The Notice to Applicants,
volumes 2 and 6 have been updated with the publication of the updated
application form for the submission of variations and renewal.
volumes 2 and 6 have been updated with the publication of the updated
application form for the submission of variations and renewal.
Volume 2C : Human medicinal products – Regulatory Guidelines
Volume 6C : Veterinary medicinal products – Regulatory Guidelines
The electronic version of the new
variation and renewal application forms are made available by the
European Medicines Agency at http://esubmission.emea.europa.eu/eaf/index.html