FOI release

MHRA FOIA Request Disclosure Log 1 July to 30 September 2020

Updated 10 January 2022
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REF SUBJECT RESPONSE SENT RESULT
FOI 20/269 Information request on headcount, annual budgets, criminal investigations for period 2019-2020, fraud loss figures, and criminal sanctions 15/07/2020 Disclosed in full
FOI 20/271 With reference to the request below, we would like to have access to the data supporting the statement that ‘Since the reclassification of Viagra Connect, no additional safety concern has been raised as a result of its availability as a P product’ as stated in page 5 of the Sildenafil PAR linked to FOI 20/242. 27/07/2020 Disclosed in full
FOI 20/273 MHRA updates of clinical trial statuses on EudraCT - progress 30/07/2020 Disclosed in full
FOI 20/274 I would like to make a FOIA request for any line listings / demographics / reactions information on products with the following active ingredients for human medicines - Pentosan polysulfate 07/07/2020 Disclosed in full
FOI 20/275 Safety incidents at BSL-4 labs 31/07/2020 Disclosed in full
FOI 20/276 Inspection report for - ALMAC CLINICAL SERVICES LIMITED 05/08/2020 Disclosed in part
FOI 20/277 what I want to know now is whether otsuka are giving you funding during the Brexit transition. Or if not, what antipsychotic/antidepressant companies are giving you money? 27/07/2020 Disclosed in full
FOI 20/278 Request for Information - Telephone Maintenance 07/08/2020 Disclosed in full
FOI 20/279 Request for Information - IT budgets, software, Intranet solution, IT services 23/07/2020 Disclosed in full
FOI 20/280 Safety and efficacy assessment of surgical mesh implants 10/07/2020 Disclosed in full
FOI 20/281 Request for copy of SOP 10/08/2020 Disclosed in full
FOI 20/282 adverse drug reactions, excluding vaccines, fatalities, excluding vaccines, adverse vaccine reactions and fatalities as a result of vaccines 03/08/2020 Disclosed in full
FOI 20/283 Side effects connected with off label injections of BoNT/A (also BoNT/B) 06/08/2020 Disclosed in full
FOI 20/285 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 October 2019 - 31st Dec 2019 11/08/2020 Disclosed in part
FOI 20/286 Please can you confirm if PL 40147/0041 “ENNOGEN PHARMA Furosemide Tablets BP 500mg”, which has a UK Product Birth Date of  26/11/1992, was created following a change of ownership of a pre-existing Product Licence? 16/07/2020 Disclosed in full
FOI 20/287 High frequency ultrasound machines in cosmetic surgery 07/08/2020 Not held
FOI 20/289 I would like to request for Module 5.3.1, Module 2.7, Module 2.4 and Module 2.5 submitted for (PL 17907/0596) Flucloxacillin 250 mg / 5ml Powder for Oral Solution, Sugar Free (Bristol Laboratories Ltd). Not set Disclosed ion part
FOI 20/290 I request the data related to the following questions:  Whether the pharmaceutical companies which distribute BoNT/A (also BonT/B) on the british/English market have provided the MHRA with the data that  every vial with botulinum toxin realesed on the market is fully sterile? How often are product inspections in their factories to check that the vials are 100 percent sterile? 10/08/2020 Disclosed in full
FOI 20/291 I request the data related to the following questions: - Whether the pharmaceutical companies which distribute BoNT/A (also BonT/B) on the british/English market have provided the MHRA with the data that  every vial with botulinum toxin realesed on the market is fully sterile? How often are product inspections in their factories to check that the vials are 100 percent sterile? Second question: Does the company IPSEN responsible for Azzalure have information about the pharmacokinetics of the botulinum toxin and therefore its absorption, distribution, metabolism and elimination? Third question: Did IPSEN present any human studies with the possible list of side effects before Azzalure was released on the market? If so, did part of this study was checking the partcicipants of the medical experiment on the presence of the botulinum toxin in the blood? The MHRA is responsible for issues related to drug safety, information leaflets, MARKETING AUTHORISATIONS, licensing guidance etc. That's why I asked you about it because the MRHA has to check every aspect connected to medications, all have to be examined carefully by your agency before the medication could be released on the market.  05/08/2020 Disclosed in full
