dealer licences. These can then be investigated further to decide whether a side effect is truly from a . 29.3 KB. Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely. The lists of suspensions and revocations have been updated. You can change your cookie settings at any time. Published updated Revoked manufacturing and wholesale distribution authorisations list. We will also tell you what you can do that might stop us from revoking your licence. We use some essential cookies to make this website work. 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 'Revoked manufacturing and wholesale distribution authorisations' list. List of suspended licences for manufacturers and wholesalers of medicines updated, Updated the suspended list with two new suspensions and corrected suspension date for St Helen's Millennium Centre Services Limited. List of suspended manufacturing and wholesale distribution authorisations updated. 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. New version of the revocation and suspension lists has been uploaded. An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees. 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. An example of when we might do this is if you are convicted of a relevant criminal offence. LE4 3EH, Added updated list of suspended manufacturing and wholesale distribution authorisations. Updated the Suspended manufacturing and wholesale distribution authorisations list. Updated list of terminated and cancelled manufacturing and wholesale 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: . You can read our guidance about the submission of ASMFs. 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. Copy CSV Excel PDF Print Showing 1 to 10 of 325 entries Previous 1 2 3 4 5 33 Next BEESTON, Suspended manufacturing and wholesale distribution authorisations list updated. Published updated version of Suspended manufacturing and wholesale distribution authorisations list. Any submission that does not meet the requirements will be rejected. Replaced the PDF with a more accessible file. BUILDING 20, STATION CLOSE, Please note, this includes changes to MHRA Guidance Note 6 1. EMA is recommending that patients stop using Picato (ingenol mebutate), a gel for treating the skin condition actinic keratosis, while it continues its review of the medicine's safety. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. It also covers 'sunset-clause' monitoring. You must do so within 21 days of the revocation coming into effect. If your organisation operates a PO system, please make sure that the relevant PO is provided to the MHRA before the invoice is issued. In April 2018, C+D reported that the suspension had been extended due to remaining "non-compliance issues". 9-11 HILLHOUSE LANE, An updated list of suspended licenses has been uploaded. Suspended vs. Revoked License: The Differences, Driving with a Suspended License: What You Need to Know. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. 09/02/2023. View online Accumulating too many driving record points. When autocomplete results are available use up and down arrows to review and enter to select. You can change your cookie settings at any time. Common: Headache, dizziness. Uploaded new Suspended manufacturing and wholesale distribution authorisations list. You will need to register if you havent already. This does not replace your right of appeal through the courts. Updated revoked and suspended documents on the page. 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. Well send you a link to a feedback form. UNITED KINGDOM, BCM LIMITED, For example, in Kentucky, it takes an accumulation of 12 points over the course of 2 years in order to receive a suspension. Drug wholesaler hit by MHRA suspension hires advisers to find funding injection, Converse Pharma distributes a range of generic drugs. 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). WELBECK PHARMACEUTICALS & HOSPITAL SUPPLIES LIMITED , 35 DEVONSHIRE STREET, LONDON, W1G 6PZ, UNITED KINGDOM. The above events are generally reversible and are usually reported in patients with renal impairment, or with other predisposing factors (see 4.4 Special Warnings . We use some essential cookies to make this website work. Dont worry we wont send you spam or share your email address with anyone. posted on Updated the list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. Published new list of terminated and cancelled manufacturing and wholesale dealer licences, Publish list of terminated and cancelled licenses from August 2017 to July 2018. Melatonin 4mg/5ml oral suspension STD, SF, LF, AF, NSF 150ml 20620 8 Menadiol 5mg/5ml oral suspension STD, SF, LF, CF . MHRA's primary role is to protect public health and the IAG process forms a regulatory tool to manage this. Name and address of the site: NISA RETAIL LIMITED , BLOOM LANE, NORMANBY ENTERPRISE PARK, SCUNTHORPE, DN15 9YA, UNITED KINGDOM. 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. Join 1,972,984 Americans who searched for Car Insurance Rates: Please enter your ZIP Code to access Suspended License specific to your state: 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). 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 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 Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. mhra licence suspension mhra licence suspension vo 9 Thng Su, 2022 vo 9 Thng Su, 2022 UK Licence No: PL 04425/0697 . Updated the suspended manufacturing and wholesale distribution authorisations list. If a submission is rejected, we will email you the reasons for the rejection. Subscribe to stay in the loop & on the road! Published updated versions of the Revoked manufacturing and wholesale distribution authorisations list and the Suspended manufacturing and wholesale distribution authorisations list. MIDLAND MILL, You should submit your application using the electronic Common Technical Document (eCTD). Call us at (847) 390-8500 or submit your information via our contact form to arrange a free consultation. It is an additional route of appeal that we offer so that you can appeal in a way that does not incur court costs. . 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. Manufacturing and Wholesale What the data show Since September 2020, 15 Companies were affected. Uploaded new version of Suspended manufacturing and wholesale distribution authorisations. HUDDERSFIELD, Added new list of terminated and cancelled manufacturing and wholesale dealer licences. 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. The list of suspended licences has been updated. Suspensions & Reinstatements. New version of document has been uploaded. You can appeal our decision to suspend your licence in a Magistrates or Sheriff Court. Under 'Ways to make your submission', Updated email address and naming to Department of Health and Social Care. Dont worry we wont send you spam or share your email address with anyone. 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. Report a side effect with a medicine or medical device. If your application for these types of licences is pending and you no longer wish to proceed, you need to withdraw it. 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. 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. If you do not respond to our letter we will revoke your licence automatically after 21 days. Published updated 'Suspended manufacturing and wholesale distribution authorisations' spreadsheet. Terminated and cancelled manufacturing and wholesale dealer licences for January through to February 2016. Updated: list of revoked manufacturing and wholesale distribution authorisations. Latest list of suspended licenses added to the page. 