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

FACTS ON DRUG REGULATIONS

The pharmaceutical products are very much driven by the drug regulation imposed by ministry of health in individual countries. The basic facts on regulations is that they are mandatory and noncompliant are punishable und...

FORMULATION AND IN-VITRO EVALUATION OF HOLLOW MICROSPHERES OF GLIPIZIDE

Present work involves attempts to improve floating time of glipizide by formulation of hollow microspheres incorporating Glyceryl Monostearate and acryflow. The floating microspheres were evaluated for percentage yield,...

ACTD: BRIDGE BETWEEN REGULATORY REQUIREMENTS OF DEVELOPED AND DEVELOPING COUNTRIES

Regulatory Dossier contains data which when submitted to the regulatory authority, provides for the review and ultimate approval of a drug product. Once approved, an applicant may manufacture and market the drug to provi...

METHOD DEVELOPMENT AND VALIDATION OF STABILITY INDICATING UPLC ASSAY METHOD FOR NIFEDIPINE

A simple and rapid stability indicating, ultra performance liquid chromatographic (UPLC) method was developed and validated for the determination of Nifedipine. The quantitative determination of Nifedipine drug was perfo...

Drug approval process in US, Europe and India and its regulatory requirements: A Review

Current constrain of Regulatory Affairs reveals diverse countries need to follow different regulatory requirements for marketing authorization Application (MAA) approval of new drugs. In this present exertion, study expr...

Download PDF file
  • EP ID EP338421
  • DOI -
  • Views 105
  • 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