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09:31:432025-06-24

Application for Pharmaceutical Product Certificate (CPP)

HEADQUARTERS AEMPS > Procedures > Medicinal products for human use > Application for Pharmaceutical Product Certificate (CPP)
Access to the app
Target persons

This application is aimed at proprietary laboratories, distribution entities, manufacturers and local representatives for obtaining Pharmaceutical Product Certificates (CPPs) for medicines for human use completed and registered in Spain.

To access this application, two requirements must be met:

  • The first step is to perform theRequest for accessTo obtain a valid username and password.
  • The second is to make sure that you have installed in the web browser that you are going to use to access the application aDigital certificateValid and not revoked.

Once this is doneClick hereTo view the App Access screen in your browser. Fill in the user and password fields with the data that the AEMPS has sent you.

Once you have accessed the application, you will have access to the form that has to be filled out and sent. All fields marked with (*) must be completed.

Registered users will be able to access the application as many times as they wish to check the evolution of their files. By clicking on the logo of the application, a list will appear with all the procedures that are open and the status of each one.

Administrative procedure(s) included:

Code: Name of the Procedure Object
– Application for the pharmaceutical product certificate Obtaining the pharmaceutical product certificate for finished and registered medicines in Spain.
Request for access

Access to registered medicines via the import box must be requestedimh@aemps.esProviding the following data:

  • Name of the person who will access the application.
  • Surnames of the person who will access the application.
  • NIF of the person who will access the application, if they are of Spanish nationality. If the person is a foreigner, you must tell us the type of identifier that you provide us with together with the country where it was issued.
  • Email: It is necessary to have a personal email account, and it is recommended that it be associated with the laboratory.
  • CIFs/NIFs/VATs of the laboratories they will represent (if they are foreigners, the country must also be indicated).
  • Social reason of, or the laboratories.

Documentation

User manual for companies(version 1.0)

Characteristics of the client equipment

What authentication methods will be needed?

  • Digital certificate
  • Electronic DNI
  • 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 (it is known who modifies and what).
  • Time out of connection.
Answers to frequently asked questions (FAQs)

I do not have a certificate:

A digital certificate is a file that authenticates the person and can be obtained in about 24 hours completely free of charge. For more information on obtaining, installing and using digital certificates,click here.

You can also access the app if you have an electronic ID and a compatible reader.

Notification of errors

If you experience errors or difficulties with the application, please contact us at the following email address:administrador_sinaem@aemps.es. Include as much information as possible about the incident, including screenshots, error messages, etc. To make it easier for our technicians to detect and resolve the problem.

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