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How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
How the MHRA makes decisions on what is a medicinal product (borderline products).
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Get help to classify pharmaceutical products used to treat or prevent diseases or ailments (in humans or animals), including comparators used in clinical trials and placebos.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)
Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
Competent authorities of exporting countries should use the relevant model health certificate as a template to create a version exporters can apply for to export porcine germinal products to Great Britain, the Channel Islands or Isle of Man.
Advice for manufacturers of Class I medical devices for placing products on the UK market
Information to support commercial fishers on under 12 metre English vessels.
Guidance for the pharmaceutical industry on how to apply to vary a veterinary Marketing Authorisation (MA) or Homeopathic Remedy.
Get help to classify plastics for import and export.
Explainer for the pharmaceutical industry on the ongoing implementation of the Veterinary Medicines Regulation relating to applications and authorisations for veterinary medicines.
Competent authorities of exporting countries should use the relevant model health certificate as a template to create a version exporters can apply for to export meat products to Great Britain, the Channel Islands or Isle of Man.
Product Safety Report for Esapharma Movate Steroid Cream presenting a serious chemical risk.
How a marketing authorisation holder should report a defect with a veterinary medicine.
Product recall for Tzumi LED Strip / Multi Colour Light Bar Products presenting a choking and injuries hazard due to easy access to button batteries.
Guidance for healthcare professionals on managing specific medicines and medical devices and using them safely.
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