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05:01:262025-09-29

Registration of medicinal products for human use RAEFAR

AEMPS HEADQUARTERS > Procedures > Medicinal products for human use > Raefar
Access to RAEFAR
Target persons

To the pharmaceutical laboratories to carry out the following procedures:

The administrative procedures that can be performed through this application are as follows:

Code Name of the Procedure Object
080180 Marketing authorisation for industrially manufactured medicinal products or other medicinal products for human use. Obtain the authorization of marketing of medicines by the procedures of national, mutual recognition and decentralized.
080190 Suspension and revocation of the authorization of medicines. Suspend or revoke the authorization of a drug “Extensions and Uprisings”.
080210 Authorisation of major variations in Type II medicinal products. (FOLLOW-UP). Modify higher-importance specifications of an already authorized drug.
080620 Authorizations for minor variations in Type I A and Type I B Drugs. (FOLLOW-UP). Authorise minor modifications of a medicinal product.
202099 Notifications about marketing of medicines.
202101 Five-year revalidation. (FOLLOW-UP). The Five-Year Revalidation of the Marketing Authorisation of the medicinal product taking into account scientific technical progress.
202102 Free samples. Request for free samples of Medicines for those that do not contain psychotropic or narcotic drugs, that do not create dependency and are not qualified as special control.
202103 Modifications of Centralized. Communication of centralized drug authorizations. More information in the information note (Submission of the application for national code and conditioning material through RAEFAR II for centrally authorised medicinal products).
202104 Request for Request for National Codes. Request for National Codes of those products authorized by Mutual Recognition or Decentralized that have authorized the formats and that is thus included in the technical file.
– Telematic Management of Technical Data Sheet and Prospectus. Telematic management of the technical data sheets and leaflets during the processes of authorisation of a new medicine (provided that it has obtained a favourable report from CODEM in the case of nationals, or when the translation phase has begun in the case of MRP) and of variation of the marketing authorisation that leads to a modification of the texts.
– Parallel Imports. Solicitud de comercialización paralela de medicamentos de uso humano autorizados un medicamento autorizado en un Estado miembro (REAL DECRETO 11/2005).
– Non-Industrial Medicines. Marketing authorization of medicines for human use Non-Industrial.
– Transfers. (Request for Transfers 801, 802, 803 and 804).
– Notifications of Article 61.3. Notifications of Article 61.3.
– Request for Centralized National Code (eAF). Presentation of the application for the National Code and Conditioning Material for centrally authorised medicines.
– Application of Homeopathic. Obtain the marketing authorization of homeopathic medicines.
Documentation
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)
Notification of errors

If you experience errors or difficulties with the application, please let us know by registering a request at the following link:https://servicedesk.aemps.es/servicedesk/customer/portal/2/.

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.

Rates

For fee-related issues, if you experience errors or difficulties regarding the payment of fees, please let us know by registering an application at the following link:https://servicedesk.aemps.es/servicedesk/customer/portal/2/(Incidents – Application FEES).