Added a link to the User Guide for the electronic application form. Penalty fees may be incurred for non-payment. In August 2018, EnteroBiotix announced that the company had been awarded a manufacturer's specials license . We find an easy way to remember is to set a recurrent reminder in your Outlook calendar or Gmail diary. If you use assistive technology (such as a screen reader) and need a We will also tell you what you can do that might stop us from revoking your licence. We aim to respond to queries within 18 working days, however, where expert advice is required from other parties this may take longer. Cancellation of a licence, authorisation or registration is when MHRA makes a decision to cancel the licence, authorisation or registration. Updated the list of 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. Updated 'Suspended manufacturing and wholesale distribution authorisations' list, Updated 'Revoked manufacturing and wholesale distribution authorisations' list. 1 MEER END, All Rights Reserved. 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. PEEL PARK CAMPUS, EAST KILBRIDE, You can use the A-Z list to find an active substance, or search for a medicine. Please ensure that you limit bulk cancellations to a maximum of 10 product licenses showing per application form. 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. 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. UNIT 191, CAMBRIDGE SCIENCE PARK, The suspension of the license will last until "Teva has completed its investigation and resolved the underlying issues ", the MHRA wrote. DEESIDE, Complete the cancellation form (MS Word Document, 33.5 KB) if youre a UK applicant as well as following the European process at step 1. 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). An example of when we might do this is if you are convicted of a relevant criminal offence. NJ MVC | Suspensions and Restorations Suspensions and Restorations Information about restoring your license or registration Restoring Your License or Registration If your license has expired, you will need to renew it in-person. You must then resend the entire submission with the errors corrected. Compare over 50 top car insurance quotes and save. Updated document - Suspended manufacturing and wholesale distribution authorisations. 94 RICKMANSWORTH ROAD, You must do so within 21 days of the revocation coming into effect. Updated Suspended manufacturing and wholesale distribution authorisations CSV file. CAMBRIDGE, These can then be investigated further to decide whether a side effect is truly from a . Updated list of terminated and cancelled manufacturing and wholesale Updated both attachments with newer files. 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. Download CSV 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. (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). GLASGOW, THANE ROAD, MHRA considers each application for a product name to ensure that the proposed name will allow the medicine to be taken safely and correctly. Alpha Release This is a new service - your feedback will help improve it. Updated 'Suspended manufacturing and wholesale distribution authorisations' link. Well send you a link to a feedback form. Updated: list of terminated and cancelled manufacturing and wholesale dealer licences. Updated list of suspended licences added to the page. If you have submitted an application for a new MA, traditional herbal remedy and/or a parallel import product licence and you no longer want to proceed with application, you need to submit a withdrawal form. Maalox oral suspension - Magnesium hydroxide; Aluminium hydroxide gel dried Magnesium hydroxide; . Uploaded new version of Suspended and revoked licences list. You can also tell us about any factual errors that may have affected our decision. It is your responsibility to make sure the invoices for your submissions are paid on time. 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. The Site Number is a specific number allocated to one site. 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. List of suspended licences for manufacturers and wholesalers of medicines updated, Updated the suspended list with two new suspensions and corrected suspension date for St Helen's Millennium Centre Services Limited. Updated list of terminated and cancelled manufacturing and wholesale dealer licences up to May 2019 added to the page. 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). 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. It will take only 2 minutes to fill in. You have rejected additional cookies. UNITED KINGDOM, BCM LIMITED, You have accepted additional cookies. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. 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. 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. You should submit your application using the electronic Common Technical Document (eCTD). It will take only 2 minutes to fill in. Uploaded new Suspended manufacturing and Revoked spreadsheets. Uploaded updated suspended and revoked licences lists. Published updated list of Suspended manufacturing and wholesale distribution authorisations. Updated lists of suspended and revoked licenses. It can also be checked on the following register: At 1936 per MHRA inspection or re-inspection, you want as few visits as possible. 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. List of API manufacturers, importers and distributors, see EUDRAGMDP link above. We publish scientific assessment reports called a Public Assessment Report (PAR) available for new marketing authorisations granted after 30 October 2005. Pay Restoration Fee Provide proof of payment of outstanding fines/tickets Parking Violations How to Pay Parking Tickets You have accepted additional cookies. It is the MA applicants responsibility to make sure that the ASMF is submitted either before you submit your application or at the same time, as your application will not be valid without it. 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 To make a request for fast tracking your marketing authorisation you should email a letter of no more than 3 pages to RIS.NA@mhra.gov.uk. Occupational Licenses. Since inspections of manufacturers of active substances are based on risk,. New version of suspended list has been uploaded. You can change your cookie settings at any time. The List of Terminated and Cancelled Licences has been updated. (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. Use the pre-submission checklist (PDF, 129 KB, 7 pages) to help you with your application. 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. 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. 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. Melatonin 4mg/5ml oral suspension STD, SF, LF, AF, NSF 150ml 20620 8 Menadiol 5mg/5ml oral suspension STD, SF, LF, CF . IAG are non-statutory multi-disciplinary groups which advise MHRA's Director of IE&S on recommendations for regulatory action. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. The MHRA-GMDP database contains the following information issued by the MHRA relating to manufacturing and wholesale authorisations and certificates. Published 4 February 2015 Last updated 5 January. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. 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. posted on You should read the guidance for your specific pathway for any extra information or steps that might be required. MHRA is the Government body set up to discharge the responsibilities of the Licensing Authority, under powers delegated by those Ministers. The use of POs is an internal control process and cannot be used as a reason to withhold payment of legitimate invoices. Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. MHRA alerts & recalls PharmData maintains a list of all MHRA alerts and recalls relevant to community pharmacy. You can appeal our decision to suspend your licence in a Magistrates or Sheriff Court. Dont include personal or financial information like your National Insurance number or credit card details. 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.

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