의약품 관련 법령
Resolution RDC 253: Amends Resolution RDC 20/2013 on the Electronic Submission Procedure Applied to the Marketing Authorization of New Medicinal Products
| 작성자 | 관리자 | ||
|---|---|---|---|
| 작성일 | 2018-12-04 | 조회수 | 1,074 |
| 국가정보 | 남 아메리카>브라질 | ||
| 출처 | ANVISA | ||
| 원문 | http://portal.anvisa.gov.br/ | ||
| 첨부파일 | |||
Amends Resolution RDC 20_2013 on the Electronic Submission Procedure Applied to the Marketing Authorization of New Medicinal Products.pdf(418.89KB)This Resolution amends Resolution RDC 20/2013 , which introduces a mandatory electronic submission procedure for the registration (“registro”) of new medicinal products, i.e. products that contain at least one active pharmaceutical ingredient which has not yet been approved for marketing in Brazil or new salts, isomers, or mix of isomers, esters, compounds or the registered correspon...
- 이전글 PEI: C Rebuild - electronic submission of applications for batch release applications
- 다음글 BfArM: Information Note on the Electronic Declaration of Marketed Medicinal Products Not Requiring Marketing Authorization
