Title:Post-Approval Changes in Pharmaceuticals: Regulatory Perspectives in Europe
VOLUME: 2 ISSUE: 2
Author(s):Pankaj Kumar, Vibhu Yadav and Deepak Kaushik
Affiliation:Faculty of Pharmaceutical Sciences, M.D. University, Rohtak-124001, India.
Keywords:Centralised procedure, EMA, post approval changes, variation filing.
Abstract:Post approval changes are an integral part of pharmaceutical product life cycle management.
These changes need to be carefully monitored and must follow proper regulatory path of given
jurisdiction. The present work identifies the post approval changes, policies, guidelines and procedure
for submission of post approval changes in Europe. The European medical agency (EMA) in their
several guidelines has clearly defined the regulatory framework for post approval changes which are
known as variation filing in Europe. The article further describes the types of changes, categorization
and procedure for the submission of variation changes. In Europe, variations are classified as Type-IA
for minor changes, Type-IB for moderate changes and Type-II for major changes. These minor changes can be implemented
without an approval from the agency but should be reported and the major changes needs an approval letter from
the agency. The case study on the product Humalog (insulin lispro) has been described to obtain better understanding of
post approval changes in Europe.
