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.

When connecting to the Order Management Station (OMS) regulatory system for the KAZ and UZB markets, you can request crypto codes for the serial numbers from OMS.

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.
AF countriesConditionalAs the MAH, provide country-specific master data of the product. AF market-specific setting. Required when uploading master data to TRVST.
EU countriesConditionalAs the MAH (also repacker), provide country-specific master data of the product. EU market-specific setting. Required when uploading master data to the EU Hub.
DSCSAConditionalAs the manufacturer of a product in the USA market, configure the responder settings. USA market-specific setting.
  • Add new products to the Lookup Directory (LD).
  • If there is a change in the record in the LD, update the LD.


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.


FieldMarketAction
Product version numberAll
(Primarily EU)
Specify the product version number. You can track each change in the product master data with a new version number, and the history is stored in the background. By default, the application offers "1" as the product version number. The field is read-only until the market is selected in the Target market field.

The product version number is important primarily for the EU market. The following description applies to the EU market:

Creating product master data

When creating product master data, make sure that you are using a product version number that is not occupied yet in the EU Hub and other systems.

Once EU is selected in the Target market field, you can modify the version number to avoid overwriting a version that was previously uploaded to the EU Hub from a third-party system.

If the version number is already in use and you do not change it, that version will be overwritten in the EU Hub and it might cause discrepancies across multiple systems.

If you are unsure about the product version number to use, create the product, retrieve the product master data stored in the EU Hub (if any) and change the product version number later. For more information on retrieving the product master data, see Retrieving Product Master Data Stored in the EU Hub (EU Market Only).

Updating product master data

When updating product master data that has not been uploaded to the EU Hub yet, you can change the product version number by using the Edit product version number button.

When updating product master data that was previously uploaded to the EU Hub:
  • You can change the product version number by using the Edit product version number button.
  • You can increase the product version number by one by clicking the Update product version number button.

For more information about the logic, see Uploading Master Data to the EU Hub (EU Market Only).

If you are unsure about the product version number to use, retrieve the product master data stored in the EU Hub (if any) and change the product version number accordingly. For more information on retrieving the product master data, see Retrieving Product Master Data Stored in the EU Hub (EU Market Only).
Select product code schemaAllSelect the product code schema:
  • GTIN
  • PPN
  • CUSTOM
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. The product code alias is an internal identifier of the product typically used in your ERP system. For example, material number. It is a free-form text field.
Product name aliasAllOptionally, enter the product name alias. The product name alias is an internal naming of the product typically used in your ERP system. It is a free-form text field.
Product nameAllAdd the official product name. It is a free-form text field.
GS1 company prefixAllEnter the GS1 company prefix that can be derived from the product code.

This information is required when registering products for the UK market (Novumgen). For other markets, giving the company prefix in this field is optional.
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) are not available in the list. These fields can be managed separately in the form when the EU market is selected.

You can clear the field by clicking on the X button.
Target marketAllSelect the target market that was previously defined under the Settings tab. The form dynamically changes and displays market-specific fields and additional tabs.

Note: You must register the applicable market under the Settings tab in advance.

You can clear the field by clicking on the X button.
Pharmaceutical FormAFThe physical way how the medicine (the active substance) is presented. For example, “Tablet”, “Capsule”, or “Suspension for Injection”. ISO11239 or the US FDA Structured Product Labelling are both acceptable.
Pack TypeAFThe type of packaging, for example, “Box”, “Bottle”, or “Bag”.
Net contentAFThe amount of the medicinal product contained by a pack, as claimed on the label. For example, 10 tablets or 100ml.
Separable dosage unitsAF

The number of re-packable units of doses in the pack. Positive integer between 1 and 999999999. Examples:

  • A pack of tablets that can only be repacked as a whole. This value will represent the number of tablets in the pack.
  • A pack of tablets that contains 4 blister packs. This value will represent the number of blister packs in the pack.
  • A powder or syrup that cannot be readily re-packed. Regardless of volume, the pack size will be set as ‘1’.
Product license (NIE)IDNEnter the NIE product license code. It is a free-form text field.

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.


