Registration: In-License Products in Veeva

This video provides a detailed, step-by-step training on how to manage the registration and regulatory actions for in-licensed products within Veeva Vault. The primary context revolves around a scenario where a company, Envu, has the right to register and sell a pesticide under its own brand, even though the core data and original registration are owned by a third party. The video aims to guide users through the specific workflows required to accurately reflect these complex arrangements in Veeva Vault, emphasizing regulatory compliance and internal process management.

The training meticulously covers the creation of a new product registration, beginning with the input of essential metadata such as the registered trade name (as per the competent authority, e.g., EPA), the internal trade name Envu plans to use, product line details, and classifying the business decision as "active in-license." It then progresses to adding detailed registration information, including the official registration number, internal trade names, and defining product involvement roles for both the original registration holder (e.g., "allball") and the marketing distributor (Envu). A significant portion of the video addresses current system limitations, demonstrating workarounds like using mock submission dates to transition a registration to "approved" status, a step acknowledged as temporary until future system enhancements are implemented.

Following the registration setup, the video moves into creating a regulatory action, which is crucial for managing subsequent changes or updates to the product. This involves specifying the action process (e.g., "Amendment" for changes in composition or label elements) and linking it to the relevant regulatory documentation. The speaker provides practical guidance on uploading and classifying various documents into Veeva, including the EPA PINPUNCH form, the stamped approved label (often a PDF requiring conversion to Word for the master label), and the master label itself. The process ensures these documents are correctly associated with the regulatory action, maintaining a comprehensive audit trail. Finally, the video details the creation of a Print Restricted Label (PRL), which serves as a placeholder for third-party registrations, ensuring that internal documentation accurately reflects the source of the label and facilitates communication with the supply chain for state-registered label creation.

Key Takeaways:

• Veeva Vault as a Central Regulatory Hub: The video underscores Veeva Vault's role as an indispensable platform for managing complex regulatory processes, specifically for product registrations and subsequent regulatory actions in the life sciences and agricultural chemical sectors.
• Precise Metadata Management for In-Licensed Products: It is critical to differentiate and accurately record both the registered trade name (from the competent authority like EPA) and the internal trade name used by the licensee (e.g., Envu) within Veeva, along with specifying the "active in-license" business decision.
• Defining Product Involvement Roles: The system requires clear identification of all parties involved, such as the "registration holder" (the original owner of the data/registration) and the "marketing distributor" (the company licensing and selling the product), including their respective contact information.
• Navigating Regulatory Action Types: Users must correctly identify and select the appropriate regulatory action process, such as "Amendment" for changes in composition or label elements, to ensure accurate tracking and compliance.
• Comprehensive Document Management: The process involves uploading and classifying several key documents, including the EPA PINPUNCH form (e.g., 85705), the stamped approved label, and a Word version of the master label, ensuring they are linked to the correct regulatory action.
• Workarounds for System Limitations: The video highlights practical workarounds for current system limitations, such as using "mock submission dates" to push registrations and regulatory actions to "approved" status, acknowledging these are temporary until enhancements are made.
• Creation of Print Restricted Labels (PRL): For in-licensed products, creating a PRL (often a copy of the master label with specific disclaimers) is essential. This serves as a placeholder to attach state-registered labels and clarifies that the licensee is not responsible for its creation.
• Interdepartmental Communication: The process necessitates communication with other departments, such as emailing the "spec office" for product line numbers and sending notifications to "supply chain" when a PRL is ready for state-registered label creation.
• Ensuring Data Integrity and Traceability: The emphasis on linking documents, adding relationships between master labels and PRLs, and accurately filling in dates (e.g., approval dates from EPA's website) ensures a robust audit trail and data integrity.
• Regulatory Compliance Focus: The entire workflow is geared towards maintaining compliance with regulatory bodies like the EPA, ensuring that all product information and actions are accurately recorded and traceable within Veeva Vault.
• Anticipation of System Enhancements: The speaker repeatedly mentions that certain steps and workarounds are temporary, indicating an ongoing process of system improvement and a future vision for a more streamlined user experience.
• Understanding In-Licensing Complexities: The video implicitly demonstrates how enterprise software like Veeva Vault is configured to manage the specific legal and operational complexities associated with in-licensed products, where ownership and marketing rights are separated.

Tools/Resources Mentioned:

• Veeva Vault: The primary platform for managing registrations and regulatory actions.
• EPA's Website: Used as a source for original submission dates, approval dates, and forms (e.g., PINPUNCH form).
• PDF to Word Converter: Implied tool used to convert stamped PDF labels into editable Word documents for the master label upload.

Key Concepts:

• In-Licensed Products: Products where a company has the right to register and sell under its own name, but the underlying data and original registration are owned by a third party.
• Registration (Regulatory): The formal process of recording a product with a competent authority (e.g., EPA) to permit its sale and distribution.
• Regulatory Action: Any formal submission or update made to a competent authority regarding a registered product, such as amendments, changes in composition, or label updates.
• Competent Authority: The government agency responsible for regulating specific products (e.g., EPA for pesticides in the US).
• Registered Trade Name: The product name officially registered with the competent authority.
• Internal Trade Name: The name a licensee company plans to use for marketing and selling an in-licensed product.
• Product Involvement: Defining the roles of different companies associated with a product's registration (e.g., Registration Holder, Marketing Distributor).
• PINPUNCH Form (EPA 85705): A specific form from the EPA, likely related to pesticide product registration or action.
• Stamped Label: The official product label approved and stamped by the competent authority.
• Master Label: The comprehensive, internal version of a product label, often in an editable format (e.g., Word document), used for internal management and as a basis for other label types.
• Print Restricted Label (PRL): A specific type of label in Veeva Vault, often a placeholder for in-licensed products, indicating that the licensee is not responsible for its creation and is used to attach state-registered labels.
• Priia Label: Refers to the Pesticide Registration Improvement Act, indicating a specific type of regulatory action or label under this act.
• CSF Amendment: Refers to a Confidential Statement of Formula Amendment, indicating a change in the product's composition.