Updated suspended manufacturing and wholesale distribution authorisations. 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. Added a link to the User Guide for the electronic application form. Alpha Release This is a new service - your feedback will help improve it. The list of suspensions and revocations is updated on the same day that the suspension or revocation takes place. Updated list of suspended licenses added to the page. Updated list of terminated and cancelled manufacturing and wholesale dealer licences up to May 2019 added to the page. mhra licence suspensionhow to calculate solow residual mhra licence suspension. . dealer licences. Added updated list of suspended manufacturing and wholesale distribution authorisations. HUDDERSFIELD, 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. 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. Submit the relevant forms above to MHRA via the MHRA portal if youre a UK applicant. Dont worry we wont send you spam or share your email address with anyone. The information published in this Register was that held by the MHRA on the date of publication. The Process Licensing Office sits within the Inspectorate and Process Licensing Group of the Inspection, Enforcement and Standards division. PL 04425/0697 . Cancellation of a licence, authorisation or registration is when MHRA makes a decision to cancel the licence, authorisation or registration. Reinstating Your License. The MHRA announces recall of paracetamol tablets, after certain products were found to be discoloured due to the presence of fungi. An example of when we might do this is if you are under police investigation for a serious offence. 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. You can change your cookie settings at any time. Updated: list of terminated and cancelled manufacturing and wholesale dealer licences. You can print blog posts using the keyboard shortcuts "Control P" or "Command P". 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. CAMBRIDGE, New version of document has been uploaded. Marketing. Dont worry we wont send you spam or share your email address with anyone. Phase 4 studies. Report a side effect with a medicine or medical device. This will ensure you are not charged a periodic fee for the period 1 April 2016 to 31 March 2017. Please note that companies are not required to make payment on submission of both initial and variation application for all wholesale dealer and manufacturing licences invoices are sent via email once the companys application has been processed by the process licensing team. MHRA's primary role is to protect public health and the IAG process forms a regulatory tool to manage this. This file may not be suitable for users of assistive technology. 9-11 HILLHOUSE LANE, NISA RETAIL LIMITED. Updated list of suspended manufacturing and wholesale distribution authorisations added to the page. The use of POs is an internal control process and cannot be used as a reason to withhold payment of legitimate invoices. Published updated list of Suspended manufacturing and wholesale distribution authorisations. You can also tell us about any factual errors that may have affected our decision. BUILDING 4, Converse Pharma distributes a range of generic drugs, including flu vaccines, employing close to 1,000 people at 11 sites across the country. 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. We also use cookies set by other sites to help us deliver content from their services. The lenders have hired PricewaterhouseCoopers to advise them, according to one insider. Compare over 50 top car insurance quotes and save. 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). Updated: list of suspended manufacturing and wholesale distribution authorisations, Updated: list of revoked manufacturing and wholesale distribution authorisations. You have rejected additional cookies. 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 have updated the list of suspended and revoked licenses and registrations, updated Suspended manufacturing and wholesale distribution authorisations, New version of Suspended manufacturing and wholesale distribution authorisations list has been uploded. If you use assistive technology (such as a screen reader) and need a 1 REDWOOD AVENUE, Is there any portal where we can check the list of MIA holders? This means that you can still work during your appeal, unless we have also suspended your licence. Updated file 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. You can read our guidance about the submission of ASMFs. The revelation of investment talks follows a challenging period during which the DE Group had its licence suspended by the MHRA for multiple breaches of its terms. 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. 94 RICKMANSWORTH ROAD, Uploaded new Suspended manufacturing and wholesale distribution authorisations list. ASMFs holders must submit their dossier to the MHRA. 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 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. Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission. the mentholatum company limited, 1 redwood avenue, peel park campus, east kilbride, glasgow, g74 5pe, united kingdom 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. If a submission is rejected, we will email you the reasons for the rejection. Alpha Release This is a new service - your feedback will help improve it. 1 MEER END, updated suspended and revoked lists added to the page. 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. Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences' link to latest January 2021 version. Comment by Certificates of Suitability (CEPs) continue to be acceptable in support of UK and GB national authorisations.. UNITED KINGDOM, DENDRON BRANDS LIMITED, There is no additional fee for fast-tracking applications. 