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Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended. When autocomplete results are available use up and down arrows to review and enter to select. 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. 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 also use cookies set by other sites to help us deliver content from their services. Added August file for - Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences. Dont include personal or financial information like your National Insurance number or credit card details. Healthcare. M&A Pharmachem, a UK-based producer of complex molecules and OTC products, is recalling two batches of paracetamol 500mg tablets, each containing 12 pots of 1,000 tablets. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. MHRA Suspended Licence checks are a critical part of your Quality Management System and Risk Management processes, so keep on top of them. 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. Published new list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. The Agency has the power to withdraw a product from the market, and in the case of medicines, to suspend production. Please note the site register will be updated on a quarterly basis. Read More Contract Manufacture 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. 9-11 HILLHOUSE LANE, Marketing. Updated Suspended manufacturing and wholesale distribution authorisations List, Updated the list of Suspended manufacturing and wholesale distribution authorisations. Publish list of terminated and cancelled licenses from July 2017 to June 2018. 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 List of Terminated and Cancelled Licences has been updated. To help us improve GOV.UK, wed like to know more about your visit today. posted on It is the MA applicants responsibility to make sure that the ASMF is submitted either before you submit your application or at the same time, as your application will not be valid without it. BEESTON, the mentholatum company limited, 1 redwood avenue, peel park campus, east kilbride, glasgow, g74 5pe, united kingdom 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. THANE ROAD, UNITED KINGDOM, DENDRON BRANDS LIMITED, New version of document has been uploaded. Published new list of terminated and cancelled manufacturing and wholesale dealer licences, Publish list of terminated and cancelled licenses from August 2017 to July 2018. Yesterday MHRA released an update on suspended manufacturing and wholesale distribution authorization. We use some essential cookies to make this website work. Dealer Licences 2016 to October, Updated list of terminated and cancelled licences. We recommend that you use a validation tool to check your submission as we You have accepted additional cookies. 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 . 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. You have rejected additional cookies. 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. All Rights Reserved. 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. BIRSTALL, Depending on the state you live in, you may incur a suspension for a different amount of points. Welcome to the MHRA Process Licensing Portal. EnteroBiotix secures key additional MHRA license and announces regulatory milestones. 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. Added a link to the User Guide for the electronic application form. 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 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. If your application for these types of licences is pending and you no longer wish to proceed, you need to withdraw it. Drug wholesaler hit by MHRA suspension hires advisers to find funding injection, Converse Pharma distributes a range of generic drugs. MHRA considers each application for a product name to ensure that the proposed name will allow the medicine to be taken safely and correctly. Updated list of terminated and cancelled manufacturing and wholesale dealer licences. CDL Disqualifications. Converse Pharma could not be reached for comment. New version of Revocation list has been uploaded. posted on Cancellation of a licence, authorisation or registration is when MHRA makes a decision to cancel the licence, authorisation or registration. Sara Berry 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. 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 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. WD18 7JJ, Latest list of suspended licenses added to the page. Medical Evaluation Process. G74 5PE, These can then be investigated further to decide whether a side effect is truly from a . Full document as sent to the MHRA on 21st July 2020: Published Medicines: terminated and cancelled manufacturing and wholesale dealer licences for August 2019. You can change your cookie settings at any time. 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. Updated both attachments with newer files. We aim to respond to queries within 18 working days, however, where expert advice is required from other parties this may take longer. Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. Details of the penalties are explained in ourFees Regulations. 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. We also use cookies set by other sites to help us deliver content from their services. You should also use our eAF and cover letter tool to determine what information you need to include in your application. MILTON ROAD, 1 CHURCH ROAD, 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. View online Published new list of Suspended manufacturing and wholesale distribution authorisations. TW9 2QE, Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. 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. Once your application has been validated you will receive an invoice so that you can make a payment for the outstanding amount. Dont worry we wont send you spam or share your email address with anyone. Maalox 175mg/200mg Oral Suspension . Added links to pages providing further information on some of the procedures. UNITED KINGDOM, BARD PHARMACEUTICALS LIMITED, DEESIDE INDUSTRIAL PARK, Uploaded new Suspended manufacturing and Revoked spreadsheets. 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. NG90 2PR, You have accepted additional cookies. List of API manufacturers, importers and distributors, see EUDRAGMDP link above. NOTTINGHAM, 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. At 1936 per MHRA inspection or re-inspection, you want as few visits as possible. We find an easy way to remember is to set a recurrent reminder in your Outlook calendar or Gmail diary. (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. List of suspended licences for manufacturers and wholesalers of medicines updated, Updated the suspended list with two new suspensions and corrected suspension date for St Helen's Millennium Centre Services Limited. 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. 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 list of suspensions. Updated list of medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences for February. Submission of a new ASMF and any update to an ASMF should be made by the ASMF holder using MHRA Submissions . 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. This does not replace your right of appeal through the courts. Alpha Release This is a new service - your feedback will help improve it. Anyone in the pharmaceutical or medicinal supply chain should use this list to ensure they are dealing with a valid licence or authorisation holder. 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. Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. 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. Failure to Appear. You can use the A-Z list to find an active substance, or search for a medicine. Uploaded new Suspended manufacturing and wholesale distribution authorisations list. 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: Updated lists of suspended and revoked licences. 