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06:58:282025-08-13

Computer Application of Medicines in Special Situations

AEMPS HEADQUARTERS > Procedures > Medicinal products for human use > Computer Application of Medicines in Special Situations
Access to the app
Target persons

Computer application for the management of requests for medicines in special situations addressed to Laboratories, Health Centres, Autonomous Communities and other authorized bodies:

It will allow importing laboratories to:

  • Receive, through telematics, the orders for the supply of medicines authorized by the AEMPS.
  • Receive, through telematics, the import authorizations generated by the AEMPS.
  • Make requests for stock changes.

It will allow health centres and authorised bodies to:

  • Request, via telematics, individualized treatments as well as the continuation of these treatments.
  • Request, via telematics, packages of medicines subject to “Temporary Authorisations of Use” or “Protocols of Use”.
  • Access on-line to information about this type of medication, and to the data of the treatments requested.

It will allow the autonomous communities and authorized agencies to:

  • Access online to information about this type of medication, and data on the treatments requested by the centers of your community.
Request for access

Laboratories:

The application is only accessible to the laboratories authorized by the AEMPS, if you are an authorized laboratory you can request your username and password for which you must first fill in the form.APPLICATION FORM FOR ACCESS TO MEDICINES IN SPECIAL SITUATIONSby legal representative of the company and send it by email to: medicamentosespecial@aemps.es

Health Centers and Authorized Agencies:

The application is only accessible to health centers authorized by the AEMPS, if you are an authorized health center you can request your username and password for which you must first fill out the form.APPLICATION FORM FOR ACCESS TO MEDICINES IN SPECIAL SITUATIONSBy legal representative of the health center and send it by email to:medicamentosespeciales@aemps.es.

Autonomous Communities:

The application is only accessible to the autonomous communities authorized by the AEMPS, if you are an authorized autonomous community you can request your username and password for which you must first fill out the form.APPLICATION FORM FOR ACCESS TO THE E-OFFICE OF THE AEMPSBy legal representative of the corresponding body of the Autonomous Community and send it by email to:medicamentosespeciales@aemps.es

Both Health Centers and authorized agencies, CCAA and laboratories may use the following email address for any communication with the AEMPS:medicamentosespeciales@aemps.es. You can also change your initial password from the application itself using the “Change Password” menu option.

You can also change your initial password from the application itself using the “Change Password” menu option.

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

Documentation
Characteristics of the client teams

What authentication methods will be needed?

  • Digital certificate
  • Electronic ID
  • Cl@ve PIN
  • In some cases it will not be necessary to have any method of authentication

What characteristics do the client teams have to have?

  • Next generation browser: Edge, Chrome, Firefox, Safari or similar.
  • The use of Internet Explorer is not recommended.
  • Any PDF document viewer. You can download the Adobe Acrobat Reader at the address http://www.adobe.com/.
  • User authorization and password of RPS.
  • Application security: activate the Java Script option in the browser if it is not active (this option comes by default).

Since it is a Web application, there are no operating system or memory or disk requirements beyond those necessary for the operating system, browser and PDF viewer chosen.

What are the security elements that the applications incorporate?

  • 128-bit SSL communications encryption.
  • User authentication using USER and password.
  • Autenticación de usuario de segundo nivel, mediante TOKEN UNICO por solicitud que el usuario debe introducir para el envío de las mismas.
  • Each external user can only access the data of the entity it represents.
  • Log of accesses and audit of modifications (you know who modifies and what).
  • Time out of connection.
Answers to frequently asked questions (FAQs)

Do I need a digital certificate to access the app? What kind of certificate?

Laboratories do not, for Health Centers it is optional and they need to be in possession of a digital certificate, valid and not revoked, to digitally sign the applications you make.

You can use a digital certificate from any of the providers of electronic signature certification services recognized by the Ministry of Industry, Tourism and Commerce. You can consult this list of providers at the following address:
https://sedeaplicaciones2.minetur.gob.es/prestadores/.

If you wish, you can ask the FNMT for a Class 2 CA Digital Certificate for natural persons. How to obtain a Digital Certificate?. For more information, see the Web:http://www.cert.fnmt.es/.

How do I access the app?

You must perform the following steps to access the application:

Enter the following URL in your browser: https://mse-pilot-info.aemps.es/. Two fields labeled “User” and “Password” will appear. This is where you need to enter the access credentials that we have provided to you. Press the “Login” button and you will access the application options.

I am a health center and I have problems signing my applications I see a window with the following error text:
“Error: The automation server cannot create the object”

You must have the security of Internet Explorer at the highest, so for you not to see this error you have to do the following:

  • Open your Internet Explorer browser and click on Tools/Internet Options.
  • Select the Security tab and click on the Internet icon.
  • Add the web of applications of the “Spanish Agency of Medicines and Health Products” as a trusted site, for this we click on “Trusted Sites” and “Sites…”.
  • We enter https://sinaem4.agemed.es/ in “Add this website to the area” and click “Add” and “Accept”.
  • Having selected “Trusted sites”, follow the steps below depending on your browser version:
  1. For Internet Explorer 6.x
    • Click on the “default level” button and then on “custom level”.
    • In the list that is displayed, go to the field “ActiveX controls and add-ons” and activate the option “Initialize and activate the script of ActiveX controls not marked as safe”. Apply the changes.
    • Finally close the browser and try to authenticate again.
  2. For Internet Explorer 7.x
    • Click on the “default level” button and then on “custom level”.
    • In the list that is displayed, go to the field “ActiveX controls and add-ons” and enable the option “Initialize and generate scripts from unmarked activeX controls as secure for scripts”. Apply the changes.
    • Close the browser and try to authenticate again.

In both cases, once the user and password screen has appeared, you can again leave the option modified with the original value.

Can I type the username and password in upper or lower case letters indifferently?

The username is not sensitive to upper and lower case letters, so you can type it as you wish. But the password is, so it will have to be written exactly as you have been given it, or as you have been given it. He wrote it the last time he changed it.

How many passwords do I have to enter?

Remember not to confuse the password of your digital certificate with that of access to the application.

In the first case, you can optionally set up your digital certificate to ask you for a password each time it is to be used. This password should only be known to you.

The second is the password of the application, which we initially provided to you, but which you can change when you want.

Notification of errors

If you experience errors or technical difficulties or functionality with the application, you will have to contact the incident team through the PortalService Desk.

    • In the next window, enter the email account you want to sign up with (make sure it is a correct email account as it will be your user on this platform and is where you will receive notifications regarding the incident you register), the password, your name and the requested captcha. If the captcha is not displayed clearly, click on the icon represented with two blue circular arrows to display a new one.

    You will have to register on the portal, to do this, select the link “Regístrate para crear una cuenta” that appears at the bottom of the window.

        • Press the “ buttonRegistrarse”
        • In the window that will appear, select the option “Gestión de Accesos” => ”Problemas de acceso”. Fill in the form that will appear on the screen describing the problem in detail.

    For questions related to business logic, the operation of the application or any query you wish to make, contact us at the addressmedicamentosespeciales@aemps.es.

    In any case, it is recommended to consult prior to our FAQs section in case the doubt or solution to the problem has already been described.