raefar ii - user guide for the application of transfers of …€¦ · once obtained marketing...

RAEFAR II - User guide for the applica-tion of transfers of medicinal products authorized by procedure MRP/DCP or National.

Version 1.0.0

Spanish Agency of Medicines and Health Products (AEMPS)

Publication date: October, 10th 2018 IT Department

RAEFAR II - User guides for the application of transfers of medicinal products authorized by procedure MRP/DCP or National.


MINISTERIO DE SANIDAD, CONSUMO Y BIENESTAR SOCIAL

Agencia Española de Medi-camentos y Productos Sanitarios, AEMPS

INDEX

INDEX ............................................................................................................................................. 1

INTRODUCTION ............................................................................................................................. 1

GETTING STARTED ......................................................................................................................... 1

1. APPLICATION FOR ACCESS TO RAEFAR II .................................................................................. 1

2. NUEVA SOLICITUD (NEW APPLICATION) .................................................................................. 2

2.1. DATOS GENERALES (General Data Form) .................................................................................... 4

2.2. JUSTIFICANTES DE TASAS (Proof of payment of the fee) ............................................................. 8

2.3 ACCIONES (Actions to be taken) ................................................................................................ 10

3. CONSULTA MIS SOLICITUDES/INF. ADICIONAL (FIND AN APPLICATION SUBMISSION OF TRANSFER /SEND ADDITIONAL INFORMATION) ..................................................................... 11

3.1. ENVIO INFORMACION ADICIONAL / SOLICITUD DE DESISTIMIENTO (Send additional information/ Send the withdrawal submission of your application) ......................................... 12

REFERENCIAS (REFERENCES) ....................................................................................................... 14




Agencia Española de Medi-camentos y Productos Sanitarios, AEMPS

INTRODUCTION

The Spanish Agency of medicines and health products (AEMPS) has adopted an initiative for which, once obtained marketing authorization in the AEMPS of a medicinal product authorized by procedure MRP/DCP or National, to apply for the transfer of laboratory holder, change your local representative, or both to another laboratory or local representative previously registered in our database.

The submission of the documentation via CESP does not exempt the obligation of filliing up a transfer application via the system explained in this document.

GETTING STARTED

1. APPLICATION FOR ACCESS TO RAEFAR II

The application requires that all users who will access, should be registered in our database and be authorized by any holder laboratory also previously registered in RAEFAR II. In case, you were not regis-tered, you must apply for registration via email ([email protected] ), or by sending a request for the corresponding application. Once registered, you can access to the application RAEFAR II with your cre-dentials.

To apply for the registration of a new laboratory and a new user, you should refer to the application AEMPS User Management portal at https://sinaem.agemed.es/registroaemps/Pages/acceso.aspx.

In case, the laboratory holder has been registered previously, and you want to be registered as a new user and ask for accessing to his products, must get in contact with the "admin user" appointed to this laboratory holder. In case you do not know who the “admin user” appointed to this laboratory, contact with [email protected].

https://cespportal.hma.eu/

mailto:[email protected]

https://sinaem.agemed.es/registroaemps/Pages/acceso.aspx

mailto:[email protected]



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Agencia Española de Medicamentos y Pro-ductos Sanitarios, AEMPS

Whatever the type of transfer you want to apply, the application will show you two options to choose:

- NUEVA SOLICITUD (New application)

- CONSULTA MIS SOLICITUDES/INF ADICIONAL (Query my applications/sending additional information)

2. NUEVA SOLICITUD (New application)

From here we can start the draft of our request for transfer. For this, we have to click on the ACCEDER (Enter), button.

Once we enter, an application number (Clave), is assigned. This “Clave” (key), will help us identify our request in the application. Besides, we have to select the laboratory applicant at "Titular Solicitante". For this we have to click on the corresponding field, write the name of the laboratory applicant and select it from the drop-down list. Then, we click on CONFIRMAR DATOS (confirm), to generate the ap-plication form.



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IMPORTANT:

Unlike the Change Local Representative request, which must be requested by the laboratory holder (MAH); the request for Laboratory Holder Transfer, can be requested both for the laboratory holder (MAH), and for the new holder of the product. In this case, it is "highly recommended" the applicant is the "new laboratory holder" of the product. This, for two important reasons:

- If it is necessary to send an additional information after to the submission of the application (which will only have access the laboratory “applicant”, who made the request).

