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Subscribe to stay in the loop & on the road! You can change your cookie settings at any time. EN6 1TL, And it ensures the safety and effectiveness of medicines in the UK. the mentholatum company limited, 1 redwood avenue, peel park campus, east kilbride, glasgow, g74 5pe, united kingdom Name and address of the site: NISA RETAIL LIMITED , BLOOM LANE, NORMANBY ENTERPRISE PARK, SCUNTHORPE, DN15 9YA, UNITED KINGDOM. "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. 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 MIDLAND MILL, Please note the site register will be updated on a quarterly basis. We can revoke (take away) your licence if you no longer meet our licensing criteria. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Updated list of companies in the UK who have had their licence to manufacture or wholesale medicines suspended. We also use cookies set by other sites to help us deliver content from their services. UNITED KINGDOM, CONSILIENT HEALTH (UK) LIMITED, Check benefits and financial support you can get, Find out about the Energy Bills Support Scheme, Drug or alcohol misuse or dependence: assessing fitness to drive, Declaration of voluntary surrender for medical reasons, Psychiatric disorders: assessing fitness to drive, Can I drive while my application is with DVLA? The design, evaluation, and management of immunisation programmes 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. The lenders have hired PricewaterhouseCoopers to advise them, according to one insider. This file may not be suitable for users of assistive technology. Suspensions & Reinstatements. WATFORD, For example, in Kentucky, it takes an accumulation of 12 points over the course of 2 years in order to receive a suspension. You have rejected additional cookies. Since inspections of manufacturers of active substances are based on risk,. List of revoked manufacturing sites updated. You cannot legally undertake licensable activity while your licence is suspended this includes during an appeal. MHRA Process Licensing: useful information - MHRA Inspectorate You can find out more about the fees we charge in the guidance MHRA fees. To help us improve GOV.UK, wed like to know more about your visit today. Occupational Licenses. 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. The portal should be used for wholesale distribution authorisations [WDA(H)] and active substance manufacturers, importers and distributors new applications, variation applications and annual compliance reports (active substance manufacturers, importers or distributors only). Updated ist of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked. UNITED KINGDOM, BCM LIMITED, You should read the guidance for your specific pathway for any extra information or steps that might be required. PDF Notes for applicants and holders of a Manufacturer's Licence - GOV.UK Please note, this includes changes to MHRA Guidance Note 6 1. Dont include personal or financial information like your National Insurance number or credit card details. You must do so within 21 days of the revocation coming into effect. It is your responsibility to make sure the invoices for your submissions are paid on time. 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. You can change your cookie settings at any time. Syri Limited suspension has been lifted. 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. Medicine Supply Notification: Ranitidine all formulations - Update Sara Berry If we intend to revoke or suspend your licence we will write to you to tell you why. We will revoke (take away) your licence if: We will write to you before we revoke your licence, telling you what we intend to do and why. We recommend that you use a validation tool to check your submission as we MHRA approves licence extension for Novartis' targeted therapy for The MHRA products website allows you to find: You can look for any word, phrase or Product Licence number (PL) using the search tool. 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. Under 'Ways to make your submission', Updated email address and naming to Department of Health and Social Care. On-site inspections will resume as soon as travel restrictions permit. 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. We will write to you when we suspend your licence, telling you what we have done and why. Copy CSV Excel PDF Print Showing 1 to 10 of 325 entries Previous 1 2 3 4 5 33 Next You have accepted additional cookies. 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. Maalox oral suspension - Magnesium hydroxide; Aluminium hydroxide gel dried Magnesium hydroxide; . City editor 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. Medical Evaluation Process. You can appeal our decision to suspend your licence in a Magistrates or Sheriff Court. The Site Number is a specific number allocated to one site. These can then be investigated further to decide whether a side effect is truly from a . You have rejected additional cookies. You can change your cookie settings at any time. New September 2020 version of 'Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences'. 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 clarifying remark section of individual GMP and GDP certificates will indicate any exceptions. 