Drug product registration and marketing authorization procedures in EU-A perspective

Yıl 2013, Cilt: 17 Sayı: 1, 1 - 6, 07.03.2014

Ashish Kekare Jagadish Pc Manthan Janodia Krishnamurthy Bhat Swati Karande N Udupa

Öz

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.
KEYWORDS: European Economic Area, marketing authorization.

Anahtar Kelimeler

European Economic Area, marketing authorization.

There are 27 European Union (EU) member states, 3 European Economic Area (EEA) and

Öz

Kaynakça

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