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MEDICINES FOR HUMAN USE (CLINICAL TRIALS)
REGULATIONS 2004
Memorandum of Understanding between MARA,
ORES, GTA and APEC
Version 2 April 2010MHRA/ORES/GTA/APEC memorandum of understanding
Version 2
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What is medicines for human use?
Medicines for human use are drugs or pharmaceutical products that are intended for the treatment, cure, prevention, or diagnosis of diseases in humans.
Who is required to file medicines for human use?
Manufacturers, importers, distributors, and marketers of medicines for human use are required to file with the appropriate regulatory authorities.
How to fill out medicines for human use?
Medicines for human use should be filled out accurately and completely according to the guidelines provided by the regulatory authorities.
What is the purpose of medicines for human use?
The purpose of medicines for human use is to improve health, treat diseases, alleviate symptoms, and enhance the quality of life for individuals.
What information must be reported on medicines for human use?
Information such as the name of the medicine, active ingredients, dosage, administration route, indications, contraindications, side effects, and precautions must be reported on medicines for human use.
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