Corrigendum to the Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMA/410/01 rev. 3) (Official Journal of the European Union C 73 of 5 March 2011) 2011/C 182/14
Grade B
mapped from publisher markup. A grade says how a document's structure was obtained, not how reliable the law is.
Address https://gelex.eu/eli/EU/corrigendum/oj/C/2011/182/14@2011-06-23/en
Contents
On page 4, Section 3.1 Scientific principles for minimising risk: for: read: (1) nature of animal material used in manufacture and any procedures in place to avoid (2) cross-contamination with higher risk materials,, (3) nature of animal material used in manufacture and any procedures in place to avoid cross-contamination with higher risk materials,;
corr_1 —
nature of animal material used in manufacture and any procedures in place to avoid
cross-contamination with higher risk materials,,
nature of animal material used in manufacture and any procedures in place to avoid cross-contamination with higher risk materials,;
on page 14, text to be included at the top of the Annex Major categories of infectivity: for: Data entries are shown as follows: + Presence of infectivity or PrPTSE – Absence of detectable infectivity or PrPTSE NT Not tested ? Controversial or uncertain results, read: Data entries are shown as follows: + Presence of infectivity or PrPTSE – Absence of detectable infectivity or PrPTSE NT Not tested NA Not applicable ? Uncertain interpretation ( ) Limited or preliminary data [ ] Infectivity or PrPTSE data based exclusively on bioassays in transgenic (Tg) mice over-expressing the PrP-encoding gene or PrPTSE amplification methods.;
on page 14, heading of the table: for: LymphoretIculart issues, read: Lymphoreticular tissues;
on page 15, heading of the table: for: Alimentary truct, read: Alimentary tract;
Category IB: Category IC:
on page 16, heading of the table: for: Lower infectivity tissues, read: Tissues with no detected infectivity;
on page 17, heading of the table: for: Musculo-skeletalt issues, read: Musculo-skeletal tissues.