Introductory Text
Article 1.Subject-matter
Article 2.Definitions
Article 3.Inspections
Article 4.Conformity with good manufacturing practice
Article 5.Compliance with marketing authorisation
Article 6.Pharmaceutical quality system
Article 7.Personnel
Article 8.Premises and equipment
Article 9.Documentation
Article 10.Production
Article 11.Quality control
Article 12.Outsourced operations
Article 13.Complaints and product recall
Article 14.Self-inspection
Article 15.Repeal of Directive 2003/94/EC
Article 16.Transposition
Article 17.Entry into force
Article 18.Addressees
Signature
ANNEX
Correlation table