General principles regarding the smpc

Generic/hybrid/biosimilar products - European Medicines …

SmPC information • In general, the content of the SmPC should be consistent with the reference medicinal product • Any differences with the reference medicinal product should be

  General, Product, Generic, Hybrid, Biosimilars, Mscp, Generic hybrid biosimilar products, The smpc

Version 1.4.1 November 2011 - Europa

In line with the general principles of the ICH eCTD Specification, it is intended that XML will eventually become the sole submission format for administrative forms and product information

  General, Principles, 2011, November, General principles, November 2011

Implications of the new CHMP Guideline on the ...

Dr. Herta Reile February 2007 6 are mostly developed for an international market divergence in regulatory requirements is a large drawback for product development.

Global Development Strategy for Generic Medicinal Products ...

Global Development Strategy for Generic Medicinal Products with Regard to Bioequivalence Studies – Special Focus on the Biowaiver Approach in Canada, Australia and Brazil