Rechtsbibliotheek en dossieranalyse · Oostenrijk · België · Europese Unie
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MT · S.L. 458.33

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

Van kracht16 artikelenTekst gecontroleerd op 24.10.2026

Inhoud

  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.