Guidance and regulation

Monthly PDF editions of the Drug Safety Update newsletter from MHRA and its independent advisor, the Commission on Human Medicines

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 29 April 2024

Details of the Yellow Card scheme, which is the system for recording adverse incidents with medicines and medical devices in the UK.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 1 January 2021

How to package medicines for sale and what information you must provide to consumers and healthcare professionals.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 7 March 2024

Safety leaflet on opioid medicines to help patients and their families reduce the risks of harm.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 3 August 2021

Take care when using creams to treat dry skin conditions as they can easily dry onto clothing, bedding and bandages making them more flammable.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 26 May 2021

This guidance summarises our approach to pharmacovigilance

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 28 October 2022

Safety leaflet to help you understand the latest information about the effects of pregabalin during pregnancy.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 19 April 2022

How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 12 June 2023

Comply with good pharmacovigilance practice and prepare for an inspection.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 11 January 2021

These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 29 April 2024

How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 30 April 2024

Guidance on how to submit changes to labelling and patient information leaflets to MHRA.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 22 December 2023

Advice on writing clear notices and maximising replies to your FSNs.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 1 January 2021

How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 31 December 2020

Safety leaflet on epilepsy medicines and pregnancy to help patients and their families understanding the risks.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 7 January 2021

Guidance for dispensing of valproate-containing medicines in the manufacturer’s original full pack, following amendments to the Human Medicines Regulations (HMRs).

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 11 October 2023

Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 15 September 2021

Information for patients, healthcare professionals and developers of new medicines

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 10 August 2022

Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by Marketing Authorisation Holders (MAHs)

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 1 February 2023

Reporting, investigating and recalling suspected defective medicinal products to the Defective Medicines Report Centre (DMRC).

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 2 August 2021