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MEDICINES FOR HUMAN USE (CLINICAL TRIALS) REGULATIONS 2004Memorandum of understanding between MARA, CORE and GTAC1. Purpose and scope1.1Regulation 27A of the Medicines for Human Use (Clinical Trials)
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What is medicines for human use?
Medicines for human use are drugs and pharmaceutical products intended for the prevention, treatment, or management of diseases or medical conditions in humans.
Who is required to file medicines for human use?
Manufacturers, importers, and distributors of medicines for human use are required to file necessary documentation with regulatory authorities.
How to fill out medicines for human use?
Medicines for human use must be filled out accurately and completely with relevant information regarding the product, its ingredients, dosage, side effects, etc.
What is the purpose of medicines for human use?
The purpose of medicines for human use is to improve or maintain human health by providing access to safe and effective pharmaceutical products.
What information must be reported on medicines for human use?
Information such as product name, active ingredients, dosage form, indications, contraindications, side effects, and storage instructions must be reported on medicines for human use.
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