EU GMP

Regulatory

EU standards for pharmaceutical manufacturing under Directive 2001/83/EC, enforced by national competent authorities.

Common questions

What is EU GMP and how do I get certified?

EU Good Manufacturing Practice (GMP) is the EU standard for pharmaceutical manufacturing. Indian API and finished dose manufacturers must have EU GMP certification to sell to EU pharmaceutical companies or patients. Process: (1) implement EU GMP (Annex 1-16) in your facility, (2) an EU national competent authority (MHRA, ANSM, BfArM, etc.) or EMA conducts an inspection, (3) if compliant, a GMP certificate is issued, valid 3 years. PHARMEXCIL coordinates EU GMP audit preparation for Indian pharma companies.

Related terms

• BIS Standards
• CBAM
• CDSCO
• CE Marking
• Certificate of Suitability
• CSRD

Sources

1. EUR-Lex (Official Journal of the European Union) eur-lex.europa.eu accessed 20 August 2026

From the AJG lexicon archive (July 2026); fact-checked against primary sources 20 August 2026.