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. On-site inspections will resume as soon as travel restrictions permit. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. We can suspend your licence for one or both of the following reasons: For example, we will suspend your licence if: Examples of what we mean by serious relevant offence are: terrorism, murder, manslaughter, rape, assault occasioning bodily harm (actual or grievous), battery, kidnapping, possession of indecent photographs of children, restriction of production and supply of controlled drugs. You should submit your application using the electronic Common Technical Document (eCTD). The information published in this Register was that held by the MHRA on the date of publication. Please ensure that you limit bulk cancellations to a maximum of 10 product licenses showing per application form. We can revoke (take away) your licence if you no longer meet our licensing criteria. 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. 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 . LE4 3EH, News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Updated list of suspended manufacturing and wholesale distribution authorisations. You can also use the A-Z list to find the active substance. UNITED KINGDOM, MYONEX LIMITED, July update to Terminated, Revoked, Cancelled licences file. Added new list of terminated and cancelled manufacturing and wholesale dealer licences. You have accepted additional cookies. To help us improve GOV.UK, wed like to know more about your visit today. This includes information of a commercially sensitive or personal nature, that may need to be restricted in the interests of security. You have accepted additional cookies. Updated 'Suspended manufacturing and wholesale distribution authorisations' link. Uploaded new Suspended manufacturing and wholesale distribution authorisations spreadsheet. London, UK, 23 December 2021 Today Novartis announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved the marketing authorisation to extend the licence in Great Britain for Piqray (alpelisib) for use in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor You should also use our eAF and cover letter tool to determine what information you need to include in your application. The lists of suspensions and revocations have been updated. Failure to Appear. Phase 4 studies. PEEL PARK CAMPUS, EAST KILBRIDE, We use some essential cookies to make this website work. You can appeal our decision to suspend your licence in a Magistrates or Sheriff Court. Added spreadsheet under "types of application" heading. Download CSV Some information may have been excluded from public view. This is based on the MHRA assessment report with any commercially or personally confidential information removed. Submit the relevant forms above to MHRA via the MHRA portal if youre a UK applicant. HUDDERSFIELD, Updated list of suspended licences and registrations for manufacturers and wholesalers of medicines and ingredients. Updated list of suspensions. Maalox oral suspension - Magnesium hydroxide; Aluminium hydroxide gel dried Magnesium hydroxide; . Accumulating too many driving record points. 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. 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. 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. Since inspections of manufacturers of active substances are based on risk, some active substance manufacturers may not be in possession of a GMP certificate. If your application for these types of licences is pending and you no longer wish to proceed, you need to withdraw it. 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. CAMBRIDGE, The Licence Number is a specific number allocated to one company. City sources said the company, which was formed from a management buyout in 2013, was in talks with its lenders at the state-backed NatWest Group and Secure Trust Bank about the process. Occupational Licenses. 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. We may lift the suspension if you are found not guilty or the charges are dropped. . To help us improve GOV.UK, wed like to know more about your visit today. The use of POs is an internal control process and cannot be used as a reason to withhold payment of legitimate invoices. If you have any questions about the Submissions Portal, you should email submissions@mhra.gov.uk. Alpha Release This is a new service - your feedback will help improve it. 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. Actavis, Forley Generics, and Goldshield Group also . We find an easy way to remember is to set a recurrent reminder in your Outlook calendar or Gmail diary. We updated the list of suspended manufacturing and wholesale distribution authorisations. 9-11 HILLHOUSE LANE, We look forward to hearing from you to discuss your case. Updated 'Suspended manufacturing and wholesale distribution authorisations' list, Updated 'Revoked manufacturing and wholesale distribution authorisations' list. Report a side effect with a medicine or medical device. Please note, this includes changes to MHRA Guidance Note 6 1. Replaced the PDF with a more accessible file. 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. 3.85 KB, View online 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. 