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

Overview

Enables the applicant to get an authorisation for veterinary medicinal products that are authorised through regulation 5 of S.L 437.115 in line with Article 5(6) of Regulation (EU) 2019/6

What you'll get

Authorisation document if the application is positively evaluated.

Eligibility

Veterinary wholesale distributors and authorisation holders.

How to apply

Fill in the online form and submit.

 

Required documents:

 

  1. Copy of a Good Manufacturing Practice (GMP) granted to the manufacturer of the product (if available).
  2. Curriculum Vitae of the Person in charge of report of Adverse Drug Reactions (ADR) and product defects.
  3. Copies of the proposed Summary of Product Characteristics (SmPC) (if applicable), Package Information Leaflet (PIL) (if applicable),  and mock-ups of outer and inner packs.
  4. Proof of payment.
  5. Label on the outer pack that indicated that the product is for non-food animals. The target species should be mentioned in some part of the Product Information.
  6. A copy of Good Manufacturing Practice (GMP) provided to the product manufacturer (if available).
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