Maalox oral suspension - Magnesium hydroxide; Aluminium hydroxide gel dried Magnesium hydroxide; . The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated. Updated 'Suspended manufacturing and wholesale distribution authorisations' link. Well send you a link to a feedback form. If you do not respond to our letter we will revoke your licence automatically after 21 days. 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. HUDDERSFIELD, Updated ist of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked. Updated list of suspended licenses added to the page. Phase 4 studies. You will not be charged if your submission is rejected for technical reasons. Yesterday MHRA released an update on suspended manufacturing and wholesale distribution authorization. Converse Pharma distributes a range of generic drugs, including flu vaccines, employing close to 1,000 people at 11 sites across the country. updated Suspended and revoked licences for manufacturers and wholesalers of medicines, list of suspended manufacturing and wholesale distribution authorisations updated. PL 04425/0697 . UNITED KINGDOM, BCM LIMITED, Updated: list of revoked manufacturing and wholesale distribution authorisations. 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. Added new list of terminated and cancelled manufacturing and wholesale dealer licences. Updated list of suspended manufacturing and wholesale distribution authorisations added to the page. It can also be checked on the following register: List of suspended manufacturing and wholesale distribution authorisations updated. Depending on the state you live in, you may incur a suspension for a different amount of points. 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? The absence of a GMP certificate should not be understood as meaning that the active substance manufacturer in question does not comply with GMP. 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. UK Licence No: PL 04425/0697 . 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. If we suspend your licence, the suspension comes into effect immediately. All other specific services or enquiries contact can be found via the following link: https://www.gov.uk/guidance/contact-mhra#contents, Medicines and Healthcare products Regulatory Agency, Inspection, Enforcement & Standards Division Inspectorate and Process licensing, 10 South Colonnade, Canary Wharf, London E14 4PU, Dont miss the next post, sign up to be notified by email when a new post comes out, Comment by MHRA reserves the right. 09 October 2019. MILTON ROAD, Dont include personal or financial information like your National Insurance number or credit card details. You can also tell us about any factual errors that may have affected our decision. BUILDING 4, Uploaded updated Suspended manufacturing and wholesale distribution authorisations list. 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. MHRA's primary role is to protect public health and the IAG process forms a regulatory tool to manage this. have helped thousands of drivers regain their driving privileges after cancellation, suspension or revocation. Cancellation of a licence, authorisation or registration is when MHRA makes a decision to cancel the licence, authorisation or registration. Download CSV You can appeal our decision to suspend your licence in a Magistrates or Sheriff Court. @MarkKleinmanSky. Details of the penalties are explained in ourFees Regulations. 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 . Do not send the corrected deficiencies by email. 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. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Published a new version of the 'Get Licensed' document. Actavis, Forley Generics, and Goldshield Group also . Department of Health and Social Care (DHSC) has issued a medicine supply notification for Ranitidine (all formulations) . 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. 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. 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. We use some essential cookies to make this website work. Published updated version of Suspended manufacturing and wholesale distribution authorisations list. Monthly update to 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. It will take only 2 minutes to fill in. Drug wholesaler hit by MHRA suspension hires advisers to find funding injection, Converse Pharma distributes a range of generic drugs. New version of Revocation list has been uploaded. Added list of terminated and cancelled licences for April 2019. DEESIDE, 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. either alone or jointly. 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. Some information may have been excluded from public view. Since inspections of manufacturers of active substances are based on risk, some active substance manufacturers may not be in possession of a GMP certificate. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced the licence suspension of ingenol mebutate gel (Picato). Accumulating too many driving record points. Updated lists of suspended and revoked licences. Dont include personal or financial information like your National Insurance number or credit card details. 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. Alternatively, we can maintain the suspension until we have all of the information we require to make a licensing decision. This means that you can still work during your appeal, unless we have also suspended your licence. Sky News has learnt that Converse Pharma Group, which is one of the biggest suppliers to community pharmacies across the UK, is working with Teneo Restructuring on a hunt for additional capital. 