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. 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). 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. Our legal power to do this is explained in Get Licensed (PDF, 3.03 MB, 90 pages). Department of Health and Social Care (DHSC) has issued a medicine supply notification for Ranitidine (all formulations) . NOTTINGHAM, Following recent advice from the EMA, the MHRA have suspended all licenses for ranitidine products. MHRA alerts & recalls PharmData maintains a list of all MHRA alerts and recalls relevant to community pharmacy. 09/02/2023. 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. 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. Fees vary depending on the type and route of application. You can find out more about how to pay your fees in our guidance on making a payment to MHRA. Updated 'Suspended manufacturing and wholesale distribution authorisations' list, Updated 'Revoked manufacturing and wholesale distribution authorisations' list. We use some essential cookies to make this website work. WATFORD, The List of Terminated, Revoked and Cancelled Licences has been updated. The Licence Number is a specific number allocated to one company. Common: Headache, dizziness. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Updated both 'revoked' and 'Suspended' manufacturing and wholesale distribution authorisations lists. Published 4 February 2015 Last updated 5 January. 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). Published updated 'Suspended manufacturing and wholesale distribution authorisations' spreadsheet. UNIT 191, CAMBRIDGE SCIENCE PARK, A drug distributor which had its licence suspended earlier this year by Britain's medicines watchdog has hired City advisers to raise tens of millions of pounds of new funding. Updated list of medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences for February. Updated list of suspended licences and registrations for manufacturers and wholesalers of medicines and ingredients. Ilyas ali The attorneys at The Davis Law Group, P.C. Suspended Driver's License. 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 Terminated and cancelled manufacturing and wholesale dealer licences for January through to February 2016. 1999 - 2023 DMV.ORG. Join 1,972,984 Americans who searched for Car Insurance Rates: Please enter your ZIP Code to access Suspended License specific to your state: 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). CB4 0GW, Suspended list updated to show licenses that have been terminated/revoked and therefore no longer suspended. List of suspended manufacturing and wholesale distribution authorisations updated. You should submit your application using the electronic Common Technical Document (eCTD). Updated ist of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked. You can find out more in our naming of medicines guidance (PDF, 235 KB, 20 pages). WD18 7JJ, Since inspections of manufacturers of active substances are based on risk, some active substance manufacturers may not be in possession of a GMP certificate. This includes information of a commercially sensitive or personal nature, that may need to be restricted in the interests of security. New list of suspended licenses added to the page. Please note, this includes changes to MHRA Guidance Note 6 1. We updated the list of suspended manufacturing and wholesale distribution authorisations. 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. It will take only 2 minutes to fill in. Published Medicines: terminated and cancelled manufacturing and wholesale dealer licences for August 2019. UNITED KINGDOM, THE MENTHOLATUM COMPANY LIMITED, View online New list of suspended manufacturing and wholesale distribution authorisations added to the page. Subscribe to stay in the loop & on the road! It will take only 2 minutes to fill in. latest Suspended manufacturing and wholesale distribution authorisations, Updated Suspended manufacturing and wholesale distribution authorisations, Updated suspended manufacturing and wholesale distribution authorisations. Accumulating too many driving record points. Updated list of terminated, revoked and cancelled licences. 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: 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. have helped thousands of drivers regain their driving privileges after cancellation, suspension or revocation. You should also use this form if you want to withdraw a variation application or amendment for an existing MA. MIDLAND MILL, List of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. The MHRA products website allows you to find: You can look for any word, phrase or Product Licence number (PL) using the search tool. Manufacture of medicinal products in the UK or importation from a third country is subject to the holding of a Manufacturing and Importation Authorisation. You should also use our eAF and cover letter tool to determine what information you need to include in your application. Published updated versions of the Revoked manufacturing and wholesale distribution authorisations list and the Suspended manufacturing and wholesale distribution authorisations list. Published updated Revoked manufacturing and wholesale distribution authorisations list. You have accepted additional cookies. Published new list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. Updated the 'When we suspend your licence' section to include reference to open public investigations. 