mhra licence suspension mhra licence suspension

Uploaded updated suspended and revoked licences lists. LICENCE TYPE MA Manufacture and Assembly . You can find out more about how to pay your fees in our guidance on making a payment to MHRA. The Agency has the power to withdraw a product from the market, and in the case of medicines, to suspend production. 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. There is no additional fee for fast-tracking applications. . 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. We will write to you when we suspend your licence, telling you what we have done and why. Well send you a link to a feedback form. When autocomplete results are available use up and down arrows to review and enter to select. Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. You should also use our eAF and cover letter tool to determine what information you need to include in your application. 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. Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences' attachment to latest version. (INF188/6), Assessing fitness to drive: guide for medical professionals, you applied for it using fraudulent documents and/or using a fraudulent identity, you allow someone else to use your licence to engage in licensable conduct, you do not have the qualifications that you claimed to have on your application, you receive a sentence or disposal for a relevant offence and the date your sentence restrictions end means that you fall into the Automatic Refusal category of our licence criteria, you do not have the right to work in the UK (unless you are a director of a UK-registered company), you breach our licence criteria (as set out in, you break any of the licence conditions - this includes any additional conditions that we have placed on your licence, you do not do the training that we ask you to do, you receive a sentence or disposal for a relevant offence and the date your sentence restrictions end means that you fall into the Consider Additional Factors category of our licence criteria, we decide that you are not a fit and proper person to hold a licence, our decision is found to have been based on information that is factually incorrect, we are instructed to do so by the courts as the result of a legal appeal, we believe that you may be a threat to public safety, we believe that it is in the public interest to do so, you have been charged with a serious relevant offence, the police or another public body are investigating you for a serious relevant offence, lift the suspension and reinstate your licence, require you to take some form of remedial action before we will lift the suspension (for example, we may require you to take additional training). In August 2018, EnteroBiotix announced that the company had been awarded a manufacturer's specials license . This is based on the MHRA assessment report with any commercially or personally confidential information removed. 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. 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. IAG are non-statutory multi-disciplinary groups which advise MHRA's Director of IE&S on recommendations for regulatory action. Any submission that does not meet the requirements will be rejected. Dont worry we wont send you spam or share your email address with anyone. 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. Submission of a new ASMF and any update to an ASMF should be made by the ASMF holder using MHRA Submissions . TRIDENT PLACE, MOSQUITO WAY, You have accepted additional cookies. The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated to include May 2015. Added links to pages providing further information on some of the procedures. Published updated 'Suspended manufacturing and wholesale distribution authorisations' spreadsheet. G74 5PE, Well send you a link to a feedback form. Updated the terminated and cancelled manufacturing and wholesale dealer licences for September 2021. 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. UK Licence No: PL 04425/0697 . Under 'Ways to make your submission', Updated email address and naming to Department of Health and Social Care. If we intend to revoke or suspend your licence we will write to you to tell you why. Updated list of suspended licences added to the page. Updated 'Revoked manufacturing and wholesale distribution authorisations' and 'Suspended manufacturing and wholesale distribution authorisations' lists. Updated list of medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences for February. UNITED KINGDOM, WOODLEY BIOREG LIMITED, Drug wholesaler hit by MHRA suspension hires advisers to find funding injection, Converse Pharma distributes a range of generic drugs. 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. Ranitidine 50mg/2ml injection is anticipated to be unavailable from the end of May 2020 until further notice. If a submission is rejected, we will email you the reasons for the rejection. 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. 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. We will also tell you what you can do that might stop us from revoking your licence. 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. Suspensions & Reinstatements. Company name,Licence revoked,Date of revocation,Reason PRESTFORD LIMITED,WDA(H) 43010,04-Apr-22,Regulatory Action ACCENDO PHARMA LIMITED,WDA(H) 43391,16-Dec-21,Regulatory Action CHOPRAS PHARMACY LIMITED,WDA(H) 39745,17-Nov-21,Regulatory Action CELTICPHARM LIMITED,WDA(H) 44336,11-Nov-21,Regulatory Action WISE PHARMACIES LIMITED,WDA(H) 41881,11-Oct-21,Regulatory Action GIS MEDICAL & SURGICAL . 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. 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. If your application for these types of licences is pending and you no longer wish to proceed, you need to withdraw it. Alternatively, we can maintain the suspension until we have all of the information we require to make a licensing decision. Updated list of companies in the UK who have had their licence to manufacture or wholesale medicines suspended. To help us improve GOV.UK, wed like to know more about your visit today. You can also use the A-Z list to find the active substance. 