You can read our guidance about the submission of ASMFs. Uploaded updated Suspended manufacturing and wholesale distribution authorisations list. Or if you need to cancel a parallel import product. We use some essential cookies to make this website work. People are at the heart of Good Distribution Practice (GDP) and the RP is the central person within a Licence Holder's operations ensuring compliance with the conditions of the licence and ensuring the quality of the medicinal products handled. Subscribe to our News and Updates to stay in the loop and on the road! Any submission that does not meet the requirements will be rejected. This does not replace your right of appeal through the courts. Submit the relevant forms above to MHRA via the MHRA portal if youre a UK applicant. 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. An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees. Published Medicines: terminated and cancelled manufacturing and wholesale dealer licences for August 2019. Reinstating Your License. ASMFs holders must submit their dossier to the MHRA. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Its licence was "largely reinstated" following a re-investigation in April, says Sky. It can also be checked on the following register: 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. PILs are based on the Summaries of Product Characteristics (SPCs) which are a description of a medicinal products properties and the conditions attached to its use. Dont include personal or financial information like your National Insurance number or credit card details. 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. We find an easy way to remember is to set a recurrent reminder in your Outlook calendar or Gmail diary. The Agency has the power to withdraw a product from the market, and in the case of medicines, to suspend production. Suspended vs. Revoked License: The Differences, Driving with a Suspended License: What You Need to Know. UK WDA (H) 12426. have helped thousands of drivers regain their driving privileges after cancellation, suspension or revocation. Well send you a link to a feedback form. You must do so within 21 days of the suspension coming into effect. MHRA alerts & recalls PharmData maintains a list of all MHRA alerts and recalls relevant to community pharmacy. It is an additional route of appeal that we offer so that you can appeal in a way that does not incur court costs. 2 NEWTECH SQUARE, UNITED KINGDOM, VIATRIS UK HEALTHCARE LIMITED, . Check benefits and financial support you can get, Find out about the Energy Bills Support Scheme, Manufacturing, wholesaling, importing and exporting medicines, Medicines and Healthcare products Regulatory Agency, Medicines: terminated and cancelled manufacturing and wholesale dealer licences, Human and veterinary medicines: register of licensed wholesale distribution sites, Medicines: new manufacturing and wholesale dealer licences, Human and veterinary medicines: register of licensed manufacturing sites, Apply for manufacturer or wholesaler of medicines licences, Licences to manufacture or wholesale medicines. Updated 'Revoked manufacturing and wholesale distribution authorisations' and 'Suspended manufacturing and wholesale distribution authorisations' lists. You can change your cookie settings at any time. 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. You have rejected additional cookies. New September 2020 version of 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. The summary of product characteristics (SmPC) should be submitted to the MHRA in the correct format using the SPC template (MS Word Document, 36 KB). We use some essential cookies to make this website work. Updated: list of terminated and cancelled manufacturing and wholesale dealer licences, Updated: list of terminated revoked and cancelled licences, Updated: List of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. If you do not include the correct information your application will not be validated. Updated the suspended manufacturing and wholesale distribution authorisations list. Published 4 February 2015 Last updated 5 January. It is the MA applicants responsibility to make sure that the ASMF is submitted either before you submit your application or at the same time, as your application will not be valid without it. You should also use this form if you want to withdraw a variation application or amendment for an existing MA. You can also use the A-Z list to find the active substance. An example of when we might do this is if you are convicted of a relevant criminal offence. The clarifying remark section of individual GMP and GDP certificates will indicate any exceptions. The MHRA-GMDP database contains the following information issued by the MHRA relating to manufacturing and wholesale authorisations and certificates. D ate of . 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: . Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences' attachment to latest version. New document added to page for September 2017. Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission. Company name,Licence revoked,Date of revocation,Reason PRESTFORD LIMITED,WDA(H) 43010,04-Apr-22,Regulatory Action ACCENDO PHARMA LIMITED,WDA(H) 43391,16-Dec-21,Regulatory Action CHOPRAS PHARMACY LIMITED,WDA(H) 39745,17-Nov-21,Regulatory Action CELTICPHARM LIMITED,WDA(H) 44336,11-Nov-21,Regulatory Action WISE PHARMACIES LIMITED,WDA(H) 41881,11-Oct-21,Regulatory Action GIS MEDICAL & SURGICAL . Updated lists of suspended and revoked licenses. Published updated version of Suspended manufacturing and wholesale distribution authorisations list. This includes information of a commercially sensitive or personal nature, that may need to be restricted in the interests of security. If you think your submission has been wrongly rejected, you should email ris.na@mhra.gov.uk. List of suspended manufacturing and wholesale distribution authorisations updated. Link to companies GMP and GDP certificates, see EUDRAGMDP link above. 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. New list of suspended manufacturing and wholesale distribution authorisations added to the page. What the data show Since September 2020, 15 Companies were affected. Published updated list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. Our letter will also tell you how to appeal against our decision. 10 October 2019, MIA holders can be checked on the Eudra GMDP webpage for validity. