Registration of a Veterinary Medicine in line with Article 116 of Regulation (EU) 2019/6

Overview

Enables the applicant to get a positive evaluation for veterinary medicinal products that are submitted through Regulation 7 of SL 437.47.

What you'll get

Certificate if the application is positively evaluated.

Eligibility

Veterinary wholesale dealers and intended registration holders.

How to apply

Fill in the online form and submit.

Required documents:
i) Proof of payment
ii) Curriculum Vitae of Qualified Person for Adverse Drug Reactions (ADR) and product defects
iii) Copies of the most recently approved Summary of Product Characteristics (SmPC) and Package Information Leaflet (PIL) of the product authorised in the EU/EEA country of source
iv) Proof of establishment of the proposed Registration Holder in an EU/EEA country
v) Copy of the marketing authorisation in the country of source
vi) Letter of access of Market Authorisation Holders (MAH) to the person responsible for the authorisation (if applicable)
vii) Mock-ups of the outer and immediate labelling (the Marketing Authorisation number should be clearly)
viii) Note that the product is not for food producing species or if the product is for food producing species the relevant extract from the table of allowed substances in Regulation (EU) 37/2010)
apply