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The word “Dossier” has its English meaning as - a collection or file of documents on the same subject, especially a file containing detailed information about a person or a topic. Any preparation for human use that is intended to modify or explore physiological systems or pathological states for the benefit of the recipient is called as “pharmaceutical product for human use”. Process of reviewing and assessing the dossier of a pharmaceutical product containing its detailed data (administrative, chemistry, pre-clinical and clinical)  and the permission granted by the Regulatory Agencies of a country with a view to support its marketing / approval in a country is called as the “Marketing Approval  or the “Registration” “Marketing Authorization” or the “Product Licensing”. Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.


Dossier GMP Pharmaceutical Production Registration marketing authorization

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