Manual aplicación para el envío de información sobre comercialización de … · 2020-04-07 ·...

APPLICATION FOR SUBMITTING INFORMATION ON

COMMERCIALIZATION OF HUMAN MEDICINAL PRODUCTS

User guide

Version 5.5

Application for submitting information on commercialization of Human Medicinal Products

INDEX

INDEX

OPTION 1: UPDATE FORMATS CURRENTLY ON THE MARKET

OPTION 2 : ANNUAL DECLARATION OF INTENT TO COMMERCIALIZE MEDICINES

OPTION 3 : DATE OF PLACING THE FIRST BATCH OF MEDICINES ON THE MARKET

OPTION 4 : ANNUAL MAINTENANCE FEE OF AUTHORIZED MEDICINES

OPTION 5: SERIALIZATION OF MEDICINES

OPTION 6: STOCK OF MEDICINES


How to access to the application

The user credentials to get access to this application are the same as accessing the RAEFAR II software application. Users who do not have user credentials must apply

for one with the Spanish Agency of Medicines and Medical Devices (AEMPS) in accordance with the procedure established in the virtual office

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

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).

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

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

IMPORTANT!! The MAH has to update the information related to their medicine products currently

on the market (option 1), before doing the annual declaration of intent to market(option 2).

The CIMA database is updated daily with the information indicated in “option 1”;therefore, it is mandatory to complete “option 1” with the current status of yourproducts.

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


Available submissions

English translations:

OPTION 1: UPDATE OF THE CURRENT STATUS OF THE

FORMATS IN THE MARKET.

Application for submitting information on commercialization of

Human Medicinal Products

Go back to the index


Option 1: Update of the current status of the formats in the market.

Marketing Authorization Holder (MAH) informationAt this screen, the user may choose the MAH of the medicine products 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 human medicinal products that laboratory holds.

Marketed Formats

This section shows the human medicinal formats that are held by the MAH that was

previously selected.

In order to change the current status of a human medicinal format (from “Commercialized” to “Not

commercialized”, or vice versa), please tick the corresponding check box at the column on the right

of the form (“Comercializado” or “No comercializado”). In case a lot of medicine formats, to view

them click on the page numbers at the bottom of the form.

Once you have indicated the status changes of the medicinal formats currently on the market,

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



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

correct it and resubmit it.

Updating the format status to “COMERCIALIZADO”, generates an “inception date of marketing“

(Fecha efecto). This date will be used for the AEMPS list of commercialized medicines (Nomenclator

database), and if applicable, in the Financing List developed by the SNS and Pharmacy Basic

Services Portfolio Department.

Updating the format status to “NO COMERCIALIZADO”, imply the next:

If it is not a financed medicine, the change will appear in CIMA at 24 hours after the change is

made.

If it is a financed medicine, the change must be evaluated by the Ministry of Health so the

change may take up to two months to become effective.

IMPORTANT:In order to be part of the Nomenclator database, the “inception date ofmarketing” of the format must be done prior to the 16th of the month prior tothe one in which you wish to appear on this list. Example: If you want your medicine to appear on the list of marketed

medicines (Nomenclator database) in July, you must be sure that you haveupdated the status of the format and ticked “commercialized" by the 15thof June.



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



Modify the date when the format appear at CIMA database as “commercialized”:

Normally, the change of the new status of the format in the market is shown in CIMA database 24

hours after the change is made. If you want to delay this change to another day, indicate this day at

the DATE OF PLACING THE FIRST BATCH OF MEDICINES ON THE MARKET (option 3), and return

to the option 1 in order to mark the box “Fecha 1º lote = Fecha de comercializacion CIMA” (Date of

1st batch = CIMA commercialization date).

Example: If you want a new medicine and its formats to be included on the list of marketed medicines in July, but you do not want it to appear as “commercialized” on CIMA until July 10th; firstly, you must indicate this date in “DATE OF PLACING THE FIRST BATCH OF MEDICINES ON THE MARKET“ (option 3). Then, you have to update the status of the formats on the market and tick “commercialized" by the 15th June at the latest in UPDATE FORMATS CURRENTLY ON THE MARKET (option 1). Finally, you have to tick the box “Fecha 1º lote = Fecha de comercializacion CIMA” (Date of 1st batch = CIMA commercialization date). Of this way, the medicine will not appear on the CIMA database as “commercialized” until July 10th .



FIELDS IN THE APPLICATION FORM :

Cód. Nacional (National Code): National code number of authorized medicine format.

Estado (Application status): Status of the application. It could be ACEPTADA (accepted), or SOLICITUD (ongoing)

Fecha Solicitud (Submission date): Date of the application submission.

