Batch certification document Certificate of Analysis / Certificate of Compliance-Reference-Cited by-同舟云学术

Batch certification document Certificate of Analysis / Certificate of Compliance

Published:2022-12-31 Issue:03 Volume:68 Page:187-188
ISSN:1857-8969
Container-title:Macedonian Pharmaceutical Bulletin
language:en
Short-container-title:Maced. Pharm. Bull.

Author:

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

Affiliation:

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

Publisher

Macedonian Pharmaceutical Association

Subject

General Medicine

Link

https://bulletin.mfd.org.mk/volumes/Volume%2068_3/68_3_089.pdf

Reference5 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://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF

2. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use Available at: https://eur-lex.europa.eu › legal-content › EN › ALL › ?uri=CELEX:32001L0083

3. Law on Medicines and Medical Devices (Official Gazette 106/2007)\. Available at: https://malmed.gov.mk/wp-content/uploads/2-Zakon-za-lekovite-i-medicinskite-pomagala-osnoven-tekst-Sl.Vesnik-br.106-od-2007.pdf

4. Rulebook on amending and supplementing the rulebook on the content of the request, documentation and detailed conditions regarding the space, equipment and staff for obtaining approval for the production of drugs Official Gazette 55/2017). Available at: https://malmed.gov.mk/wp-content/uploads/Izmeni_pravilnik_za_baranje_dokumentacija_proizvodstvo_na_lekovi_55-od-2017.pdf

5. 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