Manage market-specific product master data and serial configuration under the Products --> Products tab in the Serialized Manufacturing application:


AreaRequired, Optional, or Conditional?Description
Master dataRequiredYou can search for, create, update, and delete products, and associate products with product groups.


It is mandatory to register the products in Movilitas.Cloud.


For the EU market, you can upload the master data to the EU Hub.

Serial managementOptionalYou can configure the serial number source, configure automatic serial replenishment, and manually generate or request serials to fill the serial number pool in Movilitas.Cloud.

If you have your own unique and GS1-compliant serial numbers and you do not want to manage the serial numbers from Movilitas.Cloud, ignore this section. In this use case, you just update Movilitas.Cloud about external serialization activities over API.
EU countriesConditionalAs the MAH, provide country-specific master data of the product. EU market-specific setting. Required when uploading master data to the EU Hub.


List of Procedures


Registering Master Data for a Product


Perform the following actions when you want to register the master data of a product.


Before You Begin


Make sure that you have created the market profiles (target markets) under the Settings tab.


Procedure


1. In the Serialized Manufacturing application, select Products --> Products tab.


The application displays the list of products and the Create product form. You can create a product or find and select an existing product for editing. Depending on your action, the application displays Create product or Update product form, respectively.


Note: When viewing the details of a product, you can open the Create product form by clicking Create.


The following example illustrates the opening page:



2. On the Master data tab of the form, fill in the fields as described below. The required fields are marked with an asterisk (*) in the form.

  • The application displays the product version number. By default, it is 1. This parameter is applicable to EU market only. For other markets, ignore the parameter because you cannot manipulate it.
  • For EU market, you can step the product version number after the product master data is uploaded to the EU Hub. For more information on master data upload, see Uploading Master Data to the EU Hub (EU Market Only).


FieldMarketAction
Select product code schemaAllSelect the product code schema. The application supports GTIN or PPN.
Product codeAllEnter the product code as per the GS1 standard. It is the global identifier of the product.
Product code aliasAllOptionally, enter the product code alias. It is an internal identifier of the product typically used in your ERP system, such as material number.
Product nameAllAdd a product name. It is a free-form text field.
Product groupsAllOptionally, select one or more product groups previously given under the Products --> Product groups tab.

Note: Product groups for the European Pharmaceutical markets (Common Name, Pharmaceutical Form, Pack Type) are not available in the list. These fields can be managed separately in the form when the EU market is selected.
Target marketAllSelect the target market that was previously defined under the Settings tab. The form dynamically changes and displays different fields depending on the selected market. For certain markets, the application also displays additional tabs.

Note: You must register the applicable market under the Settings tab in advance.
Product license (NIE)IDNEnter the NIE product license code. It is a free-form text field. Displayed when the Indonesian (IDN) market is selected.

Note: You must fill in the NIE product license to commission items to the IDN market. If the license is not given, you cannot commission the items to the IDN market.
NIE Expiration dateIDN

Enter the NIE expiration date. Displayed when the Indonesian (IDN) market is selected.  


The application handles the date format flexibly. For example, you can write the date in YYMMDD or YYYYMMDD format.

Highest retail price (HET)IDNEnter the highest retail price. Displayed when the Indonesian (IDN) market is selected.
Chinese product descriptionCHNEnter the product description in Chinese. Displayed when the Chinese (CHN) market is selected.

Note: Comma is not allowed.
Product licenseCHNEnter the product license code. The field supports Chinese characters. Displayed when the Chinese (CHN) market is selected.

Note: Comma is not allowed.
Company identifierCHNEnter the company identifier. Displayed when the Chinese (CHN) market is selected.

Note: Comma is not allowed.
Phone numberCHNEnter the contact phone number in the international format. Apply the plus sign (+) prefix at the beginning. Displayed when the Chinese (CHN) market is selected.

Note: Comma is not allowed.
StrengthEU

Enter the strength value of the medicine. It is a free-form text field.


The strength is the content of the active substances expressed quantitatively per dosage unit, per unit of volume or weight according to the dosage form. For example, 250 milligram (mg) per tablet.

Pack sizeEUEnter the number of (repackable) doses in the pack (dose count). For example, if there are 30 pills or tablets in a pack, then enter 30. For non-repackable items, like powder or syrup, the value is 1.
Common NameEUProvide the International Non-proprietary Name or the usual common name of the active substance(s), for example, “Amoxicillin”.

