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

Overview

Enables the applicant to register veterinary medicinal products that are submitted through regulation 8 of  S.L 437.115 in line with Article 116 of Regulation (EU) 2019/6

What you'll get

Registration document if the application is positively evaluated.

Eligibility

Veterinary wholesale distributors and registration holders.

How to apply

Fill in the online form and submit.

 

Required documents:

 

  1. Proof of payment
  2. Curriculum Vitae of  the Person in charge for report of Adverse Drug Reactions (ADR) and product defects.
  3. Copies of the most recently approved Summary of Product Characteristics (SmPC) and Package Information Leaflet (PL) of the product authorised in the country of source.
  4. Copy of the Marketing Authorisation in the country of source, if available.
  5. Letter of access of Market Authorisation Holders (MAH) to the person responsible for the registration, if applicable.
  6. Mock-ups of the outer and immediate labelling (the Marketing Authorisation number should be clearly visible).
  7. If the product is for food producing species,  the relevant extract from the table of allowed substances in Regulation (EU) 37/2010).
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