Replaced the PDF with a more accessible file. 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. If your organisation operates a PO system, please make sure that the relevant PO is provided to the MHRA before the invoice is issued. The agency advised healthcare professionals to immediately stop supplying the batches and to quarantine and remove all remaining stock. 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. 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. Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. 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. The MHRA has been assured that acceptable standards of Good Manufacturing Practice are in place for . Find out more about the different national and international procedures. 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. Failure to Appear. An example of when we might do this is if you are under police investigation for a serious offence. Suspended vs. Revoked License: The Differences, Driving with a Suspended License: What You Need to Know. ALR Program. 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". Suspended Driver's License. If you use assistive technology (such as a screen reader) and need a You have rejected additional cookies. 1 MEER END, You have accepted additional cookies. Please note, you are required as a company to ensure that all personal details provided to the MHRA are up to date and the MHRA needs to be notified within any application if any changes in personal details need to be updated, including email addresses and telephone numbers. 2. . 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 . You must do so within 21 days of the suspension coming into effect. CAMBRIDGE, You should submit your application using the electronic Common Technical Document (eCTD). Full document as sent to the MHRA on 21st July 2020: Also is there any process to verify that MIA licence is still valid? Updated list of terminated and cancelled manufacturing and wholesale UNITED KINGDOM, WOODLEY BIOREG LIMITED, Please ensure that you limit bulk cancellations to a maximum of 10 product licenses showing per application form. GLASGOW, PEEL PARK CAMPUS, EAST KILBRIDE, All UK and Great Britain (England, Scotland and Wales) national applications should be submitted through the MHRA Submissions Portal. 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. UNIT 191, CAMBRIDGE SCIENCE PARK, To help us improve GOV.UK, wed like to know more about your visit today. We will also tell you what you can do that might stop us from revoking your licence. 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: 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. Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. UNITED KINGDOM, DENDRON BRANDS LIMITED, Submission of a new ASMF and any update to an ASMF should be made by the ASMF holder using MHRA Submissions . Fees vary depending on the type and route of application. HATFIELD, 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. MHRA alerts & recalls PharmData maintains a list of all MHRA alerts and recalls relevant to community pharmacy. Reinstating Your License. Updated the list of cancelled and revoked licenses, Updated list of terminated, cancelled and revoked licenses, Updated list of terminated, cancelled and revoked manufacturing and wholesaler dealer licences, Updated list of terminated, cancelled and revoked manufacturing and wholesale dealer licences. Get free quotes from the nation's biggest auto insurance providers. 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. Publish list of terminated and cancelled licenses from July 2017 to June 2018. MHRA's primary role is to protect public health and the IAG process forms a regulatory tool to manage this. 1 REDWOOD AVENUE, 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. Download CSV dealer licences. will check that NeeS and eCTD submissions are technically valid using the Extedo Eurs is Yours (EiY) validation tool. You can appeal our decision to suspend your licence in a Magistrates or Sheriff Court. Compare over 50 top car insurance quotes and save. 2 NEWTECH SQUARE, WATFORD, News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Updated list of terminated, revoked and cancelled licences. We recommend that you use a validation tool to check your submission as we 09 October 2019. 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. Updated list of suspended licences added to the page. Published updated version of Suspended manufacturing and wholesale distribution authorisations list. ; Getting multiple traffic violations or speeding tickets. the mentholatum company limited, 1 redwood avenue, peel park campus, east kilbride, glasgow, g74 5pe, united kingdom SR-22 Insurance Certificates. Ilyas ali Suspensions & Reinstatements. The Site Number is a specific number allocated to one site. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced the licence suspension of ingenol mebutate gel (Picato). 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. Dont worry we wont send you spam or share your email address with anyone. Welcome to the MHRA Process Licensing Portal. Do not send the corrected deficiencies by email. BIRSTALL, Depending on the state you live in, you may incur a suspension for a different amount of points. Wholesale dealer licences/API/broker licences: GDP.Inspectorate@mhra.gov.uk, Manufacturing licences: gmpinspectorate@mhra.gov.uk. 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.. Converse Pharma distributes a range of generic drugs, including flu vaccines, employing close to 1,000 people at 11 sites across the country. 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. An updated list of suspended authorisations was attached. Is there any portal where we can check the list of MIA holders? Marketing. Added new list of terminated and cancelled manufacturing and wholesale dealer licences. TRIDENT PLACE, MOSQUITO WAY, An example of when we might do this is if you are under police. You have rejected additional cookies. Proposed suspension, variation . Updated document - Suspended manufacturing and wholesale distribution authorisations. 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 updated the list of suspended manufacturing and wholesale distribution authorisations. 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. The Process Licensing Office sits within the Inspectorate and Process Licensing Group of the Inspection, Enforcement and Standards division. 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. New version of Revocation list has been uploaded. You should read the guidance for your specific pathway for any extra information or steps that might be required. 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/.
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