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00:35:192025-11-14

Application for sending information on marketing of medicines

AEMPS HEADQUARTERS > Procedures > Medicinal products for human use > Application for sending information on marketing of medicines
Access to the app
Terms of Use

Communicate the annual marketing intention

The holder of the marketing authorization of a drug will comply with the obligation to make an annual declaration of MARKETING INTENTION through this telematic service. The deadline for submitting these statements is one month and begins in the month of October of the previous year.

For each medicinal product with a marketing declaration, the holder must indicate which of the formats are actually available and which will remain unmarketed. The laboratory must also indicate whether it intends to request the suspension or cancellation of the medicine in the following year.

Communicate the placing on the market of the first batch

Procedure applicable only to medicines authorized after October 13, 2007, date of entry into force of Royal Decree 1345/2007.

The holder must report the date on which the first batch of the drug is available in pharmacies. From that date, the medicinal product must be on the market continuously and must inform the Agency of any delivery problems that arise or of the intention to suspend marketing at least two months in advance.

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

Update the information on formats currently available in the market

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

This option can be used at any time and independently of the communication processes of the first batch or annual marketing declaration.

Procedures via telematics

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

Communicate the intention and annual maintenance of marketing

The holder of the marketing authorization of a drug will comply with the obligation to make the declarations of INTENTION TO MARKET AND ANNUAL MAINTENANCE of its products through this telematic service. The period of time for submitting these declarations begins in October and ends in December of the year prior to the year in question.

For each medicinal product, the holder must indicate his or her intention to continue marketing the medicinal product or not. In addition, you can indicate which of the formats will be effectively available and which will remain uncommercialized. On the other hand, once the notification to perform the annual maintenance has been received, the laboratory must proceed to the payment of the corresponding fee, as indicated in the marketing intention.

Communicate the placing on the market of the first batch

Procedure applicable only to medicines authorized after October 13, 2007, date of entry into force of Royal Decree 1345/2007.The holder must report the date on which the first batch of the drug is available in pharmacies. From that date, the medicinal product must be on the market continuously and must inform the Agency of any delivery problems that arise or of the intention to suspend marketing at least two months in advance.

Update the information on formats currently available in the market

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

This option can be used at any time and independently of the communication processes of the first batch or annual marketing declaration.

Manual
Notification of errors

In case of incident or consultation you can contact edossier@aemps.es

If such management is not possible due to the fact that it is a foreign laboratory or some other exceptional case, you can fill in the APPLICATION FORM FOR ACCESS TO THE E-OFFICE OF THE AEMPS by legal representative of the company and send it by e-mail to the addresssupport_applications@aemps.es.

By email, users will be informed of their access code at the time they are registered in the system.

Once the user has authenticated and the laboratory has been determined, the medicines that the laboratory owns will appear, but not those that the laboratory is the local representative if the ownership corresponds to another company.