Spring Intro 2023

03/03/2023

MRP

● Application may be withdrawn from one country at any time during the procedure ● However, if withdrawal is as a consequence of a “Serious public health concern” – procedure will be referred to CMD(h) unless all applications and existing MAs are withdrawn

The Organisation for Professionals in Regulatory Affairs

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Where to submit?

● Commercialisation strategy & target markets ● Requires an appraisal of SmPCs of market leader(s) for generics - indications - contraindications - dosage regimen ● Does the reference product in your “equivalence studies” match up with the product in proposed MSs? ● Pack sizes and packaging ● Price

The Organisation for Professionals in Regulatory Affairs

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