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? We recommend that you use a validation tool to check your submission as we View online Updated 'Suspended manufacturing and wholesale distribution authorisations' link. 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. BEESTON, Updated the terminated and cancelled manufacturing and wholesale dealer licences for September 2021. We publish scientific assessment reports called a Public Assessment Report (PAR) available for new marketing authorisations granted after 30 October 2005. We publish the most up-to-date information for a medicine according to its licence history. This information is common to all procedures. You can change your cookie settings at any time. Andrew Bailey says 'nothing is decided' suggesting interest rates may rise less than thought We have updated the list of suspended and revoked licenses and registrations, updated Suspended manufacturing and wholesale distribution authorisations, New version of Suspended manufacturing and wholesale distribution authorisations list has been uploded. 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 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. Published Medicines: terminated and cancelled manufacturing and wholesale dealer licences for August 2019. Please note, you are required as a company to ensure that all personal details provided to the MHRA are up to date and the MHRA needs to be notified within any application if any changes in personal details need to be updated, including email addresses and telephone numbers. Uploaded new version of Suspended manufacturing and wholesale distribution authorisations. Published new version of the suspended manufacturing and wholesale distribution authorisations list. Depending on the state you live in, you may incur a suspension for a different amount of points. 1 CHURCH ROAD, An updated list of suspended licenses has been uploaded. 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 UNITED KINGDOM, THE MENTHOLATUM COMPANY LIMITED, The pathway that you follow will depend on your intended market and the type of application you are making. Updated list of medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences for February. Or you can submit the forms to us by email to withdrawcancel@mhra.gov.uk. Occupational Licenses. Alternatively, we can maintain the suspension until we have all of the information we require to make a licensing decision. Updated attachment - March to Feb 2019 edition, Updated list of terminated and cancelled manufacturing and wholesale dealer licences. The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated to include May 2015. This does not replace your right of appeal through the courts. 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. The MHRA announces recall of paracetamol tablets, after certain products were found to be discoloured due to the presence of fungi. You can read our guidance about the submission of ASMFs. 2 NEWTECH SQUARE, Updated: list of revoked manufacturing and wholesale distribution authorisations. Or if you need to cancel a parallel import product licence, complete the cancellation form (PDF, 525 KB, 3 pages). New list of terminated licenses, August 2016 to July 2017 added to the page. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. mhra licence suspensionhow to calculate solow residual mhra licence suspension. Published updated versions of the Revoked manufacturing and wholesale distribution authorisations list and the Suspended manufacturing and wholesale distribution authorisations list. It will take only 2 minutes to fill in. BIRSTALL, Truancy. ; Getting multiple traffic violations or speeding tickets. Report a side effect with a medicine or medical device. The DHSC contact for fast-tracking a licence has changed. 3.85 KB, View online Learn more about the circumstances that can lead to a licence holder losing their licence, either permanently or temporarily. List of suspended licences for manufacturers and wholesalers of medicines updated, Updated the suspended list with two new suspensions and corrected suspension date for St Helen's Millennium Centre Services Limited. 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. 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. Full document as sent to the MHRA on 21st July 2020: 1 REDWOOD AVENUE, You can go to the MHRA-GMDP website to view the lists of: Updated the suspended and revoked licenses list. 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). Published updated version of Suspended manufacturing and wholesale distribution authorisations list. 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. We also use cookies set by other sites to help us deliver content from their services. Published 4 February 2015 Last updated 5 January. Uploaded updated suspended and revoked licences lists. Anyone in the pharmaceutical or medicinal supply chain should use this list to ensure they are dealing with a valid licence or authorisation holder. 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. 09/02/2023. 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. Phase 4 studies. The MHRA has been assured that acceptable standards of Good Manufacturing Practice are in place for . We use some essential cookies to make this website work. Updated lists of suspended and revoked licenses. Uploaded updated Suspended manufacturing and wholesale distribution authorisations list. Complete the cancellation form (MS Word Document, 33.5 KB) if you're a UK applicant as well as following the European process at step 1. 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. 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.
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