ABSTRACT
The pharmaceutical industry of the European Union maintains high standards of quality assurance in the development, manufacture, and control of medicinal products. A system of Marketing Authorizations ensures that all medicinal products are assessed by a competent authority to ensure compliance with contemporary requirements of safety, quality, and efficacy. A system of manufacturing authorizations ensures that all products authorized on the European market are manufactured only by authorized manufacturers, whose activities are regularly inspected by the competent authorities. Manufacturing authorizations are required by all pharmaceutical manufacturers in the European Community whether the products are sold within or outside the Community.
