India to EU compliance · Medicines, active ingredients and contract manufacturing
Indian pharmaceuticals and EU GMP
What does an Indian pharmaceutical manufacturer need for the EU market?
A medicine needs an EU marketing authorisation, compliant manufacturing evidence and batch release by an EU qualified person. Indian sites remain open to inspection by EU authorities.
What an Indian company should prepare
- Choose the marketing-authorisation route and establish the EU applicant.
- Document EU GMP compliance for the Indian manufacturing site.
- Set up EU batch release, pharmacovigilance and anti-counterfeit controls.
Read the complete requirement, EU article references and official sources
Relevant EU judgments
These judgments are selected from the EU register by fixed legal terms for this requirement. The list is updated when new judgments are read into the register.
- C-604/24 · Decided 2026-05-21 · FARMAKEIO YZ & SIA O.E. v Ypourgos Anaptyxis kai Ependyseon and Ypourgos Ygeias
Reference for a preliminary ruling – Medicinal products for human use – Directive 2001/83/EC – Article 85c(1) and (2) – Non-prescription medicinal products – Prohibition of the sal