What does the EU require of Indian pharmaceutical manufacturers?
A marketing authorisation held by an applicant established in the Union, a site inspected against EU GMP, batch release by a qualified person in the EU, pharmacovigilance with a qualified person resident in the Union, and the falsified medicines safety features on the pack.
What has to be done
- Secure a marketing authorisation on the right route: centralised through EMA, or decentralised and mutual recognition through national agencies.
- Have the manufacturing site inspected against EU GMP, or covered by a written confirmation from the competent Indian authority where the regime allows it.
- Appoint the qualified person in the EU who certifies and releases each imported batch; batch release cannot happen in India.
Citations
Full requirement
Source and version
- Read date
- 2026-08-26
- Address
- /in/questions/pharma-eu-gmp
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