New Rules on Importing Active Pharmaceutical Ingredients
The European Union has reformed the rules for importing active substances for medicinal products for human use. As of 2 January 2013, all imported active substances must have been manufactured in compliance with standards of good manufacturing practices (GMP) at least equivalent to the GMP of the EU. The manufacturing standards in the EU for active substances are those of the International Conference for Harmonisation – ICH Q7. As of 2 July 2013, this compliance must be confirmed in writing by the competent authority of the exporting country. More information is available on the DG SANCO’s website.