Please note that in Austria, national requirements also apply in addition to the European requirements.

Forms

The application forms for marketing authorization applications and variations are available at esubmission.ema.europa.eu/eaf/.

Marketing Authorisation

Detailed information can be found at:

• Heads of Medicines Agencies: Applications for Marketing Authorisation
• EudraLex - Volume 5 - European Commission

Life Cycle

• Detailed information can be found at: Heads of Medicines Agencies: Variations

Variations not requiring assessment (VNRA)

Variations not requiring assessment have to be submitted and processed directly via the UPD. For information on the UPD, please visit www.ema.europa.eu/en/veterinary-regulatory/overview/veterinary-medicines-regulation/union-product-database, EMA support can be contacted via the following link: https://support.ema.europa.eu/esc.

Please bear in mind that such changes can also be submitted up to 30 days retrospectively.

Variations requiring assessment (VRA)

Changes requiring assessment (VRA) have to be submitted as usual via CESP.