mhra licence suspension

The pathway that you follow will depend on your intended market and the type of application you are making. 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. The lenders have hired PricewaterhouseCoopers to advise them, according to one insider. 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. We will also tell you what you can do that might stop us from revoking your licence. Download CSV Well send you a link to a feedback form. UNITED KINGDOM, DENDRON BRANDS LIMITED, TW9 2QE, Call us at (847) 390-8500 or submit your information via our contact form to arrange a free consultation. It will take only 2 minutes to fill in. Suspensions & Reinstatements. We may lift the suspension if you are found not guilty or the charges are dropped. We use some essential cookies to make this website work. 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. It is your responsibility to make sure the invoices for your submissions are paid on time. We publish scientific assessment reports called a Public Assessment Report (PAR) available for new marketing authorisations granted after 30 October 2005. List of manufacturer specials (human) (MS) and manufacturer specials authorisation (veterinary): https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-manufacturing-sites, List of licensed wholesale distribution sites (human and veterinary): https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-wholesale-distribution-sites, List of brokers: https://www.gov.uk/government/publications/register-of-brokers-authorised-to-deal-in-human-medicines, List of suspended and revoked licences and authorisations: https://www.gov.uk/government/publications/suspended-licences-for-manufacturers-and-wholesalers-of-medicines, Export certificates: https://www.gov.uk/export-a-human-medicine, Terminated and cancelled manufacturing and wholesale dealer licences: https://www.gov.uk/government/publications/medicines-terminated-and-cancelled-manufacturing-and-wholesale-dealer-licences. 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. All Rights Reserved. mhra licence suspensionhow to calculate solow residual mhra licence suspension. When autocomplete results are available use up and down arrows to review and enter to select. This file may not be suitable for users of assistive technology. Updated document - Suspended manufacturing and wholesale distribution authorisations. You should submit your application using the electronic Common Technical Document (eCTD). Monthly update to 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. Uploaded new version of Suspended manufacturing and wholesale distribution authorisations. Published Medicines: terminated and cancelled manufacturing and wholesale dealer licences for August 2019. 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 suspended manufacturing and wholesale distribution authorisations. An industry source said on Wednesday that Converse Pharma had intended to explore a sale process as part of a planned exit for its shareholders shortly before the MHRA suspension was implemented. Published updated list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. You must cancel your marketing authorisation or other licence by 31 December if you want it to be cancelled by 31 March 2016. If we intend to revoke or suspend your licence we will write to you to tell you why. UNITED KINGDOM, CONSILIENT HEALTH (UK) LIMITED, The suspension of the license will last until "Teva has completed its investigation and resolved the underlying issues ", the MHRA wrote. It will take only 2 minutes to fill in. You have rejected additional cookies. To help us improve GOV.UK, wed like to know more about your visit today. 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. An updated list of suspended licenses has been uploaded. List of revoked manufacturing sites updated. 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. You should read the guidance for your specific pathway for any extra information or steps that might be required. 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). New version of suspended list has been uploaded. updated suspended and revoked lists added to the page. Added spreadsheet under "types of application" heading. 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. Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended. This portal allows registered users to submit WDA (H) Wholesale Distribution Authorisation applications and variations API Active Pharmaceutical. Under 'Ways to make your submission', Updated email address and naming to Department of Health and Social Care. List of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. 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. 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. Updated list of suspended licences added to the page. 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. WD18 7JJ, Please ensure that you limit bulk cancellations to a maximum of 10 product licenses showing per application form. Actavis, Forley Generics, and Goldshield Group also . Published updated versions of the Revoked manufacturing and wholesale distribution authorisations list and the Suspended manufacturing and wholesale distribution authorisations list. TRIDENT PLACE, MOSQUITO WAY, 9-11 HILLHOUSE LANE, The attorneys at The Davis Law Group, P.C. HATFIELD, 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 We use some essential cookies to make this website work. 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. EnteroBiotix secures key additional MHRA license and announces regulatory milestones. The list of suspensions and revocations is updated on the same day that the suspension or revocation takes place. 