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Administrative procedurer ved godkendelse af nye lægemidler

Forfatter(e)
Mark A. Ainsworth1 ,2 & Sinan B. Sarac1
1) Medicinsk Evaluering og Biostatistik, Lægemiddelstyrelsen 2) Afdeling for Medicinske Mavetarmsygdomme, Odense Universitetshospital

Ugeskr Læger 2019;181:V10180677

Reference: 
Ugeskr Læger 2019;181: V10180677

Mark A. Ainsworth & Sinan B. Sarac:

Approval of new medicinal products – administrative procedures

Ugeskr Læger 2019;181: V10180677

In this review, we discuss the approval of new medicinal products in Europe, which in particular for products with a new active substance is increasingly being approved through formalised collaboration between the member states of the European Union. The collaboration has resulted in a strengthening and harmonisation of the administrative procedures leading to approval of new medicinal products.

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