mhra licence suspension
You have rejected additional cookies. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. UNITED KINGDOM, BCM LIMITED, For 1 company the licence was terminated. You should submit your application using the electronic Common Technical Document (eCTD). BUILDING 4, List of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. @MarkKleinmanSky. BIRSTALL, News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Accumulating too many driving record points. You must cancel your marketing authorisation or other licence by 31 December if you want it to be cancelled by 31 March 2016. ASMFs holders must submit their dossier to the MHRA. New list of suspended licenses added to the page. Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission. An example of when we might do this is if you are convicted of a relevant criminal offence. Updated ist of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked. Uploaded new Suspended manufacturing and wholesale distribution authorisations list. HUDDERSFIELD, 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. SR-22 Insurance Certificates. Uploaded updated Medicines terminated and cancelled manufacturing and wholesale dealer licences PDF. Also is there any process to verify that MIA licence is still valid? Drug wholesaler hit by MHRA suspension hires advisers to find funding injection, Converse Pharma distributes a range of generic drugs. Published new suspended manufacturing and wholesale distribution authorisations list. 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. We use some essential cookies to make this website work. We also use cookies set by other sites to help us deliver content from their services. The lists of suspensions and revocations have been updated. Updated: list of revoked manufacturing and wholesale distribution authorisations. Full document as sent to the MHRA on 21st July 2020: The MHRA Suspended and Revoked page states; "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 investigate a licence holder" Terminated Licence: Copy CSV Excel PDF Print Showing 1 to 10 of 325 entries Previous 1 2 3 4 5 33 Next All Rights Reserved. On-site inspections will resume as soon as travel restrictions permit. updated suspended and revoked lists added to the page. 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). Penalty fees may be incurred for non-payment. Manufacturing and Wholesale REACTA BIOTECH LIMITED T/A REACTA HEALTHCARE, Updated list of suspended licences for manufacturers and wholesalers of medicines. Dont worry we wont send you spam or share your email address with anyone. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. The Site Number is a specific number allocated to one site. The MHRA products website allows you to find: You can look for any word, phrase or Product Licence number (PL) using the search tool. We may lift the suspension if you are found not guilty or the charges are dropped. 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. Compare over 50 top car insurance quotes and save. List of terminated and cancelled manufacturers and wholesale dealers licenses updates. G74 5PE, Published new version of the suspended manufacturing and wholesale distribution authorisations list. Well send you a link to a feedback form. 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. At 1936 per MHRA inspection or re-inspection, you want as few visits as possible. 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. Updated lists of suspended and revoked licenses. To help us improve GOV.UK, wed like to know more about your visit today. Since inspections of manufacturers of active substances are based on risk,. TW9 2QE, If we suspend your licence, the suspension comes into effect immediately. Updated both attachments with newer files. UNITED KINGDOM, BARD PHARMACEUTICALS LIMITED, 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. The absence of a GMP certificate should not be understood as meaning that the active substance manufacturer in question does not comply with GMP. If you do not respond to our letter we will revoke your licence automatically after 21 days. Find out more about the different national and international procedures. You can find out more about how to pay your fees in our guidance on making a payment to MHRA. Added spreadsheet under "types of application" heading. the mentholatum company limited, 1 redwood avenue, peel park campus, east kilbride, glasgow, g74 5pe, united kingdom 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. Energy bill support to be extended as price rise looms, Arm snubs London to float on the New York Stock Exchange despite PM's efforts but announces new Bristol site, Body blow for Downing Street and govt promise to turn UK into 'new Silicon Valley'. Updated the list of suspended licences for manufacturers and wholesalers of medicines. D ate of . The Process Licensing Office sits within the Inspectorate and Process Licensing Group of the Inspection, Enforcement and Standards division. City editor New list of terminated licenses, August 2016 to July 2017 added to the page. Dont worry we wont send you spam or share your email address with anyone. An example of when we might do this is if you are under police. If you have any questions about MHRA Submissions , you should email submissions@mhra.gov.uk. Link to companies GMP and GDP certificates, see EUDRAGMDP link above. WELBECK PHARMACEUTICALS & HOSPITAL SUPPLIES LIMITED , 35 DEVONSHIRE STREET, LONDON, W1G 6PZ, UNITED KINGDOM. UNITED KINGDOM, THE MENTHOLATUM COMPANY LIMITED, 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. Check benefits and financial support you can get, Find out about the Energy Bills Support Scheme, Marketing authorisations, variations and licensing guidance, Medicines and Healthcare products Regulatory Agency, Decentralised and mutual recognition reliance procedure for marketing authorisations, Medicines: apply for a variation to your marketing authorisation, Electronic Application Form and Cover Letter Tool, a brief description of the major clinical properties of the product, evidence supporting the claimed benefits of the product for the proposed indication(s). 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/. will check that NeeS and eCTD submissions are technically valid using the Extedo Eurs is Yours (EiY) validation tool. We aim to respond to queries within 18 working days, however, where expert advice is required from other parties this may take longer. We will write to you when we suspend your licence, telling you what we have done and why. "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. Suspended vs. Revoked License: The Differences, Driving with a Suspended License: What You Need to Know. Added August file for - Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences. Call us at (847) 390-8500 or submit your information via our contact form to arrange a free consultation. Co-Amoxiclav DST Grunenthal 300/42.75mg Granules for Oral Suspension; Co-Amoxiclav DST Grunenthal 400/57mg Granules for Oral Suspension; Co-amoxiclav for Injection 1000/20mg; Co-amoxiclav for Injection 500/100mg; Co-Amoxiclav Injection 500/100; Co-Amoxiclav Oral Suspension 125mg/31.25mg/5ml Amoxi-Co 125/31 Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. You have rejected additional cookies. Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences' link to latest January 2021 version. 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. 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). Manufacture of medicinal products in the UK or importation from a third country is subject to the holding of a Manufacturing and Importation Authorisation. Levothyroxine 100 mcg tablets in Numark packaging are the same product as the Teva branded version and are also affected by suspension of the license. The agency advised healthcare professionals to immediately stop supplying the batches and to quarantine and remove all remaining stock. Failure to Appear. Suspensions & Reinstatements. 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. TRIDENT PLACE, MOSQUITO WAY, 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. 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. Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. You can change your cookie settings at any time. 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. posted on Uploaded new Suspended manufacturing and Revoked spreadsheets. Wholesale dealer licences/API/broker licences: GDP.Inspectorate@mhra.gov.uk, Manufacturing licences: gmpinspectorate@mhra.gov.uk. You have rejected additional cookies. Added links to pages providing further information on some of the procedures. Our legal power to do this is explained in Get Licensed (PDF, 3.03 MB, 90 pages). Well send you a link to a feedback form. 2 NEWTECH SQUARE, You have accepted additional cookies. New version of document has been uploaded. 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. 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. 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. Published a new version of the 'Get Licensed' document. We publish scientific assessment reports called a Public Assessment Report (PAR) available for new marketing authorisations granted after 30 October 2005. CDL Disqualifications. It also covers 'sunset-clause' monitoring. 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). List of new manufacturing licences and wholesale distribution authorisations 2015: https://www.gov.uk/government/publications/medicines-new-manufacturing-and-wholesale-dealer-licences, List of manufacturers licences MIA and MANA, MIA(IMP) on EUDRAGMDP link below: http://eudragmdp.ema.europa.eu/inspections/displayHome.do.