Article 14–Article 15 · 2 articles
Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Fees
Member States may levy a fee when they carry out safety assessment activities as a safety assessing Member State and establish reduced fees for non-commercial clinical trials in accordance with Article 86 of Regulation (EU) No 536/2014.
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 31 January 2022.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.