Laboratoire Druide Inc. – 705517 – 05/29/2025
CGMP/Finished Pharmaceuticals/Adulterated
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Sprout Pharmaceuticals, Inc. – 709942 – 05/29/2025
False & Misleading Claims/Misbranded -
American Behavioral Research Institute, LLC – 705629 – 04/30/2025
Clinical Investigator (Sponsor) -
Amish Origins Management, LLC – 704166 – 05/29/2025
CGMP/Finished Pharmaceuticals/Adulterated -
Sexual Enhancement and Energy Product Notifications
Learn about the warnings for sexual enhancement and energy products that contain hidden drugs and other hidden ingredients. -
Sleep, Skin and Bodybuilding Product Notifications
Learn about the warnings for sleep, skin and bodybuilding products that contain hidden drugs and other hidden ingredients. -
Decentralised manufacture: Clinical Trial Authorisation (CTA) and Good Clinical Practice (GCP)
Guidance for clinical trials that use Decentralised Manufactured Investigational Medicinal Products (IMPs).
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Decentralised manufacture: UK Guideline on Good Manufacturing Practice (GMP)
UK guideline on GMP for decentralised manufacturing, ensuring compliance with EU GMP principles for safe, quality medicinal products.
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Decentralised Manufacture: Labelling
Guidance on labelling requirements pertinent to the type of medicinal product and its supply status, as defined in UK legislation.
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Decentralised Manufacture: UK Guideline of Good Pharmacovigilance Practices
Guidance covering various aspects of pharmacovigilance for authorised and unauthorised medicinal products (Specials and the Early Access to Medicines Scheme (EAMS)).
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Decentralised Manufacture: Marketing Authorisation application
Guidance on applying for a Marketing Authorisation for Decentralised Manufacture, including eligibility, process, and requirements.
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Decentralised manufacture: The designation step
MHRA’s mechanism for evaluating the justifications supplied by applicant organisations who plan to utilise decentralised manufacture.