FOI release
MHRA FOIA Request Disclosure Log 1 April - 31 June 2020
Updated 10 January 2022
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| REF | SUBJECT | RESPONSE SENT | RESULT |
|---|---|---|---|
| FOI 20/158 | I herewith request the Pharmacovigilance Inspection Reports for all companies that had Critical and/or Major findings in 2019 | 01/05/2020 | Disclosed in part |
| FOI 20/159 | Please name the Importers who charged: a) South Kent CCG just £0.46 per tablet during March 2019, b) South Kent CCG £3.26 per tablet during April 2019 and c) NHS Enfield CCG £5.22 per tablet during July and December 2019 | 20/04/2020 | Disclosed in part |
| FOI 20/161 | Please can the MHRA confirm if the product Hanixol 50 mg Tablets (50 mg of 6-mercaptopurine), which has a Marketing authorisation number of PL 42924/0019 and for which Fontus Health Ltd is the Marketing Authorisation Holder, is linked to the DCP procedure IE/H/1080/001 (product name: Mercaptopurine 50 mg tablets; Date of outcome: 22.01.2019), which has Ireland as a RMS and the UK as a CMS. | 15/04/2020 | Disclosed in full |
| FOI 20/162 | Can you provide me will all risk assessments, meeting minutes, internal emails, and other documentation which relate to the decision to introduce these flexibilities and the justification for introducing GDP flexibilities. | 04/05/2020 | Disclosed in part |
| FOI 20/163 | A randomized, double-blind, placebo-controlled, single-center, phase IIb efficacy and safety trial was conducted at h-VIVO Services Ltd (London, UK). The study (ClinicalTrials.gov: NCT03180801, EudraCT: 2016-002134-74) was approved by UK’s Medicines and Healthcare products Regulatory Agency and the North East-York Research Ethics Committee and registered on 8 June 2017 report. | 20/04/2020 | Disclosed in full |
| FOI 20/165 | Please could you tell me the total number of adverse drug reactions (ADRs) reported to you through the Yellow Card scheme in the 2019 calendar year? In relation to the figures for 2019 could you also provide (i) the number of UK suspected ADR reports received with a fatal outcome, (ii) number of ADR reports received which resulted in prolonged hospitalisation and (iii) the number of reports received which resulted in prolonged hospitalisation A | 01/05/2020 | Disclosed in full |
| FOI 20/166 | What is the safe level of adjuvants in vaccines? | 01/05/2020 | Disclosed in full |
| FOI 20/167 | Vaccine Safety Studies for vaccines administered to babies up to 6 months | 11/05/2020 | Disclosed in full |
| FOI 20/168 | I am trying to secure a list of all companies that are not sole traders/ single person companies, who hold a valid industrial hemp growing licence | 20/04/2020 | Not held |
| FOI 20/169 | RMP for product Zofran Flexi-amp Injection 2 mg/ml, Novartis Pharmaceuticals UK Ltd | 28/04/2020 | Disclosed in part |
| FOI 20/170 | RMP or the table of safety concerns of PRISTIQ® Tablets | 17/04/2020 | Not held |
| FOI 20/171 | I would like to have access to the list of 100 countries, and to know the names of the Commonwealth countries where it forms an inherent part of established medicines legislation. The years I am particularly interested in are either 1997 or 2002, but the most recently available list would be suitable | 12/05/2020 | Disclosed in full |
| FOI 20/172 | I request a copy of the non-clinical and clinical overviews/studies used in support of PL 0011/5014R Mucaine Suspension | 14/05/2020 | Disclosed in part |
| FOI 20/175 | pharmacovigilance & GCP inspection reports be provided for all Companies that had major or critical findings please from September 1st 2019 – 31st March 2020 | 18/05/2020 | Disclosed in part |
| FOI 20/176 | pharmacovigilance & GCP inspection reports be provided for all Companies that had major or critical findings please from April 1st 2019 – 31st August 2019 | 18/05/2020 | Disclosed in part |
| FOI 20/177 | Public Assessment Report and Clinical Overview for the licence for PL 44673/0081, PL 14338/0010 and PL 44673/0185 | 23/04/2020 | Disclosed in part |
| FOI 20/178 | Request for GMP inspection report for Symbiosis Pharmaceutical Services LTD | 19/05/2020 | Disclosed in part |
| FOI 20/179 | Assessment Report of PL 00031/0027R Efudix Cream | 18/05/2020 | Disclosed in part |
| FOI 20/180 | Please may I have a copy of the note which Professor Sir Mike Rawlins, then Chairman of the Committee on the Safety of Medicines (part of what is now MHRA), sent to Baroness Jay, Parliamentary Secretary (Lords) at the Department of Health in approximately the first quarter of 1998 | 18/05/2020 | Not held |
| FOI 20/181 | I am writing this email to request for clinical study reports from the clinical trials on the anti-depressant duloxetine submitted to the Medicines and Healthcare products Regulatory Agency, United Kingdom from the pharmaceutical industry. The trials could be pre-authorization or post-authorization | 07/05/2020 | Disclosed in part |
