Register of medicines for human use


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To whom is it addressed?


RAEFAR is addressed to the Pharmacy Industry to apply for the next procedures:

The administrative procedures you can do through Raefar are:

Code Procedure Object
080180

Marketing authorization for other medicines for human use manufactured industrially.

To obtain the marketing authorization of medicines for national procedures, mutual recognition and decentralized.
080190 Suspension and revocation of the authorization of medicines. Suspend or revocation about the authorization of a medicinal product "deferral and lifting".
080210 Authorization variations of major importance in Type II drugs. Modify specifications of major importance for a product already authorized.
080620

Released minor variations in Medicines Type IA and Type IB.

Authorize the minor variations of a medicine.
202099 Notifications about medicines commercialisation.
202101 Quinquenial Renewals. The Five-Year Revalidation Authorisation for the medicine considering scientific technical progress.
202102

Free Samples.

Request free samples of medications should not contain psychotropic or narcotic dependence and who do not believe are not qualified special control.
202103 Centralized Modifications. Communication centralized drug approvals. More information in the note (Presentación de la solicitud de código nacional y del material de acondicionamiento a través de RAEFAR II para medicamentos autorizados por procedimiento centralizado) (Spanish version).
202104 Request National Codes. Application of national codes of those products authorized by mutual recognition or decentralized having authorized formats and so it is listed in the data sheet.
- Management on line for Technical data sheet and patient information leaflet. Management telematics Technical data sheet and patient information leaflet during the authorization process for a new medicine (provided that it has obtained a favorable report by the CODEM in the national event, or when you launched the translation phase in the case of MRP) and variation of the marketing authorization involving a modification of the texts.

Application access


AEMPS Users Management

It has been put into production, an application, through which laboratory administrators can manage the users by themselves.

The application has a user manual with instructions: https://sinaem.agemed.es/registroaemps.

In case of incident or inquiry please contact. edossier@aemps.es.

If this management is not possible because any exceptional situation you can fill in the application form Application Form Access to the AEMPS Virtual Office and send it to soporte_aplicaciones@aemps.es.

Users will receive access code and password by email.

Characteristics of the teams client


Client systems should includes:

  • Internet Explorer 8.0 or up, for 128 bits.

Frequently Asked Questions (FAQ)


FAQs RAEFAR (Spanish version).

eAF FAQ (English versión) october, 1st 2018.

I need to download some Authorizations/Notifications but I don’t have a digital certificate

You can download Authorizations/Notifications without certificate through:

Ask for credentials at edossier@aemps.es.

Notification of errors


Data

To notify Quality data errors you cand send it to this e-mail address: administrador_sinaem@aemps.es.

Functionality

To notify any functionality error you can send the description and screenshot to this e-mail address: administrador_sinaem@aemps.es.

Suggestions


Any suggestions can be sent to:

Thanks a lot for your cooperation.

Entrance to the application


The URL to access RAEFAR (https is required).