terminated 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). Find out more about the different national and international procedures. 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. Updated list of suspended licences for manufacturers and wholesalers of medicines. 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 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. 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 'When we suspend your licence' section to include reference to open public investigations. You have accepted additional cookies. We publish scientific assessment reports called a Public Assessment Report (PAR) available for new marketing authorisations granted after 30 October 2005. ninja foodi digital air fry oven chicken tenders. The MHRA also enforces European drug licensing regulations in the UK. Suspension lifted for Metro Pharmacy Limited. Converse Pharma could not be reached for comment. We publish the most up-to-date information for a medicine according to its licence history. LE4 3EH, Dont include personal or financial information like your National Insurance number or credit card details. 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. 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. Published updated list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. The Licence Number is a specific number allocated to one company. UNITED KINGDOM, MYONEX LIMITED, NOTTINGHAM, 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. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Refrain from driving for a period of time. 10 October 2019, MIA holders can be checked on the Eudra GMDP webpage for validity. 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? BUILDING 20, STATION CLOSE, Updated the list of suspended manufacturing and wholesale distribution authorisations. Well send you a link to a feedback form. You must then resend the entire submission with the errors corrected. Report a side effect with a medicine or medical device. To help us improve GOV.UK, wed like to know more about your visit today. If you do not use this template your submission will be rejected. RICHMOND, If we suspend your licence, the suspension comes into effect immediately. 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 Sara Berry 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). Updated list of medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences for February. PEEL PARK CAMPUS, EAST KILBRIDE, Alpha Release This is a new service - your feedback will help improve it. Refusal of licence / variation or an existing licence being revoked. An example of when we might do this is if you are convicted of a relevant criminal offence. UNIT 191, CAMBRIDGE SCIENCE PARK, Full Service We develop, source and fill an extensive range of packaging types to suit product function, brand design and especially consumer driven needs, which we monitor with our non-stop trends service. Published updated list of Suspended manufacturing and wholesale distribution authorisations. SR-22 Insurance Certificates. You should also use this form if you want to withdraw a variation application or amendment for an existing MA. EN6 1TL, Ilyas ali Updated revoked and suspended documents on the page. All invoices must be settled upon receipt. Uploaded new Suspended manufacturing and Revoked spreadsheets. 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). 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. Compare over 50 top car insurance quotes and save. The Process Licensing Office sits within the Inspectorate and Process Licensing Group of the Inspection, Enforcement and Standards division. 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. Updated: list of revoked manufacturing and wholesale distribution authorisations. Use the pre-submission checklist (PDF, 129 KB, 7 pages) to help you with your application. 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. 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. Added list of terminated and cancelled licences for April 2019. 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. For example, in Kentucky, it takes an accumulation of 12 points over the course of 2 years in order to receive a suspension. It will take only 2 minutes to fill in. UNITED KINGDOM, BCM LIMITED, Phase 4 studies. The MHRA products website allows you to find: You can look for any word, phrase or Product Licence number (PL) using the search tool. When autocomplete results are available use up and down arrows to review and enter to select. Get free quotes from the nation's biggest auto insurance providers. Or if you need to cancel a parallel import product. Updated suspended manufacturing and wholesale distribution authorisations. Visit the European Medicines Agency website for more information on the European requirements for cancellations or email the MHRA for UK requirements. Marketing. We find an easy way to remember is to set a recurrent reminder in your Outlook calendar or Gmail diary. 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. 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 terminated and cancelled manufacturing and wholesale dealer licences has been updated. On-site inspections will resume as soon as travel restrictions permit. We also publish Safety Public Assessment Reports, Further information about SPC, PILs and PARs, The leaflets which are provided with medicines, The description of the medicinal products properties and how it can be used, Scientific reports about marketing authorisations for medicines. Once your application has been validated you will receive an invoice so that you can make a payment for the outstanding amount. We may lift the suspension if you are found not guilty or the charges are dropped. The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated to include May 2015.
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