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. Cancellation of a licence, authorisation or registration is when MHRA makes a decision to cancel the licence, authorisation or registration. Dont worry we wont send you spam or share your email address with anyone. Converse Pharma distributes a range of generic drugs, including flu vaccines, employing close to 1,000 people at 11 sites across the country. Truancy. Details of the penalties are explained in ourFees Regulations. For example, in Kentucky, it takes an accumulation of 12 points over the course of 2 years in order to receive a suspension. varied or suspended by the Medicines and Healthcare products Regulatory Agency (MHRA). https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-manufacturing-sites. https://mhrainspectorate.blog.gov.uk/2019/10/04/mhra-process-licensing-useful-information/. Uploaded updated Suspended manufacturing and wholesale distribution authorisations list. These can then be investigated further to decide whether a side effect is truly from a . 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. This information is common to all procedures. 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). Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. New version of Revocation list has been uploaded. Our letter will also tell you how to appeal against our decision. 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. And it ensures the safety and effectiveness of medicines in the UK. List of terminated and cancelled manufacturers and wholesale dealers licenses updates. Aventis Pharma Limited . Added August file for - Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences. Syri Limited suspension has been lifted. You can print blog posts using the keyboard shortcuts "Control P" or "Command P". 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. Certificates of Suitability (CEPs) continue to be acceptable in support of UK and GB national authorisations.. REACTA BIOTECH LIMITED T/A REACTA HEALTHCARE, MIDLAND MILL, Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences' link to latest January 2021 version. The attorneys at The Davis Law Group, P.C. If a submission is rejected, we will email you the reasons for the rejection. There is no additional fee for fast-tracking applications. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. It will take only 2 minutes to fill in. 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). 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. Updated both 'revoked' and 'Suspended' manufacturing and wholesale distribution authorisations lists. You must do so within 21 days of the revocation coming into effect. Any questions on the content of this database should be addressed to IE&S-IMT@mhra.gov.uk. 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. Publish list of terminated and cancelled licenses from July 2017 to June 2018. 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. ASMFs holders must submit their dossier to the MHRA. CH5 2NT, Updated attachment - March to Feb 2019 edition, Updated list of terminated and cancelled manufacturing and wholesale dealer licences. updated suspended and revoked lists added to the page. Reinstating Your License. Common: Headache, dizziness. 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. UK Licence No: PL 04425/0697 . Updated the terminated and cancelled manufacturing and wholesale dealer licences list. If we intend to revoke or suspend your licence we will write to you to tell you why. New version of document has been uploaded. Wholesale dealer licences/API/broker licences: GDP.Inspectorate@mhra.gov.uk, Manufacturing licences: gmpinspectorate@mhra.gov.uk. 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. 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 . 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. 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. Please note the site register will be updated on a quarterly basis. Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission. Use the pre-submission checklist (PDF, 129 KB, 7 pages) to help you with your application. Updated the 'When we suspend your licence' section to include reference to open public investigations. We publish scientific assessment reports called a Public Assessment Report (PAR) available for new marketing authorisations granted after 30 October 2005. Updated list of suspended licences added to the page. Name and address of the site: NISA RETAIL LIMITED , BLOOM LANE, NORMANBY ENTERPRISE PARK, SCUNTHORPE, DN15 9YA, UNITED KINGDOM. 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). Updated: list of terminated and cancelled manufacturing and wholesale dealer licences. Updated document - Suspended manufacturing and wholesale distribution authorisations. Updated suspension list added to the page. WELBECK PHARMACEUTICALS & HOSPITAL SUPPLIES LIMITED , 35 DEVONSHIRE STREET, LONDON, W1G 6PZ, UNITED KINGDOM. MHRA alerts & recalls PharmData maintains a list of all MHRA alerts and recalls relevant to community pharmacy. 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. 