Abstract
The pharmaceutical industry maintains a high standard of quality assurance in the development, production and control of drugs. The procedure for issuing a manufacturing authorization for a medicinal product ensures the compliance of medicinal products with the applicable requirements in terms of safety, quality and efficacy, which are assessed by the competent institutions. The procedure for issuing a manufacturing authorization ensures that all medicinal products that have a manufacturing authorization are manufactured/imported by manufacturers who have a manufacturing authorization and who are regularly inspected by the competent institution, applying the principle of Quality Risk Management. A manufacturing license is required for all drug manufacturers.
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