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. List of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. Updated suspension list for manufacturing and wholesale distribution authorisations. We may lift the suspension if you are found not guilty or the charges are dropped. Read More Contract Manufacture NISA RETAIL LIMITED. latest Suspended manufacturing and wholesale distribution authorisations, Updated Suspended manufacturing and wholesale distribution authorisations, Updated suspended manufacturing and wholesale distribution authorisations. Updated lists of suspended and revoked licences. PEEL PARK CAMPUS, EAST KILBRIDE, 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. Updated both attachments with newer files. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. 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 suspension list added to the page. July update to Terminated, Revoked, Cancelled licences file. 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 Download CSV 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. Published updated Revoked manufacturing and wholesale distribution authorisations list. 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. Updated document - Suspended manufacturing and wholesale distribution authorisations. 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 use of POs is an internal control process and cannot be used as a reason to withhold payment of legitimate invoices. You must do so within 21 days of the revocation coming into effect. You can change your cookie settings at any time. The Medicines and Healthcare products Regulatory Agency (MHRA) is a government body which was set up in 2003 to bring together the functions of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). mhra licence suspensionhow to calculate solow residual mhra licence suspension. You can use the A-Z list to find an active substance, or search for a medicine. posted on 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. Once we revoke your licence we cannot change our decision unless it is for one of the following reasons: You can appeal our decision to revoke your licence in a Magistrates or Sheriff Court. 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 In certain circumstances MHRA will permanently revoke a licence. Converse Pharma distributes a range of generic drugs, including flu vaccines, employing close to 1,000 people at 11 sites across the country. Check benefits and financial support you can get, Find out about the Energy Bills Support Scheme, Marketing authorisations, variations and licensing guidance, Medicines and Healthcare products Regulatory Agency, Decentralised and mutual recognition reliance procedure for marketing authorisations, Medicines: apply for a variation to your marketing authorisation, Electronic Application Form and Cover Letter Tool, a brief description of the major clinical properties of the product, evidence supporting the claimed benefits of the product for the proposed indication(s). BUILDING 20, STATION CLOSE, Updated: list of revoked manufacturing and wholesale distribution authorisations. Published 4 February 2015 Last updated 5 January. updated suspended and revoked lists added to the page. Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended. 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. You can also tell us about any factual errors that may have affected our decision. either alone or jointly. All Rights Reserved. Updated the suspended manufacturing and wholesale distribution authorisations list. dealer licences. 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. Or if you need to cancel a parallel import product licence, complete the cancellation form (PDF, 525 KB, 3 pages). UK WDA (H) 12426. Is there any portal where we can check the list of MIA holders? Our letter will also tell you how to appeal against our decision. 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). MHRA's primary role is to protect public health and the IAG process forms a regulatory tool to manage this. The attorneys at The Davis Law Group, P.C. Dont worry we wont send you spam or share your email address with anyone. Updated the Suspended manufacturing and wholesale distribution authorisations list. Well send you a link to a feedback form. Following the end of the transition period, published information on new procedures for obtaining a marketing authorisation in the UK, Great Britain (England, Scotland and Wales) or Northern Ireland. 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. CDL Disqualifications. LEICESTER, 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. It also covers 'sunset-clause' monitoring. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Suspension lifted for Metro Pharmacy Limited. Its licence was "largely reinstated" following a re-investigation in April, says Sky. You have rejected additional cookies. RICHMOND, We publish scientific assessment reports called a Public Assessment Report (PAR) available for new marketing authorisations granted after 30 October 2005. Welcome to the MHRA Process Licensing Portal. Updated the 'When we suspend your licence' section to include reference to open public investigations. Dont include personal or financial information like your National Insurance number or credit card details. You will need to register if you havent already. . 94 RICKMANSWORTH ROAD, New version of suspended list has been uploaded. We can revoke (take away) your licence if you no longer meet our licensing criteria. This will ensure you are not charged a periodic fee for the period 1 April 2016 to 31 March 2017. 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. The agency advised healthcare professionals to immediately stop supplying the batches and to quarantine and remove all remaining stock. It will take only 2 minutes to fill in. The Process Licensing Office sits within the Inspectorate and Process Licensing Group of the Inspection, Enforcement and Standards division. 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 have any questions about submitting your application you should email ris.na@mhra.gov.uk. You can print blog posts using the keyboard shortcuts "Control P" or "Command P". 