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MIA | MHRA - Medicines and Healthcare products Regulatory Agency In April 2018, C+D reported that the suspension had been extended due to remaining "non-compliance issues". It will take only 2 minutes to fill in. We publish the most up-to-date information for a medicine according to its licence history. Uploaded new version of Suspended and revoked licences list. The lists of suspensions and revocations have been updated. Uploaded new Suspended manufacturing and wholesale distribution authorisations spreadsheet. Truancy. 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. MHRA alerts & recalls PharmData maintains a list of all MHRA alerts and recalls relevant to community pharmacy. Report a side effect with a medicine or medical device. . New document added to page for September 2017. 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. MHRA Process Licensing: useful information - MHRA Inspectorate MHRA | MHRA - Medicines and Healthcare products Regulatory Agency WDA Suspended, Terminated, Cancelled And Revoked What Do These Terms Find out more about the different national and international procedures. We use some essential cookies to make this website work. The Site Number is a specific number allocated to one site. Cancellation of a licence, authorisation or registration is when MHRA makes a decision to cancel the licence, authorisation or registration. We will also tell you what you can do that might stop us from revoking your licence. 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. AL10 9UL, Dont worry we wont send you spam or share your email address with anyone. WELBECK PHARMACEUTICALS & HOSPITAL SUPPLIES LIMITED , 35 DEVONSHIRE STREET, LONDON, W1G 6PZ, UNITED KINGDOM. HD1 6EF, DEESIDE, Reinstating Your 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. It will take only 2 minutes to fill in. HATFIELD, 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. The list of suspended licences has been updated. Occupational Licenses. Penalty fees may be incurred for non-payment. The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated to include May 2015. Also is there any process to verify that MIA licence is still valid? 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: . WDA | MHRA - Medicines and Healthcare products Regulatory Agency UNITED KINGDOM, THE MENTHOLATUM COMPANY LIMITED, Drug wholesaler hit by MHRA suspension hires advisers to find funding injection, Converse Pharma distributes a range of generic drugs. Call us at (847) 390-8500 or submit your information via our contact form to arrange a free consultation. New version of Revocation list has been uploaded. This information is common to all procedures. List of revoked manufacturing sites updated. 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. Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely. 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. 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. For example, in Kentucky, it takes an accumulation of 12 points over the course of 2 years in order to receive a suspension. HUDDERSFIELD, ; Getting multiple traffic violations or speeding tickets. We recommend that you use a validation tool to check your submission as we 1 MEER END, 1 REDWOOD AVENUE, Dont include personal or financial information like your National Insurance number or credit card details. D ate of . Your Guide To Reinstating Suspended Licenses | DMV.com 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. Termination of a licence, authorisation or registration takes place at the request of the holder of the licence, authorisation or registrant, for example, the business decides they no longer wish to perform an activity that requires a licence, authorisation or registration. It also covers 'sunset-clause' monitoring. You must do so within 21 days of the suspension coming into effect. 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. 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. Added updated list of suspended manufacturing and wholesale distribution authorisations. This will ensure you are not charged a periodic fee for the period 1 April 2016 to 31 March 2017. 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, The Licence Number is a specific number allocated to one company. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Terminated and cancelled manufacturing and wholesale dealer licences for January through to February 2016. Submission of a new ASMF and any update to an ASMF should be made by the ASMF holder using MHRA Submissions . 1 CHURCH ROAD, 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. The absence of a GMP certificate should not be understood as meaning that the active substance manufacturer in question does not comply with GMP. You must then resend the entire submission with the errors corrected. either alone or jointly. Sara Berry We updated the list of suspended manufacturing and wholesale distribution authorisations. Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. You can also use the A-Z list to find the active substance. Apply for a licence to market a medicine in the UK - GOV.UK 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. Refusal of licence / variation or an existing licence being revoked. Updated the terminated and cancelled manufacturing and wholesale dealer licences list. Updated list of suspended manufacturing and wholesale distribution authorisations. 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. Learn more about the circumstances that can lead to a licence holder losing their licence, either permanently or temporarily. GDP | MHRA - Medicines and Healthcare products Regulatory Agency Its licence was "largely reinstated" following a re-investigation in April, says Sky. 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.