FOI release
MHRA FOIA Request Disclosure Log 1 January - 31 March 2020
Updated 10 January 2022
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| Ref | Subject | Response sent | Result |
|---|---|---|---|
| FOI 20/001 | Total number spam/malicious emails blocked by your organisation over the last 2 calendar years (2019 and 2018) broken down by year. | 30/01/2020 | Disclosed in part |
| FOI 20/002 | Request list of organisations that operates under this FOI email (if the answers are different for each organisation/there are multiple organisations). Name of SIRO (Senior Information Risk Owner) or similar post (Chief Information Governance Officer etc), or responsible person for SIRO duties. Contact email of person named in request | 16/01/2020 | Disclosed in part |
| FOI 20/003 | Request the data of all adverse incidents reported for Electroconvulsive Therapy (ECT) or Electroshock machines? | 22/01/2020 | Disclosed in part |
| FOI 20/007 | Arsenic Trioxide RMP | 03/02/2020 | Disclosed in part |
| FOI 20/008 | inspection reports be provided for all Companies that had major or critical findings please from September 1st 2016 – 31st March 2017. | 30/01/2020 | Disclosed in part |
| FOI 20/009 | Domperidone RMP | 22/01/2020 | Disclosed in part |
| FOI 20/010 | I require statistics on the amount of fake medicines seized by the MHRA in the UK, for the years you have this data available | 28/01/2020 | Disclosed in full |
| FOI 20/011 | Please provide the drug analysis print (DAP) for the HPV vaccine, which lists all UK spontaneous adverse drug reactions (ADRs) on your database(s) associated with HPV vaccinations for the period 05/05/2006 (earliest report) to 31/12/2019 inclusive. | 04/02/2020 | Disclosed in full |
| FOI 20/012 | Hi please could you send me the links/ information tables for the first year of baby vaccines for adverse reactions, clinical trials and the outcomes, any deaths, and could you tell me where I can find the ingredients for each Infanrix hexa Bexsero Rotarix Prevnar 13 Menitorix Mmr vaxpro or priorix | 03/02/2020 | Disclosed in full |
| FOI 20/013 | Please provide a detailed update and confirm the numbers of all reports received of 1. Breast Implant Cancer 2. BIA-ALCL 3. All Other Malignancies, including breast cancer 4. MGUS, In UK women with breast implants. | 05/02/2020 | Disclosed in part |
| FOI 20/014 | I was wondering whether you are able to disclose (or have already published) which anti-tnfs the mothers of the 4 affected infants were reported to have taken and if any further reports have been made since for the infants of patients on anti tnfs (or other biologics)? | 30/01/2020 | Disclosed in full |
| FOI 20/015 | Please release all data/clinical trial results relating to GR Lanes Health Products' Kalms Day product and correspondence relating to the decision to grant it a licence | 29/01/2020 | Disclosed in part |
| FOI 20/016 | I am looking for information regarding reported suspected adverse reactions to the MMR vaccine . . I am particularly interested in reactions such as rashes , seizures, psychiatric disorders and disorders associated with the nervous system but I am also interested in looking all the different reactions that have been reported in the years 2000 - present day | 10/02/2020 | Disclosed in full |
| FOI 20/017 | All MHRA pharmacovigilance inspection reports for the last 12 month period from any company | 10/02/2020 | Disclosed in part |
