Rechtsbibliothek und Fallanalyse · Österreich · Belgien · Europäische Union
LAWxPERT Anmelden Kostenloses Konto

MT · S.L. 458.33

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

In Kraft16 ArtikelText geprüft am 24.10.2026

Inhalt

  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.