Avrupa Birliǧi'nde ilaç ruhsatlandi{dotless}rma süreci

Translated title of the contribution: Drug product registration and marketing authorization procedures in EU-A perspective

Research output: Contribution to journalReview article

Abstract

There are 27 European Union (EU) member states, 3 European Economic Area (EEA) and European Free Trade Association (EFTA) states. For a company willing to market the medicinal product in to the EEA, marketing authorization (MA) for the respective product must be issued by competent authority of member state or authorization granted according to Regulation (EC) No. 726/2004 for entire community. Europe constitutes large population and European government is alert regarding safety of the public in EU. There are changes in the procedures for the marketing authorization by the EU. Different types of procedures for the application of marketing authorization are available in the EU and these procedures are discussed here.

Original languageTurkish
Pages (from-to)1-6
Number of pages6
JournalMarmara Pharmaceutical Journal
Volume17
Issue number1
DOIs
Publication statusPublished - 2013

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European Union
Marketing
Pharmaceutical Preparations
Economics
Free Association
Safety
Population

All Science Journal Classification (ASJC) codes

  • Pharmacology, Toxicology and Pharmaceutics(all)
  • Pharmacology (medical)

Cite this

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title = "Avrupa Birliǧi'nde ila{\cc} ruhsatlandi{dotless}rma s{\"u}reci",
abstract = "There are 27 European Union (EU) member states, 3 European Economic Area (EEA) and European Free Trade Association (EFTA) states. For a company willing to market the medicinal product in to the EEA, marketing authorization (MA) for the respective product must be issued by competent authority of member state or authorization granted according to Regulation (EC) No. 726/2004 for entire community. Europe constitutes large population and European government is alert regarding safety of the public in EU. There are changes in the procedures for the marketing authorization by the EU. Different types of procedures for the application of marketing authorization are available in the EU and these procedures are discussed here.",
author = "Ashish Kekare and Jagadish, {P. C.} and Manthan Janodia and Krishnamurthy Bhat and Swati Karande and N. Udupa",
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Avrupa Birliǧi'nde ilaç ruhsatlandi{dotless}rma süreci. / Kekare, Ashish; Jagadish, P. C.; Janodia, Manthan; Bhat, Krishnamurthy; Karande, Swati; Udupa, N.

In: Marmara Pharmaceutical Journal, Vol. 17, No. 1, 2013, p. 1-6.

Research output: Contribution to journalReview article

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AU - Kekare, Ashish

AU - Jagadish, P. C.

AU - Janodia, Manthan

AU - Bhat, Krishnamurthy

AU - Karande, Swati

AU - Udupa, N.

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