Good Distribution Practices in Europe

 

The EMA has recently updated this FAQ relating to ‘Frequently asked questions about parallel distribution’.

 

The update includes new Q&As on:-

 

• ·         What are the procedures of parallel distribution?
• ·         Can the parallel distribution notice be transferred?
• ·         What is a safety update?
• ·         How to submit safety update.
• ·         What is the scope of a bulk change?
• ·         How to submit a bulk change.

 

See: https://www.ema.europa.eu/en/human-regulatory/post-authorisation/parallel-distribution/frequently-asked-questions-about-parallel-distribution

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)