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. Its licence was "largely reinstated" following a re-investigation in April, says Sky. (INF188/6), Assessing fitness to drive: guide for medical professionals, you applied for it using fraudulent documents and/or using a fraudulent identity, you allow someone else to use your licence to engage in licensable conduct, you do not have the qualifications that you claimed to have on your application, you receive a sentence or disposal for a relevant offence and the date your sentence restrictions end means that you fall into the Automatic Refusal category of our licence criteria, you do not have the right to work in the UK (unless you are a director of a UK-registered company), you breach our licence criteria (as set out in, you break any of the licence conditions - this includes any additional conditions that we have placed on your licence, you do not do the training that we ask you to do, you receive a sentence or disposal for a relevant offence and the date your sentence restrictions end means that you fall into the Consider Additional Factors category of our licence criteria, we decide that you are not a fit and proper person to hold a licence, our decision is found to have been based on information that is factually incorrect, we are instructed to do so by the courts as the result of a legal appeal, we believe that you may be a threat to public safety, we believe that it is in the public interest to do so, you have been charged with a serious relevant offence, the police or another public body are investigating you for a serious relevant offence, lift the suspension and reinstate your licence, require you to take some form of remedial action before we will lift the suspension (for example, we may require you to take additional training). . Dont include personal or financial information like your National Insurance number or credit card details. 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/. Wholesale dealer licences/API/broker licences: GDP.Inspectorate@mhra.gov.uk, Manufacturing licences: gmpinspectorate@mhra.gov.uk. You have accepted additional cookies. 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. You will need to register if you havent already. Updated: list of revoked manufacturing and wholesale distribution authorisations. It will take only 2 minutes to fill in. Well send you a link to a feedback form. To help us improve GOV.UK, wed like to know more about your visit today. Published new list of terminated and cancelled manufacturing and wholesale dealer licences, Publish list of terminated and cancelled licenses from August 2017 to July 2018. These templates should not be altered in any way, other than inserting the relevant information. The information published in this Register was that held by the MHRA on the date of publication. Accumulating too many driving record points. RICHMOND, Updated list of suspensions. 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. 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. You can also tell us about any factual errors that may have affected our decision. To help us improve GOV.UK, wed like to know more about your visit today. Comment by Andrew Bailey says 'nothing is decided' suggesting interest rates may rise less than thought We also use cookies set by other sites to help us deliver content from their services. An example of when we might do this is if you are convicted of a relevant criminal offence. We use some essential cookies to make this website work. Healthcare products Regulatory Agency (MHRA) inspectorate as soon as possible. Dont worry we wont send you spam or share your email address with anyone. The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated to include May 2015. MILTON ROAD, 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). latest Suspended manufacturing and wholesale distribution authorisations, Updated Suspended manufacturing and wholesale distribution authorisations, Updated suspended manufacturing and wholesale distribution authorisations. This is based on the MHRA assessment report with any commercially or personally confidential information removed. Updated list of suspended licenses added to the page. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. EN6 1TL, Report a side effect with a medicine or medical device. BUILDING 4, You have accepted additional cookies. Published 4 February 2015 Last updated 5 January. 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. 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. Any submission that does not meet the requirements will be rejected. It will take only 2 minutes to fill in. Updated the 'When we suspend your licence' section to include reference to open public investigations. UNITED KINGDOM, VIATRIS UK HEALTHCARE LIMITED, IAG are non-statutory multi-disciplinary groups which advise MHRA's Director of IE&S on recommendations for regulatory action. You will not be charged if your submission is rejected for technical reasons. You can print blog posts using the keyboard shortcuts "Control P" or "Command P". News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. New version of Revocation list has been uploaded. WATFORD, "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. This includes information of a commercially sensitive or personal nature, that may need to be restricted in the interests of security. LICENCE TYPE MA Manufacture and Assembly . Melatonin 4mg/5ml oral suspension STD, SF, LF, AF, NSF 150ml 20620 8 Menadiol 5mg/5ml oral suspension STD, SF, LF, CF . MHRA alerts & recalls PharmData maintains a list of all MHRA alerts and recalls relevant to community pharmacy. If you have any questions about MHRA Submissions , you should email submissions@mhra.gov.uk. 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. You have accepted additional cookies. The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated. Alpha Release This is a new service - your feedback will help improve it. HUDDERSFIELD, 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. BIRSTALL, Dont include personal or financial information like your National Insurance number or credit card details. In this situation the licence holder who is performing the testing and acts as the contract acceptor should be named as a contract laboratory on the contract giver's licence. Or you can submit the forms to us by email to withdrawcancel@mhra.gov.uk. We can also suspend your licence if we believe that you are a threat to public safety or that it is in the public interest to do so. Uploaded new version of Suspended and revoked licences list. NOTTINGHAM, Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely. 