Application for the Pharmaceutical Product Certificate (CPP)
Target persons
This application is aimed at incumbent 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 user and password.
- The second is to make sure that you have installed in the web browser that is going to be used 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 sent to you by the AEMPS.
Once you have accessed the application, you will have access to the form to be filled out and sent. All fields marked with (*) must be filled in.
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 must be requested through the import box for registered medicinesimh@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, in case of being 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 is associated with the laboratory.
- CIFs/NIFs/VATs of the laboratories that it 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 teams
What authentication methods are needed?
- Digital certificate
- Electronic ID
- Cl@ve PIN
- Cl@ve Permanente
What characteristics should the computer equipment have?
- Updated web browser (Microsoft Edge, Google Chrome, Mozilla Firefox, Safari or similar).
- Any PDF document viewer. Adobe Acrobat Reader can be downloaded at the address https://www.adobe.com/.
-
Application security: enable the JavaScript option in your browser if it is not enabled (this option is enabled by default).
As it is a web application, there are no specific requirements for operating system, memory or storage capacity, beyond those necessary for the operation of the operating system, browser and PDF viewer used.
What are the security elements that the applications incorporate?
- 128-bit SSL communications encryption.
- Autenticación de usuario de segundo nivel, mediante un token único por solicitud que deberá introducirse para su envío.
- Each external user can only access the data of the entity they represent.
- Log of accesses and audit of modifications, which allows to identify who makes each modification and what changes have been made).
- Connection waiting time (timeout).
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 application 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 email addressadministrador_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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