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. Yesterday MHRA released an update on suspended manufacturing and wholesale distribution authorization. MHRA FMD - Medicines and Healthcare products Regulatory Agency Uploaded updated suspended and revoked licences lists. 09 October 2019. Any submission that does not meet the requirements will be rejected. 1999 - 2023 DMV.ORG. Published updated Revoked manufacturing and wholesale distribution authorisations list. Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. TRIDENT PLACE, MOSQUITO WAY, Sara Berry For example, in Kentucky, it takes an accumulation of 12 points over the course of 2 years in order to receive a suspension. It can also be checked on the following register: You should also use our eAF and cover letter tool to determine what information you need to include in your application. Updated the terminated and cancelled manufacturing and wholesale dealer licences for September 2021. Cancellation of a licence, authorisation or registration is when MHRA makes a decision to cancel the licence, authorisation or registration. MIDLAND MILL, Well send you a link to a feedback form. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Monthly update to 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. 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. 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. Alternatively, we can maintain the suspension until we have all of the information we require to make a licensing decision. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. 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. Also is there any process to verify that MIA licence is still valid? Applications can be fast tracked if there is compelling evidence of benefit in a public health emergency or if there is a shortage of supply of an essential medicine that has been verified by the Department of Health and Social Care (DHSC). This includes information of a commercially sensitive or personal nature, that may need to be restricted in the interests of security. Copy CSV Excel PDF Print Showing 1 to 10 of 325 entries Previous 1 2 3 4 5 33 Next Dont worry we wont send you spam or share your email address with anyone. Or if you need to cancel a parallel import product licence, complete the cancellation form (PDF, 525 KB, 3 pages). 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 . 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. You should submit your application using the electronic Common Technical Document (eCTD). Updated list of suspended licences added to the page. Refrain from driving for a period of time. Added new list of terminated and cancelled manufacturing and wholesale dealer licences. Published Medicines: terminated and cancelled manufacturing and wholesale dealer licences for August 2019. Dont include personal or financial information like your National Insurance number or credit card details. An updated list of suspended authorisations was attached. A certificate of Good Distribution Practice (GDP) is issued to a wholesale distributor if the outcome of the inspection confirms that the wholesale distributor complies with Good Distribution Practice. PILs are based on the Summaries of Product Characteristics (SPCs) which are a description of a medicinal products properties and the conditions attached to its use. The portal should be used for wholesale distribution authorisations [WDA(H)] and active substance manufacturers, importers and distributors new applications, variation applications and annual compliance reports (active substance manufacturers, importers or distributors only). Uploaded new Suspended manufacturing and wholesale distribution authorisations spreadsheet. The information published in this Register was that held by the MHRA on the date of publication. List of API manufacturers, importers and distributors, see EUDRAGMDP link above. New list of suspended licenses added to the page. Updated both 'revoked' and 'Suspended' manufacturing and wholesale distribution authorisations lists. We will write to you when we suspend your licence, telling you what we have done and why. Updated the 'When we suspend your licence' section to include reference to open public investigations. The design, evaluation, and management of immunisation programmes REACTA BIOTECH LIMITED T/A REACTA HEALTHCARE, MHRA considers each application for a product name to ensure that the proposed name will allow the medicine to be taken safely and correctly. LICENCE TYPE MA Manufacture and Assembly . MHRA reserves the right. Suspended vs. Revoked License: The Differences, Driving with a Suspended License: What You Need to Know. All Rights Reserved. Notifying a change of marketing status | European Medicines Agency Under 'Ways to make your submission', Updated email address and naming to Department of Health and Social Care. 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. You can also submit the forms via the Central European System Platform (CESP). Submission of a new ASMF and any update to an ASMF should be made by the ASMF holder using MHRA Submissions . "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. It also covers 'sunset-clause' monitoring. For 1 company the licence was terminated. The Agency has the power to withdraw a product from the market, and in the case of medicines, to suspend production. 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. There is no additional fee for fast-tracking applications. 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 PDF Actions as a Result of Referral to the Inspection Action Group 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. Updated both attachments with newer files. UNITED KINGDOM, VIATRIS UK HEALTHCARE LIMITED, The list of suspended licences has been 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. 