Pharmaceuticals and EU GMP

A medicinal product needs a marketing authorisation before it may be placed on the EU market, held by an applicant established in the Union, and every batch imported from India must be released by a qualified person in the EU. The manufacturing site needs a written confirmation of EU GMP compliance or coverage by an inspection, and the site is subject to inspection by an EU authority regardless of where it stands.

• 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.
• Operate pharmacovigilance with a qualified person for pharmacovigilance resident in the Union and a pharmacovigilance system master file.
• Apply the falsified medicines safety features: the unique identifier, the anti-tampering device and upload to the European Medicines Verification System.

• Directive (EU) 2024/2853 on liability for defective productsArticle node

• Directive 2001/83/EC on medicinal products for human use
• Regulation (EC) 726/2004 laying down Union procedures for authorisation
• Directive 2011/62/EU on falsified medicinal products

• What does the EU require of Indian pharmaceutical manufacturers?

• Medical devices and diagnostics
• REACH and chemicals
• EU representative and responsible person
• All requirements
• Indian law against EU law

Sector

Pharmaceuticals, APIs, contract manufacturing

Read date

2026-08-26

Register version

in-export-v1.0.0

Address

/in/export/pharma