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.
Packaging formatIDNEnter the packaging format.
Chinese product descriptionCHNEnter the product description in Chinese.

Note: Comma is not allowed.
Product licenseCHNEnter the product license code. The field supports Chinese characters.

Note: Comma is not allowed.
Company identifierCHNEnter the company identifier.

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

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 milligrams (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.

You can clear the field by clicking on the X button.
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”.
  1. Type an expression in the field and the application offers the relevant standard terms defined by the European Directorate for the Quality of Medicines & Healthcare (EDQM).
  2. Select the value from the offered list.

You can clear the field by clicking on the X button.
Pack TypeEUProvide the type of packaging, for example, “Box”, “Bottle”, or “Bag”.
  1. Type an expression in the field and the application offers the relevant standard terms defined by the European Directorate for the Quality of Medicines & Healthcare (EDQM).
  2. Select the value from the offered list.

You can clear the field by clicking on the X button.
Repacked productEUIf 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.
Non-serialized origin product codeEUEnter the non-serialized origin product code for the repacked product.

If you are a repacker in the EU market, this data is required to be able to commission to the EU Hub. However, you do not have to specify the original product code scheme and the original batch value. Once the data of the new packs are fed into the application, the application automatically determines these values and includes them in the commissioning request to the EU Hub:
  • The original product code scheme is always GTIN.
  • The original batch value is the one given with the packs to be commissioned.
TN VEDKAZEnter a TN VED code. TN VED is the Commodity Nomenclature for Foreign Economic Activity and it is used in the Kazakhstani market.

Note: The application can overwrite the entered value by using the value in the generic report from SAP ATTP. The generic report is an import request to Kazakhstan.


3. Click Save or continue with other tabs.

  • You can save the product settings tab by tab or all the settings at once. After saving, the product is created or updated and the product is available in the list.
  • For the USA market, save the product master data first, and then you can specify the responder role.


Next Steps


Perform one of the following:


Back to the list of procedures



Retrieving Product Master Data Stored in the EU Hub (EU Market Only)


To verify that the current product version number is not in use in the EU Hub, you can retrieve the product master data stored in the EU Hub. Then, you can change the product version number not to overwrite a version that was previously uploaded to the EU Hub.


Procedure


1. On the Update product form, select the Master data tab and click on the Request master data report button.


Example:



The application displays one of the following:

  • If the EU Hub channel is not configured, an appropriate error message.
  • If the EU Hub channel is configured, the application displays the PDF (Download master data report) button next to the Request master data report button.


2. To download the report, click on the PDF (Download master data report) button.


Example:



The system response is one of the following:


System ResponseDescription
The master data report is being processed and you need to retry downloading the file later.
Save as window to download the file to the local computerThe master data report is available for download.

Select the location to download the file.
The requested product master data is not available in the EU Hub.


Note: By requesting the master data report again, the whole process restarts.


Back to the list of procedures



Configuring Serial Management


To generate serial numbers in Movilitas.Cloud or 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 (channel) 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.


When connecting to the Order Management Station (OMS) for the KAZ or UZB market, you can request crypto codes for the serial numbers available in the pool.


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 update Movilitas.Cloud with the 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 for a product in the EU market:



The following example illustrates the case when we are configuring the serial management from scratch for a product in the KAZ market or the UZB market with a connection to OMS:



FieldAction
Crypto code sourceSelect a crypto code source from the list. The application offers the previously configured Order Management Station (OMS) regulatory channels for selection:
  • OMS Cloud for the KAZ market.
  • Code OMS for the UZB market.


Note: Only applicable to the case when connecting to OMS for the KAZ or UZB market .

Serial number source

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


You can select from the following sources (channels):

  • Serial Number Management (SNM)
  • SAP Information Collaboration Hub for Life Sciences (SAP ICH)
  • SAP Advanced Track and Trace for Pharmaceuticals (SAP ATTP)
  • TraceLink
  • Novumgen
Marketing Authorization HolderWhen a 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 the Site management --> MAHs tab in advance.
SiteWhen a 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 the 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 amount

The Filling amount field represents the maximum number of serials that can be added to the pool in one step. The total amount to be filled is reached in multiple steps. When set to 0, the required amount of serials is added to the pool at once (in one single step).


