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A batch of Depo-Medrone has been released to the market with an error. The vial over label incorrectly states that the total vial content is 40 mg in 1 mL, when the correct total vial content is 80mg in 2...
Activase Pharmaceuticals Limited is recalling two batches of Prednisolone 5mg Soluble Tablets as a precautionary measure due to a limited number of reports of blister pockets becoming swollen over time.
How to show the MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
Recommendations for a temporary class drug order on a number of methylphenidate-based novel psychoactive substances.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
For manufacturers and distributors of intermediate and final feedingstuffs containing a medicinal premix or specified feed additives in Great Britain and Northern Ireland.
Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.
How to get information including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
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