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. 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. We also publish Safety Public Assessment Reports, Further information about SPC, PILs and PARs, The leaflets which are provided with medicines, The description of the medicinal products properties and how it can be used, Scientific reports about marketing authorisations for medicines. Updated revoked and suspended documents on the page. MILTON ROAD, Updated file 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. The lenders have hired PricewaterhouseCoopers to advise them, according to one insider. Details of the penalties are explained in ourFees Regulations. MHRA is the Government body set up to discharge the responsibilities of the Licensing Authority, under powers delegated by those Ministers. Dont worry we wont send you spam or share your email address with anyone. Updated both 'revoked' and 'Suspended' manufacturing and wholesale distribution authorisations lists. Drug wholesaler hit by MHRA suspension hires advisers to find funding injection, Converse Pharma distributes a range of generic drugs. It is your responsibility to make sure the invoices for your submissions are paid on time. Or you can submit the forms to us by email to withdrawcancel@mhra.gov.uk. Any questions on the content of this database should be addressed to IE&S-IMT@mhra.gov.uk. Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. UNITED KINGDOM, MYONEX LIMITED, You can also tell us about any factual errors that may have affected our decision. Updated both attachments with newer files. HD1 6EF, Please note the site register will be updated on a quarterly basis. We publish scientific assessment reports called a Public Assessment Report (PAR) available for new marketing authorisations granted after 30 October 2005. Suspended Driver's License. TRIDENT PLACE, MOSQUITO WAY, You have accepted additional cookies. This means that you can still work during your appeal, unless we have also suspended your licence. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. 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. We also use cookies set by other sites to help us deliver content from their services. Published a new version of the 'Get Licensed' document. If you have any questions about submitting your application you should email ris.na@mhra.gov.uk. The MHRA announces recall of paracetamol tablets, after certain products were found to be discoloured due to the presence of fungi. Failure to Appear. UNITED KINGDOM, BCM LIMITED, Uploaded updated suspended and revoked licences lists. Uploaded new Suspended manufacturing and wholesale distribution authorisations spreadsheet. 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. It will take only 2 minutes to fill in. @MarkKleinmanSky. Refusal to pay outstanding fees on the grounds that the PO is not provided on the invoice will not be accepted. Published new list of Suspended manufacturing and wholesale distribution authorisations. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. 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. New version of Revocation list has been uploaded. 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. Updated the list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. 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). Common: Headache, dizziness. Healthcare. 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. View online Updated list of suspended licences and registrations for manufacturers and wholesalers of medicines and ingredients. Wholesale dealer licences/API/broker licences: GDP.Inspectorate@mhra.gov.uk, Manufacturing licences: gmpinspectorate@mhra.gov.uk. Under 'Ways to make your submission', Updated email address and naming to Department of Health and Social Care. You cannot legally undertake licensable activity while your licence is suspended this includes during an appeal. Uploaded new version of Suspended and revoked licences list. If you have submitted an application for a new MA, traditional herbal remedy and/or a parallel import product licence and you no longer want to proceed with application, you need to submit a withdrawal form. If you do not respond to our letter we will revoke your licence automatically after 21 days. https://mhrainspectorate.blog.gov.uk/2019/10/04/mhra-process-licensing-useful-information/. POTTERS BAR, The Process Licensing Office sits within the Inspectorate and Process Licensing Group of the Inspection, Enforcement and Standards division. Updated the terminated and cancelled manufacturing and wholesale dealer licences for September 2021. This is based on the MHRA assessment report with any commercially or personally confidential information removed. This information is common to all procedures. 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. posted on Suspended list updated to show licenses that have been terminated/revoked and therefore no longer suspended. Proposed suspension, variation . MHRA Suspended Licence checks are a critical part of your Quality Management System and Risk Management processes, so keep on top of them. We use some essential cookies to make this website work. The wholesale distribution of medicinal products and importation of medicines certified by a Qualified Person in accordance with Article 51 of Directive 2001/83/EC from listed countries is subject to the holding of a Wholesale Distribution Authorisation. Since inspections of manufacturers of active substances are based on risk,. Our legal power to do this is explained in Get Licensed (PDF, 3.03 MB, 90 pages). You can change your cookie settings at any time. Phase 4 studies. The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated to include May 2015. BEESTON, This will ensure you are not charged a periodic fee for the period 1 April 2016 to 31 March 2017. If you have any questions about the Submissions Portal, you should email submissions@mhra.gov.uk. 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/. Well send you a link to a feedback form. Updated attachment - March to Feb 2019 edition, Updated list of terminated and cancelled manufacturing and wholesale dealer licences. The licence of DE Group's Testerworld unit is understood to have been largely reinstated in April following re-inspections by the agency. For example, in Kentucky, it takes an accumulation of 12 points over the course of 2 years in order to receive a suspension. Alternatively, we can maintain the suspension until we have all of the information we require to make a licensing decision. 