CRED SMPC 2024

17/09/2024

Basic Implementation Flow for Artwork

No = iterations

Reg Submission needed?

Regulatory Submission Process

Produce Submission Artwork/Mockup

Produce Commercial Artwork

Change or New Label

Sub. Artwork needed?

Reg. Approval?

Y

Y

Y

Ready to Produce

No

Submission Artwork (AW) is often quicker than commercial but can still take ~4-6 weeks. Plan ahead – it can be difficult to meet submission timelines if there are delays in requesting the AW mockup!

Commercial AW produced directly can take several months. Priority is driven not just by implementation dates but by Production Schedules. Contract Manufacturers can be slower.

Commercial AW produced from approved Submission AW can be quick but depending on the amount of technical assessment done for Submission AW it can still take several weeks.

CONSIDER Extensive changes can cause technical challenges. Early awareness/notice can save time by moving the technical checks off the critical path.

The Organisation for Professionals in Regulatory Affairs

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Typical Timeline

⚫ For a “business as usual” change in Europe:

Jan to… Jul?

● ~3 months from request to approved artwork. ● 2 more months to procure components

● 1 month for manufacture/release ● 1-2 weeks to ship to distributor ● Regular shipping to pharmacies

⚫ Manufacture outside of Europe?

Or Oct?

● Shipping (weeks/months), retesting (weeks), re-release (weeks) ● Challenging to meet implementation times committed to in regulatory variation…

CONSIDER Not all markets have “fixed” implementation periods (e.g. 6 months). Some apply zero grace period or up to 1 year (dependent on change).

The Organisation for Professionals in Regulatory Affairs

10