Fecha Efecto (Inception date): Inception date of marketing. It is the same of the “submission date” by default and

should not be modified.

Descripción (Details): Type of change request.

Comentarios MSC ( Ministry of Health comments):In case the AEMPS evaluator of the application needs to put in

contact with the MAH)

Comentarios Laboratorio MAH comments): To response the questions/requests of the AEMPS evaluator.

Documentos (Upload documents): From here you can upload documents requested by the AEMPS evaluator..

OPTION 2: ANNUAL DECLARATION OF INTENT TO

COMMERCIALIZE MEDICINES.





Option 2: Annual declaration of intent to commercialize medicines

Before you start the annual declaration of intent to commercialize medicines (option 2), you mustfirst update the medicine formats currently on the market (option 1), and do not forget to mark thecheck box:

If you want to consult the annual declaration of intent to commercialize medicines 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.

In the section “Realizar Intención de Comercialización”, select the year in which you intend to market the medicines and click on “Realizar Intención” (Make the declare of intent to market next year) button:


Option 2: Annual declaration of intent to commercialise medicines

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

medicinal products that laboratory holds.

Information about the MAHOn the next screen, the user can select the MAH for which he/she is going to submit the

information. The name of the MAH appears on a drop-down menu. If the user has

access permission regarding to more than one MAH, he/she can select which one

he/she is going to work with.

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

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

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

If currently, a medicine is not on the market and you don´t intend to put this medicine on the marketnext year, but you have the intention to put this medicine on the market the following year after this, donot tick any option.

You can save the information as many times as you want by 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.


Option 2: Annual declaration of intent to commercialize medicines

IMPORTANT: Once the application has been submitted, it cannot be modified. If corrections

are needed please contact [email protected]

mailto:[email protected]

OPTION 3: DATE OF PLACING THE FIRST BATCH OF A

MEDICINE ON THE MARKET.





Option 3: Date of placing the first batch of a medicine on the market.

Information about the MAH

On the next screen, the user can select the MAH for which he/she is going to

submit the information. The name of the MAH appears on a drop-down menu.

If the user has access permission regarding to more than one MAH, he/she

can select which one he/she is going to work with.

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

the medicines that MAH holds.

Important: Only medicines whose authorization dates are after 2008, will be shown (RD 1345/2007).

Hacemos clic en seleccionar y se visualizarán los siguientes campos:



To complete this section, click on “Seleccionar” button at the corresponding medicine andthen indicate the release date on the calendar below. Don’t forget to click on “GrabarFecha” button (Save the release date), to save it.

IMPORTANT: Once a release date has been recorded, and you need to modify it, pleasecontact [email protected]


In the other hand, in this section, you have to attach the SIGRE certificate. Once the

file has been selected from the desired location, click on “Adjuntar” button to attach

it. The certificate can also be deleted (in case of error), by clicking on the “Eliminar”

button, and repeating the process over again.



OPTION 4: ANNUAL MAINTENANCE FEE FOR AUTHORIZED

MEDICINES





Option 4 – Annual maintenance fee for authorized medicines

2. CONSULTA DE MANTENIMIENTO DE MEDICAMENTOS REALIZADOS

(Consult of the annual maintenance of previous years): In this section, you have

to select the year before of the declaration effect from the drop down list Then, to

consult the annual maintenance, click on “Realizar Mantenimiento” (Make the

annual fee maintenance) button.

At this option, we can find two sections:

1. REALIZAR MANTENIMIENTO DE MEDICAMENTOS (Making the annual

maintenance fee): In this section, you have to indicate the corresponding year and

click on “Realizar Mantenimiento” (Make the annual fee maintenance) button.



Once the MAH has been selected, click on Buscar (Search) button.

Information about the MAHOn the next screen, the user can select the MAH for which he/she is going to submit the

information. The name of the laboratory appears on a drop-down menu. If the user has

access permission regarding to more than one MAH, he/she can select which one he/she is

going to work with.

Only the medicines which the applicant is the MAH, will be shown (the withdrawn

medicines and CENTRALIZED being exempted).

To make the annual maintenance of a medicine format, you have to,click the box with one asterisk (*). You

can find two (02) buttons:

• Guardar (Save) button: In case of a lot of medicine formats, this button allow us to save the advanced

work and continue later.

• Tramitar Solicitud (Generate combined payment application form) button: This button groups all the

medicine formats together into one payment application form, and changes the status of the payment

application to “PENDIENTE” (Pending to complete). To proceed with the payment, you have to click

on the “eye” icon that appear in the “Detalle-Tasas” column.



