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Medicines, medical devices

Guidance and regulation

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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