Enter the term in the free-form text field:
  • If the value is existing in the system, you can select it from the list offered by the application.
  • If it is a new value, you can add it by clicking on the Add new Common Name button.

If this field is not existing in regulatory submissions, leave the field blank.

The field is a predefined product group type. Once a value is given, the product group type with the given product group code (value) is added to the list of product groups. For more information, see the Products --> Product groups tab.
Pharmaceutical FormEUProvide the pharmaceutical form of the medicine. The pharmaceutical form is the physical way how the medicine (the active substance) is presented. For example, “Film-coated tablet”. Follow the standard terms of European Directorate for the Quality of Medicines & Healthcare (EDQM).

Enter the term in the free-form text field:
  • If the value is existing in the system, you can select it from the list offered by the application.
  • If it is a new value, you can add it by clicking on the Add new Pharmaceutical Form button.

The field is a predefined product group type. Once a value is given, the product group type with the given product group code (value) is added to the list of product groups. For more information, see the Products --> Product groups tab.
Pack TypeEUProvide the type of packaging, for example, “Box”, “Bottle”, or “Bag”. Follow the standard terms of European Directorate for the Quality of Medicines & Healthcare (EDQM).

Enter the term in the free-form text field:
  • If the value is existing in the system, you can select it from the list offered by the application.
  • If it is a new value, you can add it by clicking on the Add new Pack Type button.

The field is a predefined product group type. Once a value is given, the product group type with the given product group code (value) is added to the list of product groups. For more information, see the Products --> Product groups tab.
Repacked productAllIf the product is a repacked product, select the Repacked product checkbox and enter the non-serialized origin product code in the field displayed after the checkbox.


3. Click Save or continue with serial management and, for the EU market, with EU countries.


You can save the product settings tab by tab or all the settings at once. After saving, the product is created or updated and is available in the list.



Next Steps


You can configure the serial management or the EU countries. For more information see Configuring Serial Management and Configuring EU Countries (EU Market Only).


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Configuring Serial Management


To generate serial numbers in Movilitas.Cloud or to request serial numbers from external systems through Movilitas.Cloud, you need to configure the serial management for a registered product.  


After the serial number source is configured, it is possible to manually generate or request serial numbers, but you can also activate automatic replenishment to execute this action automatically. In all cases, the pool is filled with the new serial numbers.


Note: If you use your own serial number management solution with ready-to-use, unique, and GS1-compliant serial numbers, skip the Serial management tab. In this use case, you just update Movilitas.Cloud about external serialization activities over API.


Procedure


1. On the Create product or Update product form, select the Serial management tab and perform the actions described below.


The following example illustrates the case when we are configuring the serial management from scratch:



FieldAction
Serial number source

Select a serial number source from the ones that you created earlier.


You can select from the following sources:

  • Serial Number Management (SNM)
  • SAP Information Collaboration Hub for Life Sciences (SAP ICH)
  • SAP Advanced Track and Trace for Pharmaceuticals (SAP ATTP)
  • TraceLink
Marketing Authorization HolderWhen TraceLink channel is used for serials, select the MAH that receives the serial request. The application offers only the previously registered MAHs for selection.

Note: Only applicable to TraceLink channel. Make sure that you have registered the required MAH under Site management --> MAHs tab in advance.
SiteWhen TraceLink channel is used for serials, select the site that sends the serial request to the MAH. This is the location where the product is produced. The application offers only the previously registered sites for selection.

Note: Only applicable to TraceLink channel. Make sure that you have registered the required site under Site management --> Sites tab in advance.
Automatic replenish

Select the Automatic replenish checkbox to automatically fill the pool with serials.


Whenever there is a request for serials in the system and there are not enough serials left to fulfill that request, new ones are generated or fetched from the source automatically.

You can extend its functionality by specifying the Filling amount and Threshold fields.
  • When the Filling amount field is set, you control the maximum number of serials that can be added to the pool at once.
  • When the Threshold field is set, Movilitas.Cloud periodically checks if the number of serials available in the pool is below the threshold. If this is the case, the pool is automatically filled with new serials up to the threshold.
Filling amountSet Filling amount and Threshold fields together and apply them with automatic replenishment.
  • The Filling amount field represents the maximum number of serials that can be added to the pool in one step. The total filling can be facilitated in multiple steps. When set to 0, the required amount of serials is added to the pool at once (in one single step).
  • The Threshold field specifies how many extra serial numbers you want to make available in the system. When set to 0, there will be no extra serial number in the pool.


