Spring Intro 2023

30/03/2023

How ? Rest of World

• The majority of filings in Rest of World (ROW) Markets can only be made following approval of the product in a major reference market (e.g. US, Europe, Japan, Australia, Canada, GB)

• Provides assurance to authorities that product data has been fully reviewed

• Approval and launch of the product in the ‘source’ country is key

• The definition of source country will vary on a country by country basis, based on manufacturing or importation route e.g. • product manufacture, primary packaging, secondary packaging & release, source of importation

Confirmation of approval in a reference country is often demonstrated through the use of a Certificate of Pharmaceutical Product (CPP)

The Organisation for Professionals in Regulatory Affairs

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How ? The CPP

•CPP = Certificate of Pharmaceutical Product

What is a CPP?

•Benchmark health authorities

Who issues it?

• Product specific and country specific information •Certifies product is approved and marketed

What does it state

How is it used •May replace resource intensive full “Quality, Safety and Efficacy” regulatory assessment • Includes approved prescribing information in the CPP issuing country

Establish whether a CPP is: Required for filing Required during review Required for final approval

Establish which CPP is required EU or US CPP Source manufacturing country CPP Other reference country CPP

The Organisation for Professionals in Regulatory Affairs

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