MHRA reserves the right. Published updated versions of the Revoked manufacturing and wholesale distribution authorisations list and the Suspended manufacturing and wholesale distribution authorisations list. EnteroBiotix secures key additional MHRA license and announces regulatory milestones. "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. 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).. You can get a suspended license for reasons including: . 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. For example, in Kentucky, it takes an accumulation of 12 points over the course of 2 years in order to receive a suspension. UNITED KINGDOM, VIATRIS UK HEALTHCARE LIMITED, Uploaded new Suspended manufacturing and wholesale distribution authorisations list. We find an easy way to remember is to set a recurrent reminder in your Outlook calendar or Gmail diary. Alpha Release This is a new service - your feedback will help improve it. You must do so within 21 days of the suspension coming into effect. Published a new version of the Suspended manufacturing and wholesale distribution authorisations list. Updated suspension list for manufacturing and wholesale distribution authorisations. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. We may lift the suspension if you are found not guilty or the charges are dropped. 783 Bytes. The lenders have hired PricewaterhouseCoopers to advise them, according to one insider. Updated list of suspended licences for manufacturers and wholesalers of medicines. Dont include personal or financial information like your National Insurance number or credit card details. Refrain from driving for a period of time. Following recent advice from the EMA, the MHRA have suspended all licenses for ranitidine products. Removed link to Excel spreadsheet list of products. It will take only 2 minutes to fill in. TW9 2QE, We use some essential cookies to make this website work. Updated the terminated and cancelled manufacturing and wholesale dealer licences list. If we suspend your licence, the suspension comes into effect immediately. Updated list of terminated and cancelled manufacturing and wholesale Accumulating too many driving record points. You have accepted additional cookies. Dont worry we wont send you spam or share your email address with anyone. IAG are non-statutory multi-disciplinary groups which advise MHRA's Director of IE&S on recommendations for regulatory action. G74 5PE, BEESTON, 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. Updated the 'When we revoke your licence' section to: clarify how we will consider new criminality on the licence holder's record; clarify that "licence conditions" includes any additional conditions we have placed on the licence; make explicit that a licence may be revoked if the licence holder breaches our licence criteria. Drug wholesaler hit by MHRA suspension hires advisers to find funding injection, Converse Pharma distributes a range of generic drugs. updated Suspended and revoked licences for manufacturers and wholesalers of medicines, list of suspended manufacturing and wholesale distribution authorisations updated. You have rejected additional cookies. 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. 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. You can use the A-Z list to find an active substance, or search for a medicine. The absence of a GMP certificate should not be understood as meaning that the active substance manufacturer in question does not comply with GMP. The list of suspensions and revocations is updated on the same day that the suspension or revocation takes place. Welcome to the MHRA Process Licensing Portal. The clarifying remark section of individual GMP and GDP certificates will indicate any exceptions. We may still revoke your licence. Monthly update to 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. 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. List of suspended manufacturing and wholesale distribution authorisations updated. Updates and Changes to the August 2014 published guidance The process of publication of a list of inspected GMP QC laboratories by MHRA has been removed. posted on UNITED KINGDOM, VIATRIS UK HEALTHCARE LIMITED, 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'. Andrew Bailey says 'nothing is decided' suggesting interest rates may rise less than thought 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. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Find out more about the different national and international procedures. 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. 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. Under 'Ways to make your submission', Updated email address and naming to Department of Health and Social Care. Published 4 February 2015 Last updated 5 January. The suspension of the license will last until "Teva has completed its investigation and resolved the underlying issues ", the MHRA wrote. To help us improve GOV.UK, wed like to know more about your visit today. Actavis, Forley Generics, and Goldshield Group also . Once your application has been validated you will receive an invoice so that you can make a payment for the outstanding amount. DEESIDE, You can go to the MHRA-GMDP website to view the lists of: Updated the suspended and revoked licenses list. Name and address of the site: NISA RETAIL LIMITED , BLOOM LANE, NORMANBY ENTERPRISE PARK, SCUNTHORPE, DN15 9YA, UNITED KINGDOM. LICENCE TYPE MA Manufacture and Assembly . Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely. Subscribe to stay in the loop & on the road! Certificates of Suitability (CEPs) continue to be acceptable in support of UK and GB national authorisations.. TRIDENT PLACE, MOSQUITO WAY, The List of Terminated, Revoked and Cancelled Licences has been updated. You have accepted additional cookies. 94 RICKMANSWORTH ROAD, You should also use our eAF and cover letter tool to determine what information you need to include in your application. 9-11 HILLHOUSE LANE, Negligent failures of senior UK dermatologists, and senior MHRA doctors, are such that the MHRA should immediately suspend isotretinoin's licence for the treatment of under-18s, and introduce a substantive consent form for all other patients. Latest list of suspended licenses added to the page. Also is there any process to verify that MIA licence is still valid? Updated lists of suspended and revoked licenses. Published Medicines: terminated and cancelled manufacturing and wholesale dealer licences for August 2019. Updated the 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. We use some essential cookies to make this website work. 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 The Process Licensing Office sits within the Inspectorate and Process Licensing Group of the Inspection, Enforcement and Standards division. Dont include personal or financial information like your National Insurance number or credit card details. Occupational Licenses. dealer licences. MHRA Suspended Licence checks are a critical part of your Quality Management System and Risk Management processes, so keep on top of them. Updated Suspended manufacturing and wholesale distribution authorisations CSV file. For 1 company the licence was terminated. Replaced the PDF with a more accessible file. Suspended vs. Revoked License: The Differences, Driving with a Suspended License: What You Need to Know. If you use assistive technology (such as a screen reader) and need a Medical Evaluation Process. Phase 4 studies. Publish list of terminated and cancelled licenses from July 2017 to June 2018. You can read our guidance about the submission of ASMFs. 