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 [email protected] before you submit your. Read More Contract Manufacture will check that NeeS and eCTD submissions are technically valid using the Extedo Eurs is Yours (EiY) validation tool. REACTA BIOTECH LIMITED T/A REACTA HEALTHCARE, You cannot legally undertake licensable activity while your licence is suspended this includes during an appeal. Dont worry we wont send you spam or share your email address with anyone. Updated suspension list added to the page. You can change your cookie settings at any time. Published new list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. varied or suspended by the Medicines and Healthcare products Regulatory Agency (MHRA). Added a link to the User Guide for the electronic application form. Failure to Appear. Added links to pages providing further information on some of the procedures. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. mhra licence suspension Updated the 'When we suspend your licence' section to include reference to open public investigations. Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended. Published a new version of the Suspended manufacturing and wholesale distribution authorisations list. If we suspend your licence, the suspension comes into effect immediately. posted on Yesterday MHRA released an update on suspended manufacturing and wholesale distribution authorization. @MarkKleinmanSky. Updated list of suspended licences and registrations for manufacturers and wholesalers of medicines and ingredients. 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. To make a request for fast tracking your marketing authorisation you should email a letter of no more than 3 pages to [email protected]. Updated the list of suspended licences for manufacturers and wholesalers of medicines. List of API manufacturers, importers and distributors, see EUDRAGMDP link above. TW9 2QE, Dont worry we wont send you spam or share your email address with anyone. Pay Restoration Fee Provide proof of payment of outstanding fines/tickets Parking Violations How to Pay Parking Tickets You can go to the MHRA-GMDP website to view the lists of: Updated the suspended and revoked licenses list. An updated list of suspended authorisations was attached. 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. Reinstating Your License. Applications can be fast tracked if there is compelling evidence of benefit in a public health emergency or if there is a shortage of supply of an essential medicine that has been verified by the Department of Health and Social Care (DHSC). Occupational Licenses. 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. The List of Terminated and Cancelled Licences has been updated. 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. 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. Converse Pharma could not be reached for comment. Department of Health and Social Care (DHSC) has issued a medicine supply notification for Ranitidine (all formulations) . There is no additional fee for fast-tracking applications. 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). 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. List of revoked manufacturing sites updated. 1 MEER END, G74 5PE, To help us improve GOV.UK, wed like to know more about your visit today. Check benefits and financial support you can get, Find out about the Energy Bills Support Scheme, Medicines and Healthcare products Regulatory Agency, application to withdraw a pending application, Renewal form: human medicine marketing authorisation, Renew: marketing authorisation for a human medicine, Traditional herbal medicines: registration form and guidance, Herbal medicines granted a traditional herbal registration (THR), List of banned or restricted herbal ingredients for medicinal use, Marketing authorisations, variations and licensing guidance. Compare over 50 top car insurance quotes and save. Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission. To help us improve GOV.UK, wed like to know more about your visit today. MHRA alerts & recalls PharmData maintains a list of all MHRA alerts and recalls relevant to community pharmacy. GLASGOW, 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. You should also use this form if you want to withdraw a variation application or amendment for an existing MA. Please note the site register will be updated on a quarterly basis. Sara Berry 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. 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. DEESIDE, All applications or queries regarding applications can be sent to the PCL team via email: [email protected] - stating in the subject box: Initial/Variation/Query type of licence held - company name/number (for example: Initial MIA 12345). UNITED KINGDOM, CONSILIENT HEALTH (UK) LIMITED, We updated the list of suspended manufacturing and wholesale distribution authorisations. 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 have rejected additional cookies. You can find out more about how to pay your fees in our guidance on making a payment to MHRA. TRIDENT PLACE, MOSQUITO WAY, latest Suspended manufacturing and wholesale distribution authorisations, Updated Suspended manufacturing and wholesale distribution authorisations, Updated suspended manufacturing and wholesale distribution authorisations. 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. Updated Suspended manufacturing and wholesale distribution authorisations List, Updated the list of Suspended manufacturing and wholesale distribution authorisations. New version of suspended list has been uploaded. Updated list of companies in the UK who have had their licence to manufacture or wholesale medicines suspended. Download CSV LEICESTER, the mentholatum company limited, 1 redwood avenue, peel park campus, east kilbride, glasgow, g74 5pe, united kingdom We find an easy way to remember is to set a recurrent reminder in your Outlook calendar or Gmail diary. MHRA is the Government body set up to discharge the responsibilities of the Licensing Authority, under powers delegated by those Ministers. The Licence Number is a specific number allocated to one company. This means that you can still work during your appeal, unless we have also suspended your licence. 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 . Published new suspended manufacturing and wholesale distribution authorisations list. Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences' link to latest January 2021 version. Updated the list of suspended manufacturing and wholesale distribution authorisations. . Added list of terminated and cancelled licences for April 2019. Updated the terminated and cancelled manufacturing and wholesale dealer licences for September 2021. You can find out more about the fees we charge in the guidance MHRA fees. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Maalox oral suspension - Magnesium hydroxide; Aluminium hydroxide gel dried Magnesium hydroxide; . If you have any questions about MHRA Submissions , you should email [email protected]. 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. Added August file for - Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences. . To help us improve GOV.UK, wed like to know more about your visit today. Updated list of suspended licences for manufacturers and wholesalers of medicines.
