MHRA Suspended Licence checks are a critical part of your Quality Management System and Risk Management processes, so keep on top of them. We may still revoke your licence. ASMFs holders must submit their dossier to the MHRA. 10 October 2019, MIA holders can be checked on the Eudra GMDP webpage for validity. UNITED KINGDOM, MYONEX LIMITED, Uploaded new version of Suspended and revoked licences list. Published new list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. Replaced the PDF with a more accessible file. 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. Published a new version of the 'Get Licensed' document. You have rejected additional cookies. There is no additional fee for fast-tracking applications. At 1936 per MHRA inspection or re-inspection, you want as few visits as possible. mhra licence suspension Suspension lifted for Metro Pharmacy Limited. Added new list of terminated and cancelled manufacturing and wholesale dealer licences. Published 4 February 2015 Last updated 5 January. Published a new version of the Suspended manufacturing and wholesale distribution authorisations list. Our letter will also tell you how to appeal against our decision. TRIDENT PLACE, MOSQUITO WAY, Updated the suspended manufacturing and wholesale distribution authorisations list. Dont worry we wont send you spam or share your email address with anyone. The MHRA has been assured that acceptable standards of Good Manufacturing Practice are in place for . The clarifying remark section of individual GMP and GDP certificates will indicate any exceptions. 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. UNITED KINGDOM, DENDRON BRANDS LIMITED, 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. If a submission is rejected, we will email you the reasons for the rejection. You can also submit the forms via the Central European System Platform (CESP). This portal allows registered users to submit WDA (H) Wholesale Distribution Authorisation applications and variations API Active Pharmaceutical. LE4 3EH, https://mhrainspectorate.blog.gov.uk/2019/10/04/mhra-process-licensing-useful-information/. Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences' link to latest January 2021 version. Dont worry we wont send you spam or share your email address with anyone. It typically deals with the manufacture, assembly and wholesale distribution of medicinal products under UK and EU legislation, these licences are often called process licences and include: The MHRA Process Licensing Portal is part of the government's Digital by Default agenda and is a web application which provides a secure environment and an easy to use platform which allows customers to submit new applications and variations to existing wholesale distribution authorisations electronically via https://pclportal.mhra.gov.uk/. Since inspections of manufacturers of active substances are based on risk,. 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). If you use assistive technology (such as a screen reader) and need a Following recent advice from the EMA, the MHRA have suspended all licenses for ranitidine products. Welcome to the MHRA Process Licensing Portal. The information published in this Register was that held by the MHRA on the date of publication. 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 Uploaded new Suspended manufacturing and wholesale distribution authorisations list. The current Call us at (847) 390-8500 or submit your information via our contact form to arrange a free consultation. Updated both attachments with newer files. We use some essential cookies to make this website work. Alpha Release This is a new service - your feedback will help improve it. Updated lists of suspended and revoked licences. HATFIELD, Updated list of suspended licences added to the page. The DHSC contact for fast-tracking a licence has changed. 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. We also use cookies set by other sites to help us deliver content from their services. "The sector as a whole is expected to grow at pace in the next five years, meaning there is significant potential for Converse Pharma if it can raise the funding it needs," the industry source added. This means that you can still work during your appeal, unless we have also suspended your licence. 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. Melatonin 4mg/5ml oral suspension STD, SF, LF, AF, NSF 150ml 20620 8 Menadiol 5mg/5ml oral suspension STD, SF, LF, CF . Well send you a link to a feedback form. Added list of terminated and cancelled licences for April 2019. If you do not respond to our letter we will revoke your licence automatically after 21 days. Published new suspended manufacturing and wholesale distribution authorisations list. Updated suspension list for manufacturing and wholesale distribution authorisations. Updated the 'When we suspend your licence' section to include reference to open public investigations. Yesterday MHRA released an update on suspended manufacturing and wholesale distribution authorization. You can find out more about how to pay your fees in our guidance on making a payment to MHRA. New document added to page for September 2017. The list of suspended manufacturing and wholesale distribution authorisations has been updated. You cannot legally undertake licensable activity while your licence is suspended this includes during an appeal. either alone or jointly. 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. BUILDING 4, Under 'Ways to make your submission', Updated email address and naming to Department of Health and Social Care. IAG are non-statutory multi-disciplinary groups which advise MHRA's Director of IE&S on recommendations for regulatory action. It will take only 2 minutes to fill in. The use of POs is an internal control process and cannot be used as a reason to withhold payment of legitimate invoices. Sara Berry Or if you need to cancel a parallel import product. CH5 2NT, Updated document - Suspended manufacturing and wholesale distribution authorisations. TW9 2QE, 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. 09 October 2019. 2 NEWTECH SQUARE, This information is common to all procedures. EN6 1TL, On-site inspections will resume as soon as travel restrictions permit. The absence of a GMP certificate should not be understood as meaning that the active substance manufacturer in question does not comply with GMP. If you have any questions about MHRA Submissions , you should email submissions@mhra.gov.uk. 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. This file may not be suitable for users of assistive technology. Published updated version of Suspended manufacturing and wholesale distribution authorisations list. The Licence Number is a specific number allocated to one company. Fees vary depending on the type and route of application. 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. To help us improve GOV.UK, wed like to know more about your visit today. If you think your submission has been wrongly rejected, you should email ris.na@mhra.gov.uk. This includes information of a commercially sensitive or personal nature, that may need to be restricted in the interests of security. This does not replace your right of appeal through the courts. Report a side effect with a medicine or medical device. Its licence was "largely reinstated" following a re-investigation in April, says Sky. . latest Suspended manufacturing and wholesale distribution authorisations, Updated Suspended manufacturing and wholesale distribution authorisations, Updated suspended manufacturing and wholesale distribution authorisations. We updated the list of suspended manufacturing and wholesale distribution authorisations. Cancellation of a licence, authorisation or registration is when MHRA makes a decision to cancel the licence, authorisation or registration. 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. 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. If the referral results in an immediate suspension of a manufacturer's/wholesale dealer's licence, there are no rights of appeal for the immediate suspension (which can last no longer than 3 months), but the suspension can be challenged in the High Court. We also use cookies set by other sites to help us deliver content from their services. It can also be checked on the following register: Subscribe to stay in the loop & on the road!