QP Declaration: EMA publishes Comments

QP Declaration: EMA publishes Comments

http://www.gmp-compliance.org/enews_4526_QP-Declaration-EMA-publishes-Comments_8261,8530,Z-QAMPP_n.html

More than three years ago, the EMA has published two draft documents for a template for the QP’s declaration concerning GMP compliance of the API used as starting material and verification of its supply chain called “The QP declaration template“:

1. The draft template for the Qualified Person’s declaration

and

2. the respective draft Q&A on the template for the Qualified Person’s declaration

The QP Declaration should be provided in support of an application for a new marketing authorisation, variation or renewal of a medicinal product(s) authorised in the Community, using EU or national procedures within the scope of the respective Directives.

The consultation for the template ended on 30 April 2011. In June 2014, the final version was published together with a template guidance. Now, three months after publication of the final document, the comments from 2011 have been published.

The…