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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

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: E2F – Development Safety Update Report (PDF)

Found: development programme, including restri ctions on use or population treated; o Communications to 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: S5(R3) – Revision of S5 Guidelines on Detection of Toxicity to Reproduction for Human Pharmaceuticals (PDF)

Found: Note that acceptance of an assay by one regulatory authority does not bind other health authorities

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: Q3D(R2) – Guideline for Elemental Impurities (PDF)

Found: findings (liver capsule inflammation, liver cell necrosis, and liver degeneration.) were the most sensitive

Non-Departmental Publication (Statistics)
Advisory Council on the Misuse of Drugs

Mar. 28 2024

Source Page: Uncontrolled novel benzodiazepines: 2024 update
Document: ACMD report: recently encountered uncontrolled novel benzodiazepines and related compounds (2024 update) (PDF)

Found: The MHRA, an executive agency of the Department o f Health and Social Care (DHSC) that decides which

Departmental Publication (Guidance and Regulation)
Department of Health and Social Care

Mar. 28 2024

Source Page: General Medical Services Statement of Financial Entitlements Directions: previous directions
Document: The General Medical Services Statement of Financial Entitlements (Amendment) Directions 2020 (PDF)

Found: DIRECTIONS NATIONAL HEALTH SERVICE, ENGLAND The General Medical Services Statement of Financial

Departmental Publication (Guidance and Regulation)
Department of Health and Social Care

Mar. 28 2024

Source Page: General Medical Services Statement of Financial Entitlements Directions: previous directions
Document: The Statement of Financial Entitlements (Amendment) Directions 2012 (PDF)

Found: makes treatment of their condition inappropriate e.g. cholesterol reduction where the patient has liver

Departmental Publication (Guidance and Regulation)
Department of Health and Social Care

Mar. 28 2024

Source Page: General Medical Services Statement of Financial Entitlements Directions: previous directions
Document: The General Medical Services Statement of Financial Entitlements Directions 2013 (PDF)

Found: Disabilities Heal th Check Scheme – Health Check Completion Payments Learning Disabilities Health

Departmental Publication (Guidance and Regulation)
Department of Health and Social Care

Mar. 28 2024

Source Page: General Medical Services Statement of Financial Entitlements Directions: previous directions
Document: The General Medical Services Statement of Financial Entitlements (Amendment) Directions 2014 (PDF)

Found: FINAL: 2014.03.28 DIRECTIONS NATIONAL HEALTH SERVICE, ENGLAND The General Medical Services