| FOI 20/018 | By species: How many animals were used in research by "The Public Authority" from January 1st, 2019 to December 31st, 2019? Minutes, reports and correspondence of any Animal Welfare & Ethical Review Board (“AWERB”), formerly known as the Ethical Review Committee (“ERC”), or sub-committee at University level, including but not limited to departmental committees, from January 2019, where these relate to experimentation or other work involving captive live animals, in addition to any guidance issued by these committees at any time if currently in use. For the avoidance of doubt the term ‘committee’ is used in broad definition and is inclusive of boards, groups or similarly natured structural enterprises. | 11/02/2020 | Disclosed in part |
| FOI 20/019 | A) Any HR policy relating to the appointment of senior personnel (e.g. Directors and Chief Executive) to outside bodies or organisations which is designed to protect the organisation from undue influence or the perception of undue influence). B) Any log, register or list which details the interest registered by Directors and Senior Managers (including Directors, Chairs, Chief Executives and Non executive Directors) for the financial years 2017-18; 2018-19; 2019-2020. C) Any logs, registers or lists which detail meetings between senior members of staff (including Directors, Chairs, Chief Executives and Non executive Directors) and outside organisations and companies for the financial years 2017-18 2018-19 2019-2020 | 11/02/2020 | Disclosed in full |
| FOI 20/020 | Could you please give me the reason why the authorisation for Zaditen has been cancelled as it’s in the public interest? | 30/01/2020 | Disclosed in full |
| FOI 20/022 | Please can you tell me the number of reports of haemorrhage and stroke for patients having intravitreal Avastin for Macular degeneration in the last 15 years. Please can you also report the number of cases with haemorrhagic stroke in patients using Avastin for any other medical condition in the last 15 years. | 10/02/2020 | Disclosed in full |
| FOI 20/023 | Carbimazole testing in relation to a suspected defect | 12/02/2020 | Disclosed in part |
| FOI 20/024 | I would be happy to restrict my request to those on the routine childhood vaccine schedule, thank you for your guidance | 11/02/2020 | Disclosed in full |
| FOI 20/025 | All e-mail correspondence between MHRA and DHSC during the period 1st July 2017 - 31st August 2017 containing the search term "blood inquiry" in the e-mail subject or body. | 14/02/2020 | Disclosed in part |
| FOI 20/026 | 1. How many Yellow Card incidents has the MHRA received in the last five years relating to e-cigrettes and e-liquids? Please could you break down by year, and type (e-cigarette or liquid) 2. Could you detail the nature of each Yellow Card received relating to e-cigarettes and e-liquids? 2. Has the MHRA contacted PHE, Trading Standards or the Department of Health with any concerns about e-cigarettes following Yellow Card reporting? 3. Could you provide me with correspondence between the MHRA and British American Tobacco regarding the licensing of e-voke and the subsequent decision not to release the product? | 14/02/2020 | Disclosed in full |
| FOI 20/027 | CRADLECREST LIMITED INSPECTION REPORT | 13/02/2020 | Disclosed in part |
| FOI 20/028 | Health Counter Limited site authorised under WDA(H) 42958 Inspection report | 13/02/2020 | Disclosed in part |
| FOI 20/029 | report arising from any MHRA GMDP Inspection of the DAY LEWIS PLC - MAIL ORDER\INTERNET PHARMACY (198) SITE ID : 11666457 authorised under WDA(H) 10259 | 17/02/2020 | Disclosed in part |
| FOI 20/030 | Adverse vaccine reaction reports | 17/02/2020 | Disclosed in full |
| FOI 20/031 | Statistic and Database on MF licenses issued and inspection reports | 12/02/2020 | Disclosed in full |
| FOI 20/032 | I would like to request some information under FOIA : MHRA sanctions and enforcement as a result of critical and major inspection findings during last 3 years | 03/02/2020 | Disclosed in full |
| FOI 20/033 | ADRs Sanofi flu jab | 14/02/2020 | Disclosed in full |
