D&D Masterclass Knowledge Assessment
D&D Masterclass Knowledge Assessment
Test your expertise in drug development and marketing authorization processes with the D&D Masterclass Knowledge Assessment. This quiz is designed to challenge your understanding of key concepts and scenarios related to product discontinuation, license cancellation, and information dissemination.
- 6 multiple choice questions
- Deepen your knowledge of D&D processes
- Score points and improve your understanding
Product discontinuation is a situation where
AstraZeneca are not the MA holder of the licence. The licence however, is still maintained even though the product is no longer supplied to the market.
AstraZeneca are still the Marketing Authorisation holder (MAH) of the licence. The licence is still maintained however the product is no longer supplied to the market.
AstraZeneca are still the Marketing Authorisation holder (MAH) of the licence. The licence is not maintained however the product is supplied or sourced via a 3rd country.
Licence cancellation is a situation whereby
The licence is cancelled, and AstraZeneca are no longer MAH therefore the licence is no longer maintained
The licence is cancelled, and AstraZeneca can no longer market this product following a legal injunction
The licence is cancelled not withdrawn, AstraZeneca remains MAH therefore product can still be supplied
With a licenced product divestment
AstraZeneca cedes the MAH to another company. Licence is transferred but AstraZeneca retains all responsibilities (MI, PV)
AstraZeneca cedes the MAH to another company. Licence is transferred alongside other responsibilities (MI, PV)
AstraZeneca cedes the MAH to another company. A Licence Sharing Agreement (LSA) is established between the two companies alongside responsibilities (MI, PV) 0%
How long can a product D&D process take from date PDC is notified to MI notifying external stakeholders?
1-3 months
1-3 months
Up to 9 months depending on when all requirements are met
The Notice of Product Discontinuation or Divestment is sent to MI by
Regulatory Affairs
Medical Affairs
Supply Chain
Medical Information is responsible to inform which external stakeholders?
Dm+d and MIMS
BNF and MIMS
Dm+d and BNF
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