application manual for sending information on the

Users guide

Version 4,0

Application for submitting information on commercialization of Veterinary

Medicinal Products (VMPs)

Application for submitting information on commercialization of Veterinary Medicinal Products (VMPs)

Index

INDEX

OPTION 1: UPDATE VMP FORMATS CURRENTLY ON THE MARKET

OPTION 2 : ANNUAL DECLARATION OF INTENT TO MARKET VMPs

OPTION 3 : PLACING THE FIRST BATCH OF VMPs ON THE MARKET

OPTION 4 : PICTURES OF THE VMPs

OPTION 5: VMP SHORTAGE NOTIFICATION

Application for submitting information on commercialization of Veterinary Medicinal Products

Access requirements

The user credentials to get access to this application are the same as accessing theRAEVET II software application. Those users who do not have a user credentials mustapply for one with the Spanish Agency of Medicines and Medical Devices (AEMPS) inaccordance with the procedure established in the virtual office(https://sede.aemps.gob.es/usoVet/raevet.html)

In order to access the commercialization software application, please click on the link below, complete the fields USUARIO (user) and CONTRASEÑA (password), and click on the button INICIO DE SESION (login).

https://sinaem.agemed.es/WebComercializacion/login.aspx?opc=veterinaria

IMPORTANT: In order to usethis application properly, youhave to disable the pop-upblocker on your internetbrowser.

https://sede.aemps.gob.es/usoVet/raevet.html

https://sinaem.agemed.es/WebComercializacion/login.aspx?opc=veterinaria


Available submissions

IMPORTANT!! The MAH has to update the information of their VMPs currently on the market (option 1), before

doing the annual declaration of intent to market VMPs(option 2). The CIMAVET database is updated daily with the information indicated in “option 1”; therefore, it

is mandatory to change the status on the market if your products have to be updated in thisoption.

The application offers five different options to submit information to AEMPS:

Application for submitting information on commercialization of

Veterinary Medicinal Products (VMPs)

OPTION 1: UPDATE VMP FORMATS CURRENTLY ON THE MARKET.

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Option 1: Update VMP formats currently on the market

Marketing Authorization Holder (MAH) informationAt this screen, the user may choose the MAH of the VMPs whose market situation

needs to be updated. The name of the MAH appears on a drop-down menu. If the

user has permissions on more than one MAH, he/she may choose which one of them

to work with.

Once a MAH has been selected, click on “Buscar” (search) button to show all the

VMPs that laboratory holds.


Option 1: Update VMP formats currently on the market

In order to change the current status of a VMP format (from “Commercialized” to “Notcommercialized”, or vice versa), please tick the corresponding check box at the column onthe right of the form (“Comercializado” or “No comercializado”).

To view more authorized formats click on the page numbers at the bottom of the form. Once you have indicated the status changes of the VMP formats currently on the market,

please click on the “Enviar a AEMPS” (Send to AEMPS) button.

Marketed Formats: This section shows the VMPs that are held by the MAH that wasselected.

IMPORTANT: If you need to correct an application that has already been submitted, simply

correct it and resubmit it.



OPTION 2 : ANNUAL DECLARATION OF INTENT TO MARKET VMPs



Option 2: Annual declaration of intent to market VMPs

In the section “Realizar Intención de Comercialización”, select the year in which you intend to market the VMP and click on “Realizar Intención” (Make the intention) button:

Before you start the “annual declaration of intent to market VMPs (option 2)”, you must firstupdate the VMP formats currently on the market (option 1), and do not forget to mark the check box:

If you want to consult the annual declaration of intent to market VMPs for previous years, please select the year in the drop-down list at the “Consulta de Intenciones de Comercializacion” (Search previous years intentions) section and click on the “Consultar” (search) button.

IMPORTANT: CIMAVET is updated with the data indicated in the Option 1. Such updating has to be done from January 1st of the year declared , or in any case, whenever the administrative situation of VMP has been changed. When option 1 has not been updated the VMP will be showed as “Suspended” in CIMAVET.



Marketing Authorization Holder (MAH) informationAt this screen, the user may choose the MAH of the VMPs for which you want to make

the annual declaration of intent to market VMPs. The name of the MAH appears on

a drop-down menu. If the user has permissions on more than one MAH, he/she may

choose which one of them to work with.





If you intend to market a new VMP, or want to continue marketing a VMP already on the market thefollowing year, please tick the check box with one asterisk (*).

In order to apply for the withdrawal of the marketing authorization of a VMP, please choose the checkbox with two asterisks (**).

If you don´t intend to put the VMP on the market next year, but want to put the VMP on the marketthe following year, do not tick any option.

You can save the information as many times as you want clicking on “Guardar” (Save) button andaccessing the application again later and modifying or ticking new boxes.

In order to submit the application click on Enviar AEMPS button.

The medicines (VMPs) and their formats of which the MAH owns will be shown :

IMPORTANT: Once the application is submitted, it cannot be modified. If corrections are

needed please contact [email protected]

mailto:[email protected]



Payment of fee for annual declaration of intent to market VMPsClicking on the eye icon ( ) in the “DETALLE TASAS” column, will display a form whereyou can make the payment. For this, you have to click on IR A TASAS (Go to Payment Feesapp) button. Once you are in the Payment of Fees software application, you have to follow the instructions indicated in the application.