783 Bytes. 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. 09 October 2019. CH5 2NT, You have accepted additional cookies. The MHRA also enforces European drug licensing regulations in the UK. Please note that companies are not required to make payment on submission of both initial and variation application for all wholesale dealer and manufacturing licences invoices are sent via email once the companys application has been processed by the process licensing team. Report a side effect with a medicine or medical device. will check that NeeS and eCTD submissions are technically valid using the Extedo Eurs is Yours (EiY) validation tool. The suspension of the license will last until "Teva has completed its investigation and resolved the underlying issues ", the MHRA wrote. 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. G74 5PE, Replaced the PDF with a more accessible file. You can find out more about how to pay your fees in our guidance on making a payment to MHRA. 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. Updated list of terminated and cancelled manufacturing and wholesale dealer licences, List of terminated and cancelled licences updated, Updated list of terminated and cancelled licenses, Updated List of Terminated and Cancelled Manufacturing and Wholesale Dealer Licences, Updated List of Terminated and Cancelled Updated list of terminated and cancelled manufacturing and wholesale Suspended manufacturing and wholesale distribution authorisations list updated. Updated suspended manufacturing and wholesale distribution authorisations. Added updated list of suspended manufacturing and wholesale distribution authorisations. You have rejected additional cookies. 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. 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. Updated the terminated and cancelled manufacturing and wholesale dealer licences list. Download CSV Published updated versions of the Revoked manufacturing and wholesale distribution authorisations list and the Suspended manufacturing and wholesale distribution authorisations list. Published a new version of the Suspended manufacturing and wholesale distribution authorisations list. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. 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 BUILDING 20, STATION CLOSE, Updated list of suspended licences for manufacturers and wholesalers of medicines. Sara Berry If we suspend your licence, the suspension comes into effect immediately. If a submission is rejected, we will email you the reasons for the rejection. Dont worry we wont send you spam or share your email address with anyone. Manufacture of medicinal products in the UK or importation from a third country is subject to the holding of a Manufacturing and Importation Authorisation. Uploaded new version of Suspended manufacturing and wholesale distribution authorisations. Accumulating too many driving record points. 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. 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 list of suspensions. Also is there any process to verify that MIA licence is still valid? (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). Updated suspension list added to the page. In August 2018, EnteroBiotix announced that the company had been awarded a manufacturer's specials license . 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. You should read the guidance for your specific pathway for any extra information or steps that might be required. Marketing. For 1 company the licence was terminated. Updated: list of terminated and cancelled manufacturing and wholesale dealer licences. The attorneys at The Davis Law Group, P.C. Healthcare products Regulatory Agency (MHRA) inspectorate as soon as possible. Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended. GLASGOW, 1 CHURCH ROAD, Do not send the corrected deficiencies by email. 9-11 HILLHOUSE LANE, 29.3 KB. mhra licence suspension Added spreadsheet under "types of application" heading. 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. You have rejected additional cookies. posted on You have accepted additional cookies. Following the MHRA's confirmation of "more than 40 arrests" and the suspension of five pharmacists, the BBC - which claimed to have seen a full copy of the watchdog's intelligence report - said 19 wholesalers are still "under suspicion as investigations into the criminal network continue". 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. Updated Suspended manufacturing and wholesale distribution authorisations List, Updated the list of Suspended manufacturing and wholesale distribution authorisations. We recommend that you use a validation tool to check your submission as we Updated list of terminated and cancelled manufacturing and wholesale dealer licences. 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. WATFORD, News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. MHRA reserves the right. 94 RICKMANSWORTH ROAD, updated Suspended and revoked licences for manufacturers and wholesalers of medicines, list of suspended manufacturing and wholesale distribution authorisations updated. We may lift the suspension if you are found not guilty or the charges are dropped. If the outcome of the inspection is that the manufacturer does not comply, a statement of non-compliance may be issued and entered into MHRA-GMDP. You can go to the MHRA-GMDP website to view the lists of: Updated the suspended and revoked licenses list. Penalty fees may be incurred for non-payment. Medical Evaluation Process. Updated the list of suspended licences for manufacturers and wholesalers of medicines. The information published in this Register was that held by the MHRA on the date of publication. The list of suspensions and revocations is updated on the same day that the suspension or revocation takes place. 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. 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. These templates should not be altered in any way, other than inserting the relevant information. Updated 'Suspended manufacturing and wholesale distribution authorisations' link. Melatonin 4mg/5ml oral suspension STD, SF, LF, AF, NSF 150ml 20620 8 Menadiol 5mg/5ml oral suspension STD, SF, LF, CF .