If the number of serials available in the pool is less than the threshold, new ones are generated or fetched from the source automatically in the amount specified in the Filling amount field, until the threshold is reached in one or more steps.


For example:

  • You set 100 for the Filling amount. This is the maximum number of serials that can be added to the pool at one step.
  • You set 1000 for the Threshold.
  • If the number of available serials goes below 1000, for example, to 800, then the system will fill the pool with new serials until we reach 1000 again in two steps. In each step, we add 100 serials to the pool.
  • If the number of available serials goes below 1000, for example, to 720, then the system will fill the pool with new serials until we reach 1000 again in three steps:
    • In the first step, 100 serials are added. We reached 820.
    • In the second step, 100 serials are added. We reached 920.
    • In the last step, only 80 serials are added. We reached 1000 again.


Note: Setting both fields to 0 is equivalent to leaving these fields blank. If this is the case, the pool is filled up in one single step only to the amount that fulfills the specific request.

Threshold


The following example illustrates a serial configuration with TraceLink source:

  • Site "Plant 2" requests serials from MAH "Movilitas Pharma" over TraceLink.
  • Automatic replenishment is active.
  • Filling amount and threshold values are 0, meaning that the pool is filled up in one single step only to the amount that fulfills the specific request.



The following example illustrates a serial configuration with SNM source:

  • Automatic replenishment is active.
  • As the threshold is set to 30, there will always be 30 serials available in the pool.
  • The pool is filled up with a maximum of 10 serials in each step until the threshold is reached.



2. Click Save or, for the EU market, continue with the EU countries tab.


After clicking Save:

  • If SNM source is configured, the application displays the Generate serials panel under the Update product form to manually generate a certain amount of serials in Movilitas.Cloud.
  • If SAP ICH or TraceLink source is configured, the application displays the Request serials panel under the Update product form to manually request a certain amount of serials from SAP ICH or TraceLink, respectively.

3. Fill the pool with serials by using the configured source.

  1. Enter the required number of serials in the Amount field on the Generate serials panel or the Request serials panel, depending on the serial number source.
  2. Click Generate or Request, respectively.


The serial number pool will be filled with the new serial numbers in the specified amount. For more information, check the SN/SSCC pool --> Serial number pool tab.


When requesting serial numbers from an external system, you can also check the status of the request on the respective channel, SAP ICH or TraceLink Partner.


In the following example, we are generating 100 serial numbers by using the SNM source:



In the following example, we are requesting 100 serial numbers from an external source (SAP ICH or TraceLink):



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Configuring EU Countries (EU Market Only)


As the MAH, you can provide country-specific master data of the product.


Procedure


1. On the Create product or Update product form, select the EU countries tab and perform the actions described below. The required fields are marked with an asterisk (*) in the form.


The following example illustrates the case when we are configuring the EU countries setting from scratch:



FieldAction
Select countrySelect a country from the list.

Note: The list contains two emulated countries, XA and XB, reserved for emulators only. Emulated markets are only available in Integrated Test Environment (ITE) and Integrated Quality Environment (IQE), but not in production.
Select MAHSelect the MAH. The application offers the MAHs registered on the EU Hub channel.
Third Party LogisticsOptionally, select one or more contracted wholesalers (3PLs) of the product in the country. The application offers the 3PLs that are registered in the Serialized Manufacturing application under the Site management --> 3PLs tab.
National codeIf NMVO requires the national code, provide the national code. Otherwise, providing the national code is optional and the MAH can decide to add it (if exists). 
Article 57 code/PCIDOptionally, provide the Article 57 code or the Packaged Medicinal Product Identifier (PCID).

The following information is reused from EMVS Master Data Guide v5.0 published by the EMVO and helps your understanding of what data you need to provide here:
  • Article 57 code is a code assigned by the European Medicines Agency (EMA) after successfully transmitting the master product data to the Extended Medicinal Product Dictionary (XEVMPD).
  • PCID is an ISO IDMP/SPOR (International Organization for Standardization Identification of Medicinal Products / Substances, Products, Organisations, and Referentials) identifier if already existing. If multiple codes exist for the market, only provide the one that matches the supplied Product name and Common Name.
  • For Switzerland and Parallel Distribution products, leave the field empty.

For more information, see EMVS Master Data Guide published by the EMVO.