FOI 20/292 I request the data related to the following questions: Did Ipsen which distribute Azzaure has provided MHRA with the following data - On Azzalure leaflets is clearly written: "Chemical and physical in-use stability has been demonstrated for 24 hours between 2 - 8°C."  Does this mean that after this period it loses its properties and using it after 24 hours will not cause relaxation of the patient's muscles? 05/08/2020 Disclosed in full
FOI 20/294 For GPVP inspections conducted during 2019 and 2020 and for which there were findings (critical, major, minor or comments) relating to the MAH’s PSMF and contracts and agreements (specifically SDEAs), please can you send me the section of the inspection reports relating to these findings. 12/08/2020 Disclosed in part
FOI 20/295 Metformin - I would be most grateful for your help and guidance and whether the manufacturers have asked for licensing. 03/08/2020 Disclosed in part
FOI 20/296 Request for data under Freedom of Information Act 2000 Re: Yours of 9 July FOI 20/249 And: letter 23 May from RECOVERY to MHRA as supplied And: letter 29 May from RECOVERY to MHRA as supplied And: SUSAR and DSUR reports for RECOVERY (hydroxychloroquine arm). 10/08/2020 Disclosed in part
FOI 20/297 ON this basis., please can i narrow my request to the time period from Jan-Oct 2019 GVP inspection reports for companies with one or more critical or major findings. Not set Dislosed in part
FOI 20/298 As per my rights under the Freedom of Information Act (2000) I hereby request statistics on the number of children who are suspected to have died following routine NHS vaccines over the past 5 years please. 20/08/2020 Disclosed in full
FOI 20/299 Can you check if Northwest Biotherapeutics and not Advent Bioservices is currently in the process of applying for licencing and accreditation from the MHRA for the Sawston site? 18/08/2020 Not held
FOI 20/300 I'm asking what happens with Azzalure when could be eventually use after its expiration date. 05/08/2020 Not held
FOI 20/301 As per my rights under the Freedom of Information Act (2000) I hereby request the Drug Analysis Print (DAP) report of suspected adverse reactions, including fatal adverse reactions to the chickenpox (varicella) vaccine. 17/08/2020 Disclosed in full
FOI 20/302 I would like a list of all registered distance sellers and I would like a copy of all entries in the register of authorised online sellers of medicine listing their name, and all their contact details in a excel format.  14/08/2020 Not released
FOI 20/303 I would like to request electronic copies of the GPvP inspection reports conducted in the period April 2018 to March 2019 from the eight inspections which have been conducted onsite according to the Pharmacovigilance Inspection Metrics Report (specified on page 2) published on MHRA's homepage. The purpose of my request is for learning purposes. 13/08/2020 Disclosed in part
FOI 20/304 Please could you send me all adverse event (yellow card) reports to date for all vaccines on uk schedule, differentiating between inactivated and LAIV flu vaccines? 25/08/2020 Disclosed in full
FOI 20/307 Can you provide a lookup table for all the Gemscript drug codes (used in CPRD) to SNOMED/ DM+D codes? An ideal format would be: Product Name, Gemscript Code, SNOMED/ DM+D code 30/07/2020 Disclosed in full
FOI 20/308 I would like to request all the 2018 and 2019 inspection reports and findings for Simbec-Orion Clinical Development and Clinical Pharmacology at the below addresses. Simbec-Orion Clinical, Development, Slough SL1 3UA 24/08/2020 Disclosed in part
FOI 20/309 I need to retrieve the PSUR for GSK’s Engerix B (hepatitis B vaccine, at those times the MAH was named SKB – SmithKlineBeecham) submitted for the initial marketing autorisation renewal – probably in 1991. 10/08/2020 Disclosed in full
FOI 20/310 I need to retrieve the table of submission dates for PSURs applicable to vaccines currently marketed in the UK. It’s released by the EMA and I need the equivalent if this document exists. I need to retrieve the latest PSURs (submitted in 2020) for GSK’s Engerix and Merck/MSD HBVaxPro. 04/08/2020 Not held
FOI 20/311 request for Module 2.4, Module 2.5, Module 3.2.P.5.5, impurity profile, Module 2.7 and Module 5.3.1 submitted for (PL 17496/0034) Cyanocobalamin 50 microgram film-coated tablets (Dalkeith Laboratories Ltd). 25/08/2020 Disclosed in part
