Aplicación de Envíos Telemáticos: Autorización de Importación de Medicamentos Registrados de Uso Humano
Target persons
This application is aimed at laboratories and manufacturers to obtain the necessary prior authorization for the import of medicines registered in Spain as well as their intermediate products and bulk.
To access this application, two requirements must be met:
- The first step is to make the access request to obtain a user and a valid password.
- The second is to make sure that you have a valid and non-revoked digital certificate installed in the web browser to be used to access the application.
Once this is done, click here to see the access screen to the application 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 |
|---|---|---|
| 997044 | Authorisations concerning the import of registered medicinal products for human use | Prior authorization necessary for the import of registered medicines in Spain as well as their intermediate products and bulk |
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)
- Update of the telematic application ”IMH” for the processing of applications for import authorisation of medicines for human use in Spain.
Informative Note MUH, 3/2016
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)
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 address incidencias applications@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.
For other topics, use the suggestion box.
For functionality errors follow the same instructions described in the previous section.