Marketing Authorization Registration (*)
For the registration of veterinary medicines with a central MA in the EOF database, it is required at the national level to submit a request for the allocation of codes for the approved forms/strengths/packaging.
The Marketing Authorization Holder (MAH) of veterinary medicinal products with a central A.C. is required to send to protokollo@eof.gr, an electronic file with the following supporting documents to the Decision-Making Department:
- Request for codes
- Relevant decision of the European Commission with its annexes and approved packaging (corresponding Annex)
- Completed form with the details of the central A.C. of the veterinary medicine
- Remuneration fee (fee) €50 (euro) per form/content payable to the EOF account at the Bank of Greece
Marketing Authorization Amendment
The Marketing Authorization Holder (MAH) of veterinary medicinal products with a central MA must inform the EOF of any positive outcome of the amendments which affect the administrative elements of the MA, by providing the EOF with the following:
- Information letter
- Relevant decision of the European Commission within two months of issuance or opinion of Coreper in any other case of amendment
- Completed form with the details of the central A.C. of the veterinary medicine
- Remuneration fee (fee) of €50 (euro) per form/strength, in the case of granting a code for a new pharmaceutical form, strength or packaging, payable to the EOF account at the Bank of Greece
- Reciprocal fee (fee) of €50 (euro) in the case of changes concerning the local representative or the C.A.K. (when there is no local representative), payable to the E.O.F. account at the Bank of Greece
- Reimbursement fee (fee) of €50 (euro) in the case of packaging deletion, payable to the EOF account at the Bank of Greece
(*) Also applies to veterinary medicines with a central marketing authorisation that are already registered in the EOF database.
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