(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). 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. 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. New version of document has been uploaded. You can find out more about how to pay your fees in our guidance on making a payment to MHRA. Dont include personal or financial information like your National Insurance number or credit card details. New version of Revocation list has been uploaded. mhra licence suspension Updated list of suspended licences and registrations for manufacturers and wholesalers of medicines and ingredients. UNITED KINGDOM, BCM LIMITED, 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. Manufacturing and Wholesale Updated file 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. Published updated list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. We publish the most up-to-date information for a medicine according to its licence history. Updated list of suspended licenses added to the page. List of terminated and cancelled manufacturers and wholesale dealers licenses updates. Refusal to pay outstanding fees on the grounds that the PO is not provided on the invoice will not be accepted. Updated revoked and suspended documents on the page. UK WDA (H) 12426. You can also tell us about any factual errors that may have affected our decision. Updated list of suspended manufacturing and wholesale distribution authorisations. Published updated Revoked manufacturing and wholesale distribution authorisations list. PL 04425/0697 . 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. We may lift the suspension if you are found not guilty or the charges are dropped. Updated the list of suspended licences for manufacturers and wholesalers of medicines. You can appeal our decision to suspend your licence in a Magistrates or Sheriff Court. NISA RETAIL LIMITED. 09/02/2023. The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated. 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. AL10 9UL, BEESTON, It can also be checked on the following register: Added spreadsheet under "types of application" heading. 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. Uploaded new version of Suspended manufacturing and wholesale distribution authorisations. Updated list of companies in the UK who have had their licence to manufacture or wholesale medicines suspended. At 1936 per MHRA inspection or re-inspection, you want as few visits as possible. You must do so within 21 days of the revocation coming into effect. CB4 0GW, Our legal power to do this is explained in Get Licensed (PDF, 3.03 MB, 90 pages). 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 What the data show Since September 2020, 15 Companies were affected. Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. Very rare: Agitation, confusion, tremor, ataxia, dysarthria, hallucinations, psychotic symptoms, convulsions, somnolence, encephalopathy, coma. Our letter will also tell you how to appeal against our decision. @MarkKleinmanSky. Wholesale dealer licences/API/broker licences: GDP.Inspectorate@mhra.gov.uk, Manufacturing licences: gmpinspectorate@mhra.gov.uk. Suspensions & Reinstatements. 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. 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. If you have any questions about MHRA Submissions , you should email submissions@mhra.gov.uk. mhra licence suspensionhow to calculate solow residual mhra licence suspension. Updated the Suspended manufacturing and wholesale distribution authorisations list. Maalox 175mg/200mg Oral Suspension . 10 October 2019, MIA holders can be checked on the Eudra GMDP webpage for validity. 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). Published updated 'Suspended manufacturing and wholesale distribution authorisations' spreadsheet. 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. 09 October 2019. Suspended vs. Revoked License: The Differences, Driving with a Suspended License: What You Need to Know. UNIT 191, CAMBRIDGE SCIENCE PARK, UNITED KINGDOM, WOODLEY BIOREG LIMITED, The use of POs is an internal control process and cannot be used as a reason to withhold payment of legitimate invoices. Dont include personal or financial information like your National Insurance number or credit card details. This will ensure you are not charged a periodic fee for the period 1 April 2016 to 31 March 2017. We publish scientific assessment reports called a Public Assessment Report (PAR) available for new marketing authorisations granted after 30 October 2005. Updated the list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. Uploaded new Suspended manufacturing and Revoked spreadsheets. 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. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Monthly update to 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. When autocomplete results are available use up and down arrows to review and enter to select. New document added to page for September 2017. For example, in Kentucky, it takes an accumulation of 12 points over the course of 2 years in order to receive a suspension. Cancellation of a licence, authorisation or registration is when MHRA makes a decision to cancel the licence, authorisation or registration. 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. You can change your cookie settings at any time. Updated the terminated and cancelled manufacturing and wholesale dealer licences for September 2021. If you use assistive technology (such as a screen reader) and need a Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. The Agency has the power to withdraw a product from the market, and in the case of medicines, to suspend production. Alpha Release This is a new service - your feedback will help improve it. Or if you need to cancel a parallel import product. Pay Restoration Fee Provide proof of payment of outstanding fines/tickets Parking Violations How to Pay Parking Tickets Medical Evaluation Process. Published a new version of the Suspended manufacturing and wholesale distribution authorisations list. If you do not respond to our letter we will revoke your licence automatically after 21 days. Melatonin 4mg/5ml oral suspension STD, SF, LF, AF, NSF 150ml 20620 8 Menadiol 5mg/5ml oral suspension STD, SF, LF, CF . We look forward to hearing from you to discuss your case. 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. Updated list of suspended licences for manufacturers and wholesalers of medicines. TRIDENT PLACE, MOSQUITO WAY, Failure to Appear. IAG are non-statutory multi-disciplinary groups which advise MHRA's Director of IE&S on recommendations for regulatory action. Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences' attachment to latest version. View online We use some essential cookies to make this website work. The absence of a GMP certificate should not be understood as meaning that the active substance manufacturer in question does not comply with GMP. We also use cookies set by other sites to help us deliver content from their services. We use some essential cookies to make this website work. Updated ist of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked. Ilyas ali You can read our guidance about the submission of ASMFs. Well send you a link to a feedback form. If you do not use this template your submission will be rejected. NJ MVC | Suspensions and Restorations Suspensions and Restorations Information about restoring your license or registration Restoring Your License or Registration If your license has expired, you will need to renew it in-person. 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 . Any questions on the content of this database should be addressed to IE&S-IMT@mhra.gov.uk. 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. HATFIELD, Publish list of terminated and cancelled licenses from July 2017 to June 2018. This means that you can still work during your appeal, unless we have also suspended your licence. Published 4 February 2015 Last updated 5 January. Updated Suspended manufacturing and wholesale distribution authorisations list. You can get a suspended license for reasons including: If you have a suspended drivers license, your state will likely require you to: Our suspended license pages for your state will help you: Click your state below for suspended license and reinstatement requirements at your states DMV, SOS, DOR, or MVD. Well send you a link to a feedback form. Updated list of terminated, revoked and cancelled licences. To help us improve GOV.UK, wed like to know more about your visit today. We recommend that you use a validation tool to check your submission as we The MHRA announces recall of paracetamol tablets, after certain products were found to be discoloured due to the presence of fungi. Replaced the PDF with a more accessible file. MILTON ROAD, Dont worry we wont send you spam or share your email address with anyone. The lists of suspensions and revocations have been updated. 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. 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. It will take only 2 minutes to fill in. Fees vary depending on the type and route of application. Please note the site register will be updated on a quarterly basis. The clarifying remark section of individual GMP and GDP certificates will indicate any exceptions. 1 MEER END, Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Updated the 'When we suspend your licence' section to include reference to open public investigations. 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. New list of suspended licenses added to the page. Published new version of the suspended manufacturing and wholesale distribution authorisations list. SR-22 Insurance Certificates. Dont worry we wont send you spam or share your email address with anyone. Accumulating too many driving record points. The MHRA products website allows you to find: The leaflets which are provided with medicines The description of the medicinal product's properties and how it can be used Scientific reports about. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. If you think your submission has been wrongly rejected, you should email ris.na@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/. (MHRA) on safety, quality and efficacy of vaccines; MHRA responsible for Yellow Card Adverse Drug Reaction reporting system; Yellow Card reports can signal possibility that a product may be associated with certain risks. Dont worry we wont send you spam or share your email address with anyone. 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. A certificate of Good Manufacturing Practice (GMP) is issued to a manufacturer if the outcome of the inspection confirms that the manufacturer complies with the principles of Good Manufacturing Practice. ALR Program. Proposed suspension, variation . On the other hand, in Florida, earning 12 points on your license within a year will get your license suspended for 30 days. 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. Phase 4 studies. If your application for these types of licences is pending and you no longer wish to proceed, you need to withdraw it. 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. Refrain from driving for a period of time. Published a new version of the 'Get Licensed' document. You have accepted additional cookies. 1 CHURCH ROAD, Updated Suspended manufacturing and wholesale distribution authorisations List, Updated the list of Suspended manufacturing and wholesale distribution authorisations. You have rejected additional cookies. Occupational Licenses. Published updated list of Suspended manufacturing and wholesale distribution authorisations. ASMFs holders must submit their dossier to the MHRA. Removed link to Excel spreadsheet list of products. MHRA is the Government body set up to discharge the responsibilities of the Licensing Authority, under powers delegated by those Ministers. If you have any questions about submitting your application you should email ris.na@mhra.gov.uk. 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. ; Getting multiple traffic violations or speeding tickets. PEEL PARK CAMPUS, EAST KILBRIDE, 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). We will also tell you what you can do that might stop us from revoking your licence. 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. The Site Number is a specific number allocated to one site. Get free quotes from the nation's biggest auto insurance providers. Uploaded updated Suspended manufacturing and wholesale distribution authorisations list. MHRA's primary role is to protect public health and the IAG process forms a regulatory tool to manage this. 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: Please ensure that you limit bulk cancellations to a maximum of 10 product licenses showing per application form. Full document as sent to the MHRA on 21st July 2020: These templates should not be altered in any way, other than inserting the relevant information. Dealer Licences 2016 to October, Updated list of terminated and cancelled licences. the mentholatum company limited, 1 redwood avenue, peel park campus, east kilbride, glasgow, g74 5pe, united kingdom EnteroBiotix secures key additional MHRA license and announces regulatory milestones. Updated: list of suspended manufacturing and wholesale distribution authorisations, Updated: list of revoked manufacturing and wholesale distribution authorisations. UNITED KINGDOM, VIATRIS UK HEALTHCARE LIMITED,

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