You can also use the A-Z list to find the active substance. Occupational Licenses. 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. The Licence Number is a specific number allocated to one company. Converse Pharma could not be reached for comment. You should also use our eAF and cover letter tool to determine what information you need to include in your application. Uploaded updated Medicines terminated and cancelled manufacturing and wholesale dealer licences PDF. "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 file may not be suitable for users of assistive technology. We publish scientific assessment reports called a Public Assessment Report (PAR) available for new marketing authorisations granted after 30 October 2005. Syri Limited suspension has been lifted. Updated both attachments - Revoked manufacturing and wholesale distribution authorisations and Suspended manufacturing and wholesale distribution authorisations, New list of Suspended manufacturing and wholesale distribution authorisations uploaded, Updated 'Suspended manufacturing and wholesale distribution authorisations' csv file, Added NECESSITY SUPPLIES LIMITED and their suspension till Feb 2020, We have updated the current suspended list, Suspended manufacturing and wholesale distribution authorisations update, We have updated the Suspended manufacturing and wholesale distribution authorisations data, We have updated the suspended manufacturing and wholesale distribution authorisations list, Published updated lists of suspended and revoked licences. Alpha Release This is a new service - your feedback will help improve it. The pathway that you follow will depend on your intended market and the type of application you are making. This is based on the MHRA assessment report with any commercially or personally confidential information removed. PEEL PARK CAMPUS, EAST KILBRIDE, The MHRA also enforces European drug licensing regulations in the UK. NG90 2PR, 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 The current An updated list of suspended authorisations was attached. If you want to fast track your application because of a shortage of supply we recommend you discuss this with DHSC by emailing DHSCmedicinesupplyteam@dhsc.gov.uk. You should also use this form if you want to withdraw a variation application or amendment for an existing MA. If you have any questions about submitting your application you should email ris.na@mhra.gov.uk. Uploaded new version of Suspended manufacturing and wholesale distribution authorisations. This means that you can still work during your appeal, unless we have also suspended your licence. UNITED KINGDOM, MYONEX LIMITED, UNITED KINGDOM, BCM LIMITED, 10 October 2019, MIA holders can be checked on the Eudra GMDP webpage for validity. 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. It also covers 'sunset-clause' monitoring. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely. 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 lenders have hired PricewaterhouseCoopers to advise them, according to one insider. 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. Dont worry we wont send you spam or share your email address with anyone. If the referral results in an immediate suspension of a manufacturer's/wholesale dealer's licence, there are no rights of appeal for the immediate suspension (which can last no longer than 3 months), but the suspension can be challenged in the High Court. You have accepted additional cookies. Dont worry we wont send you spam or share your email address with anyone. 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. Ranitidine 50mg/2ml injection is anticipated to be unavailable from the end of May 2020 until further notice. Published updated list of Suspended manufacturing and wholesale distribution authorisations. 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. Aventis Pharma Limited . 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. RICHMOND, Updated list of terminated and cancelled manufacturing and wholesale dealer licences. Maalox oral suspension - Magnesium hydroxide; Aluminium hydroxide gel dried Magnesium hydroxide; . Failure to Appear. 94 RICKMANSWORTH ROAD, Updated list of suspensions. If you do not include the correct information your application will not be validated. UNITED KINGDOM, VIATRIS UK HEALTHCARE LIMITED, Uploaded new Suspended manufacturing and Revoked spreadsheets. 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 Added updated list of suspended manufacturing and wholesale distribution authorisations. The attorneys at The Davis Law Group, P.C. List of revoked manufacturing sites updated. To help us improve GOV.UK, wed like to know more about your visit today. On the other hand, in Florida, earning 12 points on your license within a year will get your license suspended for 30 days. Check benefits and financial support you can get, Find out about the Energy Bills Support Scheme, Drug or alcohol misuse or dependence: assessing fitness to drive, Declaration of voluntary surrender for medical reasons, Psychiatric disorders: assessing fitness to drive, Can I drive while my application is with DVLA? UNITED KINGDOM, DENDRON BRANDS LIMITED, Name and address of the site: NISA RETAIL LIMITED , BLOOM LANE, NORMANBY ENTERPRISE PARK, SCUNTHORPE, DN15 9YA, UNITED KINGDOM. Updated list of terminated and cancelled manufacturing and wholesale 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). An example of when we might do this is if you are convicted of a relevant criminal offence. 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. Under 'Ways to make your submission', Updated email address and naming to Department of Health and Social Care. Updated the list of suspended licences for manufacturers and wholesalers of medicines. Updated 'Suspended manufacturing and wholesale distribution authorisations' list, Updated 'Revoked manufacturing and wholesale distribution authorisations' list. Uploaded new Suspended manufacturing and wholesale distribution authorisations spreadsheet. List of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. 7 companies were further suspended (46% of the total), hence they were not able to overcome the reason for suspension, and only 1 had suspension lifted. These templates should not be altered in any way, other than inserting the relevant information. The Process Licensing Office sits within the Inspectorate and Process Licensing Group of the Inspection, Enforcement and Standards division. