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Guidance on labelling for medicinal products used in clinical trials.
You must get permission to export certain drugs and medicines.
How the MHRA processes variations to marketing authorisations.
Safety leaflet to help you understand the latest information about the effects of pregabalin during pregnancy.
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
The eMIT provides information about prices and usage for generic drugs and pharmaceutical products.
Take care when using creams to treat dry skin conditions as they can easily dry onto clothing, bedding and bandages making them more flammable.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Guide for marketing authorisation holders, including qualified person responsible for pharmacovigilance (PV) and pharmacovigilance system master files (PSMF).
Guidance on out of specification investigations, including definitions and laboratory analysis and phase I,II and III investigations.
Guidance on using non-investigational medicinal products in a clinical trial.
The Innovative Licensing and Access Pathway (ILAP) is focused on getting the most transformative new medicines to patients in the UK health system more quickly.
The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect, a service that provides the capability to track applications and view live authorisation details.
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)’
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
Information on comparator products used in studies supporting abridged marketing authorisation application.
Detailed guidance on advertising and promoting medicines.
Information about how the MHRA regulates medical devices in Northern Ireland and what legislation applies to manufacturers and suppliers.
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