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. In August 2018, EnteroBiotix announced that the company had been awarded a manufacturer's specials license . Maalox oral suspension - Magnesium hydroxide; Aluminium hydroxide gel dried Magnesium hydroxide; . Published a new version of the 'Get Licensed' document. Subscribe to our News and Updates to stay in the loop and on the road! You must cancel your marketing authorisation or other licence by 31 December if you want it to be cancelled by 31 March 2016. We also use cookies set by other sites to help us deliver content from their services. AL10 9UL, We can revoke (take away) your licence if you no longer meet our licensing criteria. 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. Dont include personal or financial information like your National Insurance number or credit card details. Updated revoked and suspended documents on the page. 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 EN6 1TL, 2. . 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. Any submission that does not meet the requirements will be rejected. Company name,Licence revoked,Date of revocation,Reason PRESTFORD LIMITED,WDA(H) 43010,04-Apr-22,Regulatory Action ACCENDO PHARMA LIMITED,WDA(H) 43391,16-Dec-21,Regulatory Action CHOPRAS PHARMACY LIMITED,WDA(H) 39745,17-Nov-21,Regulatory Action CELTICPHARM LIMITED,WDA(H) 44336,11-Nov-21,Regulatory Action WISE PHARMACIES LIMITED,WDA(H) 41881,11-Oct-21,Regulatory Action GIS MEDICAL & SURGICAL . Updated attachment - March to Feb 2019 edition, Updated list of terminated and cancelled manufacturing and wholesale dealer licences. The MHRA also enforces European drug licensing regulations in the UK. The revelation of investment talks follows a challenging period during which the DE Group had its licence suspended by the MHRA for multiple breaches of its terms. https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-manufacturing-sites. NOTTINGHAM, 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: Some information may have been excluded from public view. 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. This will ensure you are not charged a periodic fee for the period 1 April 2016 to 31 March 2017. Well send you a link to a feedback form. @MarkKleinmanSky. This means that you can still work during your appeal, unless we have also suspended your licence. Yesterday MHRA released an update on suspended manufacturing and wholesale distribution authorization. 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. If you do not include the correct information your application will not be validated. Well send you a link to a feedback form. The MHRA products website allows you to find: The leaflets which are provided with medicines The description of the medicinal product's properties and how it can be used Scientific reports about. Updated list of suspended and revoked licences for manufacturers and wholesalers of medicines. What the data show Since September 2020, 15 Companies were affected. Proposed suspension, variation . REACTA BIOTECH LIMITED T/A REACTA HEALTHCARE, Download CSV 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. We look forward to hearing from you to discuss your case. You have accepted additional cookies. On the other hand, in Florida, earning 12 points on your license within a year will get your license suspended for 30 days. Updated the suspended manufacturing and wholesale distribution authorisations list. This includes information of a commercially sensitive or personal nature, that may need to be restricted in the interests of security. This information is common to all procedures. You will not be charged if your submission is rejected for technical reasons. In April 2018, C+D reported that the suspension had been extended due to remaining "non-compliance issues". 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. UNITED KINGDOM, CONSILIENT HEALTH (UK) LIMITED, Published updated 'Suspended manufacturing and wholesale distribution authorisations' spreadsheet. When autocomplete results are available use up and down arrows to review and enter to select. 29.3 KB. This does not replace your right of appeal through the courts. An updated list of suspended authorisations was attached. 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. We publish scientific assessment reports called a Public Assessment Report (PAR) available for new marketing authorisations granted after 30 October 2005. You must do so within 21 days of the revocation coming into effect. 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. Comment by Updated 'Suspended manufacturing and wholesale distribution authorisations' list, Updated 'Revoked manufacturing and wholesale distribution authorisations' list. WELBECK PHARMACEUTICALS & HOSPITAL SUPPLIES LIMITED , 35 DEVONSHIRE STREET, LONDON, W1G 6PZ, UNITED KINGDOM. We recommend that you use a validation tool to check your submission as we Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended. UNITED KINGDOM, THE MENTHOLATUM COMPANY LIMITED, To help us improve GOV.UK, wed like to know more about your visit today. 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. Learn more about the circumstances that can lead to a licence holder losing their licence, either permanently or temporarily. Updated the Suspended manufacturing and wholesale distribution authorisations list. Aventis Pharma Limited . Added list of terminated and cancelled licences for April 2019. Updated suspended manufacturing and wholesale distribution authorisations. 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. HATFIELD, 10 October 2019, MIA holders can be checked on the Eudra GMDP webpage for validity. New September 2020 version of 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. Cancellation of a licence, authorisation or registration is when MHRA makes a decision to cancel the licence, authorisation or registration. 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. 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. 2 NEWTECH SQUARE, 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. UNIT 191, CAMBRIDGE SCIENCE PARK, 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). ALR Program. Download CSV Its licence was "largely reinstated" following a re-investigation in April, says Sky. WD18 7JJ, 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/. Is there any portal where we can check the list of MIA holders? Updated list of suspended licenses added to the page. To help us improve GOV.UK, wed like to know more about your visit today. An example of when we might do this is if you are under police. UNITED KINGDOM, BCM LIMITED, Updated content to reflect that the UK cannot act as a Reference Members State (RMS) for approval of marketing authorisations in decentralised and mutual recognition licensing procedures during the transition period. Updated the 'When we suspend your licence' section to include reference to open public investigations. https://mhrainspectorate.blog.gov.uk/2019/10/04/mhra-process-licensing-useful-information/. Alpha Release This is a new service - your feedback will help improve it. This portal allows registered users to submit WDA (H) Wholesale Distribution Authorisation applications and variations API Active Pharmaceutical.