Find out more about the different national and international procedures. 2. . You should submit your application using the electronic Common Technical Document (eCTD). New version of Revocation list has been uploaded. ASMFs holders must submit their dossier to the MHRA. We updated the list of suspended manufacturing and wholesale distribution authorisations. Added a link to the User Guide for the electronic application form. We will revoke (take away) your licence if: We will write to you before we revoke your licence, telling you what we intend to do and why. Dont include personal or financial information like your National Insurance number or credit card details. The MHRA Suspended and Revoked page states; "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" Terminated Licence: 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 suspended licences for manufacturers and wholesalers of medicines. TRIDENT PLACE, MOSQUITO WAY, Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. UK Licence No: PL 04425/0697 . Updated both attachments with newer files. CDL Disqualifications. The absence of a GMP certificate should not be understood as meaning that the active substance manufacturer in question does not comply with GMP. The MHRA also enforces European drug licensing regulations in the UK. 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) 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.. HATFIELD, Updated the terminated and cancelled manufacturing and wholesale dealer licences list. You have accepted additional cookies. Dont worry we wont send you spam or share your email address with anyone. An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees. 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. We also use cookies set by other sites to help us deliver content from their services. If your organisation operates a PO system, please make sure that the relevant PO is provided to the MHRA before the invoice is issued. 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. 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. If you have any questions about submitting your application you should email ris.na@mhra.gov.uk. updated suspended and revoked lists added to the page. 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. NISA RETAIL LIMITED. There is no additional fee for fast-tracking applications. DEESIDE, HUDDERSFIELD, The Site Number is a specific number allocated to one site. You can change your cookie settings at any time. 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. Link to companies GMP and GDP certificates, see EUDRAGMDP link above. 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. DEESIDE INDUSTRIAL PARK, Is there any portal where we can check the list of MIA holders? 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. Negligent failures of senior UK dermatologists, and senior MHRA doctors, are such that the MHRA should immediately suspend isotretinoin's licence for the treatment of under-18s, and introduce a substantive consent form for all other patients. G74 5PE, 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. Alpha Release This is a new service - your feedback will help improve it. WATFORD, 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. 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. Updated list of suspended and revoked licences and registrations. POTTERS BAR, The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated. 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. 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/. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced the licence suspension of ingenol mebutate gel (Picato). It is an additional route of appeal that we offer so that you can appeal in a way that does not incur court costs. The MHRA-GMDP database contains the following information issued by the MHRA relating to manufacturing and wholesale authorisations and certificates. UNITED KINGDOM, VIATRIS UK HEALTHCARE LIMITED, Any questions on the content of this database should be addressed to IE&S-IMT@mhra.gov.uk. All UK and Great Britain (England, Scotland and Wales) national applications should be submitted through the MHRA Submissions Portal. The lists of suspensions and revocations have been updated. 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. 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. 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). Melatonin 4mg/5ml oral suspension STD, SF, LF, AF, NSF 150ml 20620 8 Menadiol 5mg/5ml oral suspension STD, SF, LF, CF . . ; Getting multiple traffic violations or speeding tickets. 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. 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. If you do not respond to our letter we will revoke your licence automatically after 21 days. Complete the application to withdraw a pending application (MS Word Document, 35 KB) for and email it to us with withdrawal as your subject line. New list of terminated licenses, August 2016 to July 2017 added to the page. EnteroBiotix secures key additional MHRA license and announces regulatory milestones. An updated list of suspended licenses has been uploaded. 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. Details of the penalties are explained in ourFees Regulations. Published new version of the suspended manufacturing and wholesale distribution authorisations list. 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. Published updated 'Suspended manufacturing and wholesale distribution authorisations' spreadsheet. Updated ist of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked. You can use the A-Z list to find an active substance, or search for a medicine. Following the end of the transition period, published information on new procedures for obtaining a marketing authorisation in the UK, Great Britain (England, Scotland and Wales) or Northern Ireland. You can change your cookie settings at any time. Since inspections of manufacturers of active substances are based on risk, some active substance manufacturers may not be in possession of a GMP certificate. Your licence remains live during a court appeal. List of new manufacturing licences and wholesale distribution authorisations 2015: https://www.gov.uk/government/publications/medicines-new-manufacturing-and-wholesale-dealer-licences, List of manufacturers licences MIA and MANA, MIA(IMP) on EUDRAGMDP link below: http://eudragmdp.ema.europa.eu/inspections/displayHome.do. 