Registration of medicinal products for pediatric use and Pediatric Investigation Plan-Reference-Cited by-同舟云学术

Registration of medicinal products for pediatric use and Pediatric Investigation Plan

Published:2022-12-31 Issue:03 Volume:68 Page:201-202
ISSN:1857-8969
Container-title:Macedonian Pharmaceutical Bulletin
language:en
Short-container-title:Maced. Pharm. Bull.

Author:

Bibovska Violeta¹,Vukicevic Natasha¹,Tonikj Ribarska Jasmina²,Trajkovikj Jolevska Suzana²

Affiliation:

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

2. Faculty of Pharmacy, University “Ss Cyril and Methodius”, Mother Theresa 47, 1000 Skopje, Republic of N. Macedonia

Publisher

Macedonian Pharmaceutical Association

Subject

General Medicine

Link

https://bulletin.mfd.org.mk/volumes/Volume%2068_3/68_3_096.pdf

Reference4 articles.

1. EMA, 2021. Human regulatory. Overview: Paediatric medicines: Paediatric Regulation. Available from: https://www.ema.europa.eu/en/human regulatory/overview/paediatric-medicines/paediatric-regulation

2. EMA, 2021a. Human regulatory. Marketing authorisation: Paediatric requirements for marketing-authorisation applications. Available from: https://www.ema.europa.eu/en/humanregulatory/marketing-authorisation/paediatric-medicines/paediatric-requirements-marketing-authorisation-applications

3. Guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies. Available from: Communication from the Commission — Guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies Text with EEA relevance (europa.eu)

4. MALMED, 2007. LAW ON MEDICINAL PRODUCTS AND MEDICAL DEVICES. „Службен весник на РМ“ бр. 106 од 05.09.2007 година. Available from: ЗАКОН ЗА ЛЕКОВИТЕ И МЕДИЦИНСКИТЕ ПОМАГАЛА (malmed.gov.mk)