When the payment has been made, you must come back to this window in order to indicate the type of payment chosen, the number of proof of payment model paid(317xxxx), the date of the payment and to attach the proof of payment model paidin pdf format.

Once these steps have been completed, you have to click on “GUARDAR” (SAVE) button. In order to obtain the “acknowledgment of receipt”, click on “Acuse de recibo del envio” button.



OPTION 3: PLACING THE FIRST BATCH OF VMPs ON THE MARKET



Option 3 : Placing the first batch of VMPs on the market

Marketing Authorization Holder (MAH) information

At this screen, the user may choose the MAH of the VMPs for which you want to

indicate a release date for the first batch on the market. The name of the MAH

appears on a drop-down menu. If the user has permissions for more than one

MAH, he/she may choose which one of them to work with.




Option 3 : Placing the first batch of VMPs on the market

To complete the release date of the first batch, please click on “Seleccionar” and thenindicate the release date on the calendar below. Don’t forget to click on “Grabar Fecha”button (save the release date), to save it.

All VMPs authorized after entry into force of the Royal Decree 1246/2008, of July 18th, will be shown.

IMPORTANT: Once a date has been recorded, and you need to modify the release date please contact

[email protected]

mailto:[email protected]



OPTION 4: PICTURES OF THE VMPs



Option 4 : Pictures of the VMPs

Marketing Authorization Holder (MAH) informationAt this screen, the user may choose the MAH of the VMPs for which you want to load

the pictures of packaging and/or pharmaceutical form. The name of the MAH

appears on a drop-down menu. If the user has permissions on more than one MAH,

he/she may choose which one of them to work with.





Only the VMPs of the MAH appears on a drop-down menu. The VMP whose pictures

(packaging and/or pharmaceutical form) will be loaded must be chosen by clicking

on “Seleccionar” (Select) option:



First, you have to search for

the picture (packaging and/or

pharmaceutical form) by

clicking on “Examinar”

(Search) button.

Once the picture is selected,

you have to click on

“Actualizar” (upload) button to

upload the picture.

Supported resolutions:

320x180

640x360

1024x576

Supported file formats:

.jpg

.png

.tiff

.gif



If the picture has been uploaded successfully, a green check will be displayed, as

shown in the image below:

Image I - This column indicates whether the image of packaging has been

uploaded to system.

Image II - This column indicates whether the image of the pharmaceutical form

has been uploaded to the system.

VB. AEMPS: In this column, once the uploaded pictures have been verified and

accepted by AEMPS, a green check will be shown.

IMPORTANT: Once the pictures have been verified and accepted by AEMPS, they will be visible on

the CIMAVET portal (https://cimavet.aemps.es/cimavet/publico/home.html).

https://cimavet.aemps.es/cimavet/publico/home.html

OPTION 5: VMP SHORTAGE NOTIFICATION

Application for submitting information on commercialization of Veterinary Medicinal Products (VMPs)



Option 5 – VMP shortage notification

If there is a shortage of a medicine, you must report the shortage in option 5 -

Comunicación de desabastecimiento. Once the submitted report has been accepted

by AEMPS, the medicinal product will be included in the shortage list at CIMAVet:

(https://cimavet.aemps.es/cimavet/publico/home.html).

https://cimavet.aemps.es/cimavet/publico/home.html


Option 5 – VMP Shortage notification

In order to report a shortage, you have to click on the “edit” icon to the right of the

VMP´s name, at the “Solicitudes” (Applications) column.



You have to complete the mandatory fields indicated by an asterisk (*), and attach any

documents if necessary.

Finally, once the application form has been completed, don’t forget to click on the

“DECLARAR DESABASTECIMIENTO” (declare shortage) button to submit it to AEMPS.

IMPORTANT: Don’t forget to click on the “CERRAR” (Close) button to close the

application submission.



Once the shortage report has been submitted, the new status will appear (see column

“Estado”) and the submission will be “SOLICITADA” (requested). In this status, if the

report contains a mistake, you can delete it by clicking on the “edit” icon ( ), in the

“Solicitudes” column, on the right of the VMPs name.

The icon “View” ( ), permits you to review a report that has been previously

submitted.



Depending on the status of the submitted shortage report you will be permited to choose among the

following actions to take:

APPLICATION STATUS ACTIONS AVAILABLE ACTIONS DETAIL

Solicitada

(Submitted)

Anular

(Delete)

Delete submitted report

Validada

(Approved)

Levantamiento

(Withdrawal of the drug

shortage report)

Withdrawal of the drug

shortage report

Levantamiento en validación


shortage report on review)

Anular

(Delete)

Delete the application of

withdrawal of the drug

shortage report submitted

Fin de desabastecimiento

(End of drug shortage)

Declarar desabastecimiento

(Notifying drug shortage)

Notifying drug shortage

Rechazo de levantamiento


shortage report was rejected)

Solicitar levantamiento


shortage report)

New application of withdrawal

of the drug shortage report

IMPORTANT: At the time to request the withdraw of a shortage report of a VMP, to fill the “Fecha

prevista siguiente liberación lote” (next scheduled batch release date) field will be mandatory.

application manual for sending information on the

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