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How to write clear and effective field safety notices (FSNs) for medical devices.
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
A wholesale dealer in Great Britain may import Qualified Person certified medicines from the European Economic Area if certain checks are made by the ‘Responsible Person (import)’
Approach to MHRA’s assessment of applications for medicines that use alternative methods to replace animals in science
What you need to do before your product can be placed on the Great Britain market with a UKCA mark.
Guidance on good manufacturing practice and the use of radiopharmaceutical investigational medicinal products in clinical trials.
Safety leaflet to help you understand the latest information about the effects of pregabalin during pregnancy.
Patient factsheet providing information on respiratory syncytial virus (RSV) and RSV vaccination.
How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
How to apply for a regulatory advice meeting on medical devices and in vitro diagnostic devices.
Guidance for health institutions that manufacture general medical devices under the Health Institution Exemption (HIE).
Guidance on submitting an application for approval of a clinical trial that includes an in vitro diagnostic device.
Using the Integrated Scientific Advice service from the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE).
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
How we regulate in vitro diagnostic medical devices (IVDs) that are placed on the UK market.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
There are changes to the legislation on reference medicinal products (RMPs) used to support abridged marketing authorisation applications.
Clinical trial applications that need expert advice from a specialist group or committee.
Guidance on the safe and effective use of GLP-1 medicines for weight loss and diabetes.
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