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). The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced the licence suspension of ingenol mebutate gel (Picato). 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. 1 MEER END, Under 'Ways to make your submission', Updated email address and naming to Department of Health and Social Care. Copy CSV Excel PDF Print Showing 1 to 10 of 325 entries Previous 1 2 3 4 5 33 Next We recommend that you use a validation tool to check your submission as we News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Updated Suspended manufacturing and wholesale distribution authorisations List, Updated the list of Suspended manufacturing and wholesale distribution authorisations. Added spreadsheet under "types of application" heading. You must cancel your marketing authorisation or other licence by 31 December if you want it to be cancelled by 31 March 2016. Refusal to pay outstanding fees on the grounds that the PO is not provided on the invoice will not be accepted. 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. 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 . MHRA Suspended Licence checks are a critical part of your Quality Management System and Risk Management processes, so keep on top of them. We will write to you when we suspend your licence, telling you what we have done and why. The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Refusal of licence / variation or an existing licence being revoked. List of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. The list of suspensions and revocations is updated on the same day that the suspension or revocation takes place. New version of Revocation list has been uploaded. SR-22 Insurance Certificates. Updated both attachments with newer files. Proposed suspension, variation . 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. 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 . Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission. List of API manufacturers, importers and distributors, see EUDRAGMDP link above. Updated list of suspended licences and registrations for manufacturers and wholesalers of medicines and ingredients. 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. The current At 1936 per MHRA inspection or re-inspection, you want as few visits as possible. In April 2018, C+D reported that the suspension had been extended due to remaining "non-compliance issues". Dont include personal or financial information like your National Insurance number or credit card details. 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. Anyone in the pharmaceutical or medicinal supply chain should use this list to ensure they are dealing with a valid licence or authorisation holder. UK Licence No: PL 04425/0697 . This will ensure you are not charged a periodic fee for the period 1 April 2016 to 31 March 2017. 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. You can print blog posts using the keyboard shortcuts "Control P" or "Command P". 3.85 KB, View online 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. Uploaded updated suspended and revoked licences lists. Or if you need to cancel a parallel import product licence, complete the cancellation form (PDF, 525 KB, 3 pages). 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. Terminated and cancelled manufacturing and wholesale dealer licences for January through to February 2016. 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. Complete the application to withdraw a pending application (MS Word Document, 35 KB) for and email it to us with withdrawal as your subject line. Updated the list of suspended licences for manufacturers and wholesalers of medicines. You must do so within 21 days of the revocation coming into effect. Updated: Suspended manufacturing and wholesale distribution authorisations, Suspended and revoked licences for manufacturers and wholesalers of medicines - August 2015, Updated: suspended and revoked licences for manufacturers and wholesalers of medicines, Updated: List of suspended manufacturing and wholesale distribution authorisations, Updated list of suspended and revoked licences for manufacturers and wholesalers of medicines. Report a side effect with a medicine or medical device. NOTTINGHAM, Added new list of terminated and cancelled manufacturing and wholesale dealer licences. Dont worry we wont send you spam or share your email address with anyone. WD18 7JJ, 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. REACTA BIOTECH LIMITED T/A REACTA HEALTHCARE, The DHSC contact for fast-tracking a licence has changed. IAG are non-statutory multi-disciplinary groups which advise MHRA's Director of IE&S on recommendations for regulatory action. Or if you need to cancel a parallel import product. Drug wholesaler hit by MHRA suspension hires advisers to find funding injection, Converse Pharma distributes a range of generic drugs. BUILDING 4, 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. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Very rare: Agitation, confusion, tremor, ataxia, dysarthria, hallucinations, psychotic symptoms, convulsions, somnolence, encephalopathy, coma. Comment by EN6 1TL, It will take only 2 minutes to fill in. 09/02/2023. Visit the European Medicines Agency website for more information on the European requirements for cancellations or email the MHRA for UK requirements. UNITED KINGDOM, BARD PHARMACEUTICALS LIMITED, You can change your cookie settings at any time. Updated 'Suspended manufacturing and wholesale distribution authorisations' list, Updated 'Revoked manufacturing and wholesale distribution authorisations' list. Converse Pharma could not be reached for comment. updated suspended and revoked lists added to the page. 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). 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. Uploaded new version of Suspended manufacturing and wholesale distribution authorisations. Some information may have been excluded from public view. If you have any questions about submitting your application you should email ris.na@mhra.gov.uk. Welcome to the MHRA Process Licensing Portal. Updated list of suspended licences added to the page. WATFORD, Department of Health and Social Care (DHSC) has issued a medicine supply notification for Ranitidine (all formulations) . Syri Limited suspension has been lifted. Call us at (847) 390-8500 or submit your information via our contact form to arrange a free consultation. varied or suspended by the Medicines and Healthcare products Regulatory Agency (MHRA). These templates should not be altered in any way, other than inserting the relevant information. 