Rechtsbibliothek und Fallanalyse · Österreich · Belgien · Europäische Union
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MT · S.L. 458.42

Good Manufacturing Practice In Respect (S.L. 458.42)

In Kraft17 ArtikelText geprüft am 24.10.2026

Inhalt

  1. Art. 1 Citation.
  2. Art. 2 Scope.
  3. Art. 3 Interpretation. S.L. 458.36. S.L. 458.36.
  4. Art. 4 Inspections.
  5. Art. 5 Conformity with good manufacturing practice.
  6. Art. 6 Compliance with marketing authorisation.
  7. Art. 7 Pharmaceutical quality system.
  8. Art. 8 Personnel.
  9. Art. 9 Premises and equipment.
  10. Art. 10 Documentation. S.L. 458.36.
  11. Art. 11 Production.
  12. Art. 12 Quality control system.
  13. Art. 13 Outsourced operations. Cap. 458.
  14. Art. 14 Complaints, and product recall. Cap. 458.
  15. Art. 15 Self-inspection.
  16. Art. 16 Importation of active substances. Cap. 458.
  17. Art. 17 Offences and penalties. Cap. 458.