The lists of suspensions and revocations have been updated. Find out more about the different national and international procedures. If you do not respond to our letter we will revoke your licence automatically after 21 days. It is your responsibility to make sure the invoices for your submissions are paid on time. 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. Updated 'Revoked manufacturing and wholesale distribution authorisations' and 'Suspended manufacturing and wholesale distribution authorisations' lists. This will ensure you are not charged a periodic fee for the period 1 April 2016 to 31 March 2017. DEESIDE, Call us at (847) 390-8500 or submit your information via our contact form to arrange a free consultation. New version of the revocation and suspension lists has been uploaded. Published a new version of the Suspended manufacturing and wholesale distribution authorisations list. 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. Well send you a link to a feedback form. At 1936 per MHRA inspection or re-inspection, you want as few visits as possible. EN6 1TL, Truancy. Department of Health and Social Care (DHSC) has issued a medicine supply notification for Ranitidine (all formulations) . Submission of a new ASMF and any update to an ASMF should be made by the ASMF holder using MHRA Submissions . In August 2018, EnteroBiotix announced that the company had been awarded a manufacturer's specials license . A drug distributor which had its licence suspended earlier this year by Britain's medicines watchdog has hired City advisers to raise tens of millions of pounds of new funding. Published updated versions of the Revoked manufacturing and wholesale distribution authorisations list and the Suspended manufacturing and wholesale distribution authorisations list. 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. The list of suspended licences has been updated. The Site Number is a specific number allocated to one site. Suspensions & Reinstatements. It will take only 2 minutes to fill in. You have rejected additional cookies. If your application for these types of licences is pending and you no longer wish to proceed, you need to withdraw it. Melatonin 4mg/5ml oral suspension STD, SF, LF, AF, NSF 150ml 20620 8 Menadiol 5mg/5ml oral suspension STD, SF, LF, CF . 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. 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. The Medicines and Healthcare products Regulatory Agency (MHRA) The MHRA looks at new drugs when pharmaceutical companies want to license medicines outside of the EMA's centralised authorisation procedure. Registered users can receive instant email notifications of new alerts, and record their responses to MHRA alerts within their PharmData account. You will not be charged if your submission is rejected for technical reasons. 10 October 2019, MIA holders can be checked on the Eudra GMDP webpage for validity. You can find out more about how to pay your fees in our guidance on making a payment to MHRA. 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. 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. Revocation List updated with a new addition. UNITED KINGDOM, BCM LIMITED, Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. NOTTINGHAM, We use some essential cookies to make this website work. 9-11 HILLHOUSE LANE, 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. Uploaded new version of Suspended manufacturing and wholesale distribution authorisations. 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.. The list of suspensions and revocations is updated on the same day that the suspension or revocation takes place. Suspended manufacturing and wholesale distribution authorisations list updated. ALR Program. You will need to register if you havent already. Published updated Revoked manufacturing and wholesale distribution authorisations list. "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. The List of Terminated and Cancelled Licences has been updated. Published updated list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. You have accepted additional cookies. Monthly update to 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. REACTA BIOTECH LIMITED T/A REACTA HEALTHCARE, We use some essential cookies to make this website work. Failure to Appear. Dealer Licences 2016 to October, Updated list of terminated and cancelled licences. 2. . LE4 3EH, Updated the terminated and cancelled manufacturing and wholesale dealer licences list. List of API manufacturers, importers and distributors, see EUDRAGMDP link above. Published updated 'Suspended manufacturing and wholesale distribution authorisations' spreadsheet. . Penalty fees may be incurred for non-payment. July update to Terminated, Revoked, Cancelled licences file. 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. It can also be checked on the following register: Updated the list of terminated, cancelled and revoked manufacturing and wholesale dealer licences, Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences' attachment to December 2021, Updated list of medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences. Any questions on the content of this database should be addressed to IE&S-IMT@mhra.gov.uk. New list of suspended manufacturing and wholesale distribution authorisations added to the page. You can appeal our decision to suspend your licence in a Magistrates or Sheriff Court. TRIDENT PLACE, MOSQUITO WAY, Depending on the state you live in, you may incur a suspension for a different amount of points. Updated Suspended manufacturing and wholesale distribution authorisations list. MILTON ROAD, Subscribe to stay in the loop & on the road! CB4 0GW, (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). Comment by We also use cookies set by other sites to help us deliver content from their services. https://mhrainspectorate.blog.gov.uk/2019/10/04/mhra-process-licensing-useful-information/. Suspension lifted for Metro Pharmacy Limited. 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. Following recent advice from the EMA, the MHRA have suspended all licenses for ranitidine products. You must do so within 21 days of the suspension coming into effect. The MHRA products website allows you to find: You can look for any word, phrase or Product Licence number (PL) using the search tool. Uploaded new Suspended manufacturing and wholesale distribution authorisations list. Sara Berry The absence of a GMP certificate should not be understood as meaning that the active substance manufacturer in question does not comply with GMP. 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. Uploaded updated Medicines terminated and cancelled manufacturing and wholesale dealer licences PDF. You should submit your application using the electronic Common Technical Document (eCTD). UNITED KINGDOM, BARD PHARMACEUTICALS LIMITED, Added list of terminated and cancelled licences for April 2019. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Pay Restoration Fee Provide proof of payment of outstanding fines/tickets Parking Violations How to Pay Parking Tickets There is no additional fee for fast-tracking applications. The Licence Number is a specific number allocated to one company. List of suspended manufacturing and wholesale distribution authorisations updated. Uploaded updated suspended and revoked licences lists. 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. Updated content to reflect that the UK cannot act as a Reference Members State (RMS) for approval of marketing authorisations in decentralised and mutual recognition licensing procedures during the transition period. Added updated list of suspended manufacturing and wholesale distribution authorisations. We updated the list of suspended manufacturing and wholesale distribution authorisations. Dont worry we wont send you spam or share your email address with anyone. 