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Scottish Parliamentary Research (SPICe)
The Alcohol (Minimum Pricing)(Scotland) Act 2012 (Continuation) Order 2024
Apr. 12 2024
View source webpage
The legislation that introduced minimum unit pricing for alcohol contained a 'sunset clause'. This means the policy will expire on 30 April 2024 unless the Scottish Parliament votes for it to continue. This briefing examines the background to the policy, key areas of debate, the findings of the evaluation and the response of stakeholders.

Found: For“With regard to the ef fect on health outcomes, the estimate was a very conservative one.

Non-Departmental Publication (Transparency)
Medicines and Healthcare products Regulatory Agency

Apr. 09 2024

Source Page: MHRA FOI performance data
Document: (Excel)

Found: Tecfidera (Biogen) PLGB 22407/0012-13.The targeted questionnaires are for:Malignancies,Drug-induced liver

Non-Departmental Publication (Statistics)
Office for Health Improvement and Disparities

Apr. 08 2024

Source Page: Liver disease profile, April 2024 update
Document: Liver disease profile, April 2024 update (webpage)

Found: Liver disease profile, April 2024 update

Non-Departmental Publication (News and Communications)
Medicines and Healthcare products Regulatory Agency

Apr. 04 2024

Source Page: Combined antibiotic approved to treat adult patients with severe infections of the urinary tract and hospital-acquired pneumonia
Document: Combined antibiotic approved to treat adult patients with severe infections of the urinary tract and hospital-acquired pneumonia (webpage)

Found: to 1 in 10 people) include high levels of alanine aminotransferase and aspartate aminotransferase (liver

Non-Departmental Publication (Guidance and Regulation)
Medicines and Healthcare products Regulatory Agency

Apr. 04 2024

Source Page: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines
Document: M4E(R2) – CTD on Efficacy (PDF)

Found: development program; key risks are unfavourable effects that are important from a clinical and/or public health

Non-Departmental Publication (Guidance and Regulation)
Medicines and Healthcare products Regulatory Agency

Apr. 04 2024

Source Page: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines
Document: M7(R2) – Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk (PDF)

Found: mutagens (bacterial mutagenicity positive without S9) and compounds known to be clastogenic* Rat liver

Non-Departmental Publication (Guidance and Regulation)
Medicines and Healthcare products Regulatory Agency

Apr. 04 2024

Source Page: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines
Document: S1C(R2) – Dose Selection for Carcinogenicity Studies of Pharmaceuticals (PDF)

Found: (Environmental Health Perspectiv es, Vol. 67, pp. 201 -281, 1986) The Ministr y of Health and Welfare

Non-Departmental Publication (Guidance and Regulation)
Medicines and Healthcare products Regulatory Agency

Apr. 04 2024

Source Page: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines
Document: E2C(R2) – Periodic Benefit-Risk Evaluation Report (PDF)

Found: genetic abnormalities), and events too rare to occur in clinical trials may be observed (e.g., severe liver

Non-Departmental Publication (Guidance and Regulation)
Medicines and Healthcare products Regulatory Agency

Apr. 04 2024

Source Page: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines
Document: E2B(R3) – Questions and Answers (PDF)

Found: safety report identifier. 3.8 (011) November 2014 If a report is forwarded to a company by a Health

Non-Departmental Publication (Guidance and Regulation)
Medicines and Healthcare products Regulatory Agency

Apr. 04 2024

Source Page: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines
Document: S11 – Nonclinical Safety Testing in Support of Development of Paediatric Medicines (PDF)

Found: Amount/Type of Existing Data) Maturation of systems important for ADME such as the gastrointestinal, liver