| FOI 20/034 | can you provide me with a copy of the above report (conducted in 2019) with the capa submitted by Celgene | 11/02/2020 | Disclosed in part |
| FOI 20/035 | Clinical and Pharmacokinetic data used to support the ‘Instant claim‘ under which Galpharm Diarrhoea Relief Instants 2mg Orodispersible Tablets (PL 16028/0155) licence was granted | 18/02/2020 | Disclosed in full |
| FOI 20/036 | Please supply all correspondence between the MHRA and the Advertising Standards Authority relating to GR Lanes Health Products' adverts for its Kalms Day | 04/02/2020 | Not held |
| FOI 20/037 | New drug for dementia - aducanumab availability | 27/01/2020 | Disclosed in part |
| FOI 20/038 | Is there any trials going on for cannabis at the minute to determine the drug ? | 31/01/2020 | Disclosed in full |
| FOI 20/039 | sodium valproate: licensing evidence | 18/02/2020 | Disclosed in full |
| FOI 20/040 | Request data available about topical steroid cream use and the effects of withdrawing from using it | 14/02/2020 | Disclosed in full |
| FOI 20/042 | please like to receive a summary of the side effects or safety concerns for an e-cigarette, as were collected from the Yellow Card Scheme reporting system beginning Jan 1st 2018 | 24/02/2020 | Disclosed in full |
| FOI 20/045 | Teva Levothyroxine | 24/02/2020 | Disclosed in part |
| FOI 20/047 | relevant testing result of this batch of RABIPUR manufactured by GlaxoSmithKline | 25/02/2020 | Disclosed in full |
| FOI 20/048 | Firewall, Antivirus and Enterprise | 25/02/2020 | Disclosed in part |
| FOI 20/049 | RMP and Clinical overview for Mexitil | 21/02/2020 | Disclosed in full |
| FOI 20/050 | 1. Public Assessment Report(s) for: PL34111-0002 Omeprazole 2mg/ml Powder for Oral Suspension PL34111-0003 Omeprazole 4mg/ml Powder for Oral Suspension | 06/02/2020 | Disclosed in full |
| FOI 20/053 | inspection reports be provided for all Companies that had major or critical findings please from April 1st 2017 – 31st August 2017 | 13/02/2020 | Disclosed in part |
| FOI 20/054 | Allergan Investigators Brochure | 04/02/2020 | Not held |
| FOI 20/055 | I will be very grateful for your thoughts/advice about any feasibility of providing any further information about 2 groups of side effects regarding SGLT2 inhibitors (1. Dapagliflozin 2. Canaglifozin 3. Empagliflozin) | 28/02/2020 | Disclosed in full |
| FOI 20/057 | list of british pharmacies with an export authorisation | 17/02/2020 | Not held |
| FOI 20/058 | inspections/audits conducted by the MHRA at the following plasma donation centers • Palmview, 207 West Palma Vista Drive, Suite G-H, Palmview, TX 78572 • Pharr, 1300 U.S. Highway 83 Business, Suite 3, Pharr, TX 78577 • El Paso, Dyer, 9813 Dyer Street, Suite 300, El Paso, TX 79924 • El Paso, Stanton, 313 South Stanton Street, El Paso, TX 79901 • Laredo, 320 W Calton Road, Laredo TX 78041 | 28/02/2020 | Disclosed in part |
| FOI 20/060 | recorded fatalities in association with the use of the antipsychotic drug, Clozapine (BNF 4.2.1) for the last 10 years | 25/02/2020 | Disclosed in full |
| FOI 20/061 | Inspection report for Roche Products Limited | 24/02/2020 | Disclosed in part |
| FOI 20/062 | Hi there please can I have information on reported serious side effects and reactions to the 6 in 1 vaccine, Meningitis B vaccine, pneumococca vaccine and rota virus. | 03/03/2020 | Disclosed in full |
| FOI 20/063 | OZEMPIC OFF-LICENSE | 11/02/2020 | Disclosed in part |
| FOI 20/064 | any adverse reactions which were caused by (or suspected to have been caused by) medicines having been exposed to high temperatures | 05/03/2020 | Disclosed in full |
| FOI 20/065 | Vaping products | 03/03/2020 | Disclosed in full |
