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Glossary

Misuse of a medicinal product for illegal purposes

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Misuse for illegal purposes is misuse with the additional connotation of an intention of misusing the medicinal product to cause an effect in another person. This includes, amongst others: the sale, to other people, of medicines for recreational purposes and use of a medicinal product to facilitate assault.

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C

Commercially Confidential Information (CCI)

In relation to Policy 70, CCI shall mean any information contained in the clinical reports…

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I

Important Missing Information

Critical gaps in knowledge for specific safety issues or populations that use the marketed product.

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