THANE ROAD, 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 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. Truancy. New version of document has been uploaded. 94 RICKMANSWORTH ROAD, It is an additional route of appeal that we offer so that you can appeal in a way that does not incur court costs. Since inspections of manufacturers of active substances are based on risk,. Occupational Licenses. It can also be checked on the following register: 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. Reinstating Your License. MHRA considers each application for a product name to ensure that the proposed name will allow the medicine to be taken safely and correctly. UK Licence No: PL 04425/0697 . The attorneys at The Davis Law Group, P.C. Sara Berry If you have any questions about the Submissions Portal, you should email submissions@mhra.gov.uk. Added a link to the User Guide for the electronic application form. 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. What the data show Since September 2020, 15 Companies were affected. Updated attachment - March to Feb 2019 edition, Updated list of terminated and cancelled manufacturing and wholesale dealer licences. You can find out more about the fees we charge in the guidance MHRA fees. Uploaded new Suspended manufacturing and wholesale distribution authorisations list. TW9 2QE, These can then be investigated further to decide whether a side effect is truly from a . Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Marketing. 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. Updated suspended manufacturing and wholesale distribution authorisations. Download CSV Publish list of terminated and cancelled licenses from July 2017 to June 2018. Since inspections of manufacturers of active substances are based on risk, some active substance manufacturers may not be in possession of a GMP certificate. Any submission that does not meet the requirements will be rejected. City sources said the company, which was formed from a management buyout in 2013, was in talks with its lenders at the state-backed NatWest Group and Secure Trust Bank about the process. 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. To cancel a marketing authorisation for a medicine or a traditional herbal remedy so it can be removed from the market, you need to: Follow the European requirements on the European Medicines Agency (EMA) website completing and submitting their cover letter template and notification report table. 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. In April 2018, C+D reported that the suspension had been extended due to remaining "non-compliance issues". UNITED KINGDOM, CONSILIENT HEALTH (UK) LIMITED, Updated both 'revoked' and 'Suspended' manufacturing and wholesale distribution authorisations lists. Updated Suspended manufacturing and wholesale distribution authorisations CSV file. Suspension lifted for Metro Pharmacy Limited. Updated the Suspended manufacturing and wholesale distribution authorisations list. If a submission is rejected, we will email you the reasons for the rejection. New version of the revocation and suspension lists has been uploaded. Or if you need to cancel a parallel import product licence, complete the cancellation form (PDF, 525 KB, 3 pages). 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 This portal allows registered users to submit WDA (H) Wholesale Distribution Authorisation applications and variations API Active Pharmaceutical. Healthcare products Regulatory Agency (MHRA) inspectorate as soon as possible. Replaced the PDF with a more accessible file. You can also use the A-Z list to find the active substance. All Rights Reserved. You have rejected additional cookies. If you do not include the correct information your application will not be validated. Accumulating too many driving record points. updated Suspended and revoked licences for manufacturers and wholesalers of medicines, list of suspended manufacturing and wholesale distribution authorisations updated. You have rejected additional cookies. UNITED KINGDOM, WOODLEY BIOREG LIMITED, List of API manufacturers, importers and distributors, see EUDRAGMDP link above. It will take only 2 minutes to fill in. RICHMOND, 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. Updated lists of suspended and revoked licenses. We can revoke (take away) your licence if you no longer meet our licensing criteria. Updated 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. 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. https://www.gov.uk/government/publications/medicines-application-forms-for-a-manufacturer-licence, https://www.gov.uk/government/publications/medicines-variation-forms-for-a-manufacturer-licence, https://www.gov.uk/government/publications/mhra-fees, https://www.gov.uk/government/publications/medicines-new-manufacturing-and-wholesale-dealer-licences, http://eudragmdp.ema.europa.eu/inspections/displayHome.do, https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-manufacturing-sites, https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-wholesale-distribution-sites, https://www.gov.uk/government/publications/register-of-brokers-authorised-to-deal-in-human-medicines, https://www.gov.uk/government/publications/suspended-licences-for-manufacturers-and-wholesalers-of-medicines, https://www.gov.uk/export-a-human-medicine, https://www.gov.uk/government/publications/medicines-terminated-and-cancelled-manufacturing-and-wholesale-dealer-licences, Supply