In April 2018, C+D reported that the suspension had been extended due to remaining "non-compliance issues". You should also use our eAF and cover letter tool to determine what information you need to include in your application. 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. You must do so within 21 days of the suspension coming into effect. If you do not use this template your submission will be rejected. 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. 29.3 KB. New list of suspended manufacturing and wholesale distribution authorisations added to the page. 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. varied or suspended by the Medicines and Healthcare products Regulatory Agency (MHRA). We updated the list of suspended manufacturing and wholesale distribution authorisations. UK Licence No: PL 04425/0697 . 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. mhra licence suspensionhow to calculate solow residual mhra licence suspension. 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: . You have rejected additional cookies. Published new version of the suspended manufacturing and wholesale distribution authorisations list. Copy CSV Excel PDF Print Showing 1 to 10 of 325 entries Previous 1 2 3 4 5 33 Next Published updated Revoked manufacturing and wholesale distribution authorisations list. An example of when we might do this is if you are convicted of a relevant criminal offence. There should be a procedure that ensures there are documented checks made at least twice a month of MHRA's list of suspended licence holders and regular checks on EudraGMDP website for issued. Subscribe to stay in the loop & on the road! Dont worry we wont send you spam or share your email address with anyone. This will ensure you are not charged a periodic fee for the period 1 April 2016 to 31 March 2017. Published Medicines: terminated and cancelled manufacturing and wholesale dealer licences for August 2019. Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences' attachment to latest version. Updated list of suspended and revoked licences for manufacturers and wholesalers of medicines. The List of Terminated, Revoked and Cancelled Licences has been updated. Dealer Licences 2016 to October, Updated list of terminated and cancelled licences. 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. Following recent advice from the EMA, the MHRA have suspended all licenses for ranitidine products. We publish the most up-to-date information for a medicine according to its licence history. New September 2020 version of 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. Updated file 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. It will take only 2 minutes to fill in. UNITED KINGDOM, Terms and Conditions Opens in new window | Privacy Notice Opens in new window, Click on this link to navigate to www.mhra.gov.uk. If the unlicensed medicine is obtained from a supplier holding a MHRA Manufacturer 'Specials' Licence or Wholesale Dealer Licence, the contractor shall endorse the prescription with the initials 'SP' to claim the . The Site Number is a specific number allocated to one site. You have accepted additional cookies. Very rare: Agitation, confusion, tremor, ataxia, dysarthria, hallucinations, psychotic symptoms, convulsions, somnolence, encephalopathy, coma. 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 The current We can revoke (take away) your licence if you no longer meet our licensing criteria. Uploaded new Suspended manufacturing and Revoked spreadsheets. MHRA alerts & recalls PharmData maintains a list of all MHRA alerts and recalls relevant to community pharmacy. Updated revoked and suspended documents on the page. 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. CB4 0GW, WATFORD, https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-manufacturing-sites. View online 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. Ilyas ali The MHRA announces recall of paracetamol tablets, after certain products were found to be discoloured due to the presence of fungi. UNITED KINGDOM, WOODLEY BIOREG LIMITED, Dont worry we wont send you spam or share your email address with anyone. On-site inspections will resume as soon as travel restrictions permit. On the other hand, in Florida, earning 12 points on your license within a year will get your license suspended for 30 days. Updated: list of terminated and cancelled manufacturing and wholesale dealer licences. The use of POs is an internal control process and cannot be used as a reason to withhold payment of legitimate invoices. Manufacturing and Wholesale 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. Added updated list of suspended manufacturing and wholesale distribution authorisations. Terminated and cancelled manufacturing and wholesale dealer licences for January through to February 2016. The agency advised healthcare professionals to immediately stop supplying the batches and to quarantine and remove all remaining stock. This portal allows registered users to submit WDA (H) Wholesale Distribution Authorisation applications and variations API Active Pharmaceutical. Updated both 'revoked' and 'Suspended' manufacturing and wholesale distribution authorisations lists. SR-22 Insurance 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. Refrain from driving for a period of time. Added August file for - Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences. 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. Dont include personal or financial information like your National Insurance number or credit card details. You can print blog posts using the keyboard shortcuts "Control P" or "Command P". The MHRA-GMDP database contains the following information issued by the MHRA relating to manufacturing and wholesale authorisations and certificates. Updated the terminated and cancelled manufacturing and wholesale dealer licences for September 2021. If we intend to revoke or suspend your licence we will write to you to tell you why. Subscribe to our News and Updates to stay in the loop and on the road! 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 version of suspended list has been uploaded. 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. It will take only 2 minutes to fill in. Ranitidine 50mg/2ml injection is anticipated to be unavailable from the end of May 2020 until further notice. 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. The MHRA also enforces European drug licensing regulations in the UK. Use the pre-submission checklist (PDF, 129 KB, 7 pages) to help you with your application. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Added list of terminated and cancelled licences for April 2019. Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. 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). 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. Since inspections of manufacturers of active substances are based on risk,. You can change your cookie settings at any time. 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. We use some essential cookies to make this website work. . 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. 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. The absence of a GMP certificate should not be understood as meaning that the active substance manufacturer in question does not comply with GMP. Added new list of terminated and cancelled manufacturing and wholesale dealer licences. We publish scientific assessment reports called a Public Assessment Report (PAR) available for new marketing authorisations granted after 30 October 2005. Monthly update to 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. 1999 - 2023 DMV.ORG. Suspensions & Reinstatements. If you respond to our letter we will take what you tell us into consideration. G74 5PE, We use some essential cookies to make this website work. Phase 4 studies. Updated 'Suspended manufacturing and wholesale distribution authorisations' link. PEEL PARK CAMPUS, EAST KILBRIDE, All Rights Reserved. Updated suspension list added to the page. 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 appeal our decision to suspend your licence in a Magistrates or Sheriff Court. 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 You can also submit the forms via the Central European System Platform (CESP). You can also tell us about any factual errors that may have affected our decision. Updated 'Revoked manufacturing and wholesale distribution authorisations' and 'Suspended manufacturing and wholesale distribution authorisations' lists. All invoices must be settled upon receipt. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. MHRA is the Government body set up to discharge the responsibilities of the Licensing Authority, under powers delegated by those Ministers. HATFIELD, 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. . 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 10 October 2019, MIA holders can be checked on the Eudra GMDP webpage for validity. Please note the site register will be updated on a quarterly basis. Syri Limited suspension has been lifted. Some information may have been excluded from public view. Updated list of suspended and revoked licences and registrations. ALR Program. THANE ROAD, REACTA BIOTECH LIMITED T/A REACTA HEALTHCARE, The list of suspended manufacturing and wholesale distribution authorisations has been updated. 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. Dont worry we wont send you spam or share your email address with anyone. Published updated 'Suspended manufacturing and wholesale distribution authorisations' spreadsheet. Comment by 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. 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.