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. UNITED KINGDOM, VIATRIS UK HEALTHCARE LIMITED, The MHRA has been assured that acceptable standards of Good Manufacturing Practice are in place for . Department of Health and Social Care (DHSC) has issued a medicine supply notification for Ranitidine (all formulations) . Very rare: Agitation, confusion, tremor, ataxia, dysarthria, hallucinations, psychotic symptoms, convulsions, somnolence, encephalopathy, coma. We also use cookies set by other sites to help us deliver content from their services. https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-manufacturing-sites. 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. You can change your cookie settings at any time. 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. 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. The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated. Manufacturing and Wholesale A certificate of Good Manufacturing Practice (GMP) is issued to a manufacturer if the outcome of the inspection confirms that the manufacturer complies with the principles of Good Manufacturing Practice. Converse Pharma distributes a range of generic drugs, including flu vaccines, employing close to 1,000 people at 11 sites across the country. Updated list of suspended manufacturing and wholesale distribution authorisations. Updated the suspended manufacturing and wholesale distribution authorisations list. Suspended Driver's License. either alone or jointly. It will take only 2 minutes to fill in. To help us improve GOV.UK, wed like to know more about your visit today. ASMFs holders must submit their dossier to the MHRA. Download CSV 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. New list of terminated licenses, August 2016 to July 2017 added to the page. UNITED KINGDOM, WOODLEY BIOREG LIMITED, will check that NeeS and eCTD submissions are technically valid using the Extedo Eurs is Yours (EiY) validation tool. We will write to you when we suspend your licence, telling you what we have done and why. 29.3 KB. Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely. 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. This portal allows registered users to submit WDA (H) Wholesale Distribution Authorisation applications and variations API Active Pharmaceutical. Link to companies GMP and GDP certificates, see EUDRAGMDP link above. Fees vary depending on the type and route of application. 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 . You can change your cookie settings at any time. Well send you a link to a feedback form. 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. Please ensure that you limit bulk cancellations to a maximum of 10 product licenses showing per application form. If you do not respond to our letter we will revoke your licence automatically after 21 days. If you use assistive technology (such as a screen reader) and need a New version of the revocation and suspension lists has been uploaded. Registered users can receive instant email notifications of new alerts, and record their responses to MHRA alerts within their PharmData account. All UK and Great Britain (England, Scotland and Wales) national applications should be submitted through the MHRA Submissions Portal. Occupational Licenses. MHRA alerts & recalls PharmData maintains a list of all MHRA alerts and recalls relevant to community pharmacy. CH5 2NT, Updated list of suspended manufacturing and wholesale distribution authorisations added to the page. Dont include personal or financial information like your National Insurance number or credit card details. All invoices must be settled upon receipt. 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. You can find out more about the fees we charge in the guidance MHRA fees. 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. 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? The suspension period varies by the customer's number of convictions and age while holding a provisional driver's license: 2nd conviction over 18 years - 30 days; 2nd conviction under 18 years - 30 days suspension and employment and education restriction for 90 days effective at the removal of the suspension Common: Headache, dizziness. 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. 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. These templates should not be altered in any way, other than inserting the relevant information. 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. Added new list of terminated and cancelled manufacturing and wholesale dealer licences. Our legal power to do this is explained in Get Licensed (PDF, 3.03 MB, 90 pages). Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences' attachment to latest version. 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). latest Suspended manufacturing and wholesale distribution authorisations, Updated Suspended manufacturing and wholesale distribution authorisations, Updated suspended manufacturing and wholesale distribution authorisations. And it ensures the safety and effectiveness of medicines in the UK. You have rejected additional cookies. BUILDING 20, STATION CLOSE, Or you can submit the forms to us by email to withdrawcancel@mhra.gov.uk. 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". 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. 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. To help us improve GOV.UK, wed like to know more about your visit today. Updated the Suspended manufacturing and wholesale distribution authorisations list. Updated list of suspended and revoked licences and registrations. 94 RICKMANSWORTH ROAD, News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. If you do not include the correct information your application will not be validated. Compare over 50 top car insurance quotes and save. 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. . 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: . 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. New list of suspended licenses added to the page. Your licence remains live during a court appeal. Updated list of suspended licences and registrations for manufacturers and wholesalers of medicines and ingredients. Its licence was "largely reinstated" following a re-investigation in April, says Sky. UNIT 191, CAMBRIDGE SCIENCE PARK, 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. The Licence Number is a specific number allocated to one company. In August 2018, EnteroBiotix announced that the company had been awarded a manufacturer's specials license . REACTA BIOTECH LIMITED T/A REACTA HEALTHCARE, Updated the 'When we suspend your licence' section to include reference to open public investigations. 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. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Comment by Any submission that does not meet the requirements will be rejected. Updated suspension list added to the page. We may still revoke your licence. Updated list of suspended licences added to the page. Updated suspension list for manufacturing and wholesale distribution authorisations. 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). Report a side effect with a medicine or medical device. We may lift the suspension if you are found not guilty or the charges are dropped. Updated list of companies in the UK who have had their licence to manufacture or wholesale medicines suspended. The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated to include May 2015. MIDLAND MILL, The Site Number is a specific number allocated to one site. TRIDENT PLACE, MOSQUITO WAY, Refusal of licence / variation or an existing licence being revoked. Ranitidine 50mg/2ml injection is anticipated to be unavailable from the end of May 2020 until further notice. Monthly update to 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. HD1 6EF, Updated Suspended manufacturing and wholesale distribution authorisations list. Published updated list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. You have rejected additional cookies. Added spreadsheet under "types of application" heading. You must do so within 21 days of the suspension coming into effect. 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.

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