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EMEA/H/C/002569/WS1090/0014/G<br />
MAH: Boehringer Ingelheim International<br />
GmbH, Lead Rapporteur: Sinan B. Sarac<br />
WS1093<br />
Genvoya-<br />
EMEA/H/C/004042/WS1093/0025<br />
Stribild-EMEA/H/C/002574/WS1093/0076<br />
Tybost-EMEA/H/C/002572/WS1093/0033<br />
MAH: Gilead Sciences International Ltd, Lead<br />
Rapporteur: Robert James Hemmings<br />
B.7. DOCUMENTS TABLED IN MMD AFTER THE CHMP PLENARY<br />
B.7.1. Line listing for Variation Type I and Variation Type II (MMD only) post authorisation<br />
procedures from the beginning of the year.<br />
B.7.2. Line listing overview of all applications under the centralised procedure (MMD only).<br />
line listing - products - authorised, under evaluation, suspended.xls<br />
B.7.3. Opinion on Marketing Authorisation transfer (MMD only).<br />
B.7.4. Notifications in accordance with Article 61(3) of Council Directive 2001/83/EC<br />
(MMD only).<br />
B.7.5. Request for supplementary information relating to Notification of Type I variation<br />
(MMD only).<br />
B.7.6. Notifications of Type I Variations (MMD only).<br />
C. Annex C - Post-Authorisation Measures (PAMs), (Line listing of Post authorisation<br />
measures with a description of the PAM. Procedures starting in that given month with<br />
assessment timetabled)<br />
D. Annex D - Post-Authorisation Measures (PAMs), (Details on PAMs including description<br />
and conclusion, for adoption by CHMP in that given month, or finalised ones with PRAC<br />
recommendation and no adoption by CHMP needed)<br />
E. Annex E - EMEA CERTIFICATION OF PLASMA MASTER FILES<br />
Disclosure of information related to plasma master files cannot be released at present time as these<br />
contain commercially confidential information.<br />
Annex to December 2016 CHMP Agenda<br />
EMA/CHMP/819197/2016 Page 54/55
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