1. For standardised marketing authorisation dossier requirements, what is the difference between Module 2 and Module 3?

2. EU Member States allows the advertising to the general public of medicinal products that contain substances defined as psychotropic or narcotic by international convention.

 3. For no-sterile devices, a change in packaging from one variant of polyethylene to another is classified as (in Canada)?

4. For drug eluting stents, a manufacturing site change where a polymer and drug coating is applied is classified as (in Canada)?

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1 Difference between Module 2 and Module 3 in Marketing Authorisation Dossier Requirements Module 2 of the Common Technical Document CTD contains the ... View the full answer