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. Terminated and cancelled manufacturing and wholesale dealer licences for January through to February 2016. Updated list of terminated and cancelled manufacturing and wholesale You must cancel your marketing authorisation or other licence by 31 December if you want it to be cancelled by 31 March 2016. Once your application has been validated you will receive an invoice so that you can make a payment for the outstanding amount. This does not replace your right of appeal through the courts. Following recent advice from the EMA, the MHRA have suspended all licenses for ranitidine products. Co-Amoxiclav DST Grunenthal 300/42.75mg Granules for Oral Suspension; Co-Amoxiclav DST Grunenthal 400/57mg Granules for Oral Suspension; Co-amoxiclav for Injection 1000/20mg; Co-amoxiclav for Injection 500/100mg; Co-Amoxiclav Injection 500/100; Co-Amoxiclav Oral Suspension 125mg/31.25mg/5ml Amoxi-Co 125/31 Andrew Bailey says 'nothing is decided' suggesting interest rates may rise less than thought We recommend that you use a validation tool to check your submission as we Updated: list of revoked manufacturing and wholesale distribution authorisations. The list of suspended licences has been updated. 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. It also covers 'sunset-clause' monitoring. EnteroBiotix secures key additional MHRA license and announces regulatory milestones. Depending on the state you live in, you may incur a suspension for a different amount of points. Dealer Licences 2016 to October, Updated list of terminated and cancelled licences. 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: . 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. Published updated Revoked manufacturing and wholesale distribution authorisations list. Updated revoked and suspended documents on the page. Published new version of the suspended manufacturing and wholesale distribution authorisations list. ALR Program. 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. 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. Maalox 175mg/200mg Oral Suspension . 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. You have accepted additional cookies. Fees vary depending on the type and route of application. Energy bill support to be extended as price rise looms, Arm snubs London to float on the New York Stock Exchange despite PM's efforts but announces new Bristol site, Body blow for Downing Street and govt promise to turn UK into 'new Silicon Valley'. Refusal of licence / variation or an existing licence being revoked. 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. If we suspend your licence, the suspension comes into effect immediately. DEESIDE, Termination of a licence, authorisation or registration takes place at the request of the holder of the licence, authorisation or registrant, for example, the business decides they no longer wish to perform an activity that requires a licence, authorisation or registration. 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. Get free quotes from the nation's biggest auto insurance providers. 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. 1999 - 2023 DMV.ORG. 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 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. Since inspections of manufacturers of active substances are based on risk,. UNITED KINGDOM, VIATRIS UK HEALTHCARE LIMITED, Dont include personal or financial information like your National Insurance number or credit card details. 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? Suspension lifted for Metro Pharmacy Limited. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Published updated versions of the Revoked manufacturing and wholesale distribution authorisations list and the Suspended manufacturing and wholesale distribution authorisations list. The MHRA announces recall of paracetamol tablets, after certain products were found to be discoloured due to the presence of fungi. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Yesterday MHRA released an update on suspended manufacturing and wholesale distribution authorization. Anyone in the pharmaceutical or medicinal supply chain should use this list to ensure they are dealing with a valid licence or authorisation holder. LEICESTER, 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. New list of terminated licenses, August 2016 to July 2017 added to the page. 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. In August 2018, EnteroBiotix announced that the company had been awarded a manufacturer's specials license . 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. Read More Contract Manufacture UNITED KINGDOM, BARD PHARMACEUTICALS LIMITED, If you do not use this template your submission will be rejected. 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. Healthcare products Regulatory Agency (MHRA) inspectorate as soon as possible. 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. An example of when we might do this is if you are under police. To help us improve GOV.UK, wed like to know more about your visit today. Suspended Driver's License. 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). Dont worry we wont send you spam or share your email address with anyone. Compare over 50 top car insurance quotes and save. We also use cookies set by other sites to help us deliver content from their services. Updated list of suspended licenses added to the page. This portal allows registered users to submit WDA (H) Wholesale Distribution Authorisation applications and variations API Active Pharmaceutical. Suspended list updated to show licenses that have been terminated/revoked and therefore no longer suspended. Submission of a new ASMF and any update to an ASMF should be made by the ASMF holder using MHRA Submissions . Updated the suspended manufacturing and wholesale distribution authorisations list.
What Did Woody Harrelson Do To His Daughter,
Square D Catalog Number Lookup,
Articles M
mhra licence suspension