MARKETING AUTHORIZATION APPLICATION (MAA) FOR EUROPE MARKET

Journal Title: International Journal of Drug Regulatory Affairs - Year 2015, Vol 3, Issue 1

Abstract

This article states requirement of Marketing Authorization Application to get registration of Drug Product to EEA. The procedures for application of marketing authorization are: Centralised procedure, National procedure, Mutual recognition procedure, Decentralised procedure.

Authors and Affiliations

Bhave C, Dolhare N, Badjatya Jitendra Kumar

Keywords

Related Articles

AN OVERVIEW OF CHINESE DRUG REGULATORY SYSTEM: A REVIEW

The Drug regulatory authority of China was renewed from state pharmaceutical administration of China (SPAC) to state food and Drug administration (SFDA) with the announcement and declaration of Chinese ministry of health...

PIC/S: TRAINING THE REGULATORS TO REGULATE cGMP COMPLIANCE

PIC/S is an international Organization for implementing cGMP standards in its member countries. The basic objective of PIC/S is to improve and standardize cGMP compliance in member countries. Their aim is to enhance GMP...

Regulatory aspects for Biologic Product licensing in Australia

The TG Act defines biological as product made, from or containing, human cells or human tissues, lives animal organs, cells or tissues, and that is used to treat or prevent disease or injury, Diagnose a condition of a pe...

STEVIA AN UNTOUCHED NATURE’S GIFT CAN BE A BOON TO DIABETIC

Plants and fungi are a vital part of healthcare. Over 80% of the global population rely on traditional medicine, much of which is based on plant remedies. Traditional Chinese medicine alone uses over 5,000 plant species....

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF TELMISARTAN IN BULK AND TABLET DOSAGE FORM

A simple, sensitive, precise and specific reverse phase high performance liquid chromatographic method was developed and validated for the determination of Telmisartan in bulk and tablet dosage forms. It was found that t...

Download PDF file
  • EP ID EP338421
  • DOI -
  • Views 82
  • Downloads 0

How To Cite

Bhave C, Dolhare N, Badjatya Jitendra Kumar (2015). MARKETING AUTHORIZATION APPLICATION (MAA) FOR EUROPE MARKET. International Journal of Drug Regulatory Affairs, 3(1), 88-91. https://europub.co.uk/articles/-A-338421