Marketing Authorisation Registration (*)
For the registration of veterinary medicinal products with a centralised MA in the EOF database, a request must be submitted at the national level for the issuance of EOF codes for the approved pharmaceutical forms/strengths/pack sizes
The Marketing Authorisation Holder (MAH) of veterinary medicinal products with a centralised MA is required to send an electronic dossier to protokollo@eof.gr, addressed to the Decision Issuing Department, including the following supporting documents:
- Request for the issuance of codes
- Relevant European Commission Decision, including its Annexes and approved pack sizes (corresponding Annex)
- Completed form containing the details of the centralised MA of the veterinary medicinal product
- Administrative fee of €50 (Euros) per pharmaceutical form/strength, payable to the EOF account at the Bank of Greece
Variation of Marketing AuthorisationThe Marketing Authorisation Holder (MAH) of veterinary medicinal products with a centralised MA must notify EOF of every positive outcome regarding variations that affect the administrative data of the MA, by submitting the following to EOF:
- Cover letter
- Relevant European Commission Decision within two months of its issuance, or the EMA Opinion for any other case of variation.
- Completed form containing the details of the centralised MA of the veterinary medicinal product
- Administrative fee of €50 (Euros) per pharmaceutical form/strength/pack size, in the event of issuing a code for a new pharmaceutical form, strength, or pack size, payable to the EOF account at the Bank of Greece
- Administrative fee of €50 (Euros) in the case of variations concerning the local representative or the MAH (when no local representative is appointed), payable to the EOF account at the Bank of Greece
Administrative fee of €50 (Euros) in the case of a pack size deletion, payable to the EOF account at the Bank of Greece
(*) applies also to veterinary medicinal products with a centralised MA already registered in EOF’s database
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Excerpt from the official page. The original is authoritative.