What regulatory approvals does an Indian pharma company need to export to EU?

Curated by Vinod Kumar Jain & Amit Jain · All Frontier Global · free, no login

For finished dose medicines: EU Marketing Authorisation (MA) from EMA (centralised) or national authority (national procedure). For APIs: Certificate of Suitability (CEP) from EDQM or site registered with competent authority. For all facilities: EU GMP certification (inspection by EU competent authority). For medical devices: CE marking under EU MDR. The full EU pharma approval pathway takes 2-5 years from application to first shipment.

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