Law Summary

I. Rationale/Background

• Legal Principle: The FDA aims to align its regulations with global standards to facilitate trade and innovation while ensuring public health.
• Key Definitions:
  • Toys and Childcare Articles (TCCAs) include products intended for children and related equipment.
• Important Requirements:
  • Companies must ensure product safety and quality, with the FDA enforcing post-marketing surveillance.
• Relevant Timeframes: This circular was adopted on February 20, 2015, and filed on May 8, 2015.
• Consequences: Non-compliance can lead to penalties as per Republic Act No. 9711.

II. Scope and Coverage

• Legal Principle: Defines products covered by the guidelines.
• Key Definitions:
  • Toys: Intended for children below 14 years.
  • Childcare Articles: Includes feeding bottles, pacifiers, etc.
• Important Requirements:
  • Exemptions apply for specific toys not intended for marketing in the Philippines.
• Bullet Points:
  • Toys for children under 14 years are covered.
  • Exemptions include toys for older children, display purposes, personal use, and donations.

III. Guidelines

1. License to Operate (LTO)

• Legal Principle: Companies must possess a valid LTO before applying for e-notification.
• Key Definitions:
  • LTO: A legal document allowing the operation of a company in the pharmaceutical and food sector.
• Important Requirements:
  • Renewal of LTO must occur three months before expiration.
• Consequences: Applications with expired LTOs are disapproved.

2. Marketing Authorization

• Legal Principle: Acknowledged notifications serve as proof of product registration.
• Important Requirements:
  • Submission of laboratory test reports and compliance documentation.
• Consequences: Non-compliance can lead to product recall or seizure.

3. Applicability

• Legal Principle: Companies must notify the FDA before selling TCCAs.
• Important Requirements:
  • Online notification application must be submitted.
• Consequences: Mixing product categories in one application leads to disapproval.

4. Grounds for Disapproval/Cancellation of Notification

• Legal Principle: Lists reasons for disapproval of e-notification applications.
• Key Definitions: Notice of Deficiencies (NODS) refers to compliance issues raised by the FDA.
• Consequences:
  • Companies face disapproval for non-compliance with labeling, packaging, or submission requirements.

5. Changes of Information

• Legal Principle: Changes require a new notification application.
• Important Requirements: Submit new notification for any amendments.

6. Laboratory Test Reports

• Legal Principle: Detailed laboratory testing is mandatory.
• Important Requirements:
  • Reports must come from accredited laboratories.

7. Labeling and Packaging

• Legal Principle: Compliance with RA 10620 is necessary for labeling and packaging.
• Important Requirements:
  • Must include LTO number, age grading, and cautionary statements.
• Consequences: Violations result in penalties.

IV. Transitory Provisions

• Legal Principle: Transition to the electronic notification system.
• Important Requirements: Manual notification applications will be processed until March 2, 2015.

V. Requirements

• Legal Principle: Specific documentation is required to apply for e-notification.
• Important Requirements:
  • Authorization letter, evidence of payment, and laboratory reports.

VI. Procedure

• Legal Principle: Steps to apply for TCCAs e-notification account.
• Important Requirements:
  • Email submission of company details and authorization letter.

VII. Fees and Payment

• Legal Principle: Notification applications incur a fee.
• Important Requirements:
  • PHP 100.00 + PHP 10.00 Legal Research Fund per application.

VIII. Notification Validity

• Legal Principle: Notifications are valid for one year.
• Consequences: Expired notifications require reapplication.

IX. Separability Clause

• Legal Principle: Ensures remaining provisions remain valid if any part is invalidated.

X. Effectivity

• Legal Principle: Circular is effective from March 2, 2015.

Key Takeaways

• The FDA establishes an electronic notification system for TCCAs to streamline compliance and enhance public safety.
• Companies must maintain valid LTOs and adhere to specific labeling, packaging, and testing requirements to avoid penalties.
• Notifications are valid for one year and must be renewed; any changes require a new application.
• Non-compliance or mixing product categories can lead to disapproval or cancellation of notifications.