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. MHRA suspends license of Teva generic over dissolution fears Learn more about the circumstances that can lead to a licence holder losing their licence, either permanently or temporarily. 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 also use the A-Z list to find the active substance. 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 Your licence remains live during a court appeal. Dont worry we wont send you spam or share your email address with anyone. Published updated versions of the Revoked manufacturing and wholesale distribution authorisations list and the Suspended manufacturing and wholesale distribution authorisations list. 1999 - 2023 DMV.ORG. This includes information of a commercially sensitive or personal nature, that may need to be restricted in the interests of security. 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. Replaced the PDF with a more accessible file. 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. In August 2018, EnteroBiotix announced that the company had been awarded a manufacturer's specials license . UK WDA (H) 12426. London, UK, 23 December 2021 Today Novartis announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved the marketing authorisation to extend the licence in Great Britain for Piqray (alpelisib) for use in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor It will take only 2 minutes to fill in. Report a side effect with a medicine or medical device. What the data show Since September 2020, 15 Companies were affected. Andrew Bailey says 'nothing is decided' suggesting interest rates may rise less than thought 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. If a submission is rejected, we will email you the reasons for the rejection. LICENCE TYPE MA Manufacture and Assembly . 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. 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. 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). Gov.uk Any submission that does not meet the requirements will be rejected. 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. Zovirax Suspension - Summary of Product Characteristics (SmPC) - (emc) 783 Bytes. Pay Restoration Fee Provide proof of payment of outstanding fines/tickets Parking Violations How to Pay Parking Tickets You have accepted additional cookies. The attorneys at The Davis Law Group, P.C. mhra licence suspension DEESIDE, 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. For 1 company the licence was terminated. Updated list of suspended and revoked licences and registrations. On the other hand, in Florida, earning 12 points on your license within a year will get your license suspended for 30 days. You will not be charged if your submission is rejected for technical reasons. WELBECK PHARMACEUTICALS & HOSPITAL SUPPLIES LIMITED , 35 DEVONSHIRE STREET, LONDON, W1G 6PZ, UNITED KINGDOM. The agency advised healthcare professionals to immediately stop supplying the batches and to quarantine and remove all remaining stock. POTTERS BAR, Updated 'Suspended manufacturing and wholesale distribution authorisations' attachment, Updated 'Suspended and revoked licences and registrations for manufacturers and wholesalers of medicines and ingredients', New Suspended manufacturing and wholesale distribution authorisations published, New list of suspended manufacturing and wholesale distribution authorisations, Addition of new revocation and suspension. D ate of . Certificates of Suitability (CEPs) continue to be acceptable in support of UK and GB national authorisations.. Apply for a licence to market a medicine in the UK - GOV.UK Or if you need to cancel a parallel import product licence, complete the cancellation form (PDF, 525 KB, 3 pages). Its licence was "largely reinstated" following a re-investigation in April, says Sky. Subscribe to our News and Updates to stay in the loop and on the road! 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. The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated. Failure to Appear. AL10 9UL, MHRA FMD - Medicines and Healthcare products Regulatory Agency Updated list of medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences for February. 19 wholesalers under MHRA 'suspicion', claims BBC :: C+D Updated the 'When we suspend your licence' section to include reference to open public investigations. Published updated list of Suspended manufacturing and wholesale distribution authorisations. An updated list of suspended authorisations was attached. ; Getting multiple traffic violations or speeding tickets. Apply for new broker registrations and to vary existing broker registrations via https://fmdbroker.hma.eu/, Using link to MHRA fees: https://www.gov.uk/government/publications/mhra-fees. Dont worry we wont send you spam or share your email address with anyone. MHRA Suspended Licence - Paradigm Shift Consulting NOTTINGHAM, 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. Uploaded new version of Suspended and revoked licences list. Published new version of the suspended manufacturing and wholesale distribution authorisations list. This is based on the MHRA assessment report with any commercially or personally confidential information removed. In this situation the licence holder who is performing the testing and acts as the contract acceptor should be named as a contract laboratory on the contract giver's 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 . There is no additional fee for fast-tracking applications. 