| FOI 20/182 | We would like to refine the FOI request for Migranal 4 mg/mL nasal spray solution (PL 20072/0216) to the nonclinical overview and clinical overview. | 21/05/2020 | Disclosed in part |
| FOI 20/183 | Has your organisation in the last 12 Months procured services or resource from FDM Limited (Company number 02542980) or Sparta Global Limited (Company number 05597367) ? | 12/05/2020 | Disclosed in full |
| FOI 20/184 | IT procurement - 1. Does the organisation outsource and use 3rd party suppliers under any of the following 3 categories? -IT Hardware/Software. -IT Support. -IT Services and communication.1. If so who are the suppliers/resellers used and what has the spend been with them in the last 6 months?3. Who are the contacts/procurement in the organisation to speak with in order to get added as an IT supplier to the organisation? 4. Who are the IT managers in the organisation in place and there contact details? | 13/05/2020 | Disclosed in part |
| FOI 20/185 | I’m interested in the severe reactions/side effects and deaths caused by the MenACWY vaccine over the past 5 years? Or 10 years If data goes back that far? | 21/05/2020 | Disclosed in full |
| FOI 20/186 | * Please disclose the total amount paid in compensation to staff for personal injuries in the years 2018/19 and to date in 2019/20. * Please provide a breakdown for each year showing how much was paid in each case, what caused the injury/injuries and the nature of the injury/injuries. | 22/05/2020 | Not held |
| FOI 20/187 | A copy of the risk management plan and all annexes for the medicinal product Macrobid 100mg Prolonged-release Capsules (PL 12762/0052) | 07/05/2020 | Disclosed in part |
| FOI 20/188 | 1. How many marketing authorisation applications are currently under review for the active Dexamethasone Phosphate Solution as eye drops 2. How many marketing authorisations for Dexamethasone Phosphate Solution as eye drops are already registered in the UK 3. How many of these marketing authorisations are currently marketed in the UK | 03/06/2020 | Disclosed in part |
| FOI 20/189 | GCP inspection statements documenting serious breaches in 2018 | 22/05/2020 | Disclosed in part |
| FOI 20/190 | Please provide all details on the above government exercise ‘Cygnus’ which took place in 2016 please | 06/05/2020 | Not held |
| FOI 20/191 | We would like to request the clinical, non-clinical overviews and risk management plan for Orobalin 1 mg film-coated tablets (Cyanocobalamin) | 14/05/2020 | Disclosed in part |
| FOI 20/192 | I would like to enquire about progress with your investigation into the incident I reported via your yellow card scheme on 8th March 2020, reference number 2020/003/008/401/001 | 11/05/2020 | Disclosed in part |
| FOI 20/193 | Please can I have the updated details of the clinical research studies for each of the marketing authorisation holders from the Article 31 review of adrenaline autoinjectors | 28/05/2020 | Disclosed in part |
| FOI 20/194 | please can I received the GVP inspection report for Dr. Reddy’s Laboratories | 22/05/2020 | Disclosed in part |
| FOI 20/196 | inspection reports for the following Baxter Healthcare Ltd | 02/06/2020 | Disclosed in part |
| FOI 20/197 | Clinical Overview of the licensed medicinal product (Sialanar 320 micrograms /ml oral solution) | 29/06/2020 | Disclosed in part |
| FOI 20/199 | How much adjuvant is currently within the Anthrax vaccine admi istered on our troops! What is the adjuvant used? | 01/06/2020 | Disclosed in full |
| FOI 20/200 | I require all information you hold on this yellow card submission, including details of any associated other yellow card reports | 18/05/2020 | Disclosed in part |
| FOI 20/202 | MMR vaccine 2015-2020 reports | 04/06/2020 | Disclosed in full |
| FOI 20/203 | I would like to request a copy of the clinical overview submitted for (PL 20046/0304-0306) Nortriptyline 10/25/50mg Tablets (Focus Pharmaceuticals). Details of data submitted in support of the BCS based biowaiver claim for Nortriptyline 50mg Tablets will be helpful (eg. literatures or actual permeability studies through CaCo-2 cells). | 02/06/2020 | Disclosed in part |
| FOI 20/206 | full dossier for Viagra Connect PL 00165/0392: POM to P switch in 2017 | 20/05/2020 | Not set |
| FOI 20/207 | What Data Science and Machine Learning software tools does your organisation use? Provide information on software solutions | 09/06/2020 | Disclosed in part |
| FOI 20/208 | request for some of the organisation’s information around the internal plans and strategy documents around ICT | 09/06/2020 | Disclosed in part |
| FOI 20/209 | Inbound envelopes received via the agency and its costs and budgets | 09/06/2020 | Disclosed in full |