FOI 20/313 In relation to the role of Engagement Manager (COM028) which was advertised on the MHRA jobs website and which closed for applications on 28 June 2020, please provide the following information: a) number of applications received for this role; b) number of applications shortlisted for this role; c) number of applicants invited for interview for this role. Please provide details of the criteria or scoring / selection process used to decide which applicants progressed from stage a) to b) and from stage b) to c). 06/08/2020 Disclosed in full
FOI 20/314 What type of side effects were noted by MHRA if the injection of following products were correct and done by qualified health care professionals/doctors:Xeomin/Vistabel/Botox/Dysport/Azzalure/Bocouture/Neurobloc/Cl.botulinum toxin 28/08/2020 Disclosed in full
FOI 20/315 Under the Freedom of Information Act, could you please kindly answer the questions Telephony System 25/08/2020 Disclosed in full
FOI 20/316 We are requesting the following in relation to the following DCPs – UK/H/6086/001 – 003 Reason for negative opinion for these submissions Copy of the final Public Assessment Report. Not set Disclosed in part
FOI 20/317 I would like the data on the yellow card schemes for all the vaccinations Children have to have nowadays for the last 5yrs 28/08/2020 Disclosed in full
FOI 20/318 Freedom of Information request relating to MELATONIN 07/09/2020 Disclosed in part
FOI 20/319 I would like to put in a freedom of information request about what information you had about the psychiatric side effects of the medicines. Cipfrofloxin and Rifampicin. I am specifically referring to the information known to yourselves prior to March 2016 and during the time frame March 2016 - December 2016 in terms of information submitted to you by any individuals, by your involvement in professional regulatory networks in Europe and globally and any case studies or statistics you may hold. 08/09/2020 Disclosed in full
FOI 20/320 ." My question now is very specific - how often are the inspections in the factories to check the sterility of Azzalure (Ipsen). Please provide a very precise answer taking into consideration time intervals - for instance: one a month, one every six months etc. Im asking about very precise answer. 08/09/2020 Disclosed in full
FOI 20/321 I am looking for published data on the frequency of Metoclopramide prescriptions in Scotland (failing which, the UK) both before and after this warning was published (i.e. between August 2012 – August 2013) and after the warning (specifically between August 2013 – August 2014). I am also looking for any data about the length of time that patients continued on Metoclopramide following the MHRA warning in August 2013. 11/08/2020 Not held
FOI 20/322 I was wondering whether the 2020 pay review/settlement has now been finalised and implemented. If so, please find enclosed a Freedom of Information request regarding the 2020 pay award. If it has yet to be concluded do you happen to know when would be best to submit my request again?  21/08/2020 Disclosed in full
FOI 20/323 Please provide an Excel spreadsheet listing all such trials that have been approved since 01 January 2006. The Excel should at a minimum include the WHO primary registry number (e.g. NTC123456789, ISRCTN01020304) of each such trial. If these data are not available for the entire time span, please provide what data are available. Please detail what steps (if any) the MHRA takes to (a) detect which of these trials that have been approved and completed but have not made their outcomes public on a trial registry or in a peer reviewed academic journal, and (b) obtain the outcomes of such unpublished trials. By what date does the MHRA intend to proactively make information on such trials available to the public? 23/09/2020 Disclosed in part
FOI 20/325 Considering whole answers, I would like to ask whether each batch of Azzalure (IPSEN company) is inspected by MHRA's GMP Inspectorate for sterility/possible contamination? 09/09/2020 Disclosed in full
FOI 20/326 I would like to capture the quantity of medicines seized by MHRA that are defined as falsified and pose a danger to public health for the years 2019 and for January 2020 to July 2020. 10/09/2020 Disclosed in full