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". MHRA alerts & recalls PharmData maintains a list of all MHRA alerts and recalls relevant to community pharmacy. updated suspended and revoked lists added to the page. The absence of a GMP certificate should not be understood as meaning that the active substance manufacturer in question does not comply with GMP. New version of suspended list has been uploaded. @MarkKleinmanSky. You can read our guidance about the submission of ASMFs. Marketing. UNITED KINGDOM, THE MENTHOLATUM COMPANY LIMITED, The marketing license for ingenol mebutate gel (Picato) has been suspended by the MHRA due to studies showing an increased risk of skin malignancies from the drug. Published updated list of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled. 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. 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. Updated Suspended licences for manufacturers and wholesalers of medicines, Updated list of suspended manufacturing and wholesale distribution authorisation, Updated list of Suspended manufacturing and wholesale distribution authorisations, Updated list of suspended and revoked manufacturing and wholesale distribution authorisations, Updates list of suspended manufacturing and wholesale distribution authorisations. 09 October 2019. Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. Suspended list updated to show licenses that have been terminated/revoked and therefore no longer suspended. The list of terminated and cancelled manufacturing and wholesale dealer licences has been updated to include May 2015. Updated list of terminated and cancelled manufacturing and wholesale dealer licences, List of terminated and cancelled licences updated, Updated list of terminated and cancelled licenses, Updated List of Terminated and Cancelled Manufacturing and Wholesale Dealer Licences, Updated List of Terminated and Cancelled If you have any questions about submitting your application you should email ris.na@mhra.gov.uk. UNITED KINGDOM, BARD PHARMACEUTICALS LIMITED, 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. PDF Guidance for UK Manufactur Licence and Manufactur - GOV.UK We look forward to hearing from you to discuss your case. The wholesale distribution of medicinal products and importation of medicines certified by a Qualified Person in accordance with Article 51 of Directive 2001/83/EC from listed countries is subject to the holding of a Wholesale Distribution Authorisation. Suspended Driver's License. Read More Contract Manufacture mhra licence suspensionhow to calculate solow residual mhra licence suspension. ASMFs holders must submit their dossier to the MHRA. Since inspections of manufacturers of active substances are based on risk, some active substance manufacturers may not be in possession of a GMP certificate. Added list of terminated and cancelled licences for April 2019. An example of when we might do this is if you are under police investigation for a serious offence. This information is common to all procedures. Added August file for - Medicines terminated, cancelled and revoked manufacturing and wholesale dealer licences. MHRA Products | Home EMA suspends Picato as a precaution while review of skin cancer risk WDA Suspended, Terminated, Cancelled And Revoked What Do These Terms You have rejected additional cookies. Department of Health and Social Care (DHSC) has issued a medicine supply notification for Ranitidine (all formulations) . 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. Updated: list of terminated and cancelled manufacturing and wholesale dealer licences. Published Medicines: terminated and cancelled manufacturing and wholesale dealer licences for August 2019. Yesterday MHRA released an update on suspended manufacturing and wholesale distribution authorization. This blog shares the work of the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate, by inspectors and those the Inspectorate works with. https://mhrainspectorate.blog.gov.uk/2019/10/04/mhra-process-licensing-useful-information/. The Agency has the power to withdraw a product from the market, and in the case of medicines, to suspend production. 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. Updated the terminated and cancelled manufacturing and wholesale dealer licences for September 2021. Suspended and revoked licences and registrations for manufacturers and We also use cookies set by other sites to help us deliver content from their services. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Wholesaler tries to raise 'tens of millions' after MHRA suspension Refusal of licence / variation or an existing licence being revoked. Download CSV There should be a procedure that ensures there are documented checks made at least twice a month of MHRA's list of suspended licence holders and regular checks on EudraGMDP website for issued. New list of suspended licenses added to the page. The MHRA announces recall of paracetamol tablets, after certain products were found to be discoloured due to the presence of fungi. Comment by 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).