This field is effective with automatic replenishment and without automatic replenishment also.

ThresholdThe Threshold field specifies how many extra serial numbers you want to make available in the system while using automatic replenishment. When set to 0, there will be no extra serial number in the pool. This field is effective with automatic replenishment.


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.


The following example illustrates a serial configuration with the 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 the 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.



The following example illustrates a serial configuration with the crypto code source for the KAZ market:

  • An OMS Cloud channel is selected as the crypto code source.
  • An SNM channel is selected as the serial number source.
  • Automatic replenishment is not activated.



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


After clicking Save:

  • If the 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 the SAP ICH, TraceLink, or Novumgen 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, TraceLink, or Novumgen, respectively.
  • (KAZ/UZB markets only) If a crypto code source is configured (OMS Cloud or Code OMS channel), the application displays the Request crypto codes panel under the Generate serials or Request serials panel to manually request crypto codes for the serial numbers.
    • The panel displays the available serial numbers with and without a crypto code.
    • The maximum number of crypto codes that you can request is the amount of available serial numbers without a crypto code. If you need more crypto codes, you need to fill the pool with serial numbers first.
    • You need to select the packaging line for the request. As a prerequisite, you need to configure a packaging line under the Packaging --> Packaging lines tab.


Next Steps


Generate or request serials manually. For more information, see Generating or Requesting Serials Manually.


(KAZ/UZB markets only) Request crypto codes for the serial numbers from OMS. For more information, see Requesting Crypto Codes for the Serial Numbers from OMS (KAZ/UZB Markets Only).


Back to the list of procedures



Configuring AF Countries (AF 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 AF countries tab and perform the actions described below.


The following example illustrates the case when creating the product. The default company prefix is used from the AF market profile settings:



FieldAction
Company prefixProvide the GS1 company prefix for the product. The application displays the default company prefix that is set for the AF market profile under the Settings tab.


Example:



2. Click Save.


Back to the list of procedures



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.

You can clear the field by clicking on the X button.
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.


Back to the list of procedures



Configuring the VRS Responder Settings and Managing the Lookup Directory (DSCSA - USA Market Only)


As the manufacturer, you can configure the Verification Router Service (VRS) Responder settings to comply with DSCSA in the USA market.

  • You can add new products to the Lookup Directory (LD). This action will create a record in the LD.
  • If there is a change in the record status or in other settings, you can update the LD and hence inform other VRS providers.

The VRS requests are directed to the provided verification endpoint.


Procedure


1. On the Update product form, select the DSCSA tab. The application displays the DSCSA settings.


The following example illustrates the case when a new product is added to the LD:



2. Fill in the form as described in the table below. The required fields are marked with an asterisk (*) in the form.


FieldAction
VRS Responder GLNEnter the VRS responder GLN. Follow the GS1 standard when providing the GLN. The specified GLN will be included in the VRS response.
  • The provided GLN overwrites the default VRS responder GLN set for the USA market profile under the Settings tab.
  • If the field is not specified, the default VRS responder GLN value defined for the USA market profile is taken. If the default VRS responder GLN is not set for the USA profile either, the field remains empty and it will lead to errors when sending the VRS response.
Verification endpointEnter the verification endpoint address. The VRS requests are directed to this endpoint.

The default verification endpoint is http://pvs.movilitas.cloud/ (production environment).
Company prefix field with "Fetch record owner" button*The system does not know the NDC of the product.

Enter the company prefix and once the button is active, click Fetch record owner.

Example:


The application fetches the NDC from openFDA and identifies the record owner.
Record owner (FDA labeler code)*

The system knows the NDC of the product. The application displays the record owner, that is the 4, 5, or 6-digit FDA labeler code. No further action.