FOI 20/329 Please could you provide the PARs for these products as they do not appear on your website? I am particularly interested in the pharmacokinetic and pharmacodynamic data that would have been submitted with these products as evidence of efficacy. Did you also consider the excipient content? Please could you also confirm which company is actually the manufacturer for these product? 27/08/2020 Disclosed in part
FOI 20/331 Data inquiry regarding project to increase confidence in childhood vaccines. Request to the MHRA a list, spreadsheet, or reference papers that identify threshold exposure levels considered toxic by the MHRA, by individual's body mass, depending on exposure type, of: Aluminum, Mercury, Formaldehye , 2-Phenoxyethanol, Triton X-100 (Octoxynol-10 and Octylphenol Ethoxylate), Polysorbate 20 and Polysorbate 80 07/09/2020 Not held
FOI 20/332 Request the number of new medicinal products approved for market authorization by the MHRA, since 2000, for use in the treatment of unipolar mood disorders (e.g. dysthymia, severe depression, recurrent depression, major depression, treatment-resistant depression, or other unipolar depressive disorders), excluding license renewals or extensions for medicinal products that were already authorized by the MHRA for unipolar mood indications. The number of new medicinal products approved for market authorization by the MHRA, since 2000, for use in the treatment of tracheal, bronchus, and/or lung cancers, excluding license renewals or extensions for medicinal products that were already authorized by the MHRA for use in these cancer types. 27/08/2020 Disclosed in full
FOI 20/333 I'm requesting records for NHS Foundation Trust ("the Trust'), entitled Clinical Evaluation of DeChoker an article I'm reporting on my blog and I have no financial interest in the requested information, therefore this is to request that any fees be waived. If the fee for completing my request exceeds 5 Euros, please obtain my written approval prior to completing this request. Please send the requested records as ready rather than aggregated in a single response. 08/09/2020 Not held
FOI 20/334 What inspections activities does the Medicines and Healthcare products Regulatory Agency perform? How many inspections (of each type if possible) were performed in 2019/20? How many inspectors do you employ, and what was the annual cost of these inspectors in 2019/20? Do you use third parties to perform these inspections? If so, who did you use, and what was the annual spend in 2019/20? What information management system, if any, do you use to manage the inspections, and what was the annual spend on this in 2019/20 18/08/2020 Disclosed in part
FOI 20/336 The information I would like is the number of yellow card reports in relation to seasonal influenza vaccinations in each calendar year where the suspected adverse event included narcolepsy (going by the date of vaccination rather than the date of the report) for (a) persons under 18 yrs when vaccinated and (b) persons 18 yrs and over when vaccinated 21/09/2020 Disclosed in full
FOI 20/337 I am writing from the Department of Plastic Surgery at xxxx and would be grateful if you could provide the data for all documented Adverse Drug Reactions or Adverse Incidents pertaining to Botulinum Toxin A from April 2003 to July 2020. I am also requesting the data for ADRs held by the Medicines Control Agency from 1989 to 2003. 09/09/2020 Disclosed in full
FOI 20/340 I would like to know which services require members of the public to provide ID verification. Additionally, 'digital identity' does not include identity users inputting passwords and login information etc.The first set of questions refer specifically to members of the public providing physical documentation (such as a passport) in order to verify their ID, whilst the second set of questions refer to ID that can be verified through digital means, for example a member of the public being able to upload their passport online, enter their passport number online, enter their national insurance number online or using a digital service 23/09/2020 Disclosed in full
FOI 20/342 I require the PAR for the following PL 20046/0292, PL 0046/0293 and 20046/0294 28/08/2020 Not held
FOI 20/344 Request the interactive drug analysis profiles for all routine childhood vaccinations? 17/09/2020 Disclosed in full
