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07:49:092025-06-25

Application of Telematic Shipments: Authorization of Import of Veterinary Medicines Registered in Spain

HEADQUARTERS AEMPS > Procedures > Veterinary medicinal products > Application for sending information on marketing of Veterinary Medicines
Access to the app
Terms of Use

The actual marketing situation of authorised veterinary medicinal products is essential in order to inform healthcare professionals and facilitate prescribing. Therefore, the Spanish Agency for Medicines and Health Products requires the holders of authorised veterinary medicines to provide data on the actual availability status of each format of the medicine, both when notifying the placing on the market of the first batch and when declaring the annual marketing intention. They must also keep this information permanently updated.

Procedures via telematics

This application allows the following procedures to be carried out electronically with the AEMPS:

Update information on formats currently available on the market (OPTION 1)

In order for the information provided by the AEMPS through CIMAVET to citizens and healthcare professionals to be reliable and to reflect the actual situation of medicines on the market, the holders should keep up-to-date the data on the marketing of the various formats of a medicinal product through this option of the application.

It is essential to complete this option so that the information shown in CIMAVET is correct. It can be used at any time and independently of the communication processes of the first batch or the annual marketing declaration.

Declare the annual marketing intention (OPTION 2)

The holder of the marketing authorisation of a medicinal product shall comply with the obligation to make an annual declaration of INTENTION TO MARKET through this telematic service. The deadline for submitting these declarations for the following year is from 1 to 31 October of the current year.

For each medicinal product declared on the market, the holder must indicate which of the formats are actually available and which will remain unmarketed. You must also indicate whether you intend to request the suspension or cancellation of the medicinal product for the following year.

Once this communication is made, the holder will obtain an acknowledgement of receipt accrediting the shipment made. In order for this telematic shipment to take effect, it is also necessary to formalize the corresponding payment of fees and submit the following two documents on paper to the Agency’s registry:

    • The proof of payment of fees.
  • A copy of the receipt accrediting the telematic shipment.

Report the placing on the market of the first batch (OPTION 3)

The holder must communicate the date on which the first batch will be available in the establishments authorized for the sale of veterinary medicines, at least 15 days before the effective marketing.. From that date the medicinal product must be on the market uninterrupted and must inform the Agency of any delivery problems that arise or of any intention to suspend marketing.

The holder shall specify which of the authorised formats are put on the market and which remain unmarketed.

PICTURES OF THE DRUG (OPTION 4)

The applicant can publish the images of the medicines, which will be available at CIMAVET.

Manuals of use

*(It is recommended to read the manual before using the application.)