RAEFAR is addressed to the Pharmacy Industry to apply for the next procedures:
The administrative procedures you can do through Raefar are:
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.|
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.|
|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.|
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. firstname.lastname@example.org.
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 email@example.com.
Users will receive access code and password by email.
Client systems should includes:
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 firstname.lastname@example.org.
To notify Quality data errors you cand send it to this e-mail address: email@example.com.
To notify any functionality error you can send the description and screenshot to this e-mail address: firstname.lastname@example.org.
Any suggestions can be sent to:
Thanks a lot for your cooperation.
The URL to access RAEFAR (https is required).