Updated list of terminated and cancelled manufacturing and wholesale The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated to include May 2015. Your licence remains live during a court appeal. 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 Suspended manufacturing and wholesale distribution authorisations spreadsheet. We publish scientific assessment reports called a Public Assessment Report (PAR) available for new marketing authorisations granted after 30 October 2005. Updated Suspended manufacturing and wholesale distribution authorisations CSV file. Proposed suspension, variation . Updated list of suspended licences for manufacturers and wholesalers of medicines. For example, in Kentucky, it takes an accumulation of 12 points over the course of 2 years in order to receive a suspension. If you have any questions about submitting your application you should email ris.na@mhra.gov.uk. We also use cookies set by other sites to help us deliver content from their services. DEESIDE INDUSTRIAL PARK, An example of when we might do this is if you are under police investigation for a serious offence. Published updated 'Suspended manufacturing and wholesale distribution authorisations' spreadsheet. Termination of a licence, authorisation or registration takes place at the request of the holder of the licence, authorisation or registrant, for example, the business decides they no longer wish to perform an activity that requires a licence, authorisation or registration. 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. 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. 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. Updated list of terminated and cancelled manufacturing and wholesale dealer licences. View online If your application for these types of licences is pending and you no longer wish to proceed, you need to withdraw it. Added spreadsheet under "types of application" heading. List of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. 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 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. Dealer Licences 2016 to October, Updated list of terminated and cancelled licences. 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. Actavis, Forley Generics, and Goldshield Group also . Find out more about the different national and international procedures. Our legal power to do this is explained in Get Licensed (PDF, 3.03 MB, 90 pages). Once your application has been validated you will receive an invoice so that you can make a payment for the outstanding amount. 2 NEWTECH SQUARE, 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. The agency advised healthcare professionals to immediately stop supplying the batches and to quarantine and remove all remaining stock. Latest list of suspended licenses added to the page. posted on The pathway that you follow will depend on your intended market and the type of application you are making. The Agency has the power to withdraw a product from the market, and in the case of medicines, to suspend production. It is the MA applicants responsibility to make sure that the ASMF is submitted either before you submit your application or at the same time, as your application will not be valid without it. 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. 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 . Added updated list of suspended manufacturing and wholesale distribution authorisations. Monthly update to 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. Alpha Release This is a new service - your feedback will help improve it. Updated the terminated and cancelled manufacturing and wholesale dealer licences list. Healthcare. Andrew Bailey says 'nothing is decided' suggesting interest rates may rise less than thought Or if you need to cancel a parallel import product licence, complete the cancellation form (PDF, 525 KB, 3 pages). UNITED KINGDOM, CONSILIENT HEALTH (UK) LIMITED, Updated 'Suspended manufacturing and wholesale distribution authorisations' list, Updated 'Revoked manufacturing and wholesale distribution authorisations' list. Dont include personal or financial information like your National Insurance number or credit card details. 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. Visit the European Medicines Agency website for more information on the European requirements for cancellations or email the MHRA for UK requirements. D ate of . . Occupational Licenses. 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. Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. There is no additional fee for fast-tracking applications. Depending on the state you live in, you may incur a suspension for a different amount of points. MHRA alerts & recalls PharmData maintains a list of all MHRA alerts and recalls relevant to community pharmacy. You have rejected additional cookies. We also use cookies set by other sites to help us deliver content from their services. MHRA considers each application for a product name to ensure that the proposed name will allow the medicine to be taken safely and correctly. You must cancel your marketing authorisation or other licence by 31 December if you want it to be cancelled by 31 March 2016. Please note the site register will be updated on a quarterly basis. LE4 3EH, Uploaded new version of Suspended manufacturing and wholesale distribution authorisations. CDL Disqualifications. Uploaded updated Suspended manufacturing and wholesale distribution authorisations list. For 1 company the licence was terminated. Updated the suspended manufacturing and wholesale distribution authorisations list. The MHRA also enforces European drug licensing regulations in the UK. Anyone in the pharmaceutical or medicinal supply chain should use this list to ensure they are dealing with a valid licence or authorisation holder. 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. 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. 