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Directive (EU) 2009/53 · CELEX 32009L0053 · Industrial policy and internal market

Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products (Text with EEA relevance)

Adopted
18.06.2009
In force since
20.07.2009
Transposition deadline
20.01.2011
Transposition by country
2 / 27

EUR-Lex ↗ National measures in EUR-Lex ↗

Transposition by country

  1. BE Belgium deadline passed, no measure notified in EUR-Lex
  2. AT Austria deadline passed, no measure notified in EUR-Lex
  3. BG Bulgaria deadline passed, no measure notified in EUR-Lex
  4. HR Croatia 13 national measures · 2015
    • 17.02.2015 · 276 · Narodne Novine

      Zakon o izmjenama i dopunama Zakona o veterinarsko-medicinskim proizvodima

    • 03.07.2013 · 1797 · Narodne Novine

      Pravilnik o farmakovigilanciji

    • 03.07.2013 · 1800 · Narodne Novine

      Pravilnik o dobroj praksi u prometu lijekova, davanju dozvola za promet na veliko lijekovima, davanju dozvola za posredovanje lijekovima i davanju potvrde o dobroj praksi u prometu lijekovima na veliko

    • 03.07.2013 · 1802 · Narodne Novine

      Pravilnik o davanju odobrenja za stavljanje lijeka u promet

    • 03.07.2013 · 1522 · Narodne Novine

      Zakon o lijekovima

    • 03.07.2013 · 1799 · Narodne Novine

      Pravilnik o uvjetima za davanje proizvodne dozvole, zahtjevima dobre proizvođačke prakse te potvrdi o provođenju dobre proizvođačke prakse za lijekove

    • 18.06.2013 · 659 · Narodne Novine

      Pravilnik o veterinarsko-medicinskim proizvodima

    • 07.06.2013 · 730 · Narodne Novine

      Pravilnik o izmjenama i dopunama Pravilnika o veterinarsko-medicinskim proizvodima

    • 07.06.2013 · 1322 · Narodne Novine

      Pravilnik o izmjenama i dopunama Pravilnika o veterinarsko-medicinskim proizvodima

    • 07.06.2013 · 1151 · Narodne Novine

      Zakon o izmjenama i dopunama Zakona o veterinarsko-medicinskim proizvodima

    • 07.06.2013 · 1759 · Narodne Novine

      Pravilnik o izmjeni Pravilnika o veterinarsko-medicinskim proizvodima

    • 07.06.2013 · 344 · Narodne Novine

      Pravilnik o izmjeni Pravilnika o veterinarsko-medicinskim proizvodima

    • 07.06.2013 · 2718 · Narodne Novine

      Zakon o veterinarsko-medicinskim proizvodima

  5. CY Cyprus deadline passed, no measure notified in EUR-Lex
  6. CZ Czechia deadline passed, no measure notified in EUR-Lex
  7. DK Denmark deadline passed, no measure notified in EUR-Lex
  8. EE Estonia deadline passed, no measure notified in EUR-Lex
  9. FI Finland deadline passed, no measure notified in EUR-Lex
  10. FR France deadline passed, no measure notified in EUR-Lex
  11. DE Germany deadline passed, no measure notified in EUR-Lex
  12. EL Greece deadline passed, no measure notified in EUR-Lex
  13. HU Hungary deadline passed, no measure notified in EUR-Lex
  14. IE Ireland deadline passed, no measure notified in EUR-Lex
  15. IT Italy deadline passed, no measure notified in EUR-Lex
  16. LV Latvia deadline passed, no measure notified in EUR-Lex
  17. LT Lithuania deadline passed, no measure notified in EUR-Lex
  18. LU Luxembourg deadline passed, no measure notified in EUR-Lex
  19. MT Malta deadline passed, no measure notified in EUR-Lex
  20. NL Netherlands deadline passed, no measure notified in EUR-Lex
  21. PL Poland deadline passed, no measure notified in EUR-Lex
  22. PT Portugal deadline passed, no measure notified in EUR-Lex
  23. RO Romania deadline passed, no measure notified in EUR-Lex
  24. SK Slovakia 1 national measures · 2011
    • 29.10.2011 · 362/2011 · Zbierka zákonov SR

      Zákon č. 362/2011 Z. z. o liekoch a zdravotníckych pomôckach a o zmene a doplnení niektorých zákonov

  25. SI Slovenia deadline passed, no measure notified in EUR-Lex
  26. ES Spain deadline passed, no measure notified in EUR-Lex
  27. SE Sweden deadline passed, no measure notified in EUR-Lex

A directive binds the states to achieve a result by the deadline. Where the deadline has passed without transposition, individuals can as a rule rely on clear and unconditional provisions against the state (direct effect). The data are the measures notified by the states, not an assessment of completeness.