| FOI 20/210 | Inbound envelopes received via the agency and its costs and budgets for CHM | 08/06/2020 | Disclosed in full |
| FOI 20/211 | outbound envelopes received via the agency and its costs and budgets | 09/06/2020 | Disclosed in full |
| FOI 20/212 | I was hoping you could clarify something for me about medically licensed e-cigarettes. Is Voke the only e-cigarette style product that has been medically licensed by the MHRA? Are there any other e-cigarette products that are in the process of being licensed? I'm particularly interested in whether any tobacco companies have applied for medical licensing for their products. Is British American Tobacco the only tobacco company (through Kind Consumer and Voke) that has attempted to get an e-cigarette medically licensed? | 15/05/2020 | Disclosed in part |
| FOI 20/214 | I would like to request information about the organisation’s Local Area Network (LAN) environment | 10/06/2020 | Disclosed in part |
| FOI 20/217 | Request for Any MHRA Inspection Reports for Licence Holder MS 20363 | 15/06/2020 | Disclosed in part |
| FOI 20/219 | request to share the Clinical overview for one licence only:Panadol Advance 500 mg Tablets (PL 44673/0185) | 01/07/2020 | Disclosed in part |
| FOI 20/221 | The question is, why is Amylin not approved by yourselves? Is there a research paper I can review? Is there actually evidence based research in the UK as to why Amylin is not available through the NHS. If you care to show me the studies you have conducted in order to conclude that Amylin should not be available to the diabetics of the United Kingdom I will be happy to read it | 03/06/2020 | Disclosed in part |
| FOI 20/222 | Several issues with the product isotretinoin | 12/06/2020 | Disclosed in part |
| FOI 20/225 | Do you also have detailed ten year reports like this on all the vaccines in the current Uk childhood vaccine schedule? | 17/06/2020 | Disclosed in full |
| FOI 20/226 | The number of reports made regarding Adverse Drug Reaction(s) (ADRs) after MMR vaccination by age group and unknown between the years 2000 and 2019 • Of these reports, how many were not serious? Of these reports, how many were serious? A further breakdown of the number of reports by seriousness criteria | 22/06/2020 | Disclosed in full |
| FOI 20/227 | Applications submitted for products containing active ingredient Tapentadol | 08/06/2020 | Disclosed in part |
| FOI 20/228 | I am also interested to enquire as to reports of any issues with Emerade that would have led the MHRA and/or the distributor (be that iMed Systems Ltd (2013-2014) or subsequently, Bausch and Lomb Ltd) to consider issuing a recall or warning. This would include any QA/QC manufacturing or batch release documentation issues and any labelling errors or label failures. | 19/06/2020 | Disclosed in part |
| FOI 20/229 | What I’d like to know is the type of ADR reported - for both the injuries and deaths - for example, seizures, heart attack, stroke, organ failure, paralysis, anaphylactic shock, SIDS, encephalitis, brain injury, ASD etc. for the 10 year period to end of 2019 | 22/06/2020 | Disclosed in full |
| FOI 20/230 | Can you give me any information on the licensing of AstraZeneca and Daiichi Sankyo's Trastuzumab Deruxtecan? | 08/06/2020 | Disclosed in part |
| FOI 20/231 | Vaccine injury compensation scheme - 1) why doesn't it allow children under 2 years old to be included when vaccines begin at 8 weeks in the UK? 2) where can I see a table that shows which vaccine caused damage, what the clinical name for the reaction was, how much was paid out with the years it was paid out? | 22/06/2020 | Disclosed in full |
| FOI 20/232 | My question is when will this drug Trodelvy which was included in the Ascent Trial in the United States be available for use in the UK? | 03/06/2020 | Disclosed in part |
| FOI 20/234 | Will you please inform me if you receive money from bodies outside the Government, such as the BIll and Melinda Gates Foundation? | 29/06/2020 | Disclosed in full |
| FOI 20/236 | ALMAC CLINICAL SERVICES LIMITED inspection report | 03/07/2020 | Disclosed in part |
| FOI 20/237 | RMP and Clinical overview for full dossier for Viagra Connect PL 00165/0392: POM to P switch in 2017 | 16/07/2020 | Disclosed in part |
| FOI 20/238 | Please may we request the Non-Clinical Overview for the following product, and any document relating to the mutagenic potential for PL 20075/0664 – Trazodone HCl 150mg FC Tablets | 30/06/2020 | Disclosed in part |
| FOI 20/239 | Under the FOIA please provide the brand names of all single mumps and measles vaccines included in the import ban referred to in the BBC story below, together with the reasons why those products did not meet the required safety standards | 06/07/2020 | Disclosed in full |