IMPORTANT:

• Take into account, all the medicine formats indicated before you click on the TRAMITAR SOLICITUD

button, will be grouping in the same annual fee payment form:

• The Annual Fee payment will be set for all the authorized medicines whether they are marketed or

not. Only the withdrawn medicines and CENTRALIZED being exempted.

• If a mistake has been made, and you need to correct the payment application form, you need to

delete it. To delete the application, click on the “eye” icon to open the application, and then click on

the “Eliminar Solicitud” (Delete application form) button.

Paying the annual application form:

Clicking on the eye icon ( ) in the “DETALLE TASAS” column, will display a form where you

can make the annual fee payment. For this, you have to click on IR A TASAS (Go to the Payment

Fees application) button. Once you are in the Payment of Fees software application, you have to

follow the instructions indicated by the program.



Once the payment has been made, you must come back to this window in order to indicate the type

of payment, the number of proof of payment model paid (317xxxx), and the date of the payment. Do

not forget to attach the proof of payment model paid in 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.

Finally, click on the “FINALIZAR SOLICITUD” button to indicate the annual maintenance application

procedure was completed.

IMPORTANT: In case of error after you click on FINALIZAR

SOLICITUD, please take contact with [email protected], to return

the status of the application to PENDIENTE. Of this way, you can

delete or correct it.


OPTION 5 : SERIALIZATION OF MEDICINES




This step is only for medicines that require safety features in accordance with

Regulation (UE) 2016/161, (October 2nd 2015), and are codified with the unique

identifier GTIN (Global Trade Item Number).

Medicines that require safety features in accordance with the regulation above, but are

codified with the unique identifier NTIN (National Trade Item Number), must NOT

complete this step.

Attention: The Prescription Nomenclator database published by AEMPS will includea new column with the information about the requirement of safety featuresaccording to the Regulation (UE) 2016/161. Inside the field “Serializacion” eachNational Code will show a (“1”) if safety features is required, or (“0”) if it is notrequired.


Option 5 – Serialization of medicines.

IMPORTANT: Only the medicines products exempt to carry safety featuresmust not complete this point.

https://cima.aemps.es/cima/publico/nomenclator.html



Once the laboratory has been selected, click on Buscar (Search)

Choosing the MAH

On the next screen, the user can select the laboratory for which he/she is going

to submit the information. The name of the laboratory appears on a drop-down

menu. If the user has access permission regarding to more than one laboratory,

he/she can select which one he/she is going to work with.

This step will be performed for each authorized National Code (suspended format

included), and medicines which require safety features and are codified with the unique

identifier via GTIN (Global Trade Item Number).

The column “Estado GTIN” (GTIN status), will display a green check to confirm that the

information about serialization has been set (if at least one GTIN code has been

indicated).



Once the format has been selected, you can add all the GTINs associated with the

national code.

The GTIN codes indicated will be validated using an algorithm and control codes.

If the format has a NTIN, only a single unique code will be accepted.


Option 5 – Serializatión of medicines.

Lastly, for medicines that are affected by the Regulation (UE) 2016/161, which require safety

features and have been released before February 9, 2018 (Regulation effective date), the

field “Fecha de caducidad de último lote liberado, no serializado, conforme a la Directiva

2011/62/UE” must be completed. This date is the expiration date of last unserialized batchreleased on the market, in accordance with the Directive 2011/62/UE.

IMPORTANT: The field “Fecha de caducidad de ultimo lote liberado”, we will know the

last date until the unserialized medicines can be dispensed, even if they are affected

by this regulation; and that from this date, must be dispensed with safety features.



OPCIÓN 6 : STOCK OF MEDICINES




Aplicación para el envío de información sobre comercialización de medicamentos de uso humano.

Opción 6 : Stock de medicamentos

Choosing the MAH.

At this section, the user will select the MAH for which have to report the sales,

available units and planned manufacturing. This report must be made by

authorized and commercialized National Code Number (Código Nacional).

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

show all the medicines that MAH holds.



At this section, you may find all the medicines listed by National Code, for which the

stock report must be indicated:

In order to select the medicine, you only have to click on the SELECCIONAR

(Select), button. Then, you have to complete the next section:

Venta envases: Packages sold in january and febraury.

Ventas de envases por semana: Packages sold by weeks. This information

declared has to be made only once and it could not be modified.

Stock diario (number of packages on daily stock): This information must be

updated daily and the form will show the information of the reported stocks for the

last 3 days.

Previsión de stock (planned new package stock): At this section, you may enter

several scheduled dates indicating the number of planned stock packages.



IMPORTANT: In case of any mistaken data entered, you may modify it before

12 noon of the day of the report.

Manual aplicación para el envío de información sobre comercialización de … · 2020-04-07 ·...

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