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MT · S.L. 458.33

Medicinal Products (Labelling And (S.L. 458.33)

In force16 articlesText checked on 24 Oct 2026

Contents

  1. Art. 1 Title and scope.
  2. Art. 2 Interpretation.
  3. Art. 3 Particularsonouter packaging.
  4. Art. 4 Blister packs.
  5. Art. 5 Clarity of particulars.
  6. Art. 5A Licensing Authority may require use of certain labelling forms.
  7. Art. 6 Inclusion of package leaflet.
  8. Art. 7 Package leaflet.
  9. Art. 8 Mockups.
  10. Art. 9 Promotion not to be included.
  11. Art. 10 Labelling particulars.
  12. Art. 11 Suspension of marketing authorisation.
  13. Art. 12 Radionuclides.
  14. Art. 13 Duty of the Authority.
  15. Art. 14 Homeopathic medicinal products. S.L. 458.34
  16. Art. 15 Access to printed product information leaflet.