(1) the Administrative Document referred to in Article 23, paragraph (1) letter a according to the example in Annex V which is the integral part of this legislation.
(2) Product information document as referred to in article 23, paragraph (1) letter a consists of:
a. Summary of Product Characteristics; and
b. product information for patients
(3) Documents certifying as stipulated in article 23, paragraph (1) letter a include etiquette/label, strip/blister, ampules/vial, catch cover/envelope, and wrap the outside.
正在翻譯中..
![](//zhcntimg.ilovetranslation.com/pic/loading_3.gif?v=b9814dd30c1d7c59_8619)