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. mhra licence suspension mhra licence suspension vo 9 Thng Su, 2022 vo 9 Thng Su, 2022 HATFIELD, Terminated and cancelled manufacturing and wholesale dealer licences for January through to February 2016. Maalox oral suspension - Magnesium hydroxide; Aluminium hydroxide gel dried Magnesium hydroxide; . The use of POs is an internal control process and cannot be used as a reason to withhold payment of legitimate invoices. Published Medicines: terminated and cancelled manufacturing and wholesale dealer licences for August 2019. The licence of DE Group's Testerworld unit is understood to have been largely reinstated in April following re-inspections by the agency. Manufacturing and Wholesale Uploaded new Suspended manufacturing and Revoked spreadsheets. Copy CSV Excel PDF Print Showing 1 to 10 of 325 entries Previous 1 2 3 4 5 33 Next 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. It will take only 2 minutes to fill in. Ilyas ali Well send you a link to a feedback form. 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. Also is there any process to verify that MIA licence is still valid? DEESIDE INDUSTRIAL PARK, You have rejected additional cookies. Dont worry we wont send you spam or share your email address with anyone. Updated: list of revoked manufacturing and wholesale distribution authorisations. You can use the A-Z list to find an active substance, or search for a medicine. All UK and Great Britain (England, Scotland and Wales) national applications should be submitted through the MHRA Submissions Portal. 09/02/2023. If you do not include the correct information your application will not be validated. Updated the suspended manufacturing and wholesale distribution authorisations list. 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. You can also submit the forms via the Central European System Platform (CESP). HD1 6EF, Refusal to pay outstanding fees on the grounds that the PO is not provided on the invoice will not be accepted. Updated suspension list added to the page. Energy bill support to be extended as price rise looms, Arm snubs London to float on the New York Stock Exchange despite PM's efforts but announces new Bristol site, Body blow for Downing Street and govt promise to turn UK into 'new Silicon Valley'. Updated both 'revoked' and 'Suspended' manufacturing and wholesale distribution authorisations lists. 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. 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. Published new suspended manufacturing and wholesale distribution authorisations list. You have rejected additional cookies. 1 CHURCH ROAD, Updated list of suspended licenses added to the page. THANE ROAD, 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. You must cancel your marketing authorisation (MA), parallel import product licence and/or traditional herbal remedy registration, before a product can be removed from the market. Well send you a link to a feedback form. Updated list of suspended licences and registrations for manufacturers and wholesalers of medicines and ingredients. Under 'Ways to make your submission', Updated email address and naming to Department of Health and Social Care. Updated both attachments - Revoked manufacturing and wholesale distribution authorisations and Suspended manufacturing and wholesale distribution authorisations, New list of Suspended manufacturing and wholesale distribution authorisations uploaded, Updated 'Suspended manufacturing and wholesale distribution authorisations' csv file, Added NECESSITY SUPPLIES LIMITED and their suspension till Feb 2020, We have updated the current suspended list, Suspended manufacturing and wholesale distribution authorisations update, We have updated the Suspended manufacturing and wholesale distribution authorisations data, We have updated the suspended manufacturing and wholesale distribution authorisations list, Published updated lists of suspended and revoked licences. List of manufacturer specials (human) (MS) and manufacturer specials authorisation (veterinary): https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-manufacturing-sites, List of licensed wholesale distribution sites (human and veterinary): https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-wholesale-distribution-sites, List of brokers: https://www.gov.uk/government/publications/register-of-brokers-authorised-to-deal-in-human-medicines, List of suspended and revoked licences and authorisations: https://www.gov.uk/government/publications/suspended-licences-for-manufacturers-and-wholesalers-of-medicines, Export certificates: https://www.gov.uk/export-a-human-medicine, Terminated and cancelled manufacturing and wholesale dealer licences: https://www.gov.uk/government/publications/medicines-terminated-and-cancelled-manufacturing-and-wholesale-dealer-licences. Removed link to Excel spreadsheet list of products. This does not replace your right of appeal through the courts. BUILDING 4, Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. We use some essential cookies to make this website work. Published new list of Suspended manufacturing and wholesale distribution authorisations. We can revoke (take away) your licence if you no longer meet our licensing criteria. Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission. The MHRA-GMDP database contains the following information issued by the MHRA relating to manufacturing and wholesale authorisations and certificates. Refrain from driving for a period of time. Please note, you are required as a company to ensure that all personal details provided to the MHRA are up to date and the MHRA needs to be notified within any application if any changes in personal details need to be updated, including email addresses and telephone numbers. You can go to the MHRA-GMDP website to view the lists of: Updated the suspended and revoked licenses list. Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences' link to latest January 2021 version. 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. 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. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. We also use cookies set by other sites to help us deliver content from their services. Learn more about the circumstances that can lead to a licence holder losing their licence, either permanently or temporarily. The suspension period varies by the customer's number of convictions and age while holding a provisional driver's license: 2nd conviction over 18 years - 30 days; 2nd conviction under 18 years - 30 days suspension and employment and education restriction for 90 days effective at the removal of the suspension @MarkKleinmanSky. You can change your cookie settings at any time. 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 Submit the relevant forms above to MHRA via the MHRA portal if youre a UK applicant. We also use cookies set by other sites to help us deliver content from their services. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced the licence suspension of ingenol mebutate gel (Picato). 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. Or if you need to cancel a parallel import product. For 1 company the licence was terminated. UNIT 191, CAMBRIDGE SCIENCE PARK, These can then be investigated further to decide whether a side effect is truly from a . Updated the list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled.
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