MARKETING AUTHORIZATION APPLICATION (MAA) FOR EUROPE MARKET

  • Bhave C.
  • Dolhare N.
  • J. K. Badjatya

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.

Keywords: MAA, EU, Rapporteur, Co-Rapporteur, EMA.

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References

1. Marketing Authorization Application [Internet] European Medicines Agency; 2015 [updated 2015 March 17; Cited on 2014 Dec 21]. Available from: www.ema.europa.eu
2. Authorisation Procedures for medicinal products [Internet] European Commission; 2015 [updated 2015 March 16; Cited on 2014 Dec 27]. Available from:
http://ec.europa.eu/health/authorisation-procedures_en.htm.
3. EU: MAA Regulatory submissions [Internet] EDQM, France; 2015 [Cited on 2014 Dec 28]. Available from:
https://www.edqm.eu/en/Certification-Policy-documents-Guidelines-1658.html.
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How to Cite
C., B., D. N., and J. K. Badjatya. “MARKETING AUTHORIZATION APPLICATION (MAA) FOR EUROPE MARKET”. International Journal of Drug Regulatory Affairs, Vol. 3, no. 1, Feb. 2018, pp. 88-91, doi:10.22270/ijdra.v3i1.160.