chain security: part 1 - introduction, Round Table: The impact of Electronic Health Records on UK Clinical Trials, Manufacture of Investigational Medicinal Products Frequently Asked Questions, MHRA Process for approving Manufacturing Authorisations or API Registrations in relation to unlicensed Cannabis-Based Products for Medicinal Use, Innovation, Quality & Transparency a Compliance Team 1 Perspective, licences for the manufacture/importation of licensed medicinal products for human use, commonly abbreviated to MIA, 'specials' licences for the manufacture/importation of unlicensed medicinal products for human use, commonly abbreviated to MS, authorisations for the manufacture/importation of investigational medicinal products for human use, commonly abbreviated to MIA(IMP), authorisations for the manufacture/importation of licensed medicinal products for veterinary use (ManA), 'specials' licences for the manufacture of unlicensed medicinal products for veterinary use, (ManSA), manufacturer's licences for exempt advanced therapy medicinal products (MeAT), licences for the wholesale distribution of medicinal products for human use, commonly abbreviated to WDA (H) (including those covering unlicensed medicines obtained from another EEA member state), licences for the wholesale distribution/importation of medicinal products for veterinary use - WDA (V), active substance manufacturer, importer or distributor registrations, certificates of Good Manufacturing Practice (GMP), certificates of Good Distribution Practice (GDP), new applications typically take 90 working days to process, variations where no inspection is required: 30 working days - variations where an inspection is required: 90 working days, new applications for registration as Active Substance manufacturers, importers and distributors take 60 working days - if an inspection is required: 90 working days. Syri Limited suspension has been lifted. There is no additional fee for fast-tracking applications. We use some essential cookies to make this website work. We find an easy way to remember is to set a recurrent reminder in your Outlook calendar or Gmail diary. Compare over 50 top car insurance quotes and save. Updated list of terminated and cancelled manufacturing and wholesale dealer licences. 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. Suspended vs. Revoked License: The Differences, Driving with a Suspended License: What You Need to Know. Refrain from driving for a period of time. 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. 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). News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Published Medicines: terminated and cancelled manufacturing and wholesale dealer licences for August 2019. Updated list of terminated and cancelled manufacturing and wholesale dealer licences up to May 2019 added to the page. An example of when we might do this is if you are convicted of a relevant criminal offence. Updated list of suspended licences for manufacturers and wholesalers of medicines. 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. The MHRA announces recall of paracetamol tablets, after certain products were found to be discoloured due to the presence of fungi. Get free quotes from the nation's biggest auto insurance providers. Updated document - Suspended manufacturing and wholesale distribution authorisations. Well send you a link to a feedback form. The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated. ASMFs holders must submit their dossier to the MHRA. Well send you a link to a feedback form. 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. Updated 'Suspended manufacturing and wholesale distribution authorisations' list, Updated 'Revoked manufacturing and wholesale distribution authorisations' list. Updated list of terminated and cancelled manufacturing and wholesale UNITED KINGDOM, MYONEX LIMITED, 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. If you have any questions about MHRA Submissions , you should email submissions@mhra.gov.uk. The List of Terminated, Revoked and Cancelled Licences has been updated. Refusal of licence / variation or an existing licence being revoked. will check that NeeS and eCTD submissions are technically valid using the Extedo Eurs is Yours (EiY) validation tool. This is based on the MHRA assessment report with any commercially or personally confidential information removed. 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. 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. PILs are based on the Summaries of Product Characteristics (SPCs) which are a description of a medicinal products properties and the conditions attached to its use. We use some essential cookies to make this website work. You can appeal our decision to suspend your licence in a Magistrates or Sheriff Court. Updated: list of suspended manufacturing and wholesale distribution authorisations, Updated: list of revoked manufacturing and wholesale distribution authorisations. You have accepted additional cookies. You can change your cookie settings at any time. Updated 'Suspended manufacturing and wholesale distribution authorisations' link. