UNITED KINGDOM, MYONEX LIMITED, You have accepted additional cookies. Updated list of medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences for February. You can also submit the forms via the Central European System Platform (CESP). 29.3 KB. NOTTINGHAM, Syri Limited suspension has been lifted. Updated: list of terminated and cancelled manufacturing and wholesale 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. This does not replace your right of appeal through the courts. ALR Program. Also is there any process to verify that MIA licence is still valid? 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'. We also use cookies set by other sites to help us deliver content from their services. You can use the A-Z list to find an active substance, or search for a medicine. Common: Headache, dizziness. Suspended Driver's License. LEICESTER, BIRSTALL, You have accepted additional cookies. New version of Revocation list has been uploaded. Healthcare. In April 2018, C+D reported that the suspension had been extended due to remaining "non-compliance issues". Well send you a link to a feedback form. Link to companies GMP and GDP certificates, see EUDRAGMDP link above. The suspension of the license will last until "Teva has completed its investigation and resolved the underlying issues ", the MHRA wrote. The lenders have hired PricewaterhouseCoopers to advise them, according to one insider. You can get a suspended license for reasons including: If you have a suspended drivers license, your state will likely require you to: Our suspended license pages for your state will help you: Click your state below for suspended license and reinstatement requirements at your states DMV, SOS, DOR, or MVD. Occupational Licenses. Any questions on the content of this database should be addressed to IE&S-IMT@mhra.gov.uk. View online latest Suspended manufacturing and wholesale distribution authorisations, Updated Suspended manufacturing and wholesale distribution authorisations, Updated suspended manufacturing and wholesale distribution authorisations. Uploaded new Suspended manufacturing and wholesale distribution authorisations list. Published updated list of Suspended manufacturing and wholesale distribution authorisations. 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. All Rights Reserved. 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. This blog shares the work of the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate, by inspectors and those the Inspectorate works with. Published new suspended manufacturing and wholesale distribution authorisations list. UNITED KINGDOM, THE MENTHOLATUM COMPANY LIMITED, Your licence remains live during a court appeal. CB4 0GW, You can change your cookie settings at any time. Comment by Once your application has been validated you will receive an invoice so that you can make a payment for the outstanding amount. Name and address of the site: NISA RETAIL LIMITED , BLOOM LANE, NORMANBY ENTERPRISE PARK, SCUNTHORPE, DN15 9YA, UNITED KINGDOM. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Submit the relevant forms above to MHRA via the MHRA portal if youre a UK applicant. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. 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. IAG are non-statutory multi-disciplinary groups which advise MHRA's Director of IE&S on recommendations for regulatory action. TRIDENT PLACE, MOSQUITO WAY, NISA RETAIL LIMITED. Copy CSV Excel PDF Print Showing 1 to 10 of 325 entries Previous 1 2 3 4 5 33 Next New version of the revocation and suspension lists has been uploaded. 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. WELBECK PHARMACEUTICALS & HOSPITAL SUPPLIES LIMITED , 35 DEVONSHIRE STREET, LONDON, W1G 6PZ, UNITED KINGDOM. Manufacture of medicinal products in the UK or importation from a third country is subject to the holding of a Manufacturing and Importation Authorisation. 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. 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. If you do not respond to our letter we will revoke your licence automatically after 21 days. You can find out more about the fees we charge in the guidance MHRA fees. To help us improve GOV.UK, wed like to know more about your visit today. 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. RICHMOND, 09/02/2023. 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). Updated list of suspended licenses added to the page. Updated list of suspended licences and registrations for manufacturers and wholesalers of medicines and ingredients. List of revoked manufacturing sites updated. All invoices must be settled upon receipt. D ate of . 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. You must do so within 21 days of the suspension coming into effect. 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. 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 . Published updated version of Suspended manufacturing and wholesale distribution authorisations list. Updated the terminated and cancelled manufacturing and wholesale dealer licences for September 2021. 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. 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. Accumulating too many driving record points. You can change your cookie settings at any time. Compare over 50 top car insurance quotes and save. An example of when we might do this is if you are under police. ; Getting multiple traffic violations or speeding tickets. Certificates of Suitability (CEPs) continue to be acceptable in support of UK and GB national authorisations.. 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. We can revoke (take away) your licence if you no longer meet our licensing criteria. Added links to pages providing further information on some of the procedures. 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. Maalox oral suspension - Magnesium hydroxide; Aluminium hydroxide gel dried Magnesium hydroxide; . It will take only 2 minutes to fill in. Its licence was "largely reinstated" following a re-investigation in April, says Sky. Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. Pay Restoration Fee Provide proof of payment of outstanding fines/tickets Parking Violations How to Pay Parking Tickets Marketing. Dont include personal or financial information like your National Insurance number or credit card details. 2. . This file may not be suitable for users of assistive technology. updated Suspended and revoked licences for manufacturers and wholesalers of medicines, list of suspended manufacturing and wholesale distribution authorisations updated. MHRA reserves the right. 