Common: Headache, dizziness. We use some essential cookies to make this website work. You can find out more in our naming of medicines guidance (PDF, 235 KB, 20 pages). latest Suspended manufacturing and wholesale distribution authorisations, Updated Suspended manufacturing and wholesale distribution authorisations, Updated suspended manufacturing and wholesale distribution authorisations. 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. Added new list of terminated and cancelled manufacturing and wholesale dealer licences. The MHRA announces recall of paracetamol tablets, after certain products were found to be discoloured due to the presence of fungi. Post-license. 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. 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. Updated the list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. July update to Terminated, Revoked, Cancelled licences file. You can change your cookie settings at any time. CH5 2NT, 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: . 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. Uploaded new Suspended manufacturing and wholesale distribution authorisations list. An example of when we might do this is if you are under police investigation for a serious offence. 09/02/2023. @MarkKleinmanSky. Updated list of suspended licenses added to the page. EnteroBiotix secures key additional MHRA license and announces regulatory milestones. 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. To help us improve GOV.UK, wed like to know more about your visit today. In this situation the licence holder who is performing the testing and acts as the contract acceptor should be named as a contract laboratory on the contract giver's licence. To help us improve GOV.UK, wed like to know more about your visit today. 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 have accepted additional cookies. The current Removed link to Excel spreadsheet list of products. mhra licence suspension mhra licence suspension vo 9 Thng Su, 2022 vo 9 Thng Su, 2022 BIRSTALL, On the other hand, in Florida, earning 12 points on your license within a year will get your license suspended for 30 days. You can appeal our decision to suspend your licence in a Magistrates or Sheriff Court. The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated. Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences' link to latest January 2021 version. The List of Terminated, Revoked and Cancelled Licences has been updated. It will take only 2 minutes to fill in. If your application for these types of licences is pending and you no longer wish to proceed, you need to withdraw it. In total, it sells more than 6,000 products to 4,000 customers, the bulk of which are community pharmacies, giving the company an important role in UK healthcare provision. 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. 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. Updated suspension list for manufacturing and wholesale distribution authorisations. Updated list of suspended licences and registrations for manufacturers and wholesalers of medicines and ingredients. 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: Depending on the state you live in, you may incur a suspension for a different amount of points. Suspended list updated to show licenses that have been terminated/revoked and therefore no longer suspended. Penalty fees may be incurred for non-payment. Updated revoked and suspended documents on the page. The MHRA has been assured that acceptable standards of Good Manufacturing Practice are in place for . You cannot legally undertake licensable activity while your licence is suspended this includes during an appeal. Welcome to the MHRA Process Licensing Portal. Updated list of companies in the UK who have had their licence to manufacture or wholesale medicines suspended. Registered users can receive instant email notifications of new alerts, and record their responses to MHRA alerts within their PharmData account. Any questions on the content of this database should be addressed to IE&S-IMT@mhra.gov.uk. 1 CHURCH ROAD, 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. Cancellation of a licence, authorisation or registration is when MHRA makes a decision to cancel the licence, authorisation or registration. MHRA's primary role is to protect public health and the IAG process forms a regulatory tool to manage this. List of terminated and cancelled manufacturers and wholesale dealers licenses updates. Melatonin 4mg/5ml oral suspension STD, SF, LF, AF, NSF 150ml 20620 8 Menadiol 5mg/5ml oral suspension STD, SF, LF, CF . Suspended vs. Revoked License: The Differences, Driving with a Suspended License: What You Need to Know. It is an additional route of appeal that we offer so that you can appeal in a way that does not incur court costs. Updated: list of revoked manufacturing and wholesale distribution authorisations. WD18 7JJ, Publish list of terminated and cancelled licenses from July 2017 to June 2018. We also use cookies set by other sites to help us deliver content from their services. 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 new version of the suspended manufacturing and wholesale distribution authorisations list. Updated lists of suspended and revoked licences. List of revoked manufacturing sites updated. Compare over 50 top car insurance quotes and save. Subscribe to stay in the loop & on the road! NOTTINGHAM, 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 Updated list of suspended licences added to the page. Revocation List updated with a new addition. Any submission that does not meet the requirements will be rejected. UNITED KINGDOM, CONSILIENT HEALTH (UK) LIMITED, Syri Limited suspension has been lifted. We updated the list of suspended manufacturing and wholesale distribution authorisations. 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. Or you can submit the forms to us by email to withdrawcancel@mhra.gov.uk. The list of suspended manufacturing and wholesale distribution authorisations has been updated. The list of suspensions and revocations is updated on the same day that the suspension or revocation takes place. Negligent failures of senior UK dermatologists, and senior MHRA doctors, are such that the MHRA should immediately suspend isotretinoin's licence for the treatment of under-18s, and introduce a substantive consent form for all other patients. Copy CSV Excel PDF Print Showing 1 to 10 of 325 entries Previous 1 2 3 4 5 33 Next UNITED KINGDOM, BARD PHARMACEUTICALS LIMITED, NISA RETAIL LIMITED. Updated the Suspended manufacturing and wholesale distribution authorisations list. PL 04425/0697 . Please note the site register will be updated on a quarterly basis. The suspension of the license will last until "Teva has completed its investigation and resolved the underlying issues ", the MHRA wrote. Well send you a link to a feedback form. The attorneys at The Davis Law Group, P.C. 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. 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. ninja foodi digital air fry oven chicken tenders. These templates should not be altered in any way, other than inserting the relevant information. Alternatively, we can maintain the suspension until we have all of the information we require to make a licensing decision. Added links to pages providing further information on some of the procedures. 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. 94 RICKMANSWORTH ROAD, Updated 'Suspended manufacturing and wholesale distribution authorisations' list, Updated 'Revoked manufacturing and wholesale distribution authorisations' list. You have rejected additional cookies. 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. AL10 9UL, EN6 1TL, 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. https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-manufacturing-sites. We will write to you when we suspend your licence, telling you what we have done and why. 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. (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. The Licence Number is a specific number allocated to one company. 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. People are at the heart of Good Distribution Practice (GDP) and the RP is the central person within a Licence Holder's operations ensuring compliance with the conditions of the licence and ensuring the quality of the medicinal products handled. Dont worry we wont send you spam or share your email address with anyone. An updated list of suspended authorisations was attached. WATFORD, It can also be checked on the following register: The Agency has the power to withdraw a product from the market, and in the case of medicines, to suspend production. 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. We also use cookies set by other sites to help us deliver content from their services. BUILDING 20, STATION CLOSE, Uploaded new version of Suspended and revoked licences list. 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. It typically deals with the manufacture, assembly and wholesale distribution of medicinal products under UK and EU legislation, these licences are often called process licences and include: The MHRA Process Licensing Portal is part of the government's Digital by Default agenda and is a web application which provides a secure environment and an easy to use platform which allows customers to submit new applications and variations to existing wholesale distribution authorisations electronically via https://pclportal.mhra.gov.uk/. Updated content to reflect that the UK cannot act as a Reference Members State (RMS) for approval of marketing authorisations in decentralised and mutual recognition licensing procedures during the transition period. Updated the terminated and cancelled manufacturing and wholesale dealer licences list. Added a link to the User Guide for the electronic application form. (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).