| FOI 20/067 | provide a comparison from October 2018- January 2020 in ADR between the Seqirus Fluad Trivalent PL 46752/0001 and the Sanofi High Dose Trivalent PL 04425/0756 | 09/03/2020 | Disclosed in full |
| FOI 20/068 | internal memos, information, correspondence partaining to article 5(5)a and 5(5)c | 09/03/2020 | Disclosed in part |
| FOI 20/074 | Unreglated sellers | 20/02/2020 | Disclosed in full |
| FOI 20/075 | seizure of misoprostol | 25/02/2020 | Disclosed in full |
| FOI 20/078 | SNBTS Factor IX and possibly contaminaton | 11/03/2020 | Disclosed in full |
| FOI 20/079 | UK Assessment Report for Foscavir (foscarnet sodium) | 05/03/2020 | Disclosed in part |
| FOI 20/081 | Please could I request a copy of the most recent GMP Inspection report for Renata Limited, Bangladesh | 12/03/2020 | Disclosed in part |
| FOI 20/082 | Cannabidiol products classified as medicinal | 25/02/2020 | Disclosed in full |
| FOI 20/083 | Request information you hold on the drug Amlodipine. I understand the drug is banned in the Netherlands and other countries.Why is it still available in the UK.What are the benefits of continuing to prescribe this drug.Can you publish both Negative and positive aspects of this drug. | 19/02/2020 | Disclosed in part |
| FOI 20/084 | Could you please tell me the number of Foreign Medicine Manufacturers Authorisation Holders that exported their product in the UK, between 2010 and 2019. Can you also break down these figures by country and year | 17/02/2020 | Disclosed in full |
| FOI 20/085 | Has MHRA ever received any reports, notification or warnings from the manufacturer (Bausch & Lomb) or any other (previous) licence holder, patient or member of the medical/pharmaceutical profession, regarding suspected or observed malfunctioning or misfiring of the Emerade adrenaline autoinjector, in any of its strengths (150, 300 or 500mcg). If so, could you disclose the details of any such report. | 11/03/2020 | Disclosed in full |
| FOI 20/090 | provide a copy of the currently approved (RMP) for Ultiva (remifentanil). | 19/02/2020 | Not held |
| FOI 20/091 | Are you running an Oracle or SAP ERP solution? If so, what version are they currently running on and which modules are you using?Are you planning to upgrade in the next 12-18 months? | 18/03/2020 | Disclosed in full |
| FOI 20/092 | Request list of all the products registered in the UK which contain lidocaine, lidocaine base, lidocaine hydrochloride, lidocaine hydrochloride anhydrous, lidocaine hydrochloride monohydrate, lignocaine, lignocaine hydrochloride and lignocaine hydrochloride anhydrous as an active ingredient. In addition, could you also identify the marketing/not marketed status in the list. | 24/02/2020 | Disclosed in full |
| FOI 20/094 | Transfer of ownership of certain MA's from LPC Medical UK to Fourrts UK Pharmacare Ltd. | 05/03/2020 | Disclosed in full |
| FOI 20/095 | is the currently approved RMP (or currently approved summary of safety concerns) for other generic remifentanil products available (e.g. Sandoz, Hospira, Wockhardt)? | 19/02/2020 | Not held |
| FOI 20/096 | Request a report detailing all active parallel import licenses within the UK. I understand there is a report published with new licenses granted, but I would like to request a report in which all information is collated into one document. | 19/02/2020 | Disclosed in full |
| FOI 20/098 | Please can the MHRA confirm the regulatory history of dossiers submitted by Ennogen Pharma Limited for their products: " Nifedipine Capsules 5mg" (PL 40147/0060 - ENNOGEN PHARMA Nifedipine Capsules 5 mg)? "Nifedipine Capsules 10mg" (PL 40147/0061 - ENNOGEN PHARMA Nifedipine Capsules 10mg)? | 28/02/2020 | Disclosed in full |
| FOI 20/099 | Please could you email me the IDAPs for each of the childhood vaccines currently on the recommended UK schedule. | 09/03/2020 | Disclosed in full |