- Once authorized the transfer request, only the “applicant” has access to the corresponding office or resolution.



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2.1. DATOS GENERALES (General Data Form)

Once we confirm the data entered, from the DATOS GENERALES (General Data Form), you will have access to the new application form, where we have to complete the laboratory holder contact details (Datos del Titular), and the Responsable (user who is the contact person of this application). "These data indicate to the system whom will receive the notifications about this request."



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In addition, we will enter the drug data (Datos de la Solicitud and Otros Datos), and some annexes that will be included in the sequence, such as:

- Variation number associated (in case the change involved a change of product name).

- Type of transfer (where you will indicate if the change involves or not a change of manufacturer).

- Names and signatures of respon-sible persons.

Once completed the application form, click on GUARDAR y CONTINUAR (save and continue), to save the information entered into the form application and pro-ceed to load the documentation (sequence), link the affected drugs and indicate the current situation and proposal from the corresponding modules.

MODULOS (Modules)

At this part, you can find three (03), modules. These are mandatory to complete your application.

Module 1 : Envío de Expediente Electrónico (Sequence submission)

From this module, you can attach the eCTD/Nees sequence with the support documentation of the application or indicate the number of CESP submission corresponding.



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If you choose to upload and attach a sequence to the application by RAEFAR II, mark eCTD/NeeS, click on SELECCIONAR (select the zip file), look for the compressed file containing the sequence in the corre-sponding folder on your computer and attach it to the application by clicking on ADJUNTAR FICHERO (attach file).

In case we choose the "CESP" option, we will indicate the number of CESP submission in the “Nº de Referencia” field (reference number), and click on GUARDAR CAMBIOS (save changes).

Finally, whatever the chosen submission method, we should click on CERRAR ENVIO (close submission), to save the information in this module. Don't forget to click on VOLVER A LA SOLICITUD (return to application), to return to the application form and proceed to module 2.

Module 2: Ver medicamento (Link up medicines)

At this module, we have to link up the medicines affected for this application. For this, we must click on ADJUNTAR MEDICAMENTO (attach drug), and search for the medicines using the fields: “Nro. definitivo” (product number), or “Nombre” (product name). Once entered, click the FILTRAR (search) button to view a list of medicine products with this characteristics. Click on the name of the drug you want to linkup to the application. This last step should be done by each of the medicines products that you want to linkup to your request.

You can find more information, validation rules and guidance material at Sede electrónica de la AEMPS and eSubmission.

https://sede.aemps.gob.es/usoHum/regMed/dossi-Electro.htm

https://sede.aemps.gob.es/usoHum/regMed/dossi-Electro.htm

http://esubmission.ema.europa.eu/



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Finally, don't forget to click on VOLVER A LA SOLICITUD to return to the application form and continue with the module 3. Modulo 3: Situacion Actual / Propuesta (current situation and proposal) At this module, we have to complete the fields corresponding to points: 2.4.1, 2.4.2, 2.4.4 and 2.4.6. These points to be filled depends on the type of procedure indicated: MRP, DCP or National • 2.4.1 TITULAR DE LA AUTORIZACION (Marketing Authorization Holder - MAH) • 2.4.2 AUTORIZADO PARA LAS COMUNICACIONES (Contact person for communications) • 2.4.4 CUALIFICADO PARA FARMACOVIGILANCIA (Qualified Person for Pharmacovigilance - QPPV) • 2.4.6 REPRESENTANTE LOCAL (Local Representive)



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Once the entry of data on these tabs are finished, you don’t forget to click on VOLVER A SOLICITUD button, to return to the application and continue with the JUSTIFICANTE DE TASA section (proof of payment of the fee).

2.2. JUSTIFICANTES DE TASAS (Proof of payment of the fee)

At this section, you have to indicate the number of proof of payment of the fee at Nro. JUSTIFICANTE, put a comment about this your submission at DESCRIPCION/COMENTARIOS, and upload it in pdf format. For this, select the pdf file from SELECCIONAR and click on ADJUNTAR JUSTIFICANTE.

IMPORTANT: - Don't forget to click on GUARDAR (save), after completing each of the points. Otherwise, the entered

data is lost.