| FOI 20/240 | Can you provide me with the SNOMED/read/ other codes and the algorithm you are using to identify patients on the COVID shielded list within the CPRD database? | 10/06/2020 | Not held |
| FOI 20/241 | XCELIENCE CLINICAL SERVICES LIMITED Inspection report | 08/07/2020 | Disclosed in part |
| FOI 20/242 | We would like to request a copy of the RMP for Sildenafil 50mg Tablets switch application approved in September 2019 | 24/06/2020 | Disclosed in full |
| FOI 20/243 | Comment required for an article on recovery trials - COVID with questions such as 1. Who at MHRA made the decision to request that the RECOVERY programme initiate a review of the data? 2. What was the rationale for the request? 3. Why was the request made at that time? | 22/06/2020 | Disclosed in full |
| FOI 20/245 | Notifications for Pyridoxine (Vitamin B6) injections Lorazepam 2 mg/ml injections Isoprenaline injections Potassium chloride oral controlled release preparations | 06/07/2020 | Disclosed in full |
| FOI 20/247 | Please can you provide us with the Non-Clinical Overview for the following product and any document relating to the mutagenicity and carcinogenicity of Nefopam. PL 27827/0038 - Nefopam hydrochloride 30mg film-coated tablets | 06/07/2020 | Disclosed in part |
| FOI 20/248 | please provide me with all records associated with the review I requested including but not limited to all correspondence to and from MHRA employees. | 09/07/2020 | Disclosed in part |
| FOI 20/249 | Clinical Trials - Numerous Questions on covid 19 hydroxychloroquine trials. What were the grounds to MHRA alert to RECOVERY on 4 June? Specifically did they concern dosage? If an email or written notice or other alert was sent to the IDMC or Chief Investigators of RECOVERY on 4 June, and if so please provide a copy. How did the grounds of 4 June alert differ from the endorsement apparently provided by MHRA on 27 May, If a written endorsement was sent on 27 May by MHRA to the IDMC | 09/07/2020 | Disclosed Iin full |
| FOI 20/250 | I would also like to request for Module 5.3.1, Module 2.7 and clinical literature data submitted for (PL 20046/0304-0306) Nortriptyline 10/25/50mg Tablets (Focus Pharmaceuticals). | 13/07/2020 | Disclosed in part |
| FOI 20/251 | As a part of development process we would like to refer the 2.5 clinical overview of Epistatus 10 mg Oromucosal Solution (PL 16786/0003), under FOI | 14/08/2020 | Disclosed in part |
| FOI 20/252 | 1. how many complex parallel import applications have been approved in the last 5 years? 2. what is the average assessment time for a complex parallel inport application? | 19/06/2020 | Disclosed in full |
| FOI 20/253 | All MHRA Pharmacovigilance Inspection reports for inspections triggered by the launch of pregnancy prevention programs over the last 5 years | 21/07/2020 | Disclosed in full |
| FOI 20/254 | GMDP inspection reports for Mycoplasma | 20/07/2020 | Disclosed in part |
| FOI 20/259 | 1. Do you have any contract or agreement in place for the provision of agency staff? 2. What type of contract is in place? 3. When is this contract due to end? 4. Is there an option to renew?5. Who is the responsible officer for this contract?6. Do you have any separate agreements in place for permanent recruitment? 7. How many agency staff are there currently within your organisation? 8. Please can you provide an indication of agency staff numbers within the following department - - Inspection, Enforcement & Standards | 06/07/2020 | Disclosed in full |
| FOI 20/260 | RMP for PL 12762/0637 - 0001 Abridged | 30/06/2020 | Disclosed in full |
| FOI 20/261 | copy of the MHRA report from your Allergan/Teva inspection | 30/06/2020 | Disclosed in part |
| FOI 20/263 | ICT Strategy - Budgets, devices contracts, suppliers, a copy of your current IT and digital transformation strategy | 23/07/2020 | Disclosed in part |
| FOI 20/264 | I wish to request a copy of the Clinical Overview (CO) used in support of the Approval of PL 00289/2035-2036 | 20/07/2020 | Disclosed in part |
| FOI 20/266 | I wish to submit a request for some of the organisation’s information around the internal plans and strategy documents around ICT. | 20/07/2020 | Disclosed in part |
| FOI 20/267 | Can you tell me when the process of applying for licencing and accreditation for the Sawston site started? | 22/07/2020 | Disclosed in full |
| FOI 20/268 | I was hoping for primary sources of evidence, i.e the references used to write up the document OVERVIEW – RISK: BENEFIT OF OTC COUGH AND COLD MEDICINES IN CHILDREN. | 24/07/2020 | Disclosed in part |
| 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 20/270 | Is there a MHRA searchable database for Infringement letters or Inspection outcomes? Where can someone find results for inspection outcomes, focusing on the Investigator rather than manufacturer or device? | 28/07/2020 | Disclosed in part |
| 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 |