| FOI 20/100 | Request Environmental Risk Assessment for Topamax 25 mg film-coated tablets, marketing authorisation number: PL 00242/0301 and The marketing authorisation numbers for Ionamin in relation to which I would like access to Environmental Risk Assessment are: Ionamin 15 mg, marketing authorisation number: PL 00551/0224. | 18/03/2020 | Disclosed in part |
| FOI 20/101 | Request Yellow Card reports for the following vaccines: Infanrix Hexa Prevenar 13 Bexsero Menitorix M-M-RvaxPro Priorix Repevax Revaxis Nimenrix | 18/03/2020 | Disclosed in full |
| FOI 20/103 | The non-clinical overviews for Amantadine HCl | 19/03/2020 | Disclosed in full |
| FOI 20/107 | Could you provide me with correspondence between the MHRA and Nicoventures Trading Limited and Nicoventures Limited regarding the licensing of e-voke and the subsequent decision not to release the product | 24/04/2020 | Disclosed in part |
| FOI 20/108 | Can the following pharmacovigilance inspection reports be provided for all Companies that had major or critical findings please from September 1st 2017 – 31st March 2018. | 18/03/2020 | Disclosed in part |
| FOI 20/110 | You could please provide me with the complete data for all reports made- the drug analysis profiles | 11/03/2020 | Disclosed in full |
| FOI 20/112 | Details of all complaints about non-adherence/websites selling illegally or improperly received by the MHRA distance selling team in the last 12 months? | 25/03/2020 | Disclosed in part |
| FOI 20/113 | Following my FOI request, would it be possible for you to provide all PSURs Rapporteur's assessments for all Priorix PSURs retrieved previously ? | 10/03/2020 | Not held |
| FOI 20/114 | Tranformation deliverables and objectives | 17/03/2020 | Disclosed in full |
| FOI 20/115 | HR implementation and changes | 03/03/2020 | Disclosed in full |
| FOI 20/116 | could I please have the list of Manufacturing Licences that the MHRA issued between the year 2010 and 2019. I would love these broken down by each year. | 24/03/2020 | Disclosed in full |
| FOI 20/117 | Can you tell me whether a company has submitted a licence for Actair (tablet) in the UK? | 28/02/2020 | Disclosed in part |
| FOI 20/119 | PL 44673/0012 - Beechams Flu Plus Hot Lemon - Clinical overview | 27/03/2020 | Not held |
| FOI 20/120 | Please can the MHRA confirm the regulatory history of the ACCORD-UK LIMITED product: " METHYLDOPA TABLETS BP 125mg” Full name: Actavis UK Methyldopa Tablets BP 125mg - PL 00142/0092 | 09/03/2020 | Not held |
| FOI 20/121 | Request relating to Information Technology | 30/03/2020 | Disclosed in full |
| FOI 20/122 | Please could you inform us veterans which B. Anthracis and or batches had the serious reactions with the pertusis. Unfortunately MOD are very good at losing, misplacing or destroying data! | 30/03/2020 | Not held |
| FOI 20/123 | Please tell me how many times in the last ten years a yellow card has been submitted to the MHRA's yellow card scheme to flag an adverse reaction to the synthetic hormones used in contraception. By contraception I mean the hormonal pill, the implant, the hormonal coil and the nuva ring. By synthetic hormones I mean all combinations of synthetic hormones in different types of pill, including progesterone only pills. | 13/03/2020 | Disclosed in full |
| FOI 20/124 | Please tell me how many times in the last ten years a yellow card has been submitted to the MHRA's yellow card scheme to flag an adverse reaction to Sertraline for/from a female patient. | 13/03/2020 | Disclosed in full |
| FOI 20/125 | Request the Pharmacovigilance inspection reports from inspections that have been closed (final inspection reports) between September 2019 and February 2020. | 01/04/2020 | Disclosed in part |
