Generic drugs/products approval procedure

Until only a few years ago, a company intending to market a new drug product in the EU would submit a national NDA in each country in which authorization was sought. While national procedures may still be used in limited situations, such as for approval of product line extensions, a firm must choose the mutual recognition or centralized system. (We will not discuss the approval process for generic products.)... 

In most countries, generic drugs may be approved via an abbreviated procedure similar to the ANDA procedure in the United States. The applicant generally must show that the generic product has the... 

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