UK MHRA Guidance directory

All uk mhra guidance435 total

• Apply for a traditional herbal registration (THR)2024-01-05
• Submitting changes to labelling and patient information leaflets2023-12-22
• Combination therapies: prioritisation statement2023-11-17
• Pharmacy First contractual framework: 2023 to 20252023-11-16
• Predetermined change control plans for machine learning-enabled medical devices2023-10-23
• Full pack dispensing of valproate-containing medicines2023-10-10
• Reporting requirements for medicine shortages and discontinuations2023-09-04
• Nitrosamines impurities in medicines2023-08-24
• How tests and testing kits for coronavirus (COVID-19) work2023-08-08
• Squamous cell carcinoma (SCC) and different types of lymphomas occurring in the capsule around breast implants2023-08-07
• Borderline products: classifying medical devices and risk2023-07-11
• Regulatory status of equipment being used to help prevent coronavirus (COVID-19)2023-07-01
• Off-label use of medical devices2023-06-30
• DEHP phthalates in medical devices2023-06-30
• Virtual manufacturing of medical devices2023-06-30
• Medical devices: software applications2023-06-30
• Approved bodies for medical devices2023-06-30
• Export and hoarding of restricted medicines2023-06-28
• Dialysis guidance2023-06-21
• Adrenaline Auto-Injectors (AAIs) safety campaign2023-06-19
• Software and AI as a Medical Device Change Programme2023-06-14
• Request a change to an ACBS application form and guidance2023-05-18
• Community Pharmacy Contractual Framework: 2019 to 20242023-05-12
• MHRA Publication Scheme2023-05-05
• Symptoms sometimes referred to as Breast Implant Illness2023-04-28
• MORE platform API (Application Programming Interface) set up - user reference guide2023-04-24
• How to draft a direct healthcare professional communication2023-04-04
• Clinical platform trials for coronavirus (COVID-19) treatments2023-03-31
• Access community-based treatments for coronavirus (COVID-19)2023-03-31
• Prescription charges waiver: HEAL-COVID and STIMULATE-ICP2023-03-29
• Crafting an intended purpose in the context of Software as a Medical Device (SaMD)2023-03-22
• International Women’s Day 2023: #EmbraceEquity2023-03-08
• Responding to emerging COVID-19 variants of concern2023-02-02
• More information about the MHRA2023-01-16
• Exceptional use of non-UKCA marked medical devices2022-12-30
• The 2019 voluntary scheme for branded medicines pricing and access: payment percentage for 20232022-12-15
• Access Consortium Good Manufacturing Practice (GMP) Statement2022-11-15
• Guidance for licensing electronic cigarettes and other inhaled nicotine-containing products as medicines2022-11-03
• Canada - United Kingdom Trade Continuity Agreement Protocol for Recognition of Good Manufacturing Practices2022-09-01
• Use of medicines in pregnancy and breastfeeding2022-08-10
• Guidance on handling of Decentralised and Mutual Recognition Procedures which are approved or pending2022-06-24
• Compliance Monitor (CM) Overview and Application Process2022-06-15
• Highest-risk patients eligible for COVID-19 treatments: guide for patients2022-06-13
• Medicines shortages: regulatory processes to manage supply disruptions2022-05-22
• Pregabalin and risks in pregnancy2022-04-19
• DHSC: excess personal protective equipment (PPE) for sale2022-03-31
• Notification Fees for Great Britain and Northern Ireland2022-03-24
• Guidance on the submission and content of notifications for Northern Ireland2022-03-24
• Chapter 9 - General advice on due diligence Northern Ireland2022-03-23
• Chapter 8 - Labelling Guidance - Northern Ireland2022-03-23
• Chapter 10 - General Advice on Vigilance - Northern Ireland2022-03-23
• Importing medicines into Northern Ireland2022-03-16
• Clinical trials applications for Coronavirus (COVID-19)2022-02-23
• E-learning modules: medicines2022-02-08
• Oversight and monitoring of investigational medical product trials2022-01-28
• Risk-Adapted Approach to clinical trials and Risk Assessments2022-01-28
• Voluntary scheme for branded medicines: payment percentage for 20222022-01-20
• Acting as a Responsible Person (import)2021-12-22
• List of approved countries for authorised human medicines2021-12-22
• Supplying investigational medicinal products to Northern Ireland2021-12-22
• Regulatory status of software (including apps) used in the diagnosis, treatment and management of patients with coronavirus (COVID-19)2021-12-17
• Managing clinical trials during Coronavirus (COVID-19)2021-11-16
• Good machine learning practice for medical device development2021-10-27
• The Health Service Products Appeals Tribunal: how to appeal2021-10-21
• Infusion pumps: T34 syringe drivers2021-10-19
• Patient Involvement Strategy2021-09-30
• Guidance on GxP data integrity2021-09-27
• Access to EHR by sponsor representatives in clinical trials2021-09-08
• Opioid medicines and the risk of addiction2021-08-03
• Guidance on equipment for temperature screening in the context of the COVID-19 pandemic2021-07-30
• Drug quality assurance database (PharmaQC) information2021-06-25
• Safe use of emollient skin creams to treat dry skin conditions2021-05-26
• Register to make submissions to the MHRA2021-05-04
• Using parenteral and enteral nutrition bags manufactured by Diffuplast: guidance for patients2021-04-20
• Responding to a GLP and GCP laboratory inspection report2021-03-30
• The use and regulation of pulse oximeters (information for healthcare professionals)2021-03-26
• Supplying medical devices to Northern Ireland2021-03-05
• Guidance for 'specials' manufacturers2021-02-25
• In vitro diagnostic point-of-care test devices2021-02-03
• Prescriptions issued in the EEA and Switzerland: guidance for pharmacists2021-02-03
• Voluntary scheme for branded medicines: payment percentage for 20212021-02-02
• Responding to a GMP/GDP post inspection letter2021-01-08
• Epilepsy medicines and pregnancy2021-01-07
• Legal requirements for children's medicines2020-12-31
• Borderline products: medical devices and medicinal products2020-12-31
• EU guidance documents referred to in the Human Medicines Regulations 20122020-12-30
• Advice for developers of COVID-19 vaccines2020-11-23
• Guidance on minimising disruptions to the conduct and integrity of clinical trials of medicines during COVID-192020-11-13
• Transforming NHS pharmacy aseptic services in England2020-10-29
• Warfarin and other anticoagulants – monitoring of patients during the COVID-19 pandemic2020-10-12
• HIV pre-exposure prophylaxis (PrEP) grant determination 2020 to 20212020-09-25
• Dental radiographic X-ray imaging: dose to patients2020-09-17
• Guidance for Good Laboratory Practice (GLP) facilities in relation to coronavirus (COVID-19)2020-08-11
• MHRA regulatory flexibilities resulting from coronavirus (COVID-19)2020-08-04
• Exceptional GMP flexibilities for medicines manufacturers during the coronavirus (COVID-19) outbreak2020-07-13
• 3D printing (additive manufacturing) of medical devices or component parts during the coronavirus (COVID-19) pandemic2020-06-04
• Valproate Pregnancy Prevention Programme: temporary advice for management during coronavirus (COVID-19)2020-05-06
• Specification for ventilators to be used in UK hospitals during the coronavirus (COVID-19) outbreak2020-04-28
• Approval of GxP documents when working from home during the coronavirus (COVID-19) outbreak2020-04-09
• Guidance for manufacturers and Good Practice (GxP) laboratories on exceptional flexibilities for maintenance and calibration during the coronavirus COVID-19 outbreak2020-04-07