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. Suspended and revoked licences and registrations for manufacturers and 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 also use cookies set by other sites to help us deliver content from their services. Failure to Appear. We will also tell you what you can do that might stop us from revoking your licence. Added August file for - Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences. CAMBRIDGE, 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. Uploaded new version of Suspended manufacturing and wholesale distribution authorisations. The Licence Number is a specific number allocated to one company. 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: If a submission is rejected, we will email you the reasons for the rejection. Medical Evaluation Process. Published new version of the suspended manufacturing and wholesale distribution authorisations list. Well send you a link to a feedback form. UK WDA (H) 12426. These can then be investigated further to decide whether a side effect is truly from a . CH5 2NT, 2 NEWTECH SQUARE, The clarifying remark section of individual GMP and GDP certificates will indicate any exceptions. To help us improve GOV.UK, wed like to know more about your visit today. If we suspend your licence, the suspension comes into effect immediately. You can change your cookie settings at any time. 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. New version of document has been uploaded. This blog shares the work of the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate, by inspectors and those the Inspectorate works with. Download CSV 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. 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. July update to Terminated, Revoked, Cancelled licences file. POTTERS BAR, 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. DEESIDE, You can change your cookie settings at any time. Dont include personal or financial information like your National Insurance number or credit card details. 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. Drug wholesaler hit by MHRA suspension hires advisers to find funding injection, Converse Pharma distributes a range of generic drugs. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. PDF Department of Health and MHRA Register of Licensed Manufacturing Sites We updated the list of suspended manufacturing and wholesale distribution authorisations. Report a side effect with a medicine or medical device. 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. We may still revoke your licence. If you have any questions about the Submissions Portal, you should email submissions@mhra.gov.uk. To help us improve GOV.UK, wed like to know more about your visit today. Updated suspended manufacturing and wholesale distribution authorisations. Published updated list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. 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 "Manufacturer's Licence" and "import from a third country" 2.1 A Manufacturer's Licence (MIA) may be granted for the manufacture and assembly of Published new list of Suspended manufacturing and wholesale distribution authorisations. City editor The List of Terminated, Revoked and Cancelled Licences has been updated. If you do not use this template your submission will be rejected. Drug wholesaler hit by MHRA suspension hires advisers to - Sky News . Updated 'Revoked manufacturing and wholesale distribution authorisations' and 'Suspended manufacturing and wholesale distribution authorisations' lists. You can read our guidance about the submission of ASMFs. https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-manufacturing-sites. You have accepted additional cookies. We also use cookies set by other sites to help us deliver content from their services. Wholesale dealer licences/API/broker licences: GDP.Inspectorate@mhra.gov.uk, Manufacturing licences: gmpinspectorate@mhra.gov.uk. Updated 'Suspended manufacturing and wholesale distribution authorisations' link. Published new list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. Latest list of suspended licenses added to the page. Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. What the data show Since September 2020, 15 Companies were affected. MHRA alerts & recalls PharmData maintains a list of all MHRA alerts and recalls relevant to community pharmacy. Updated the suspended manufacturing and wholesale distribution authorisations list. 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. Link to companies GMP and GDP certificates, see EUDRAGMDP link above. Learn more about the circumstances that can lead to a licence holder losing their licence, either permanently or temporarily. NOTTINGHAM, 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'. Alpha Release This is a new service - your feedback will help improve it. You have rejected additional cookies. Syri Limited suspension has been lifted. 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. Accumulating too many driving record points. Truancy. Cancellation of a licence, authorisation or registration is when MHRA makes a decision to cancel the licence, authorisation or registration. Updated lists of suspended and revoked licenses. If you do not respond to our letter we will revoke your licence automatically after 21 days. This information is common to all procedures. 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. We recommend that you use a validation tool to check your submission as we This means that you can still work during your appeal, unless we have also suspended your licence. Penalty fees may be incurred for non-payment. Added list of terminated and cancelled licences for April 2019. And it ensures the safety and effectiveness of medicines in the UK. Some information may have been excluded from public view. UNITED KINGDOM, CONSILIENT HEALTH (UK) LIMITED, (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.