| FOI 20/126 | Can the following pharmacovigilance and GCP inspection reports be provided for all Companies that had major or critical findings please from April 1st 2018 – 31st August 2018. | 30/03/2020 | Disclosed in part |
| FOI 20/127 | MA applications submissions in respect of Fostair | 13/03/2020 | Disclosed in part |
| FOI 20/130 | Inspection Report El Paso on blood donors | 02/04/2020 | Disclosed in part |
| FOI 20/132 | Soliris RMP | 30/03/2020 | Disclosed in part |
| FOI 20/133 | reports on adverse reactions to the following: Infarix Hexa Bexsero Rotarix Prevenar 13 Menitorix MMR Vax Pro Priorix Fluenz Tetra Repevax Boostrix IPV Gardasil Revaxis Nimenrix Menveo | 17/03/2020 | Disclosed in full |
| FOI 20/134 | Tradimed Vapour & Muscle Rub Cream applicant details | 13/02/2020 | Disclosed in part |
| FOI 20/135 | All e-mail correspondence held by the Inspection, Enforcement and Standards Division containing the search term "blood inquiry" in the e-mail subject or body during the period 1st Jan 2020 - 8th March 2020 | 06/04/2020 | Not held |
| FOI 20/136 | QUOTIENT SCIENCES (READING) LIMITED | 03/03/2020 | Disclosed in part |
| FOI 20/138 | Risk Management Plan of desogestrel 75 µg film coated tablet licensed by Stragen | 25/03/2020 | Disclosed in part |
| FOI 20/141 | FOI on isotretinoin fatal cases - Under the freedom of information act I would like to know how many actual deaths have occurred(as in reported but not historical) since the decision to reconvene the EWG was made. | 14/04/2020 | Disclosed in full |
| FOI 20/143 | Please may I have the total reported deaths and serious injures for all vaccines given to children and adults in the UK in 2019? | 15/04/2020 | Disclosed in full |
| FOI 20/144 | Clinical overview, risk management plan for PL 20072/0216 Migranal 4 mg/mL nasal spray solution | 09/04/2020 | Disclosed in part |
| FOI 20/145 | Under the FOI pls provide the original pAR/clinical AR, and the synopsis of the studies used to support this original application for (PL 00095/0311). | 16/04/2020 | Disclosed in part |
| FOI 20/146 | Can the following pharmacovigilance inspection reports be provided for all Companies that had major or critical findings please from September 1st 2018 – 31st March 2019. | 17/04/2020 | Disclosed in part |
| FOI 20/147 | Request a copy of the Clinical Overview and its addendum of the licensed medicinal product (Fultium-D3 20,000 IU Capsules) | 17/04/2020 | Disclosed in part |
| FOI 20/148 | VELCADE [BORTEZOMIB] Risk Management Plan - Safety Concerns | 30/03/2020 | Not held |
| FOI 20/149 | Microsoft Office 365 Backup Policy | 20/04/2020 | Disclosed in part |
| FOI 20/150 | Temazepam Publica Assessment Reports | 31/03/2020 | Not held |
| FOI 20/151 | I would like information assessing or recording what progress has been made since 2014 or can be made towards dermal filler products becoming prescription only. Any information held by the MHRA on the number of UK citizens who, since 2014, have suffered adverse effects from dermal filling, including annual figures | 27/04/2020 | Disclosed in full |
| FOI 20/152 | telephony system | 28/04/2020 | Disclosed in full |
| FOI 20/154 | Can the following pharmacovigilance & GCP inspection reports be provided for all Companies that had major or critical findings please from April 1st 2019 – 31st August 2019 | 29/04/2020 | Disclosed in part |
| FOI 20/155 | Could MHRA allocate 24hours of manpower to specifically provide the number of White, Black, and Asian patients that reported an adverse event whilst being prescribed METFORMIN HYDROCHLORIDE during 2019? | 28/04/2020 | Disclosed in full |
| FOI 20/160 | PAR for Trimovate Cream (PL40739/0161), | 03/04/2020 | Not held |