- You must complete ALL fields. In case the current and proposed situation had not changed, should indicate the same data in both forms.



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Finally, don't forget to click on VOLVER A SOLICITUDES to continue filling in the transfer request form.

IMPORTANT:

- This part of the application must be completed 24 hours after the payment of the fee has be done. This because when the number of proof of payment of the fee be entered (point 1), this will be contrast for RAEFAR with the information that we receive from the bank system every 24 hours. In addition, the system also verifies that the number of proof of payment of fee, has not been previously entered by mistake in another procedure.



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2.3 ACCIONES (Actions to be taken)

At this section, you can find three fields: REALIZAR ACCION, ACCIONES REALIZADAS, and OFICIOS.

Realizar acción (Take action)

In this field, we can send the transfer request completed . For this, you have to choose ENVIAR BORRADOR from the drop-down list on ACCION. Otherwise, if you want to delete a transfer request, only have to choose DESCARTAR BORRADOR. Don’t forget to put a comment about your submission at COMENTARIOS and click on REALIZAR ACCION.

Acciones realizadas (Actions made)

In this field, you can view a historical of the "status" of your application. This information will be shown ranked



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chronologically. You can display different "comments" of the evaluation of your application (requests for additional information, reasons for refusal, etc.)

Oficios (Official Authorization)

From this section, once authorized the transfer request and signed the official authorization, this will be upload here. You have to click on the number below “DESCARGAR OFICIO”.

3. CONSULTA MIS SOLICITUDES/INF. ADICIONAL (Find an application submis-sion of transfer /Send additional information)

From here, you can search your transfer request submissions. Both those that we have pending to send (in draft), as well as the already sent. Furthermore, once found them, you can check their "sta-tus", read the comments of the reviewer assigned to its procedure, make the sending of additional information if the case, or download the corresponding “authorization letter” once authorized your application. In addition, if necessary, also be able to send the withdrawal of your application.



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3.1. ENVIO INFORMACION ADICIONAL / SOLICITUD DE DESISTIMIENTO (Send additional in-formation/ Send the withdrawal submission of your application)

In the same way and after sending your transfer application, you can send additional information from this option. These sendings of additional information may be "requested " or "unrequested", depending on if it was requested or not by the evaluator assigned to your procedure.

Requested by the evaluator

When the evaluator requests you for an additional information, you can find the text message “Solicitada Información Adicional”, at ACCIONES REALIZADAS section, similar to the image below.

At this case, you have to go to Modulo 1: Envío de Expediente Electrónico at DATOS GENERALES and up-

IMPORTANT: To carry out a submission of additional information "Unrequested", the status of the transfer application must be "Without evaluating"; otherwise, this option is not available. In this case, you must get in contact with the evaluator, who will activate the option of sending "Request-ed" additional information.



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load the sequence with the information requested. After this, you have to return to ACCIONES tab and choose Responder Solicitud from drop-down list. Put a comment about your submission of additional information and finally, click on REALIZAR ACCION button for sending it.

Non-requested by the evaluator

If you need to send additional information because you have forgotten any document, the sequence sent before is wrong and you need to send a new one corrected , etc; you can use this option. Only choose “Abrir envio adicional NO SOLICITADO” (Non-requested information send), go to Modulo 1: Envío de Expediente Electrónico at DATOS GENERALES and upload the sequence with the information requested. After this, you have to return to ACCIONES tab and choose Responder Solicitud from drop-down list. Put a comment about your submission of additional information and finally, click on REALIZAR ACCION button to send it.

Of this way, you can find your comment at ACCIONES REALIZADAS section. This line of text prove you that the submission was successful.



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REFERENCIAS (References)

- Registro de medicamentos de uso humano (Register of medicinal products for human use)

( https://sede.aemps.gob.es/en/usoHum/regMed/raefar.htm )

- Información del envío de Expedientes Electrónicos a la AEMPS (Relevant Regulatory Information for Marketing Authorization in Electronic format) (https://sede.aemps.gob.es/en/usoHum/regMed/dossi-Electro.htm )

https://sede.aemps.gob.es/en/usoHum/regMed/raefar.htm

https://sede.aemps.gob.es/en/usoHum/regMed/dossi-Electro.htm

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