This document is an excerpt from the EUR-Lex website
Document 32010L0084R(02)
Corrigendum to Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use ( OJ L 348, 31.12.2010 )
Corrigendum to Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use ( OJ L 348, 31.12.2010 )
Corrigendum to Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use ( OJ L 348, 31.12.2010 )
OJ L 276, 21.10.2011, p. 63–63
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
ELI: http://data.europa.eu/eli/dir/2010/84/corrigendum/2011-10-21/oj
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21.10.2011 |
EN |
Official Journal of the European Union |
L 276/63 |
Corrigendum to Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use
( Official Journal of the European Union L 348 of 31 December 2010 )
On Page 97, Article 1, point 22, new text of Article 116, second paragraph:
for:
‘A marketing authorisation may also be suspended, revoked or varied where the particulars supporting the application as provided for in Articles 8, 10 or 11 …’,
read:
‘A marketing authorisation may also be suspended, revoked or varied where the particulars supporting the application as provided for in Articles 8, 10, 10a, 10b, 10c or 11 …’.