www.fdanews.com/articles/156631-egypt-explains-submission-status-for-parenteral-biologicals-changes
Egypt Explains Submission Status for Parenteral Biologicals Changes
June 25, 2013
Egypt’s Central Administration for Pharmaceutical Affairs has issued guidelines for determining when a change in parenteral biological preparations should be submitted as a new application or a variation.
International Pharmaceutical Regulatory Monitor
International Pharmaceutical Regulatory Monitor