Euroopan komissio on julkaissut päivitetyn K&V dokumentin lääkevarmennuksesta (versio 12)

Tässä uutisessa käymme läpi dokumenttiin tehdyt muutokset. Artikkelissa olemme esittäneet tarkistukset ja muutokset.

Täydellinen K&V löytyy komission verkkosivulta: https://ec.europa.eu/health/sites/health/files/files/falsified_medicines/qa_safetyfeature_en.pdf

Muokatut kysymykset: 1.20 ja 2.21

Q 1.20

If a pack bearing the safety features is lawfully opened, can it be resealed?

(Wording revised, Answer: “Yes, in certain circumstances.” now reads, “In certain circumstances…”)

Q 2.21

Is it acceptable to use stickers to replace the unique identifier on the outer/immediate packaging?

(Added text: Answer: - “Competent national authorities authorize it due to the marketing authorization or to safeguard public health and ensure continued supply.” has extended to, “Competent national authorities authorize it due to the marketing authorization, including for parallel import or to safeguard public health and ensure continued supply.”