GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW) | ||||||
---|---|---|---|---|---|---|
|
21:19 Feb 16, 2008 |
Italian to English translations [PRO] Medical - Medical (general) | |||||||
---|---|---|---|---|---|---|---|
|
| ||||||
| Selected response from: Gilberto Lacchia Italy Local time: 18:36 | ||||||
Grading comment
|
Summary of answers provided | ||||
---|---|---|---|---|
4 +3 | marketing authorisation |
|
marketing authorisation Explanation: And MAH is the "marketing authorisation holder" http://www.emea.europa.eu/htms/human/withdraw/withdraw.htm -------------------------------------------------- Note added at 17 min (2008-02-16 21:37:26 GMT) -------------------------------------------------- 2.3.3 Marketing Authorization Holder/Manufacturer/Distributor Section 2.3.4 Marketing Authorization Section http://www.fda.gov/CbER/gdlns/ichm5.htm Products where manufacturing process changes are made in development or for which a marketing authorization has been granted. ... to support the marketing authorization. ...drug product on behalf of the marketing authorization holder http://www.fda.gov/CDER/GUIDANCE/6677fnl.htm |
| |