Spring Intro 2023

03/03/2023

EU legislative categories

• Regulations – Binding completely on all Member States (MSs) • Directives – binding with respect to result but method of achieving result left to each MS • Commission Decision – Binding in their entirety • Guidelines – Persuasive but not binding, justification required if you do not follow • Scientific advice recommendations and opinions – Persuasive, “morally binding”, very good justification required if you do not follow “Don’t ask - if you won’t act”

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Pharmaceutical legislation What do we mean by regulation?

• Product acceptability (Quality, Safety, Efficacy)

• Process Integrity (GXP) (Audit trails)

• Environmental protection

• Animal welfare

• Promotional/advertising material

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