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Terminated and cancelled manufacturing and wholesale dealer licences for January through to February 2016. New version of the revocation and suspension lists has been uploaded. Updated list of suspended manufacturing and wholesale distribution authorisations added to the page. To help us improve GOV.UK, wed like to know more about your visit today. Anyone in the pharmaceutical or medicinal supply chain should use this list to ensure they are dealing with a valid licence or authorisation holder. TRIDENT PLACE, MOSQUITO WAY, This blog shares the work of the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate, by inspectors and those the Inspectorate works with. On-site inspections will resume as soon as travel restrictions permit. dealer licences. THANE ROAD, 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. If you respond to our letter we will take what you tell us into consideration. New version of document has been uploaded. updated Suspended and revoked licences for manufacturers and wholesalers of medicines, list of suspended manufacturing and wholesale distribution authorisations updated. 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. 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. . 1 CHURCH ROAD, Welcome to the MHRA Process Licensing Portal. Dont include personal or financial information like your National Insurance number or credit card details. This includes information of a commercially sensitive or personal nature, that may need to be restricted in the interests of security. Maalox 175mg/200mg Oral Suspension . WD18 7JJ, Any submission that does not meet the requirements will be rejected. To help us improve GOV.UK, wed like to know more about your visit today. We will also tell you what you can do that might stop us from revoking your licence. The MHRA has been assured that acceptable standards of Good Manufacturing Practice are in place for . Refusal to pay outstanding fees on the grounds that the PO is not provided on the invoice will not be accepted. Uploaded updated suspended and revoked licences lists. Dont include personal or financial information like your National Insurance number or credit card details. The MHRA products website allows you to find: You can look for any word, phrase or Product Licence number (PL) using the search tool. Updated list of suspended and revoked licences for manufacturers and wholesalers of medicines. Subscribe to our News and Updates to stay in the loop and on the road! posted on 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 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. will check that NeeS and eCTD submissions are technically valid using the Extedo Eurs is Yours (EiY) validation tool. Published a new version of the Suspended manufacturing and wholesale distribution authorisations list. It will take only 2 minutes to fill in. UNITED KINGDOM, WOODLEY BIOREG LIMITED, This information is common to all procedures. Actavis, Forley Generics, and Goldshield Group also . We look forward to hearing from you to discuss your case. The List of Terminated, Revoked and Cancelled Licences has been updated. ninja foodi digital air fry oven chicken tenders. 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 . posted on Please note, you are required as a company to ensure that all personal details provided to the MHRA are up to date and the MHRA needs to be notified within any application if any changes in personal details need to be updated, including email addresses and telephone numbers. An example of when we might do this is if you are under police. You have accepted additional cookies. Updated the 'When we suspend your licence' section to include reference to open public investigations. BUILDING 4, Report a side effect with a medicine or medical device. Updated both attachments with newer files. All Rights Reserved. The agency advised healthcare professionals to immediately stop supplying the batches and to quarantine and remove all remaining stock. 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. Dont worry we wont send you spam or share your email address with anyone. Published updated list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. We use some essential cookies to make this website work. The list of suspensions and revocations is updated on the same day that the suspension or revocation takes place. Download CSV Post-license. 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". We find an easy way to remember is to set a recurrent reminder in your Outlook calendar or Gmail diary. Updated list of suspended licenses added to the page. All invoices must be settled upon receipt. 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. . Updated list of terminated and cancelled manufacturing and wholesale dealer licences up to May 2019 added to the page. Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences' attachment to latest version. 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. 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. There is no additional fee for fast-tracking applications. We use some essential cookies to make this website work. 3.85 KB, View online 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. MHRA Suspended Licence checks are a critical part of your Quality Management System and Risk Management processes, so keep on top of them. Since inspections of manufacturers of active substances are based on risk, some active substance manufacturers may not be in possession of a GMP certificate. The Agency has the power to withdraw a product from the market, and in the case of medicines, to suspend production. Updated file 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. HUDDERSFIELD, A licence suspension is not a punishment: it is a temporary measure that gives us time to look into your case and/or await the outcome of investigations being carried out by the police or other public bodies. 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. Updated list of suspended licences and registrations for manufacturers and wholesalers of medicines and ingredients. Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission. For 1 company the licence was terminated. Apply for new broker registrations and to vary existing broker registrations via https://fmdbroker.hma.eu/, Using link to MHRA fees: https://www.gov.uk/government/publications/mhra-fees. List of suspended manufacturing and wholesale distribution authorisations updated. 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: . ASMFs holders must submit their dossier to the MHRA. Very rare: Agitation, confusion, tremor, ataxia, dysarthria, hallucinations, psychotic symptoms, convulsions, somnolence, encephalopathy, coma. 