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. Learn more about the circumstances that can lead to a licence holder losing their licence, either permanently or temporarily. The DHSC contact for fast-tracking a licence has changed. What the data show Since September 2020, 15 Companies were affected. 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. UNIT 191, CAMBRIDGE SCIENCE PARK, Use the pre-submission checklist (PDF, 129 KB, 7 pages) to help you with your application. We also use cookies set by other sites to help us deliver content from their services. Maalox 175mg/200mg Oral Suspension . If you use assistive technology (such as a screen reader) and need a Or you can submit the forms to us by email to withdrawcancel@mhra.gov.uk. Converse Pharma could not be reached for comment. 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. In April 2018, C+D reported that the suspension had been extended due to remaining "non-compliance issues". You can print blog posts using the keyboard shortcuts "Control P" or "Command P". 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). If you are applying for a UK, Great Britain or Northern Ireland licence, you must get a PL number from the MHRA Portal or by emailing PLNumberAllocation@mhra.gov.uk before you submit your application. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. IAG are non-statutory multi-disciplinary groups which advise MHRA's Director of IE&S on recommendations for regulatory action. You must then resend the entire submission with the errors corrected. Do not send the corrected deficiencies by email. The agency advised healthcare professionals to immediately stop supplying the batches and to quarantine and remove all remaining stock. https://mhrainspectorate.blog.gov.uk/2019/10/04/mhra-process-licensing-useful-information/. Updated list of companies in the UK who have had their licence to manufacture or wholesale medicines suspended. MILTON ROAD, For example, in Kentucky, it takes an accumulation of 12 points over the course of 2 years in order to receive a suspension. Also is there any process to verify that MIA licence is still valid? Published updated version of Suspended manufacturing and wholesale distribution authorisations list. UNITED KINGDOM, VIATRIS UK HEALTHCARE LIMITED, Comment by You have accepted additional cookies. Updated: list of suspended manufacturing and wholesale distribution authorisations, Updated: list of revoked manufacturing and wholesale distribution authorisations. If we suspend your licence, the suspension comes into effect immediately. Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended. Updated revoked and suspended documents on the page. Published a new version of the 'Get Licensed' document. Alpha Release This is a new service - your feedback will help improve it. GLASGOW, UNITED KINGDOM, THE MENTHOLATUM COMPANY LIMITED, Download CSV If your application for these types of licences is pending and you no longer wish to proceed, you need to withdraw it. 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). Well send you a link to a feedback form. Dont worry we wont send you spam or share your email address with anyone. Anyone in the pharmaceutical or medicinal supply chain should use this list to ensure they are dealing with a valid licence or authorisation holder. You have rejected additional cookies. Truancy. RICHMOND, Or if you need to cancel a parallel import product licence, complete the cancellation form (PDF, 525 KB, 3 pages). Added updated list of suspended manufacturing and wholesale distribution authorisations. Updated list of suspended licences and registrations for manufacturers and wholesalers of medicines and ingredients. 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 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 can read our guidance about the submission of ASMFs. Updated the list of suspended manufacturing and wholesale distribution authorisations. 29.3 KB. Updated the 'When we suspend your licence' section to include reference to open public investigations. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Alternatively, we can maintain the suspension until we have all of the information we require to make a licensing decision. 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. All Rights Reserved. Updated 'Suspended manufacturing and wholesale distribution authorisations' list, Updated 'Revoked manufacturing and wholesale distribution authorisations' list. List of suspended manufacturing and wholesale distribution authorisations updated. 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. Yesterday MHRA released an update on suspended manufacturing and wholesale distribution authorization. This does not replace your right of appeal through the courts. An industry source said on Wednesday that Converse Pharma had intended to explore a sale process as part of a planned exit for its shareholders shortly before the MHRA suspension was implemented. Refusal of licence / variation or an existing licence being revoked. Replaced the PDF with a more accessible file. Certificates of Suitability (CEPs) continue to be acceptable in support of UK and GB national authorisations.. UNITED KINGDOM, Terms and Conditions Opens in new window | Privacy Notice Opens in new window, Click on this link to navigate to www.mhra.gov.uk. 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.

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