Example:


Start expiry dateEnter the start expiration date of the packs from which this tenant acts as the responder. When the batch expiration date of the pack matches this date or is later than this date but earlier than the end expiry date (if any), the VRS request goes to this responder.
End expiry dateOptionally, enter the end expiration date of the packs to which this tenant acts as the responder.
Next Record OwnerWhen the end expiration date is provided, enter the next record owner. Otherwise, leave it blank. 
Status

Select the status of the record in the LD:

  • Active (default)
  • Inactive
  • Deleted
Provide no reason in case of product identifier mismatchWhen the product identifier in a VRS request does not match any of the product identifiers in the database, the application provides an appropriate reason in the VRS response, by default. 
  • If you want to provide the reason, keep the checkbox in cleared status.
  • If you do not want to provide the reason, select this checkbox.
Manufacturer Policy

This checkbox enables the responder to apply their internal policy when returning the verification result and additional info (if any) in the following cases:

  • The batch is expired or recalled.
  • The product is suspect or illegitimate.

*Only one of the two is applicable. Either the Company prefix field and Fetch record owner button or the populated Record owner field.


System Response

  • Once all required fields are filled in and the product has not been added to the LD yet, the Add to Lookup Directory button becomes active.
  • If the product is already added to the LD but some changes are applied to the form, the application displays only the Save button. The user can update the LD by saving the form.


3. Follow one of the procedures below.


Adding the Product to the LDUpdating the LD
Click Add to Lookup Directory and then Save.

Once the product is added to the LD, the Add to Lookup Directory button disappears.


If a record is already existing in the LD in Active status for the GTIN without a next record owner, it is not possible to add the same GTIN to the LD. The application displays the following error message: Record for this GTIN already exists in the lookup directory. Please contact us at support@movilitas.cloud for more details.

Click Save.


If the product settings are complete and the provided data are new or different from the current data in the system, the application updates the LD.




Back to the list of procedures



Searching for a Product


You can search for:

  • A product that you registered.
  • A product that is assigned to your tenant (CMO) by another tenant (MAH) in a partnership within Movilitas.Cloud.


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)
  • DSCSA (USA market only)


In the following example, we are entering a part of the product code, selecting GTIN as product code schema, and selecting the IDN market. After selecting the search result, the application displays the product master data:



In the following example, we are searching for product code "99887766554433" that is registered for the Chinese (CHN) market. After selecting the search result, the application displays the product master data:



In the following example, we are searching for product code "00123456678915" that belongs to the EU market. After selecting the search result, the application displays the product master data:

  • The product master data is complete, including the settings of the EU countries. As a result, the user can upload the product master data to the EU Hub (active Upload Master Data button).
  • The product version number is 1. This is the first time the product master data will be uploaded to the EU Hub. It is possible to change the product version number.



In the following example, we are entering a part of the product code and selecting the UK market. After selecting the search result, the application displays the product master data. The form holds general product master data and the GS1 company prefix is provided because this data is required while commissioning items to Novumgen: 



Back to the list of procedures



Uploading Master Data to TRVST (AF Market Only)


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


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 TRVST. The application displays the product master data including the current product version number.


IMPORTANT: The product version number makes it possible to track each product master data upload with a separate version number in Movilitas.Cloud. However, the product version number is not passed to TRVST. TRVST automatically assigns a product version number and Movilitas.Cloud does not have control over this mechanism.


Product Version NumberEdit Product Version Number Button Visible?Update Product Version Number Button Visible?Product version number in the UI
(Example)
Description
1 or >1YesNoThis is the first time the product master data will be uploaded to TRVST from Movilitas.Cloud (independently of the displayed version number).

To change the product version number, do as follows:

1. Click on the Edit product version number button.


2. Enter the new product version number and click Save.


You can cancel the entered value by clicking X.
1 or >1YesYesProduct master data was uploaded to TRVST from Movilitas.Cloud earlier.

You can modify the product version number in one of the following ways:
  • By using the Edit product version number button.
  • By clicking the Update product version number button to increase the product version number by one.


Example for the second point:




3. Provide the product master data and the settings of the AF countries.


Note: The upload is only possible when all the required master data are provided. In this case, the Upload Master Data button is displayed in 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 TRVST for the first time:



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


Back to the list of procedures



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. Also, you need to provide a product version number that is not in use in the EU Hub. Otherwise, that version will be overwritten in the EU Hub and it might cause discrepancies across multiple systems.