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". 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. Updated list of terminated and cancelled manufacturing and wholesale dealer licences up to May 2019 added to the page. 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. You can read our guidance about the submission of ASMFs. And it ensures the safety and effectiveness of medicines in the UK. Updated both 'revoked' and 'Suspended' manufacturing and wholesale distribution authorisations lists. It also covers 'sunset-clause' monitoring. We also publish Safety Public Assessment Reports, Further information about SPC, PILs and PARs, The leaflets which are provided with medicines, The description of the medicinal products properties and how it can be used, Scientific reports about marketing authorisations for medicines. You will not be charged if your submission is rejected for technical reasons. 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. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. You should submit your application using the electronic Common Technical Document (eCTD). CH5 2NT, 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. The use of POs is an internal control process and cannot be used as a reason to withhold payment of legitimate invoices. An example of when we might do this is if you are under police. New terminated and cancelled manufacturing and wholesale dealer licences list uploaded, Updated link 'Medicines terminated and cancelled manufacturing and wholesale dealer licences', Updated list of medicines terminated and cancelled manufacturing and wholesale dealer licences. 1 REDWOOD AVENUE, We use some essential cookies to make this website work. Dont worry we wont send you spam or share your email address with anyone. New list of terminated licenses, August 2016 to July 2017 added to the page. 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. 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). We also use cookies set by other sites to help us deliver content from their services. The Licence Number is a specific number allocated to one company. The Agency has the power to withdraw a product from the market, and in the case of medicines, to suspend production. Uploaded new Suspended manufacturing and wholesale distribution authorisations spreadsheet. UNITED KINGDOM, DENDRON BRANDS LIMITED, Updated list of suspended licences and registrations, Suspended manufacturing and wholesale distribution authorisations has been updated, Updated document - Revoked manufacturing and wholesale distribution authorisations, Updated list of suspended manufacturing and wholesale distribution authorisations. All Rights Reserved. Updated Suspended manufacturing and wholesale distribution authorisations CSV file. Yesterday MHRA released an update on suspended manufacturing and wholesale distribution authorization. You should read the guidance for your specific pathway for any extra information or steps that might be required. Dont include personal or financial information like your National Insurance number or credit card details. Suspended Driver's License. ASMFs holders must submit their dossier to the MHRA. You can also submit the forms via the Central European System Platform (CESP). 29.3 KB. Well send you a link to a feedback form. 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. What the data show Since September 2020, 15 Companies were affected. 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). DEESIDE INDUSTRIAL PARK, 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. To help us improve GOV.UK, wed like to know more about your visit today. Ranitidine 50mg/2ml injection is anticipated to be unavailable from the end of May 2020 until further notice. Submit the relevant forms above to MHRA via the MHRA portal if youre a UK applicant. Suspended vs. Revoked License: The Differences, Driving with a Suspended License: What You Need to Know. You have accepted additional cookies. Updated Suspended manufacturing and wholesale distribution authorisations list. Updated the terminated and cancelled manufacturing and wholesale dealer licences list. MHRA is the Government body set up to discharge the responsibilities of the Licensing Authority, under powers delegated by those Ministers. 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. You can find out more in our naming of medicines guidance (PDF, 235 KB, 20 pages). July update to Terminated, Revoked, Cancelled licences file. This is based on the MHRA assessment report with any commercially or personally confidential information removed. Updated 'Suspended manufacturing and wholesale distribution authorisations' link. In August 2018, EnteroBiotix announced that the company had been awarded a manufacturer's specials license . 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. The MHRA products website allows you to find: You can look for any word, phrase or Product Licence number (PL) using the search tool. Maalox oral suspension - Magnesium hydroxide; Aluminium hydroxide gel dried Magnesium hydroxide; . Medical Evaluation Process. either alone or jointly. You should also use this form if you want to withdraw a variation application or amendment for an existing MA. If you do not use this template your submission will be rejected. CDL Disqualifications. Alternatively, we can maintain the suspension until we have all of the information we require to make a licensing decision. Uploaded new version of Suspended and revoked licences list. ; Getting multiple traffic violations or speeding tickets. 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. The MHRA has been assured that acceptable standards of Good Manufacturing Practice are in place for . If you have any questions about MHRA Submissions , you should email submissions@mhra.gov.uk. UNITED KINGDOM, BCM LIMITED, It will take only 2 minutes to fill in. MILTON ROAD, Updated the suspended manufacturing and wholesale distribution authorisations list. DEESIDE, 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. We find an easy way to remember is to set a recurrent reminder in your Outlook calendar or Gmail diary. 