Uploaded updated Medicines terminated and cancelled manufacturing and wholesale dealer licences PDF. You can find out more about the fees we charge in the guidance MHRA fees. The MHRA-GMDP database contains the following information issued by the MHRA relating to manufacturing and wholesale authorisations and certificates. Maalox 175mg/200mg Oral Suspension . Yesterday MHRA released an update on suspended manufacturing and wholesale distribution authorization. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. To help us improve GOV.UK, wed like to know more about your visit today. 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. 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. UK Licence No: PL 04425/0697 . New list of suspended manufacturing and wholesale distribution authorisations added to the page. Submission of a new ASMF and any update to an ASMF should be made by the ASMF holder using MHRA Submissions . You should also use this form if you want to withdraw a variation application or amendment for an existing MA. Please note, this includes changes to MHRA Guidance Note 6 1. London, UK, 23 December 2021 Today Novartis announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved the marketing authorisation to extend the licence in Great Britain for Piqray (alpelisib) for use in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor 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. 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. Report a side effect with a medicine or medical device. Updated suspension list for manufacturing and wholesale distribution authorisations. The information published in this Register was that held by the MHRA on the date of publication. Some information may have been excluded from public view. If you think your submission has been wrongly rejected, you should email [email protected]. We use some essential cookies to make this website work. You must cancel your marketing authorisation or other licence by 31 December if you want it to be cancelled by 31 March 2016. Published Medicines: terminated and cancelled manufacturing and wholesale dealer licences for August 2019. Full document as sent to the MHRA on 21st July 2020: You can find out more in our naming of medicines guidance (PDF, 235 KB, 20 pages). Published updated Revoked manufacturing and wholesale distribution authorisations list. Manufacturing and Wholesale @MarkKleinmanSky. In August 2018, EnteroBiotix announced that the company had been awarded a manufacturer's specials license . Dont include personal or financial information like your National Insurance number or credit card details. Occupational Licenses. posted on Updated suspended manufacturing and wholesale distribution authorisations. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. You have rejected additional cookies. Non-payment may also result in suspension of any licence or authorisation, followed by legal proceedings for any unpaid amounts, as a debt due to the Crown. If your application for these types of licences is pending and you no longer wish to proceed, you need to withdraw it. 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. 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. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. The MHRA has been assured that acceptable standards of Good Manufacturing Practice are in place for . Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences' attachment to latest version. Well send you a link to a feedback form. We updated the list of suspended manufacturing and wholesale distribution authorisations. Is there any portal where we can check the list of MIA holders? If you use assistive technology (such as a screen reader) and need a Pay Restoration Fee Provide proof of payment of outstanding fines/tickets Parking Violations How to Pay Parking Tickets This information is common to all procedures. Syri Limited suspension has been lifted. Our legal power to do this is explained in Get Licensed (PDF, 3.03 MB, 90 pages). 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. HD1 6EF, The licence of DE Group's Testerworld unit is understood to have been largely reinstated in April following re-inspections by the agency. 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. Wholesale dealer licences/API/broker licences: [email protected], Manufacturing licences: [email protected]. Check benefits and financial support you can get, Find out about the Energy Bills Support Scheme, Manufacturing, wholesaling, importing and exporting medicines, Medicines and Healthcare products Regulatory Agency, Medicines: terminated and cancelled manufacturing and wholesale dealer licences, Human and veterinary medicines: register of licensed wholesale distribution sites, Medicines: new manufacturing and wholesale dealer licences, Human and veterinary medicines: register of licensed manufacturing sites, Apply for manufacturer or wholesaler of medicines licences, Licences to manufacture or wholesale medicines. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Common: Headache, dizziness. 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. Dont worry we wont send you spam or share your email address with anyone. Drug wholesaler hit by MHRA suspension hires advisers to find funding injection, Converse Pharma distributes a range of generic drugs. Replaced the PDF with a more accessible file. Find out more about the different national and international procedures. At 1936 per MHRA inspection or re-inspection, you want as few visits as possible. The above events are generally reversible and are usually reported in patients with renal impairment, or with other predisposing factors (see 4.4 Special Warnings . Published 4 February 2015 Last updated 5 January. Depending on the state you live in, you may incur a suspension for a different amount of points. Uploaded new Suspended manufacturing and wholesale distribution authorisations spreadsheet. Use the pre-submission checklist (PDF, 129 KB, 7 pages) to help you with your application. Once your application has been validated you will receive an invoice so that you can make a payment for the outstanding amount. updated suspended and revoked lists added to the page. Updated Suspended manufacturing and wholesale distribution authorisations list. UK WDA (H) 12426. Well send you a link to a feedback form. You have rejected additional cookies. 