Module 6

02/10/2024

Product Launch Activities Key considerations

• Centralised procedure dictates identical packs

• MAA contains English and worst case pack layouts, ( e.g. triple language packs )

• All packs, contents, layout, words are part of approval process.

• Blue box wording ( price, bar code, identification and authenticity, legal status code or wording ) requirements should conform to the each MS local requirements. • The planning of country shared packs should be confirmed early in the MAA and before approval • Commercial considerations of volumes and profit margins so that production schedules can be planned accordingly • Regulatory need to balance commercial launch plans with length of different pricing procedures. These timelines should be built into the overall regulatory pathway timelines • You do not need to launch in all markets but there is a Sunset Clause. Inform EMA. • Implementation of approved risk minimisation plans, i.e. educational materials for physicians and /or patients • Plan for other launches in emerging markets sequentially; Middle East, Africa, China,. Some countries rely on the approval from the US or EU as part of their assessment procedure. • Assisting with health technology appraisals to achieve the right pricing and reimbursement strategy

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 1 – Develop and Shape the Brand

41

Future Product Development Extend & Maintain the Brand

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 1 – Develop and Shape the Brand

42

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