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. The Site Number is a specific number allocated to one site. 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/. Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences' link to latest January 2021 version. Updated list of companies in the UK who have had their licence to manufacture or wholesale medicines suspended. updated suspended and revoked lists added to the page. You have accepted additional cookies. 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. An updated list of suspended licenses has been uploaded. Also is there any process to verify that MIA licence is still valid? It is an additional route of appeal that we offer so that you can appeal in a way that does not incur court costs. Updated 'Revoked manufacturing and wholesale distribution authorisations' and 'Suspended manufacturing and wholesale distribution authorisations' lists. PL 04425/0697 . City editor TW9 2QE, Complete the cancellation form (MS Word Document, 33.5 KB) if you're a UK applicant as well as following the European process at step 1. You can go to the MHRA-GMDP website to view the lists of: Updated the suspended and revoked licenses list. Well send you a link to a feedback form. REACTA BIOTECH LIMITED T/A REACTA HEALTHCARE, Updated list of medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences for February. Monthly update to 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. You should read the guidance for your specific pathway for any extra information or steps that might be required. 1999 - 2023 DMV.ORG. SR-22 Insurance Certificates. We also use cookies set by other sites to help us deliver content from their services. You cannot legally undertake licensable activity while your licence is suspended this includes during an appeal. Updated the terminated and cancelled manufacturing and wholesale dealer licences for September 2021. 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. Updated suspension list for manufacturing and wholesale distribution authorisations. It will take only 2 minutes to fill in. We use some essential cookies to make this website work. Publish list of terminated and cancelled licenses from July 2017 to June 2018. 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. Published 4 February 2015 Last updated 5 January. Healthcare products Regulatory Agency (MHRA) inspectorate as soon as possible. List of API manufacturers, importers and distributors, see EUDRAGMDP link above. NISA RETAIL LIMITED. WELBECK PHARMACEUTICALS & HOSPITAL SUPPLIES LIMITED , 35 DEVONSHIRE STREET, LONDON, W1G 6PZ, UNITED KINGDOM. Well send you a link to a feedback form. Or if you need to cancel a parallel import product. 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. Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended. have helped thousands of drivers regain their driving privileges after cancellation, suspension or revocation. 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. These can then be investigated further to decide whether a side effect is truly from a . Suspended manufacturing and wholesale distribution authorisations list updated. Accumulating too many driving record points. The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated. Or you can submit the forms to us by email to withdrawcancel@mhra.gov.uk. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Converse Pharma distributes a range of generic drugs, including flu vaccines, employing close to 1,000 people at 11 sites across the country. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Or if you need to cancel a parallel import product licence, complete the cancellation form (PDF, 525 KB, 3 pages). Updated list of suspended licences for manufacturers and wholesalers of medicines. 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. D ate of . G74 5PE, Please ensure that you limit bulk cancellations to a maximum of 10 product licenses showing per application form. If we suspend your licence, the suspension comes into effect immediately. Do not send the corrected deficiencies by email. Dont include personal or financial information like your National Insurance number or credit card details. We use some essential cookies to make this website work. Updated lists of suspended and revoked licenses. Is there any portal where we can check the list of MIA holders? Ilyas ali Suspensions & Reinstatements. If you do not respond to our letter we will revoke your licence automatically after 21 days. Truancy. You can change your cookie settings at any time. 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. HD1 6EF, Well send you a link to a feedback form. Updated 'Suspended manufacturing and wholesale distribution authorisations' link. Cancellation of a licence, authorisation or registration is when MHRA makes a decision to cancel the licence, authorisation or registration. Alternatively, we can maintain the suspension until we have all of the information we require to make a licensing decision. To cancel a marketing authorisation for a medicine or a traditional herbal remedy so it can be removed from the market, you need to: Follow the European requirements on the European Medicines Agency (EMA) website completing and submitting their cover letter template and notification report table. Updated list of suspended and revoked licences and registrations. You have accepted additional cookies. Published Medicines: terminated and cancelled manufacturing and wholesale dealer licences for August 2019. List of new manufacturing licences and wholesale distribution authorisations 2015: https://www.gov.uk/government/publications/medicines-new-manufacturing-and-wholesale-dealer-licences, List of manufacturers licences MIA and MANA, MIA(IMP) on EUDRAGMDP link below: http://eudragmdp.ema.europa.eu/inspections/displayHome.do. At 1936 per MHRA inspection or re-inspection, you want as few visits as possible. Details of the penalties are explained in ourFees Regulations. Well send you a link to a feedback form. In April 2018, C+D reported that the suspension had been extended due to remaining "non-compliance issues". 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. 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). Published updated 'Suspended manufacturing and wholesale distribution authorisations' spreadsheet. Updated lists of suspended and revoked licences. 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 . Added August file for - Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences. MHRA considers each application for a product name to ensure that the proposed name will allow the medicine to be taken safely and correctly.