Avrupa Birliǧi'nde ilaç ruhsatlandi{dotless}rma süreci

Ashish Kekare; P. C. Jagadish; Manthan Janodia; Krishnamurthy Bhat; Swati Karande; N. Udupa

doi:10.12991/201317384

Avrupa Birliǧi'nde ilaç ruhsatlandi{dotless}rma süreci

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

Ashish Kekare, P. C. Jagadish, Manthan Janodia, Krishnamurthy Bhat, Swati Karande, N. Udupa

Research output: Contribution to journal › Review article › peer-review

1 Citation (Scopus)

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.

Translated title of the contribution	Drug product registration and marketing authorization procedures in EU-A perspective
Original language	Turkish
Pages (from-to)	1-6
Number of pages	6
Journal	Marmara Pharmaceutical Journal
Volume	17
Issue number	1
DOIs	https://doi.org/10.12991/201317384
Publication status	Published - 2013

All Science Journal Classification (ASJC) codes

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

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year = "2013",

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AU - Kekare, Ashish

AU - Jagadish, P. C.

AU - Janodia, Manthan

AU - Bhat, Krishnamurthy

AU - Karande, Swati

AU - Udupa, N.

PY - 2013

Y1 - 2013

N2 - 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.

AB - 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.

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Avrupa Birliǧi'nde ilaç ruhsatlandi{dotless}rma süreci

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