FOI 20/345 foi Seasonal Flu Vaccine 2020/2021 25/09/2020 Disclosed in part
FOI 20/347 under the Freedom of Information Act (2000) I hereby request the Drug Analysis Print (DAP) report of suspected adverse reactions, including fatal adverse reactions for all the vaccinations in the children's vaccination schedule. 17/09/2020 Disclosed in full
FOI 20/348 I would like to know any vaccine reactions reported for the following vaccines: MMR (since 1988), Measles live single. Reaction types include: hospitalisations, seizures, encephalitis/meningitis, other non-specified neurological disorders 02/10/2020 Disclosed in full
FOI 20/351 Request a copy of all GMP inspection reports for Patheon Pharmaceuticals site manufacturing site at Kingfisher Drive, Covingham, Swindon for inspections performed between 2000 and 2005. 29/09/2020 Disclosed in part
FOI 20/352 hereby request information on any and all applications for a marketing authorisation for a medicinal product containing melatonin, regardless of authorisation procedure or type of application (legal basis), that has been submitted or filed with the authority since 11 December 2019. 14/09/2020 Disclosed in part
FOI 20/353 Please provide me with all correspondence between MHRA representatives and any representatives of  Northamptonshire Healthcare NHS Foundation Trust regarding that agency's DeChoker study. 08/09/2020 Not held
FOI 20/354 I would like to request information for all the vaccines on the childhood immunisation schedule, for all ages, for as long as you have data going back to the inception of the adverse reactions reporting scheme please.  So these will be: Infranrix Hexa, Rotarix, Bexsero, Prevenar 13 30/09/2020 Disclosed in full
FOI 20/355 Please will you inform me if smart watches whose manufacturers claim they can detect partial fibrillation meet the criteria to become medical devices. If they don’t, why they don’t. If they do, please inform me of the smart watches that claim they can detect partial fibrillation that have a marketing authorisation for that medical device. 08/09/2020 Not held
FOI 20/357 Where can we find the "internationally agreed standards" upon which the safety testing is based?  Is this WHO-defined?  ("However, please be aware that the safety of each of the constituents of a medicine is assured by testing performed to meet internationally agreed standards which the MHRA examines in its assessment for each specific product.") 05/10/2020 Disclosed in full
FOI 20/358 Request to the organisation around their hosting contract(s) with 3rd party providers. Cloud Hosting services 07/10/2020 Disclosed in full
FOI 20/359 Information Request: Botulinum Toxin A - Adverse Reactions 07/10/2020 Disclosed in full
FOI 20/360 We wanted to know the number of missile incidents in MRI that were reported to MHRA during 2015,2016.2017,2018,2019,2020, the type of incident and if there was any patient harm. Not set Disclosed in full
FOI 20/362 Can you please supply me with details of the adverse reactions you're aware of for the UK vaccine schedule as well as flu vaccines (nasal and injected)? 30/09/2020 Disclosed in full
FOI 20/363 Bcg Marketing Authorisation Holders 07/10/2020 Disclosed in full
FOI 20/365 Please provide a copy of your most recent annual report for the JCVI (FLU VACCINE-ASSOCIATED SUSPECTED ADVERSE REACTIONS REPORTED VIA THE YELLOW CARD SCHEME) for years 2014 to 2020 by individual years. 09/10/2020 Disclosed in full
FOI 20/368 The most recent MHRA GPvP inspection reports for Celltrion Healthcare, Amgen, and Sandoz Limited. The most recent MHRA GPvP inspection reports for Biosimilar companies (within the year 2017 to 2020 Sep) - excluding Samsung Bioepis. 23/10/2020 Disclosed in full
FOI 20/369 Under the Freedom of information act, Please can you provide me with the 10 year records for reactions and deaths caused by the Typhoid, Hep b vaccines and the influenza (injection for adults) vaccines. 01/10/2020 Disclosed in full
FOI 20/370 Data medicines seized by MHRA that are defined as falsified and pose a danger to public health for the years 2019 and for January 2020 to July 2020. 17/09/2020 Disclosed in full
FOI 20/371 Request the MHRA decisions granting marketing authorisation MELATONIN products 28/09/2020 Disclosed in part
