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e-CFR data is current as of March 3, 2021

Title 21Chapter ISubchapter APart 26Subpart A → Appendix


Title 21: Food and Drugs
PART 26—MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY
Subpart A—Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices


Appendix C to Subpart A of Part 26—Indicative List of Products Covered by Subpart A

Recognizing that precise definition of medicinal products and drugs are to be found in the legislation referred to above, an indicative list of products covered by this arrangement is given below:

—human medicinal products including prescription and nonprescription drugs;

—human biologicals including vaccines, and immunologicals;

—veterinary pharmaceuticals, including prescription and nonprescription drugs, with the exclusion of veterinary immunologicals (Under 9 CFR 101.2 “veterinary immunologicals” are referred to as “veterinary biologicals”);

—premixes for the preparation of veterinary medicated feeds (EC), Type A medicated articles for the preparation of veterinary medicated feeds (United States);

—intermediate products and active pharmaceutical ingredients or bulk pharmaceuticals (United States)/starting materials (EC).

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