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. Medical Evaluation Process. You will not be charged if your submission is rejected for technical reasons. Comment by The MHRA-GMDP database contains the following information issued by the MHRA relating to manufacturing and wholesale authorisations and certificates. 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. You must do so within 21 days of the revocation coming into effect. 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. 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. EnteroBiotix secures key additional MHRA license and announces Updated the terminated and cancelled manufacturing and wholesale dealer licences list. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. For example, in Kentucky, it takes an accumulation of 12 points over the course of 2 years in order to receive a suspension. We find an easy way to remember is to set a recurrent reminder in your Outlook calendar or Gmail diary. Once your application has been validated you will receive an invoice so that you can make a payment for the outstanding amount. You have rejected additional cookies. Pay Restoration Fee Provide proof of payment of outstanding fines/tickets Parking Violations How to Pay Parking Tickets Suspended Driver's License. You have accepted additional cookies. Removed link to Excel spreadsheet list of products. If you do not include the correct information your application will not be validated. Published updated list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. TW9 2QE, 1 CHURCH ROAD, The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated to include May 2015. We also use cookies set by other sites to help us deliver content from their services. 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. You have rejected additional cookies. DEESIDE, version of this document in a more accessible format, please email, Check benefits and financial support you can get, Find out about the Energy Bills Support Scheme, Medicines and Healthcare products Regulatory Agency, Medicines: notes for applicants and holders of a wholesale dealer licence or broker registration, Veterinary Medicines Registers: manufacturing and distribution, Licences to manufacture or wholesale medicines, Medicines: variation forms for a manufacturer's licence. It will take only 2 minutes to fill in. Updated Suspended manufacturing and wholesale distribution authorisations CSV file. AstraZeneca's antibody combination, Evusheld (tixagevimab co-packaged The suspension of the license will last until "Teva has completed its investigation and resolved the underlying issues ", the MHRA wrote. Submit the relevant forms above to MHRA via the MHRA portal if youre a UK applicant. Phase 4 studies. 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. Updated both 'revoked' and 'Suspended' manufacturing and wholesale distribution authorisations lists. 29.3 KB. You have accepted additional cookies. We updated the list of suspended manufacturing and wholesale distribution authorisations. We also use cookies set by other sites to help us deliver content from their services. Updated Suspended manufacturing and wholesale distribution authorisations List, 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. 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. These can then be investigated further to decide whether a side effect is truly from a . Updated Suspended manufacturing and wholesale distribution authorisations list. MHRA update of Suspended or Revoked Businesses: are you affected? 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. WDA Suspended, Terminated, Cancelled And Revoked What Do These Terms What the data show Since September 2020, 15 Companies were affected. the mentholatum company limited, 1 redwood avenue, peel park campus, east kilbride, glasgow, g74 5pe, united kingdom You can appeal our decision to suspend your licence in a Magistrates or Sheriff Court. Common: Headache, dizziness. Learn why we would revoke or suspend your licence - GOV.UK Manufacturing and Wholesale Updated suspension list added to the page. Updated list of suspended licences and registrations for manufacturers and wholesalers of medicines and ingredients. 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 . 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. PDF 03/2023 Part VIIIB ARRANGEMENTS FOR PAYMENT FOR SPECIALS AND IMPORTED 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 MHRA's primary role is to protect public health and the IAG process forms a regulatory tool to manage this. New version of suspended list has been uploaded. mhra licence suspension mhra licence suspension vo 9 Thng Su, 2022 vo 9 Thng Su, 2022 Published a new version of the 'Get Licensed' document. Updated list of suspended licences for manufacturers and wholesalers of medicines. DEESIDE INDUSTRIAL PARK, New document added to page for September 2017. 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. The current 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). The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated. You can change your cookie settings at any time. Updated 'Suspended manufacturing and wholesale distribution authorisations' link. Well send you a link to a feedback form. Failure to Appear. 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. To help us improve GOV.UK, wed like to know more about your visit today. List of revoked manufacturing sites updated. EMA suspends Picato as a precaution while review of skin cancer risk We also use cookies set by other sites to help us deliver content from their services. posted on You have accepted additional cookies. "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. Maalox 175mg/200mg Oral Suspension . Uploaded new version of Suspended and revoked licences list. Or if you need to cancel a parallel import product licence, complete the cancellation form (PDF, 525 KB, 3 pages). Find out more about the different national and international procedures. 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: 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. 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. Gov.uk New terminated and cancelled manufacturing and wholesale dealer licences list uploaded, Updated link 'Medicines terminated and cancelled manufacturing and wholesale dealer licences', Updated list of medicines terminated and cancelled manufacturing and wholesale dealer licences. The MHRA has been assured that acceptable standards of Good Manufacturing Practice are in place for . NOTTINGHAM, The MHRA products website allows you to find: You can look for any word, phrase or Product Licence number (PL) using the search tool. Reinstating Your License. You must do so within 21 days of the suspension coming into effect. You have rejected additional cookies. This is based on the MHRA assessment report with any commercially or personally confidential information removed. MILTON ROAD, All other specific services or enquiries contact can be found via the following link: https://www.gov.uk/guidance/contact-mhra#contents, Medicines and Healthcare products Regulatory Agency, Inspection, Enforcement & Standards Division Inspectorate and Process licensing, 10 South Colonnade, Canary Wharf, London E14 4PU, Dont miss the next post, sign up to be notified by email when a new post comes out, Comment by WD18 7JJ, G74 5PE, Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. All invoices must be settled upon receipt. You can go to the MHRA-GMDP website to view the lists of: Updated the suspended and revoked licenses list. BUILDING 20, STATION CLOSE, The Process Licensing Office sits within the Inspectorate and Process Licensing Group of the Inspection, Enforcement and Standards division. We use some essential cookies to make this website work. Updated lists of suspended and revoked licences. D ate of . Updated file 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. Updated document - Suspended manufacturing and wholesale distribution authorisations. 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. will check that NeeS and eCTD submissions are technically valid using the Extedo Eurs is Yours (EiY) validation tool. 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 use of POs is an internal control process and cannot be used as a reason to withhold payment of legitimate invoices. The Responsible Person named on the WDA -Part 2: Effective Appointment