
cepPolicyBrief
Consumer & Health
Pharmacovigilance (Directive)
cepPolicyBrief

The proposed amendments are basically useful and necessary to improve the pharmacovigilance. However, details should be amended especially concerning the definition of the term “adverse reaction” and the newly introduced “essential information”.
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Pharmacovigilance COM(2008) 665 (publ. 06.13.2014) | 86 KB | Download | |
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