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. Download CSV 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. MHRA considers each application for a product name to ensure that the proposed name will allow the medicine to be taken safely and correctly. Submission of a new ASMF and any update to an ASMF should be made by the ASMF holder using MHRA Submissions . It will take only 2 minutes to fill in. Any company that has an MHRA suspended licence cannot trade, suffers loss of credibility, loss of earnings and a reduced inspection schedule, which adds further costs and regulator interaction. This is based on the MHRA assessment report with any commercially or personally confidential information removed. Uploaded new version of Suspended and revoked licences list. Copy CSV Excel PDF Print Showing 1 to 10 of 325 entries Previous 1 2 3 4 5 33 Next GLASGOW, UNITED KINGDOM, MYONEX LIMITED, Updated list of suspended and revoked licences for manufacturers and wholesalers of medicines. Melatonin 4mg/5ml oral suspension STD, SF, LF, AF, NSF 150ml 20620 8 Menadiol 5mg/5ml oral suspension STD, SF, LF, CF . Updated lists of suspended and revoked licenses. To help us improve GOV.UK, wed like to know more about your visit today. Registered users can receive instant email notifications of new alerts, and record their responses to MHRA alerts within their PharmData account. 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 Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences' attachment to latest version. Reinstating Your License. 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. RICHMOND, It is an additional route of appeal that we offer so that you can appeal in a way that does not incur court costs. Full Service We develop, source and fill an extensive range of packaging types to suit product function, brand design and especially consumer driven needs, which we monitor with our non-stop trends service. List of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. This information is common to all procedures. You can use the A-Z list to find an active substance, or search for a medicine. 1 REDWOOD AVENUE, Updated the 'When we suspend your licence' section to include reference to open public investigations. Under 'Ways to make your submission', Updated email address and naming to Department of Health and Social Care. 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). 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. LE4 3EH, mhra licence suspension THANE ROAD, 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. The MHRA also enforces European drug licensing regulations in the UK. We also use cookies set by other sites to help us deliver content from their services. Removed link to Excel spreadsheet list of products. Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. If you have any questions about submitting your application you should email ris.na@mhra.gov.uk. 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. 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. The agency advised healthcare professionals to immediately stop supplying the batches and to quarantine and remove all remaining stock. 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). For example, in Kentucky, it takes an accumulation of 12 points over the course of 2 years in order to receive a suspension. On-site inspections will resume as soon as travel restrictions permit. Updated the terminated and cancelled manufacturing and wholesale dealer licences list. varied or suspended by the Medicines and Healthcare products Regulatory Agency (MHRA). . 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. latest Suspended manufacturing and wholesale distribution authorisations, Updated Suspended manufacturing and wholesale distribution authorisations, Updated suspended manufacturing and wholesale distribution authorisations. Well send you a link to a feedback form. You can find out more in our naming of medicines guidance (PDF, 235 KB, 20 pages). Updated the list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. Updated Suspended manufacturing and wholesale distribution authorisations List, Updated the list of Suspended manufacturing and wholesale distribution authorisations. IAG are non-statutory multi-disciplinary groups which advise MHRA's Director of IE&S on recommendations for regulatory action. Anyone in the pharmaceutical or medicinal supply chain should use this list to ensure they are dealing with a valid licence or authorisation holder. Well send you a link to a feedback form. 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. The Process Licensing Office sits within the Inspectorate and Process Licensing Group of the Inspection, Enforcement and Standards division. This blog shares the work of the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate, by inspectors and those the Inspectorate works with. CAMBRIDGE, HATFIELD, . Also is there any process to verify that MIA licence is still valid? Is there any portal where we can check the list of MIA holders? Pay Restoration Fee Provide proof of payment of outstanding fines/tickets Parking Violations How to Pay Parking Tickets Cancellation of a licence, authorisation or registration is when MHRA makes a decision to cancel the licence, authorisation or registration. WELBECK PHARMACEUTICALS & HOSPITAL SUPPLIES LIMITED , 35 DEVONSHIRE STREET, LONDON, W1G 6PZ, UNITED KINGDOM. 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. Published new suspended manufacturing and wholesale distribution authorisations list.