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Could you please confirm whether PAR’s are available for these products? If any of these PARs is not available, could you please advise under which authorisation route the product was approved, and what the reference product is? • PL 00142/0977, for which Accord is the MA holder • PL 15513/0157, for which McNeil is the MA holder • PL 20416/0535, for which Crescent Pharma Limited is the MA holder • PL 46302/0011, for which Mylan is the MA holder • PL 16028/0034, for which Galpharm is the MA holder
Published: 12 August 2026
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Please can you kindly provide the finished product manufacturer(s) name(s) and address(s) as well as the Active Substance Manufacturer(s) details for: Ixazomib 2.5 mg, 3 mg and 4 mg hard capsules (previously called Ninlaro hard capsules) MA numbers: PLGB 15475/0059, PLGB 15475/0060 and PLGB 15475/0061 MAH: Takeda Pharma A/S, Delta Park 45, 2665 Vallensbaek Strand, Denmark
Published: 12 August 2026
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Please provide the following: • the number of times statutory powers were exercised to require the disclosure of documents or information in connection with enforcement action or enforcement investigations; • the number of times statutory powers were exercised to compel individuals to attend interviews in connection with enforcement action or enforcement investigations; and • the number of inspections of physical premises undertaken in connection with enforcement action or enforcement investigations.
Published: 12 August 2026
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Published: 12 August 2026
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Pursuant to the Freedom of Information Act 2000, I am writing to formally request copies of the final Good Manufacturing Practice (GMP) Inspection Reports (and any associated final compliance/closure notifications) for the inspections concluded on 24 February 2026 at the following facilities: 1. Site Name: Aptuit (Oxford) Limited * Address: Abingdon, OX14 4SD, United Kingdom * Inspection End Date: 24 February 2026 1. Site Name: Aptuit (Oxford) Limited * Address: Abingdon, OX14 4SA, United Kingdom * Inspection End Date: 24 February 2026
Published: 12 August 2026
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Please provide me with the following information under the FOIA: 1) How many peptide products were seized by the MHRA during in 2024 and 2025? Please break this down by type of peptide (e.g. Retatrutide). 2) How many peptide products were seized by the MHRA in the first 5 months of 2026? Please break this down by type of peptide.
Published: 12 August 2026
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Please can you kindly provide the public assessment report for Phosphate Sandoz PL 44490/0002 or if unable to locate a public one, please can MHRA kindly provide any aspects of the assessment report which indicate which literature references were used as the basis for approval.
Published: 12 August 2026
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The undersigned hereby requests access to the registration documentation for Alkacit 1080 mg modified-release tablets (PL 59076/0001). The request is currently limited to information regarding whether/how the applicant has established a link between the published literature and the applied-for medicinal product (pharmaceutical form, excipients, etc.).
Published: 12 August 2026
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Under the Freedom of Information Act, I respectfully request the following information regarding MHRA review timelines for oncology Marketing Authorisation Applications: 1. The average duration, in calendar days, of MHRA reviews for oncology Marketing Authorisation Applications that received a final determination between January 1, 2020 and the present. 2. The median duration, in calendar days, of MHRA reviews for oncology Marketing Authorisation Applications that received a final determination between January 1, 2020 and the present. 3. The longest review duration, in calendar days, for any oncology Marketing Authorisation Application that received a final determination during that period. 4. The number of oncology Marketing Authorisation Applications currently under review that have remained under assessment for: • More than 12 months • More than 24 months • More than 36 months 5. Any publicly releasable policies, guidance documents, performance targets, service standards, or internal metrics relating to expected review timelines for Marketing Authorisation Applications. I am not requesting confidential information relating to any specific applicant, product, or active application. I am seeking statistical and process-related information regarding MHRA review timelines and regulatory performance.
Published: 12 August 2026
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General Information: How many sites are part of this organisation? Are utilities (gas,electricity, water) procured collectively on behalf of all sites? Who is responsible for procurement decisions relating to utilities? (Please state job title) How does the organisation ensure compliance and public procurement regulations when procuring energy? Does the organisation use a framework for energy procurement? If yes, which one? Does the organisation have any sustainability or Net Zero objectives that influence procurement decisions? If yes, please summarise. Energy Procurement & Pricing How are your electricity and gas contracts procured? (e.g. direct with supplier, via broker/TPI, via framework) Which framework, DPS, or third-party broker/TPI is or was used? Please state the name. When was your current electricity contract signed or agreed? When was your current gas contract signed or agreed? What is the current contract end date for your electricity supply? What is the current contract end date for your gas supply? Who is your current electricity supplier? Who is your current gas supplier? If your electricity contract is fixed price, what is the current unit rate (p/kWh)? If your contract is flexible, half-hourly traded, or index-linked, please just confirm the contract type and we will not ask for a specific rate. If your gas contract is fixed price, what is the current unit rate (p/kWh)? If your contract is flexible, half-hourly traded, or index-linked, please just confirm the contract type and we will not ask for a specific rate. What is the current standing charge (p/day) for electricity and gas? Was a broker or Third Party Intermediary (TPI) involved in arranging your current contracts? If yes, please state their name. What commission, broker fee, or TPI payment was paid in connection with your current gas and/or electricity contracts? Please state the amount per meter, per contract, or as a p/kWh uplift. If the organisation does not hold this information, please confirm whether it has been requested from the broker or supplier. How many suppliers submitted quotations for your most recent electricity and gas procurement? Metering, MOP, DA & DC Arrangements (MOP = Meter Operator I DA = Data Aggregator I DC = Data Collector- these are contracted services that determine how your energy data is captured and settled) Are any of your electricity meters Half-Hourly (HH) settled (Profile Class 00)? If yes, how many HH meters does the organisation have, and across which sites? Who is the current Meter Operator (MOP) for your electricity meters? When was the current MOP contract signed, and what is its end date? Who is the current Data Collector (DC) and Data Aggregator (DA) for your electricity meters? What charges are applied for MOP, DA, and DC services? Are these shown as a separate line item on bills, or embedded within the unit rate? Were MOP, DA, and DC contracts competitively tendered, or were they assigned by the supplier or framework? Energy Monitoring & Management Does the organisation currently have any form of energy monitoring in place? (e.g. AMR, smart meter portal, half-hourly data access, real-time dashboards) If yes, which sites have monitoring, and what type is in place at each? Please distinguish between: real-time I live data I half-hourly/ Day+1 data I monthly smart read only I manual reads only Which platform, portal or software is used to view or analyse energy consumption data? Is gas consumption monitored separately to electricity? If yes, how? Does the organisation receive automated alerts for unusual or excessive energy consumption (e.g. overnight or weekend usage)? Does the organisation receive any bill validation or bill checking service, from a broker, consultant, or software platform? Has the organisation undertaken any energy audits, Display Energy Certificate (DEC) assessments, or ESOS compliance reporting in the last three years? Has the organisation ever used energy data to identify and evidence savings? If yes, please give a brief summary. Water Procurement & Monitoring How are your water and wastewater contracts procured? Which framework, DPS, or third-party was used? Please state the name. When was your current water contract signed or agreed? What is the current contract end date for your water supply? Who is your current water supplier? What unit rate (p/m3) are you currently paying for water and wastewater, if known? How many suppliers submitted quotations for your most recent water procurement? Was a broker or TPI used in procuring your water contract? If yes, please state their name and any fee or commission paid. Are there any additional services included such as leak detection, water efficiency, or bill validation? If yes, please describe. Does the organisation have any water monitoring or sub-metering in place to detect leaks or track consumption at site level?
Published: 12 August 2026