Example:



2. Click Save.


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Searching for a Product


Procedure


1. In the Serialized Manufacturing application, select Products --> Products tab. The application displays the list of products.


2. To search for an existing product, enter the product code or product name in the search field, select the product code schema, and the market.

  • The list of the products is filtered based on the search criteria.
  • You can reset the filter by clicking the Reset Filters icon.


3. Select the product to view its details.

  • Master data (default)
  • Serial management
  • EU countries (EU market only)


In the following example, we are entering a part of the product code, selecting GTIN as product code schema, and selecting IDN market:



In the following example, we are searching for product code "99887766554433" registered for the Chinese (CHN) market:



In the following example, we are searching for product code "00123456678915" belonging to the EU market:

  • The product master data is filled in, including the settings of the EU countries.
  • The user can upload the product master data to the EU Hub (active Upload Master Data button).
  • The product version number is 1, meaning that this is the first time the product master data will be uploaded to the EU Hub.




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Uploading Master Data to the EU Hub (EU Market Only)


To upload master data to the EU Hub, you have to provide all the required product master data and the settings of the EU countries.


As an additional function, if the Manufacturer for Pharma application is activated for your tenant, the product is created in that application after uploading the master data to the EU Hub.


Procedure


1. In the Serialized Manufacturing application, select Products --> Products tab. The application displays the list of products.


2. Find and select the product you want to register in the EU Hub. The application displays the product master data including the current product version number.


Product Version NumberUpdate Product Version Number Button Visible?Product version number in the UIDescription
1NoThere is no upload to the EU Hub yet, this is the first time the product master data will be uploaded to the EU Hub.
1YesProduct master data was uploaded to the EU Hub once. You can create a new version and modify the product master data by clicking on the Update product version number button.

The version number will be increased by one.
>1YesProduct master data was uploaded to the EU Hub the number of times as displayed in the Product version number field. You can create a new version and modify the product master data by clicking on the Update product version number button.

The version number will be increased by one.


3. Provide the product master data and the settings of the EU countries (country, MAH, and optionally contracted wholesalers).


Note: The upload is only possible when all the required master data are provided. In this case, the Upload Master Data button is displayed on the top-right corner.


4. On the Update product form, click Upload Master Data.


The following example illustrates the case when the product master data will be uploaded to the EU Hub for the first time:



After clicking on the button, the product master data is uploaded to the EU Hub. The Upload Master Data button disappears, and the Update product version number button is displayed again next to the actual product version number.


If the Manufacturer for Pharma application is activated for your tenant, the product is also created in that application after uploading the master data to the EU Hub. The product in the Manufacturer for Pharma application will take the values and settings given in the Serialized Manufacturing application except for the fields that cannot be mapped between the two applications.


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Generating or Requesting Serials Manually


After the serial number source is configured, it is possible to manually generate or request serial numbers on-demand. The pool is filled with the new serial numbers.


Note: If you use your own serial number management solution with ready-to-use, unique, and GS1-compliant serial numbers, skip the Serial management tab. In this use case, you just update Movilitas.Cloud about external serialization activities over API.


Before You Begin


Make sure that the serial number source is configured.


Procedure


1. In the Serialized Manufacturing application, select Products --> Products tab. The application displays the list of products.


2. Find and select a product for editing.


3. On the Update product form, select the Serial management tab.

  • If SNM source is configured, the application displays the Generate serials panel under the Update product form to manually generate a certain amount of serials in Movilitas.Cloud.
  • If SAP ICH or TraceLink source is configured, the application displays the Request serials panel under the Update product form to manually request a certain amount of serials from SAP ICH or TraceLink, respectively.

4. Fill the pool with serials by using the configured source.

  1. Enter the required number of serials in the Amount field on the Generate serials panel or the Request serials panel, depending on the serial number source.
  2. Click Generate or Request, respectively.


The serial number pool will be filled with the new serial numbers in the specified amount. For more information, check the SN/SSCC pool --> Serial number pool tab.


When requesting serial numbers from an external system, you can also check the status of the request on the respective channel, SAP ICH or TraceLink Partner.


In the following example, we are generating 100 serial numbers by using the SNM source:



In the following example, we are requesting 100 serial numbers from an SAP ICH source:



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Deleting a Product


Procedure


1. In the Serialized Manufacturing application, select Products --> Products tab. The application displays the list of products.


2. Find the product in the list you want to delete.


Example:



3. Click the delete icon and confirm the deletion by clicking Yes.


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