FOI 20/373 I am looking for all yellow card information received over the last 3 years for any eye drop in which Latanoprost is the active ingredient.  Please can you provide the product name and the description of the adverse reaction  (exact words please, not a summary) 15/10/2020 Disclosed in full
FOI 20/374 Request ADR - 13 side effects:Gastrointestinal Disorders: Flatulence, bloating and distortion: Flatulence, Psychiatric Disorders: Sexual Desire disorders: (i) pathological gambling, (ii) compulsive shopping, Psychiatric Disorders: Paraphilias: (i) Transvestism, (ii) voyeurism 12/10/2020 Disclosed in full
FOI 20/376 Request for information on Candidate vaccine LNP-n CoV saRNA - redirected from UK Research and Innovation under ref: FOI2020/00281 17/09/2020 Not held
FOI 20/377 under the Freedom of Information Act (2000) I hereby request the Drug Analysis Print (DAP) report of suspected adverse reactions, including fatal adverse reactions to the HPV vaccine, the 3 in 1 teenage booster and the MenACWY vaccine.  01/10/2020 Disclosed in full
FOI 20/378 under FOI, a copy of the application for CTA submitted by the Cell and Gene Therapy Catapult for Bronchopleural & Fistula 08/10/2020 Disclosed in part
FOI 20/379 Request the information relating to suspected adverse reactions to the following vaccines: - MMR vaccine (first dose and follow ups) - Nasal flu - HPV vaccine - Inactivated flu vaccine. 12/10/2020 Not set
FOI 20/380 For the 2019 calendar year could you please state the number of Adverse Reactions reported relating to breast implants used in breast enlargement surgery. For the 2019 calendar year's Adverse Reactions to breast implants used in breast enlargement surgery please could you give me a complete breakdown of the side effects that the reporter has claimed. 14/10/2020 Disclosed in full
FOI 20/381 FOI request how many deaths have been reported in total? How many suicidal attempts? How many reports have you received where people, other than the patient, has been hurt or put at risk because of the patient's irrational or aggressive behaviour? 21/10/2020 Disclosed in full
FOI 20/382 has the MHRA carried out any investigations (beyond recording the yellow card data) into the possible causal association between narcolepsy and seasonal flu vaccine in a) children and/or b) adults. If so what investigations were carried out. If no, why not 30/09/2020 Disclosed in full
FOI 20/383 Request Public assessment report or National assessment report for PL 36722/0124 SenEase 7.5mg Tablets 18 years plus? 23/09/2020 Disclosed in full
FOI 20/385 A copy of the original MCA/MHRA assessment reports for Vioxx (rofecoxib). Copies of the Expert Reports for Non-Clinical and Clinical data for Vioxx (rofecoxib). All MCA/MHRA assessment reports of Periodic Safety Update Reports on Vioxx (rofecoxib). Summary of Product Characteristics/changes to SmPCs for Vioxx (rofecoxib). Patient Information Leaflets/changes to PILs for Vioxx (rofecoxib). MCA/MHRA review of the evidence relating to the cardiovascular safety of rofecoxib and other COX-2 inhibitors conducted in Autumn 2001 25/09/2020 Disclosed in part
FOI 20/386 We are writing to ask which manufacturers of Sodium Valproate: Have been instructed to add the pregnancy prevention programme information to the Patient Information Leaflet for Valproate. Have been instructed to add the Pregnancy prevention Programme warnings to their boxes of Valproate. Change the amount of tablets per box from 100 to 28 14/12/2020 Disclosed in full
FOI 20/388 Refined request a copy of the original MCA/MHRA assessment reports for Vioxx (rofecoxib). MCA/MHRA assessment reports of Periodic Safety Update Reports on Vioxx (rofecoxib) 22/10/2020 Disclosed in part
FOI 20/390 request for Module 2.4 submitted for Nortriptyline 50 mg film-coated tablets (PL 25258/0265) Glenmark Pharmaceuticals Europe Limited & (PL 20046/0306) Focus Pharmaceuticals Limited. 20/10/2020 Disclosed in full
FOI 20/391 We are writing to ask the amount of prescriptions given for Sodium Valproate to women of child bearing potential between the ages of 15yrs – 45yrs old in England only between: April 2017 – April 2018, April 2018 – April 2019, April 2019 – April 2020, April 2020 – September 2020 28/09/2020 Not held
FOI 20/392 Please could you provide me with all MHRA PV Inspection reports related to MHRA PV inspections conducted between January 2019 and July 2019 26/10/2020 Disclosed in part
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