The European Medicines Agency (EMA) provides scientific and regulatory guidance to pharmaceutical companies whose medicinal products have been authorised in Europe. This is known as the post-authorisation stage of the product lifecycle.
This sets out the responsibilities of marketing authorisation holders in areas such as pharmacovigilance, applying to vary a marketing authorisation, submitting product data to EMA and reporting product defects or recalls.
In this section
How useful is this page?
Average rating:Based on 6 ratings
Add your rating:
- See all ratings
1 ratings1 ratings0 ratings0 ratings4 ratings