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Document 32014R0536R(04)

Corrigendum to Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014)

OJ L 311, 17.11.2016, p. 25–25 (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

ELI: http://data.europa.eu/eli/reg/2014/536/corrigendum/2016-11-17/oj

17.11.2016   

EN

Official Journal of the European Union

L 311/25

Corrigendum to Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC

( Official Journal of the European Union L 158 of 27 May 2014 )

On page 28, Article 23(5):

for:

‘Where the conclusion … is that the substantial modification is not acceptable, that conclusion shall be deemed to be the conclusion of the Member State concerned.’,

read:

‘Where the conclusion … is that the substantial modification is not acceptable, that conclusion shall be deemed to be the conclusion of all Member States concerned.’.

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