Animal vaccines: export certification
For the export of veterinary vaccines (finished medicinal products), WHO certificates of type 1 (product certificate) and/or type 2 (declaration of approval status for a pharmaceutical product) are required.
The competent authority shall certify with the certificates:
- the approval status and GMP conformity of the manufacture (type 1) of the vaccine and
- that one or more vaccines are authorised in the exporting country (type 2).
The fees are determined by the type of certificate (range from 100.00 to 425.00 euros).
There are no deadlines to be observed.
Details on certification (notes and certificate tyypes) can be found on the website of the ZLG (Quality Assurance Manual for Medicinal Products).
The text was automatically translated based on the German content.
Contact the Lower Saxony State Office for Consumer Protection and Food Safety.