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. Updated both 'revoked' and 'Suspended' manufacturing and wholesale distribution authorisations lists. REACTA BIOTECH LIMITED T/A REACTA HEALTHCARE, LEICESTER, EMA is recommending that patients stop using Picato (ingenol mebutate), a gel for treating the skin condition actinic keratosis, while it continues its review of the medicine's safety. Our letter will also tell you how to appeal against our decision. 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. 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. The list of suspended manufacturing and wholesale distribution authorisations has been updated. Latest list of suspended licenses added to the page. . Updated the suspended manufacturing and wholesale distribution authorisations list. Melatonin 4mg/5ml oral suspension STD, SF, LF, AF, NSF 150ml 20620 8 Menadiol 5mg/5ml oral suspension STD, SF, LF, CF . Updated the 'When we suspend your licence' section to include reference to open public investigations. Dont worry we wont send you spam or share your email address with anyone. Department of Health and Social Care (DHSC) has issued a medicine supply notification for Ranitidine (all formulations) . 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. Aventis Pharma Limited . An updated list of suspended licenses has been uploaded. Published updated 'Suspended manufacturing and wholesale distribution authorisations' spreadsheet. Suspended manufacturing and wholesale distribution authorisations list updated. 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 Site Number is a specific number allocated to one site. Updated list of terminated and cancelled manufacturing and wholesale dealer licences up to May 2019 added to the page. 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. the mentholatum company limited, 1 redwood avenue, peel park campus, east kilbride, glasgow, g74 5pe, united kingdom 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. We recommend that you use a validation tool to check your submission as we ninja foodi digital air fry oven chicken tenders. G74 5PE, Updated list of terminated and cancelled manufacturing and wholesale dealer licences. Any questions on the content of this database should be addressed to [email protected]. 29.3 KB. If you want to fast track your application because of a shortage of supply we recommend you discuss this with DHSC by emailing [email protected]. All invoices must be settled upon receipt. You cannot legally undertake licensable activity while your licence is suspended this includes during an appeal. 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. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced the licence suspension of ingenol mebutate gel (Picato). Details of the penalties are explained in ourFees Regulations. GLASGOW, Post-license. EN6 1TL, MHRA considers each application for a product name to ensure that the proposed name will allow the medicine to be taken safely and correctly. This will ensure you are not charged a periodic fee for the period 1 April 2016 to 31 March 2017. An updated list of suspended authorisations was attached. NISA RETAIL LIMITED. New version of suspended list has been uploaded. 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. Updated both attachments with newer files. Updated 'Suspended manufacturing and wholesale distribution authorisations' attachment, Updated 'Suspended and revoked licences and registrations for manufacturers and wholesalers of medicines and ingredients', New Suspended manufacturing and wholesale distribution authorisations published, New list of suspended manufacturing and wholesale distribution authorisations, Addition of new revocation and suspension. The Licence Number is a specific number allocated to one company. Updated 'Revoked manufacturing and wholesale distribution authorisations' and 'Suspended manufacturing and wholesale distribution authorisations' lists. Dont worry we wont send you spam or share your email address with anyone. To help us improve GOV.UK, wed like to know more about your visit today. Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission. 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. All UK and Great Britain (England, Scotland and Wales) national applications should be submitted through the MHRA Submissions Portal. You can change your cookie settings at any time. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. The list of suspended licences has been updated. 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. 2 NEWTECH SQUARE, Cancellation of a licence, authorisation or registration is when MHRA makes a decision to cancel the licence, authorisation or registration. Reinstating Your License. DEESIDE INDUSTRIAL PARK, The MHRA products website allows you to find: You can look for any word, phrase or Product Licence number (PL) using the search tool. Read More Contract Manufacture The DHSC contact for fast-tracking a licence has changed. Revocation List updated with a new addition. New document added to page for September 2017. Well send you a link to a feedback form. Copy CSV Excel PDF Print Showing 1 to 10 of 325 entries Previous 1 2 3 4 5 33 Next Updated: list of revoked manufacturing and wholesale distribution authorisations. The Agency has the power to withdraw a product from the market, and in the case of medicines, to suspend production. 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 WD18 7JJ, Penalty fees may be incurred for non-payment. Published updated list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. You can read our guidance about the submission of ASMFs. Any company that has an MHRA suspended licence cannot trade, suffers loss of credibility, loss of earnings and a reduced inspection schedule, which adds further costs and regulator interaction. UNITED KINGDOM, WOODLEY BIOREG LIMITED, List of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. 94 RICKMANSWORTH ROAD, 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. You have accepted additional cookies. Learn more about the circumstances that can lead to a licence holder losing their licence, either permanently or temporarily. Added list of terminated and cancelled licences for April 2019.