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Den europeiska läkemedelsmyndigheten får en förstärkt roll vid krisberedskap och krishantering

03/04/2022

Genom förordning 2022/123, som tillämpas från och med 1 mars 2022, ges den europeiska läkemedelsmyndigheten (EMA) en förstärkt roll vid krisberedskap och krishantering avseende läkemedel och medicintekniska produkter. Förordningen fastställer några av de processer som etablerades av EMA under Covid-19 pandemin och tillskriver även myndigheten ytterligare ansvar. Enligt förordningen ansvarar EMA t.ex. för att fortlöpande övervaka varje händelse som sannolikt kommer att leda till ett hot mot folkhälsan eller en större händelse när det gäller läkemedel eller medicintekniska produkter samt att företa viss rapportering.

Vad särskilt gäller medicintekniska produkter tillämpas förordningen från och med den 2 februari 2023.

För närvarande pågår arbetet med att anpassa EMA till de nya uppgifterna. Ytterligare information finns på EMA:s hemsida (https://www.ema.europa.eu/en/news/regulation-emas-extended-mandate-becomes-applicable?utm_campaign=lv_nyhetsbrev&utm_medium=email&utm_source=newsletter) och Läkemedelverkets nyhetsbrev (https://www.anpdm.com/newsletterweb/47455F4472404A514178434459/44435B4A7042475E4B7843435B4071).

För mer information, vänligen kontakta:

Malin Albert (Partner)

Marika Jaaniste (Associate)

Team involved

Malin von Heideken_3

Malin von Heideken

Partner

malin.vonheideken@hammarskiold.se

+46 702 38 47 00

Marika Jaaniste_2

Marika Jaaniste

Associate

marika.jaaniste@hammarskiold.se

+46 708 94 40 50

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