Importation of Active Substances- new Rules for Written Confirmation of GMP-Compliance Published
10.07.2012
- New Templates for written Confirmation of GMP-Compliance published;
applicable as of July 2, 2013 -
On July 10, 2012, the European Commission published the template for written confirmation confirming GMP-compliance of the active pharmaceutical ingredient (API) being exported from foreign countries and used in EU for the manufacture of medicinal products for human use. The competent Authority of the exporting country needs to confirm GMP-compliance equivalent to the rules applied in EU using this new template. Further information including a Question and answer document can be found under
http://ec.europa.eu/health/files/eudralex/vol-4/2012_06_19_template.pdf
http://ec.europa.eu/health/files/gmp/2012_06_04_qas.pdf
Back 