Authorisation of a Veterinary Medicine in line with Article 5 (6) of Regulation (EU) 2019/6

Overview

Enables the applicant to get a positive evaluation for veterinary medicinal products that are authorised through Regulation 4(2)of Subsidiary Legislation 437.47.

What you'll get

Certificate if the application is positively evaluated.

Eligibility

Veterinary wholesale dealers and intended authorisation holders.

How to apply

Fill in the online form and submit.

Required documents:
i) Copy of a Good Manufacturing Practice (GMP) granted to the manufacturer of the product (if available)
ii) Curriculum Vitae of the Qualified Person (QP) in charge of Adverse Drug Reactions (ADR) and product defects reporting
iii) Copies of the proposed Summary of Product Characteristics (SmPC), Package Information Leaflet (PIL) and mock-ups of outer and inner packs (if applicable)
iv) Proof of establishment of the proposed Authorisation Holder in an EU/EEA country
v) Proof of payment
vi) Label on the outer pack that indicated that the product is for non-food animals and which mentions the target species
apply