ANNEX 21 Importation of medicinal products-Reference-Cited by-同舟云学术

ANNEX 21 Importation of medicinal products

Published:2022-12-31 Issue:03 Volume:68 Page:147-148
ISSN:1857-8969
Container-title:Macedonian Pharmaceutical Bulletin
language:en
Short-container-title:Maced. Pharm. Bull.

Author:

Brzilova Milenkovikj Ksenija¹,Bobevska Vanja¹,Kimovska Jasmina¹,Jovanovska Jankovska Verče¹,Karadžinska Elizabeta¹,Popstefanova Nada¹,Paneva Olivera¹,Petrovski Stefan¹,Velinovska Cadinovska Maja¹,Uskokova Sanja¹

Affiliation:

1. ALKALOID AD Skopje, Blvd. Aleksandar Makedonski 12, 1000 Skopje, Republic of North Macedonia

Publisher

Macedonian Pharmaceutical Association

Subject

General Medicine

Link

http://bulletin.mfd.org.mk/volumes/Volume%2068_3/68_3_069.pdf

Reference4 articles.

1. Directive 2003/94 EC, for. Principles of Good Manufacturing Practice for Medicinal Products for Human Use and Research for Medicinal Products for Human Use, effective from: 14.10.2003. Available at: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF

2. The rules governing medicinal products in the European community European Union, Volume 4, Annex 16: Certification by a qualified person and placing on the market of a medicinal product, effective from 15 April 2016. Available at: https://health.ec.europa.eu/system/files/2016-11/v4_an16_201510_en_0.pdf

3. The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 21: Importation of medicinal products, effective from: 16.02.2022. Available at: https://health.ec.europa.eu/system/files/2022-03/vol4_annex21_en.pdf

4. The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Chapter 6: Quality control, effective from 28 March 2014. Available at: https://health.ec.europa.eu/system/files/2016-11/2014-11_vol4_chapter_6_0.pdf