PAAB CODE
PAAB Code
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Administrative Guidelines
1.1 About PAAB
1.2 Description of Code
1.3 PAAB Services & The Scope of The Code
1.4 Audiences & Types of Communications Covered by the Code
1.5 Materials not Subject to Preclearance
1.6 How to Submit to Paab; The Process and Operations
1.7 How to Register A Complaint Or Make An Appeal
1.8 Definitions
Key Principles
Introduction
Truthfulness
Consistency
Transparency
A. Fair balance & TMA link for Schedule Ethical, Schedule D, Schedule Prescription and controlled products
B. Fair balance & TMA link provisions specific to self-care products
C. Disclosure of Product Name
D. Presentation of Indication
E. Acknowledgement of Trademarks
F. Citations and Study Parameters
Relevancy
A. Ensure that the reference (or relevant segment of the reference) is acceptable.
B. The APS message accurately interprets the reference’s findings and presents them in a clear and balanced way:
Code Standards
2. General Requirements
3. Making Statements
4. Presentation of Data
5. Making Comparison
6. Patient Information
7. Disclosure Product Information
Materials Not Subject to Preclearance
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