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Guidance for pharmacists on prescriptions issued in EU countries, Norway, Iceland, Liechtenstein and Switzerland.
Information about how the MHRA regulates medical devices in Northern Ireland and what legislation applies to manufacturers and suppliers.
A list of herbal medicines currently holding a traditional herbal registration (THR) granted by the Medicines and Healthcare products Regulatory Agency (MHRA).
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)’
The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect, a service that provides the capability to track applications and view live authorisation details.
Take care when using creams to treat dry skin conditions as they can easily dry onto clothing, bedding and bandages making them more flammable.
The eMIT provides information about prices and usage for generic drugs and pharmaceutical products.
How to write clear and effective field safety notices (FSNs) for medical devices.
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.
Guidance on the deadlines for initial and response submissions.
Helping manufacturers define the characteristics of their devices and determine the appropriate regulatory qualification and classification.
You must get permission to export certain drugs and medicines.
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
Keep up to date with the latest information from the UK GLP monitoring authority.
Guidance on submitting an application for approval of a clinical trial that includes an in vitro diagnostic device
How to use the procedure for medicines licensing applications.
How to make a payment by credit or debit card or a bank transfer for all applications except Device Registration and Certificates of Free Sale applications.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
How to change the ownership from one marketing authorisation (MA) holder to another.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines
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