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. AstraZeneca's Evusheld (tixagevimab co-packaged with cilgavimab) is authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) and is the first antibody combination for pre-exposure prophylaxis (PrEP) against COVID-19 licensed in Great Britain. CAMBRIDGE, Updated both attachments with newer files. WELBECK PHARMACEUTICALS & HOSPITAL SUPPLIES LIMITED , 35 DEVONSHIRE STREET, LONDON, W1G 6PZ, UNITED KINGDOM. Following recent advice from the EMA, the MHRA have suspended all licenses for ranitidine products. Uploaded new version of Suspended and revoked licences list. If you think your submission has been wrongly rejected, you should email ris.na@mhra.gov.uk. Or if you need to cancel a parallel import product. "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. Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely. Link to companies GMP and GDP certificates, see EUDRAGMDP link above. 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. Updated list of companies in the UK who have had their licence to manufacture or wholesale medicines suspended. Its licence was "largely reinstated" following a re-investigation in April, says Sky. Updated the terminated and cancelled manufacturing and wholesale dealer licences for September 2021. Co-Amoxiclav DST Grunenthal 300/42.75mg Granules for Oral Suspension; Co-Amoxiclav DST Grunenthal 400/57mg Granules for Oral Suspension; Co-amoxiclav for Injection 1000/20mg; Co-amoxiclav for Injection 500/100mg; Co-Amoxiclav Injection 500/100; Co-Amoxiclav Oral Suspension 125mg/31.25mg/5ml Amoxi-Co 125/31 If you respond to our letter we will take what you tell us into consideration. The licence of DE Group's Testerworld unit is understood to have been largely reinstated in April following re-inspections by the agency. 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. Published new list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. Any questions on the content of this database should be addressed to IE&S-IMT@mhra.gov.uk. Refusal to pay outstanding fees on the grounds that the PO is not provided on the invoice will not be accepted. New list of suspended manufacturing and wholesale distribution authorisations added to the page. Updated: list of terminated and cancelled manufacturing and wholesale dealer licences. Dont worry we wont send you spam or share your email address with anyone. varied or suspended by the Medicines and Healthcare products Regulatory Agency (MHRA). Ilyas ali The suspension of the license will last until "Teva has completed its investigation and resolved the underlying issues ", the MHRA wrote. LE4 3EH, Converse Pharma distributes a range of generic drugs, including flu vaccines, employing close to 1,000 people at 11 sites across the country. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. All invoices must be settled upon receipt. Your licence remains live during a court appeal. 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. Updated file 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. On the other hand, in Florida, earning 12 points on your license within a year will get your license suspended for 30 days. MIDLAND MILL, Subscribe to stay in the loop & on the road! Converse Pharma could not be reached for comment. The list of suspensions and revocations is updated on the same day that the suspension or revocation takes place. An updated list of suspended licenses has been uploaded. 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. This will ensure you are not charged a periodic fee for the period 1 April 2016 to 31 March 2017. UK WDA (H) 12426. Dont include personal or financial information like your National Insurance number or credit card details. 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. The MHRA also enforces European drug licensing regulations in the UK. LICENCE TYPE MA Manufacture and Assembly . An example of when we might do this is if you are under police. 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. 1 MEER END, Comment by New list of suspended licenses added to the page. 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". You can use the A-Z list to find an active substance, or search for a medicine. You can find out more about how to pay your fees in our guidance on making a payment to MHRA. Find out more about the different national and international procedures. Copy CSV Excel PDF Print Showing 1 to 10 of 325 entries Previous 1 2 3 4 5 33 Next You can find out more in our naming of medicines guidance (PDF, 235 KB, 20 pages). 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. Updated the list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. At 1936 per MHRA inspection or re-inspection, you want as few visits as possible. Removed link to Excel spreadsheet list of products. If your organisation operates a PO system, please make sure that the relevant PO is provided to the MHRA before the invoice is issued. Updated 'Revoked manufacturing and wholesale distribution authorisations' and 'Suspended manufacturing and wholesale distribution authorisations' lists. Full document as sent to the MHRA on 21st July 2020: Terminated and cancelled manufacturing and wholesale dealer licences for January through to February 2016. ; Getting multiple traffic violations or speeding tickets. UNITED KINGDOM, VIATRIS UK HEALTHCARE LIMITED, 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. UNITED KINGDOM, DENDRON BRANDS LIMITED, 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). CH5 2NT, 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.