Medicated feed - prior authorisation to manufacture and use medicated feed for testing purposes

For an operator working in the animal feed or veterinary medicine sectors to be allowed to manufacture medicated feed and conduct experimental testing, authorisation must be requested from the National Authority for Animal Health (Direção-Geral de Alimentação e Veterinária - DGAV).

Service channels

Procedure and requirements

Documentos and requirements

The following documents must be attached to the duly completed forms:

  • professional licence and statement of responsibility from the veterinary medical officer of the experimental testing;
  • proof of qualifications of the person responsible for production and the person responsible for the quality of the factory authorised to produce the medicated feed;
  • authorisation from the research centre;
  • testing schedule;
  • food security statement;
  • establishment authorised to manufacture medicated feed.

Procedure

  1. Submitting the form
    • Click on the ‘realizar online' (online application) button.
    • Confirm your identity using a valid means of electronic identification (Digital Mobile Key, Citizen Card or Digital Certificate).
    • Complete the online form and attach your documents.
    • Submit your application.
  2. Examination of application
    • The form and the documents will be examined by a member of staff.
    • If everything is order, the authorisation will be granted.
    • If there are any errors, you will be asked for further information or to correct the documents. Once the applicant has provided this information, a new examination is conducted to ensure everything is correct.

How much

The application for prior authorization for the distribution of medicated feed costs € 750. Payment must be made by ATM reference or bank transfer.

Validity

The authorisation will remain valid while the testing for which it was granted is underway, and provided that all legal requirements are complied with.

Obligations

Authorisation will only be given when an operator complies with all legal requirements.

To conduct experimental testing, you must indicate:

  • the aim and schedule of the tests;
  • the location where the medicated feed is to be produced, which must be authorised for the manufacture of medicated feed (FAM), and with a duly accredited member of staff responsible for production (RP) and a duly accredited member of staff responsible for quality (RQ);
  • that you are authorised to run the tests at the location specified;
  • that the animals being tested will not enter the food chain;
  • that the person in charge of testing is a veterinary medical officer.

Legislation, refusals, contests, claims

Legislation

Reasons for refusal

  • Unclear application/notification: absence of data preventing the proper assessment of the application/notification, due to the way in which it is written or due to erasures.
  • Application/notification submitted after the closing date: submission of application/notification after the specified deadline.
  • Non-payment of application/notification fee: non-payment of any fee or charge as set out in the application/notification.
  • Failure to comply with the technical requirements: failure to comply, in whole or in part, with any of the technical requirements under the law and/or regulations.

Competent Entity

Direção-Geral de Alimentação e Veterinária

Address: Campo Grande n.º 50 1700-093 Lisboa

Phone number: 213 23 9 500

Fax: 213 463 518

Email address: geral@dgav.pt

Web url: https://www.dgav.pt/