Dont worry we wont send you spam or share your email address with anyone. If you have any questions about MHRA Submissions , you should email submissions@mhra.gov.uk. You have accepted additional cookies. You can find out more in our naming of medicines guidance (PDF, 235 KB, 20 pages). Dont worry we wont send you spam or share your email address with anyone. Well send you a link to a feedback form. NISA RETAIL LIMITED. updated Suspended and revoked licences for manufacturers and wholesalers of medicines, list of suspended manufacturing and wholesale distribution authorisations updated. UNITED KINGDOM, DENDRON BRANDS LIMITED, Published updated version of Suspended manufacturing and wholesale distribution authorisations list. The Licence Number is a specific number allocated to one company. 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. Since inspections of manufacturers of active substances are based on risk,. "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. Fees vary depending on the type and route of application. Updated the 'When we suspend your licence' section to include reference to open public investigations. Healthcare products Regulatory Agency (MHRA) inspectorate as soon as possible. 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. 2 NEWTECH SQUARE, 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 application. Latest list of suspended licenses added to the page. UNITED KINGDOM, BARD PHARMACEUTICALS LIMITED, posted on 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. If you have any questions about submitting your application you should email ris.na@mhra.gov.uk. It is an additional route of appeal that we offer so that you can appeal in a way that does not incur court costs. Or if you need to cancel a parallel import product licence, complete the cancellation form (PDF, 525 KB, 3 pages). 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. updated suspended and revoked lists added to the page. Copy CSV Excel PDF Print Showing 1 to 10 of 325 entries Previous 1 2 3 4 5 33 Next If your application for these types of licences is pending and you no longer wish to proceed, you need to withdraw it. We publish the most up-to-date information for a medicine according to its licence history. Updated list of medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences for February. On-site inspections will resume as soon as travel restrictions permit. You have rejected additional cookies. Department of Health and Social Care (DHSC) has issued a medicine supply notification for Ranitidine (all formulations) . If your organisation operates a PO system, please make sure that the relevant PO is provided to the MHRA before the invoice is issued. Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended. Is there any portal where we can check the list of MIA holders? 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'. 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. Drug wholesaler hit by MHRA suspension hires advisers to find funding injection, Converse Pharma distributes a range of generic drugs. Revocation List updated with a new addition. 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. The Agency has the power to withdraw a product from the market, and in the case of medicines, to suspend production. 1999 - 2023 DMV.ORG. 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 questions on the content of this database should be addressed to IE&S-IMT@mhra.gov.uk. Subscribe to our News and Updates to stay in the loop and on the road! You can use the A-Z list to find an active substance, or search for a medicine. Published Medicines: terminated and cancelled manufacturing and wholesale dealer licences for August 2019. LE4 3EH, will check that NeeS and eCTD submissions are technically valid using the Extedo Eurs is Yours (EiY) validation tool. Suspended list updated to show licenses that have been terminated/revoked and therefore no longer suspended. View online Updated: list of revoked manufacturing and wholesale distribution authorisations. Published 4 February 2015 Last updated 5 January. Melatonin 4mg/5ml oral suspension STD, SF, LF, AF, NSF 150ml 20620 8 Menadiol 5mg/5ml oral suspension STD, SF, LF, CF . Updated: list of terminated and cancelled manufacturing and wholesale dealer licences. 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. https://mhrainspectorate.blog.gov.uk/2019/10/04/mhra-process-licensing-useful-information/. The clarifying remark section of individual GMP and GDP certificates will indicate any exceptions. ALR Program. UNITED KINGDOM, BCM LIMITED, Following the MHRA's confirmation of "more than 40 arrests" and the suspension of five pharmacists, the BBC - which claimed to have seen a full copy of the watchdog's intelligence report - said 19 wholesalers are still "under suspicion as investigations into the criminal network continue". It will take only 2 minutes to fill in. BEESTON, Do not send the corrected deficiencies by email. UNITED KINGDOM, THE MENTHOLATUM COMPANY LIMITED, UNITED KINGDOM, VIATRIS UK HEALTHCARE LIMITED, 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. 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. The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated to include May 2015. posted on These templates should not be altered in any way, other than inserting the relevant information. The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated. 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 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. Updated Suspended manufacturing and wholesale distribution authorisations List, Updated the list of Suspended manufacturing and wholesale distribution authorisations. . And it ensures the safety and effectiveness of medicines in the UK. All invoices must be settled upon receipt. Marketing. Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences' link to latest January 2021 version. Well send you a link to a feedback form. 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 . MIDLAND MILL, Refusal of licence / variation or an existing licence being revoked. Download CSV Download CSV This blog shares the work of the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate, by inspectors and those the Inspectorate works with. MHRA reserves the right. 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 Cancellation of a licence, authorisation or registration is when MHRA makes a decision to cancel the licence, authorisation or registration. All UK and Great Britain (England, Scotland and Wales) national applications should be submitted through the MHRA Submissions Portal. Very rare: Agitation, confusion, tremor, ataxia, dysarthria, hallucinations, psychotic symptoms, convulsions, somnolence, encephalopathy, coma. 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. Link to companies GMP and GDP certificates, see EUDRAGMDP link above. Full document as sent to the MHRA on 21st July 2020: CB4 0GW, 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: You can print blog posts using the keyboard shortcuts "Control P" or "Command P". We look forward to hearing from you to discuss your case. We can revoke (take away) your licence if you no longer meet our licensing criteria. Updated list of terminated, revoked and cancelled licences. Depending on the state you live in, you may incur a suspension for a different amount of points. UNITED KINGDOM, Terms and Conditions Opens in new window | Privacy Notice Opens in new window, Click on this link to navigate to www.mhra.gov.uk. You can change your cookie settings at any time. You have rejected additional cookies. To help us improve GOV.UK, wed like to know more about your visit today. Updated both 'revoked' and 'Suspended' manufacturing and wholesale distribution authorisations lists. 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 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Updated 'Suspended manufacturing and wholesale distribution authorisations' list, Updated 'Revoked manufacturing and wholesale distribution authorisations' list. 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/. A drug distributor which had its licence suspended earlier this year by Britain's medicines watchdog has hired City advisers to raise tens of millions of pounds of new funding. Updated the terminated and cancelled manufacturing and wholesale dealer licences for September 2021. We also use cookies set by other sites to help us deliver content from their services. UK WDA (H) 12426. If you use assistive technology (such as a screen reader) and need a https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-manufacturing-sites. Reinstating Your License. Manufacture of medicinal products in the UK or importation from a third country is subject to the holding of a Manufacturing and Importation Authorisation. Our legal power to do this is explained in Get Licensed (PDF, 3.03 MB, 90 pages). If a submission is rejected, we will email you the reasons for the rejection. varied or suspended by the Medicines and Healthcare products Regulatory Agency (MHRA). 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 under police investigation for a serious offence. New version of suspended list has been uploaded. 29.3 KB. TRIDENT PLACE, MOSQUITO WAY, 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. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. 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. Truancy. 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. (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. Once your application has been validated you will receive an invoice so that you can make a payment for the outstanding amount. 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. Publish list of terminated and cancelled licenses from July 2017 to June 2018. PEEL PARK CAMPUS, EAST KILBRIDE, 1 MEER END, Maalox oral suspension - Magnesium hydroxide; Aluminium hydroxide gel dried Magnesium hydroxide; . You must do so within 21 days of the revocation coming into effect. Our letter will also tell you how to appeal against our decision. 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.
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