2 NEWTECH SQUARE, Updated list of suspended licences and registrations for manufacturers and wholesalers of medicines and ingredients. We publish the most up-to-date information for a medicine according to its licence history. The clarifying remark section of individual GMP and GDP certificates will indicate any exceptions. CAMBRIDGE, SR-22 Insurance Certificates. Download CSV BEESTON, Dealer Licences 2016 to October, Updated list of terminated and cancelled licences. Compare over 50 top car insurance quotes and save. The List of Terminated and Cancelled Licences has been updated. Manufacturing and Wholesale News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. 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. LE4 3EH, 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. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced the licence suspension of ingenol mebutate gel (Picato). Updated suspended manufacturing and wholesale distribution authorisations. Uploaded new Suspended manufacturing and wholesale distribution authorisations spreadsheet. HUDDERSFIELD, https://www.gov.uk/government/publications/medicines-application-forms-for-a-manufacturer-licence, https://www.gov.uk/government/publications/medicines-variation-forms-for-a-manufacturer-licence, https://www.gov.uk/government/publications/mhra-fees, https://www.gov.uk/government/publications/medicines-new-manufacturing-and-wholesale-dealer-licences, http://eudragmdp.ema.europa.eu/inspections/displayHome.do, https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-manufacturing-sites, https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-wholesale-distribution-sites, https://www.gov.uk/government/publications/register-of-brokers-authorised-to-deal-in-human-medicines, https://www.gov.uk/government/publications/suspended-licences-for-manufacturers-and-wholesalers-of-medicines, https://www.gov.uk/export-a-human-medicine, https://www.gov.uk/government/publications/medicines-terminated-and-cancelled-manufacturing-and-wholesale-dealer-licences, Supply chain security: part 1 - introduction, Round Table: The impact of Electronic Health Records on UK Clinical Trials, Manufacture of Investigational Medicinal Products Frequently Asked Questions, MHRA Process for approving Manufacturing Authorisations or API Registrations in relation to unlicensed Cannabis-Based Products for Medicinal Use, Innovation, Quality & Transparency a Compliance Team 1 Perspective, licences for the manufacture/importation of licensed medicinal products for human use, commonly abbreviated to MIA, 'specials' licences for the manufacture/importation of unlicensed medicinal products for human use, commonly abbreviated to MS, authorisations for the manufacture/importation of investigational medicinal products for human use, commonly abbreviated to MIA(IMP), authorisations for the manufacture/importation of licensed medicinal products for veterinary use (ManA), 'specials' licences for the manufacture of unlicensed medicinal products for veterinary use, (ManSA), manufacturer's licences for exempt advanced therapy medicinal products (MeAT), licences for the wholesale distribution of medicinal products for human use, commonly abbreviated to WDA (H) (including those covering unlicensed medicines obtained from another EEA member state), licences for the wholesale distribution/importation of medicinal products for veterinary use - WDA (V), active substance manufacturer, importer or distributor registrations, certificates of Good Manufacturing Practice (GMP), certificates of Good Distribution Practice (GDP), new applications typically take 90 working days to process, variations where no inspection is required: 30 working days - variations where an inspection is required: 90 working days, new applications for registration as Active Substance manufacturers, importers and distributors take 60 working days - if an inspection is required: 90 working days. UNIT 191, CAMBRIDGE SCIENCE PARK, MIDLAND MILL, Link to companies GMP and GDP certificates, see EUDRAGMDP link above. 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". 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. You must do so within 21 days of the suspension coming into effect. UNITED KINGDOM, CONSILIENT HEALTH (UK) LIMITED, Common: Headache, dizziness. Updated the list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. Suspended manufacturing and wholesale distribution authorisations list updated. Dont worry we wont send you spam or share your email address with anyone. An example of when we might do this is if you are under police. We updated the list of suspended manufacturing and wholesale distribution authorisations. Penalty fees may be incurred for non-payment. Sara Berry 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 . Updated the list of cancelled and revoked licenses, Updated list of terminated, cancelled and revoked licenses, Updated list of terminated, cancelled and revoked manufacturing and wholesaler dealer licences, Updated list of terminated, cancelled and revoked manufacturing and wholesale dealer licences. 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). To help us improve GOV.UK, wed like to know more about your visit today. Updated list of suspended licences for manufacturers and wholesalers of medicines. An updated list of suspended licenses has been uploaded. Melatonin 4mg/5ml oral suspension STD, SF, LF, AF, NSF 150ml 20620 8 Menadiol 5mg/5ml oral suspension STD, SF, LF, CF . This means that you can still work during your appeal, unless we have also suspended your licence. Published new list of Suspended manufacturing and wholesale distribution authorisations. You should submit your application using the electronic Common Technical Document (eCTD). It can also be checked on the following register: The absence of a GMP certificate should not be understood as meaning that the active substance manufacturer in question does not comply with GMP. Updated 'Suspended manufacturing and wholesale distribution authorisations' link. We find an easy way to remember is to set a recurrent reminder in your Outlook calendar or Gmail diary. You have rejected additional cookies. Reinstating Your License. Submit the relevant forms above to MHRA via the MHRA portal if youre a UK applicant. 1999 - 2023 DMV.ORG. If your organisation operates a PO system, please make sure that the relevant PO is provided to the MHRA before the invoice is issued. Occupational Licenses. Added updated list of suspended manufacturing and wholesale distribution authorisations. You have accepted additional cookies. 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.