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. New document added to page for September 2017. Maalox 175mg/200mg Oral Suspension . WELBECK PHARMACEUTICALS & HOSPITAL SUPPLIES LIMITED , 35 DEVONSHIRE STREET, LONDON, W1G 6PZ, UNITED KINGDOM. HD1 6EF, Full Service We develop, source and fill an extensive range of packaging types to suit product function, brand design and especially consumer driven needs, which we monitor with our non-stop trends service. If we suspend your licence, the suspension comes into effect immediately. The Medicines and Healthcare products Regulatory Agency (MHRA) The MHRA looks at new drugs when pharmaceutical companies want to license medicines outside of the EMA's centralised authorisation procedure. posted on To help us improve GOV.UK, wed like to know more about your visit today. Published new suspended manufacturing and wholesale distribution authorisations list. TRIDENT PLACE, MOSQUITO WAY, BIRSTALL, Levothyroxine 100 mcg tablets in Numark packaging are the same product as the Teva branded version and are also affected by suspension of the license. UNITED KINGDOM, VIATRIS UK HEALTHCARE LIMITED, UNITED KINGDOM, BARD PHARMACEUTICALS LIMITED, The list of suspended manufacturing and wholesale distribution authorisations has been updated. Updated Suspended manufacturing and wholesale distribution authorisations CSV file. 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 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 lists of suspended and revoked licences. Proposed suspension, variation . 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. You have rejected additional cookies. 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). Updated both attachments with newer files. On the other hand, in Florida, earning 12 points on your license within a year will get your license suspended for 30 days. The Agency has the power to withdraw a product from the market, and in the case of medicines, to suspend production. 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. Download CSV 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 MHRA Submissions , you should email submissions@mhra.gov.uk. Welcome to the MHRA Process Licensing Portal. The MHRA has been assured that acceptable standards of Good Manufacturing Practice are in place for . All other specific services or enquiries contact can be found via the following link: https://www.gov.uk/guidance/contact-mhra#contents, Medicines and Healthcare products Regulatory Agency, Inspection, Enforcement & Standards Division Inspectorate and Process licensing, 10 South Colonnade, Canary Wharf, London E14 4PU, Dont miss the next post, sign up to be notified by email when a new post comes out, Comment by Or if you need to cancel a parallel import product licence, complete the cancellation form (PDF, 525 KB, 3 pages). When autocomplete results are available use up and down arrows to review and enter to select. We use some essential cookies to make this website work. 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. On-site inspections will resume as soon as travel restrictions permit. Since inspections of manufacturers of active substances are based on risk,. The absence of a GMP certificate should not be understood as meaning that the active substance manufacturer in question does not comply with GMP. We use some essential cookies to make this website work. Updated suspension list added to the page. Any submission that does not meet the requirements will be rejected. 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. July update to Terminated, Revoked, Cancelled licences file. 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 . UK Licence No: PL 04425/0697 . The current Visit the European Medicines Agency website for more information on the European requirements for cancellations or email the MHRA for UK requirements. DEESIDE INDUSTRIAL PARK, 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. If you have any questions about submitting your application you should email ris.na@mhra.gov.uk. An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees. Dont worry we wont send you spam or share your email address with anyone. Uploaded new version of Suspended and revoked licences list. This does not replace your right of appeal through the courts. All UK and Great Britain (England, Scotland and Wales) national applications should be submitted through the MHRA Submissions Portal. It will take only 2 minutes to fill in. The licence of DE Group's Testerworld unit is understood to have been largely reinstated in April following re-inspections by the agency. Updated the terminated and cancelled manufacturing and wholesale dealer licences list. Updated contact information for Department of Health for advice when seeking to fast-track an application due to a shortage of supply of essential medicines. BUILDING 20, STATION CLOSE, We also use cookies set by other sites to help us deliver content from their services. An example of when we might do this is if you are convicted of a relevant criminal offence. We find an easy way to remember is to set a recurrent reminder in your Outlook calendar or Gmail diary. mhra licence suspension mhra licence suspension vo 9 Thng Su, 2022 vo 9 Thng Su, 2022 If you respond to our letter we will take what you tell us into consideration. This information is common to all procedures. 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. Replaced the PDF with a more accessible file. 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. . RICHMOND, Link to companies GMP and GDP certificates, see EUDRAGMDP link above. TW9 2QE, Uploaded new Suspended manufacturing and Revoked spreadsheets. If you do not use this template your submission will be rejected. either alone or jointly. It is an additional route of appeal that we offer so that you can appeal in a way that does not incur court costs. (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.