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 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. Replaced the PDF with a more accessible file. Updated: list of terminated and cancelled manufacturing and wholesale dealer licences. You can change your cookie settings at any time. Converse Pharma distributes a range of generic drugs, including flu vaccines, employing close to 1,000 people at 11 sites across the country. Published a new version of the 'Get Licensed' document. Dont include personal or financial information like your National Insurance number or credit card details. UK WDA (H) 12426. We use some essential cookies to make this website work. LE4 3EH, (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). An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees. Dont include personal or financial information like your National Insurance number or credit card details. Updated the list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. 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. We use some essential cookies to make this website work. Our legal power to do this is explained in Get Licensed (PDF, 3.03 MB, 90 pages). MHRA alerts & recalls PharmData maintains a list of all MHRA alerts and recalls relevant to community pharmacy. You can find out more about how to pay your fees in our guidance on making a payment to MHRA. On the other hand, in Florida, earning 12 points on your license within a year will get your license suspended for 30 days. Uploaded updated Suspended manufacturing and wholesale distribution authorisations list. Download CSV Your licence remains live during a court appeal. PEEL PARK CAMPUS, EAST KILBRIDE, dealer licences. The MHRA also enforces European drug licensing regulations in the UK. 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. The Process Licensing Office sits within the Inspectorate and Process Licensing Group of the Inspection, Enforcement and Standards division. Updated list of suspended and revoked licences for manufacturers and wholesalers of medicines. Certificates of Suitability (CEPs) continue to be acceptable in support of UK and GB national authorisations.. You have accepted additional cookies. 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? It can also be checked on the following register: Published updated list of Suspended manufacturing and wholesale distribution authorisations. You have accepted additional cookies. 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. BUILDING 20, STATION CLOSE, Updated list of suspensions. 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: TRIDENT PLACE, MOSQUITO WAY, We publish the most up-to-date information for a medicine according to its licence history. This file may not be suitable for users of assistive technology. You can go to the MHRA-GMDP website to view the lists of: Updated the suspended and revoked licenses list. 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. Suspension lifted for Metro Pharmacy Limited. The MHRA-GMDP database contains the following information issued by the MHRA relating to manufacturing and wholesale authorisations and certificates. 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. We will revoke (take away) your licence if: We will write to you before we revoke your licence, telling you what we intend to do and why. Maalox 175mg/200mg Oral Suspension . MHRA considers each application for a product name to ensure that the proposed name will allow the medicine to be taken safely and correctly. You must then resend the entire submission with the errors corrected. The MHRA announces recall of paracetamol tablets, after certain products were found to be discoloured due to the presence of fungi. BIRSTALL, Use the pre-submission checklist (PDF, 129 KB, 7 pages) to help you with your application. We can revoke (take away) your licence if you no longer meet our licensing criteria. Published new suspended manufacturing and wholesale distribution authorisations list. You should also use our eAF and cover letter tool to determine what information you need to include in your application. 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. Latest list of suspended licenses added to the page. Link to companies GMP and GDP certificates, see EUDRAGMDP link above. Dont include personal or financial information like your National Insurance number or credit card details. Published a new version of the Suspended manufacturing and wholesale distribution authorisations list. The information published in this Register was that held by the MHRA on the date of publication. Monthly update to 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. 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. 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. Updated document - Suspended manufacturing and wholesale distribution authorisations. If a submission is rejected, we will email you the reasons for the rejection. The summary of product characteristics (SmPC) should be submitted to the MHRA in the correct format using the SPC template (MS Word Document, 36 KB). 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.. Aventis Pharma Limited . Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. 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. Alpha Release This is a new service - your feedback will help improve it. Updated list of suspended licences and registrations for manufacturers and wholesalers of medicines and ingredients. If we intend to revoke or suspend your licence we will write to you to tell you why. You have accepted additional cookies. Updated list of suspended manufacturing and wholesale distribution authorisations. It will take only 2 minutes to fill in. Updated the Suspended manufacturing and wholesale distribution authorisations list, Added an updated version of the Suspended manufacturing and wholesale distribution authorisations list, Updated Suspended manufacturing and wholesale distribution authorisations csv file, New Suspended manufacturing and wholesale distribution authorisations list uploaded, Updated suspended manufacturing and wholesale distribution authorisations list, Suspended manufacturing and wholesale distribution authorisations updated to include HMS WHOLESALE LIMITED terminated licence, New Suspended manufacturing and wholesale distribution authorisations uploaded, New Suspended manufacturing and wholesale distribution authorisations updated.