의약품 관련 법령
BfArM FAQs: on Variations
| 작성자 | 관리자 | ||
|---|---|---|---|
| 작성일 | 2018-11-26 | 조회수 | 875 |
| 국가정보 | 유럽>독일 | ||
| 출처 | BfArM | ||
| 원문 | www.bfarm.de | ||
| 첨부파일 | |||
BfArM FAQs_ on Variations.pdf(214.14KB)
This document provides answers on frequently asked questions about variations. Among others, the following topics are treated in this document:
- implementation of QRD templates
- fee reductions for purely national authorizations and registrations that are not subject to the Variation Regulation,
- under which classification category can adaptation of the texts (SmPC/PIL/labelling) to
conform with t...
- implementation of QRD templates
- fee reductions for purely national authorizations and registrations that are not subject to the Variation Regulation,
- under which classification category can adaptation of the texts (SmPC/PIL/labelling) to
conform with t...
- 이전글 Paul Ehrlich Institute Presentation: Organization Chart
- 다음글 ANMAT-MED-BED 010-00: Guide for Scale Variations and Variations for Substances Subjected to the Demonstration of Bioequivalence