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. Updated list of suspended licences and registrations for manufacturers and wholesalers of medicines and ingredients. Some information may have been excluded from public view. We find an easy way to remember is to set a recurrent reminder in your Outlook calendar or Gmail diary. Truancy. Dont include personal or financial information like your National Insurance number or credit card details. You can also use the A-Z list to find the active substance. You have accepted additional cookies. The list of suspensions and revocations is updated on the same day that the suspension or revocation takes place. Any submission that does not meet the requirements will be rejected. NOTTINGHAM, mhra licence suspension You have accepted additional cookies. You must do so within 21 days of the suspension coming into effect. City editor Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Published updated versions of the Revoked manufacturing and wholesale distribution authorisations list and the Suspended manufacturing and wholesale distribution authorisations list. THANE ROAD, Details of the penalties are explained in ourFees Regulations. New version of the revocation and suspension lists has been uploaded. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Cancellation of a licence, authorisation or registration is when MHRA makes a decision to cancel the licence, authorisation or registration. The clarifying remark section of individual GMP and GDP certificates will indicate any exceptions. You have rejected additional cookies. Updated list of companies in the UK who have had their licence to manufacture or wholesale medicines suspended. Aventis Pharma Limited . Since inspections of manufacturers of active substances are based on risk,. 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. MILTON ROAD, 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. Updated list of suspended licences and registrations for manufacturers and wholesalers of medicines and ingredients. Updated 'Suspended manufacturing and wholesale distribution authorisations' link. Updated list of suspended licenses added to the page. Yesterday MHRA released an update on suspended manufacturing and wholesale distribution authorization. Since inspections of manufacturers of active substances are based on risk, some active substance manufacturers may not be in possession of a GMP certificate. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Maalox 175mg/200mg Oral Suspension . ASMFs holders must submit their dossier to the MHRA. We use some essential cookies to make this website work. Alpha Release This is a new service - your feedback will help improve it. MHRA Suspended Licence checks are a critical part of your Quality Management System and Risk Management processes, so keep on top of them. Complete the application to withdraw a pending application (MS Word Document, 35 KB) for and email it to us with withdrawal as your subject line. It will take only 2 minutes to fill in. CH5 2NT, BEESTON, Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission. The DHSC contact for fast-tracking a licence has changed. Updated list of suspended licences added to the page. You can get a suspended license for reasons including: If you have a suspended drivers license, your state will likely require you to: Our suspended license pages for your state will help you: Click your state below for suspended license and reinstatement requirements at your states DMV, SOS, DOR, or MVD. Download CSV EN6 1TL, Phase 4 studies. Ranitidine 50mg/2ml injection is anticipated to be unavailable from the end of May 2020 until further notice. BUILDING 4, We also use cookies set by other sites to help us deliver content from their services. updated Suspended and revoked licences for manufacturers and wholesalers of medicines, list of suspended manufacturing and wholesale distribution authorisations updated. 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. 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. We aim to respond to queries within 18 working days, however, where expert advice is required from other parties this may take longer. 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. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. We use some essential cookies to make this website work. Copy CSV Excel PDF Print Showing 1 to 10 of 325 entries Previous 1 2 3 4 5 33 Next Suspended manufacturing and wholesale distribution authorisations list updated. 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. 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. We will write to you when we suspend your licence, telling you what we have done and why. In total, it sells more than 6,000 products to 4,000 customers, the bulk of which are community pharmacies, giving the company an important role in UK healthcare provision. Updated list of suspended and revoked licences for manufacturers and wholesalers of medicines. either alone or jointly. dealer licences. Learn more about the circumstances that can lead to a licence holder losing their licence, either permanently or temporarily. https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-manufacturing-sites. If your organisation operates a PO system, please make sure that the relevant PO is provided to the MHRA before the invoice is issued. 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. the mentholatum company limited, 1 redwood avenue, peel park campus, east kilbride, glasgow, g74 5pe, united kingdom You should read the guidance for your specific pathway for any extra information or steps that might be required. 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. Publish list of terminated and cancelled licenses from July 2017 to June 2018. AL10 9UL, Once we revoke your licence we cannot change our decision unless it is for one of the following reasons: You can appeal our decision to revoke your licence in a Magistrates or Sheriff Court. Its licence was "largely reinstated" following a re-investigation in April, says Sky. Uploaded updated suspended and revoked licences lists. 3.85 KB, View online We recommend that you use a validation tool to check your submission as we Updated both 'revoked' and 'Suspended' manufacturing and wholesale distribution authorisations lists. 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. You must do so within 21 days of the revocation coming into effect. 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.
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