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. MHRA considers each application for a product name to ensure that the proposed name will allow the medicine to be taken safely and correctly. DEESIDE, The Medicines and Healthcare products Regulatory Agency (MHRA) first issued a partial suspension of the manufacturer's licence in August 2017, after it "identified non-compliance with good manufacturing practice" during an inspection of its Luton site in July.. https://mhrainspectorate.blog.gov.uk/2019/10/04/mhra-process-licensing-useful-information/. MHRA Suspended Licence checks are a critical part of your Quality Management System and Risk Management processes, so keep on top of them. 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. UK Licence No: PL 04425/0697 . 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. updated suspended and revoked lists added to the page. Updated lists of suspended and revoked licenses. All UK and Great Britain (England, Scotland and Wales) national applications should be submitted through the MHRA Submissions Portal. SR-22 Insurance Certificates. Published updated list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. The List of Terminated and Cancelled Licences has been updated. It is an additional route of appeal that we offer so that you can appeal in a way that does not incur court costs. We will also tell you what you can do that might stop us from revoking your licence. For example, in Kentucky, it takes an accumulation of 12 points over the course of 2 years in order to receive a suspension. 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. Dont worry we wont send you spam or share your email address with anyone. We may still revoke your licence. Our legal power to do this is explained in Get Licensed (PDF, 3.03 MB, 90 pages). The MHRA announces recall of paracetamol tablets, after certain products were found to be discoloured due to the presence of fungi. Dont include personal or financial information like your National Insurance number or credit card details. Updated list of terminated and cancelled manufacturing and wholesale The use of POs is an internal control process and cannot be used as a reason to withhold payment of legitimate invoices. LICENCE TYPE MA Manufacture and Assembly . Read More Contract Manufacture The Site Number is a specific number allocated to one site. 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. These can then be investigated further to decide whether a side effect is truly from a . Proposed suspension, variation . The lists of suspensions and revocations have been updated. List of suspended manufacturing and wholesale distribution authorisations updated. The Process Licensing Office sits within the Inspectorate and Process Licensing Group of the Inspection, Enforcement and Standards division. 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 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. Updated file 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. You must then resend the entire submission with the errors corrected. Replaced suspended list document with new updated version (suspended_list040518.csv), New list of suspended manufacturers and wholesalers, Updated list of suspended licences for manufacturers and wholesalers of medicines. Report a side effect with a medicine or medical device. Published updated Revoked manufacturing and wholesale distribution authorisations list. Alpha Release This is a new service - your feedback will help improve it. To help us improve GOV.UK, wed like to know more about your visit today. 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 the 'When we suspend your licence' section to include reference to open public investigations. Very rare: Agitation, confusion, tremor, ataxia, dysarthria, hallucinations, psychotic symptoms, convulsions, somnolence, encephalopathy, coma. Penalty fees may be incurred for non-payment. Drug wholesaler hit by MHRA suspension hires advisers to find funding injection, Converse Pharma distributes a range of generic drugs. We aim to respond to queries within 18 working days, however, where expert advice is required from other parties this may take longer. The clarifying remark section of individual GMP and GDP certificates will indicate any exceptions. 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 09 October 2019. 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. The list of suspended manufacturing and wholesale distribution authorisations has been updated. ASMFs holders must submit their dossier to the MHRA. BUILDING 4, 3.85 KB, View online This information is common to all procedures. the mentholatum company limited, 1 redwood avenue, peel park campus, east kilbride, glasgow, g74 5pe, united kingdom An example of when we might do this is if you are under police investigation for a serious offence. Do not send the corrected deficiencies by email. Published new list of Suspended manufacturing and wholesale distribution authorisations. Or if you need to cancel a parallel import product licence, complete the cancellation form (PDF, 525 KB, 3 pages). Added list of terminated and cancelled licences for April 2019. You can change your cookie settings at any time. Healthcare products Regulatory Agency (MHRA) inspectorate as soon as possible. You can change your cookie settings at any time. 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 . Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. 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. NG90 2PR, Updated list of suspended and revoked licences for manufacturers and wholesalers of medicines. 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. 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 appeal our decision to suspend your licence in a Magistrates or Sheriff Court. 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/. You have rejected additional cookies. BEESTON, Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences' attachment to latest version. The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated to include May 2015. Converse Pharma distributes a range of generic drugs, including flu vaccines, employing close to 1,000 people at 11 sites across the country. Dont worry we wont send you spam or share your email address with anyone. 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). Or if you need to cancel a parallel import product. 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). We use some essential cookies to make this website work. What the data show Since September 2020, 15 Companies were affected.