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 NumberEdit Product Version Number Button Visible?Update Product Version Number Button Visible?Product version number in the UI
(Example)
Description
1YesNoThis is the first time the product master data will be uploaded to the EU Hub from Movilitas.Cloud.

If the version number is 1, the product master data has never been uploaded to the EU Hub. Neither from Movilitas.Cloud, nor from a third-party system.

If you are unsure about the product version number to use, retrieve the product master data stored in the EU Hub (if any). For more information on retrieving the product master data, see Retrieving Product Master Data Stored in the EU Hub (EU Market Only).

To change the product version number, do as follows:

1. Click on the Edit product version number button.


2. Enter the new product version number and click Save.


You can cancel the entered value by clicking X.
>1YesNoThis is the first time the product master data will be uploaded to the EU Hub from Movilitas.Cloud.

However, the product master data was uploaded to the EU Hub from third-party systems earlier (outside Movilitas.Cloud). In this example, the first two uploads were performed from third-party systems, and version 3 is the first version to be uploaded from Movilitas.Cloud.

You can change the product version number at any time. It is your responsibility to ensure that the provided product version number does not conflict with a version in any other system.
1YesYesProduct master data was uploaded to the EU Hub once, and only from Movilitas.Cloud. This setup implies that a third-party system was not used for uploading product master data before.

You can modify the product version number in one of the following ways:
  • By using the Edit product version number button.
  • By clicking the Update product version number button to increase the product version number by one.


Example for the second point:



>1YesYesProduct master data was uploaded to the EU Hub the number of times as displayed in the Product version number field. At least, the last upload (version 3 in the example) was performed from Movilitas.Cloud, but earlier uploads could be uploaded from a third-party system.

You can modify the product version number in one of the following ways:
  • By using the Edit product version number button.
  • By clicking the Update product version number button to increase the product version number 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 in 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 next to the actual product version number and the Edit product version number button.


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.


Back to the list of procedures



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 action is independent of the automatic replenishment setting, meaning that you can generate or request serial numbers manually at any time. 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 the 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 the SAP ICH, TraceLink, or Novumgen 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, TraceLink, or Novumgen, 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:



Back to the list of procedures



Requesting Crypto Codes for the Serial Numbers from OMS (KAZ/UZB Markets Only)


For the serialization activities in the KAZ and UZB markets, each serial number must have a unique crypto code. You can request crypto codes from the OMS regulatory system up to the amount of available serial numbers in the pool without a crypto code. Movilitas.Cloud automatically links each received crypto code to a serial number in the pool.


Before You Begin


Make sure that the crypto code source and the serial number source are 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. The application displays the Request crypto codes panel under the Generate serials or Request serials panel to manually request crypto codes for the serial numbers.


The panel displays the available serial numbers with and without a crypto code.

  • The maximum number of crypto codes that you can request is the amount of available serial numbers without a crypto code.
  • If you need more crypto codes, you need to fill the pool with serial numbers first.
  • You also need to specify the packaging line for the request.


Example:



4. Request crypto codes for the serial numbers that do not have a crypto code. One serial number can have one unique crypto code.

  1. To see the latest amount of available serial numbers with and without a crypto code, click on the Refresh button in the top-right corner of the panel.
  2. Enter the number of crypto codes you need in the Amount field. The entered amount cannot be greater than the number of available serials without a crypto code.
  3. Select the packaging line from the drop-down list. The application offers the packaging lines previously configured under the Packaging --> Packaging lines tab.
  4. Click Request Crypto Codes. The application requests crypto codes from the OMS regulatory system. Once the OMS regulatory system sends the crypto codes, Movilitas.Cloud links each of them to a serial number in the pool.


Movilitas.Cloud sends a series of messages to the OMS regulatory system to get the crypto codes. The messages are logged on the OMS Cloud channel (KAZ) and the Code OMS channel (UZB)


In the following example, we are requesting the maximum amount of crypto codes (55), as 55 serial numbers are available without a crypto code:



Back to the list of procedures



Deleting a Product


You can delete the products registered by your tenant.


For a partnership within Movilitas.Cloud, you cannot delete the products assigned to your tenant (CMO) by another tenant (MAH).


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.


Back to the list of procedures