differences between EU Member State national rules on medicinal product
promotion versus the EU Directive - ✔✔Some Member States have
implemented processes for
preapproval of promotional material in their local mar-
ket surveillance regulations.
the impact and aims of international and European codes of conduct and their
implementation into national codes of conduct
via trade associations (PLACEHOLDER) - ✔✔
Blue Guide - ✔✔The guide to the implementation of directives based on the
New Approach and the Global Approach
, from 2000. Gives a detailed description of New Approach and Global
Approach directives
Although not formal law, the ___ ___
has influenced national laws on clinical research
throughout the world deeply, including Europe, and
continues to do so. - ✔✔Helsinki Declaration
SmPC - ✔✔A document describing the properties and the officially approved
conditions of use of a medicine. Summaries of product characteristics form
the basis of information for healthcare professionals on how to use the
medicine safely and effectively.
Impact of UK's exit from EU (on med device regs) (PLACEHOLDER) - ✔✔
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