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. Uploaded new Suspended manufacturing and Revoked spreadsheets. It is an additional route of appeal that we offer so that you can appeal in a way that does not incur court costs. Healthcare. 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 DHSC contact for fast-tracking a licence has changed. You have rejected additional cookies. Drug wholesaler hit by MHRA suspension hires advisers to find funding injection, Converse Pharma distributes a range of generic drugs. HD1 6EF, Well send you a link to a feedback form. If you think your submission has been wrongly rejected, you should email ris.na@mhra.gov.uk. Updated list of suspended manufacturing and wholesale distribution authorisations. Updated: list of terminated and cancelled manufacturing and wholesale dealer licences. Uploaded new Suspended manufacturing and wholesale distribution authorisations list. Updated list of terminated and cancelled manufacturing and wholesale posted on Uploaded updated Suspended manufacturing and wholesale distribution authorisations list. 1 REDWOOD AVENUE, The wholesale distribution of medicinal products and importation of medicines certified by a Qualified Person in accordance with Article 51 of Directive 2001/83/EC from listed countries is subject to the holding of a Wholesale Distribution Authorisation. Maalox 175mg/200mg Oral Suspension . 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. You can change your cookie settings at any time. 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. 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. Ranitidine 50mg/2ml injection is anticipated to be unavailable from the end of May 2020 until further notice. In April 2018, C+D reported that the suspension had been extended due to remaining "non-compliance issues". Once your application has been validated you will receive an invoice so that you can make a payment for the outstanding amount. . Pay Restoration Fee Provide proof of payment of outstanding fines/tickets Parking Violations How to Pay Parking Tickets The clarifying remark section of individual GMP and GDP certificates will indicate any exceptions. City editor All UK and Great Britain (England, Scotland and Wales) national applications should be submitted through the MHRA Submissions Portal. UK WDA (H) 12426. Updated suspension list added to the page. Updated: Suspended manufacturing and wholesale distribution authorisations, Suspended and revoked licences for manufacturers and wholesalers of medicines - August 2015, Updated: suspended and revoked licences for manufacturers and wholesalers of medicines, Updated: List of suspended manufacturing and wholesale distribution authorisations, Updated list of suspended and revoked licences for manufacturers and wholesalers of medicines. 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. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. 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. Our legal power to do this is explained in Get Licensed (PDF, 3.03 MB, 90 pages). Added updated list of suspended manufacturing and wholesale distribution authorisations. (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 new list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. Following recent advice from the EMA, the MHRA have suspended all licenses for ranitidine products. . Maalox oral suspension - Magnesium hydroxide; Aluminium hydroxide gel dried Magnesium hydroxide; . Please note, this includes changes to MHRA Guidance Note 6 1. Depending on the state you live in, you may incur a suspension for a different amount of points. We publish the most up-to-date information for a medicine according to its licence history. What the data show Since September 2020, 15 Companies were affected. 1 MEER END, Uploaded new Suspended manufacturing and wholesale distribution authorisations spreadsheet. This blog shares the work of the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate, by inspectors and those the Inspectorate works with. Refusal of licence / variation or an existing licence being revoked. 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. Medical Evaluation Process. Published new list of Suspended manufacturing and wholesale distribution authorisations. You have rejected additional cookies. If you respond to our letter we will take what you tell us into consideration. will check that NeeS and eCTD submissions are technically valid using the Extedo Eurs is Yours (EiY) validation tool. Any questions on the content of this database should be addressed to IE&S-IMT@mhra.gov.uk. Updated the list of suspended licences for manufacturers and wholesalers of medicines. You cannot legally undertake licensable activity while your licence is suspended this includes during an appeal. 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). Submit the relevant forms above to MHRA via the MHRA portal if youre a UK applicant. New document added to page for September 2017. You should also use our eAF and cover letter tool to determine what information you need to include in your application. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. And it ensures the safety and effectiveness of medicines in the UK. Converse Pharma Group, which supplies thousands of community pharmacies across the UK, wants to raise money after having its licence temporarily suspended by the MHRA, Sky News learns. 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. 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. Updated lists of suspended and revoked licenses. The current UNITED KINGDOM, BARD PHARMACEUTICALS LIMITED,

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