E-Library - Information At Your Fingertips: Printer Friendly 8 of 48 http://elibrary.judiciary.gov.ph/thebookshelf/showdocsfriendly/1/63027 pregnancy. b. classification of hormonal contraceptives; c. regulatory status countries; and of the products in benchmark d. mechanism of action of hormonal contraceptives based on reputable journals, meta-analyses, systemic reviews, evaluation of regulatory authorities in other countries, textbooks, among others. Step 5. Issue a notice to all concerned MAHs, requiring them to submit scientific evidence that their product is non-abortifacient, as defined in the RH Law and Imbong. Step 6. Post a list of contraceptive products which were applied for re-certification for public comments in the FDA website. Step 7. Evaluate contraceptive products for re-certification. A. Part I (Review of Chemistry, Manufacture and Controls) 1. Unit Dose and Finished Product Formulation 2. Technical Finished Product Specifications 3. Certificate of Analysis B. Part II (Evaluation Abortifacient) of Whether the Contraceptive Product is 1. Evaluation of the scientific evidence submitted by the applicant and the public. 2. Review and evaluation of extraneous evidence, e.g., scientific journals, meta-analyses, etc. Step 8. Assess and review the documentary requirements submitted by the applicant. Technical reviewers considered scientific evidence such as meta-analyses, systemic reviews, national and clinical practice guidelines and recommendations of international medical organizations submitted by the companies, organizations and individuals, to be part of the review.[34] [Emphases and Underlining supplied] The Court notes that the above-outlined procedure is deficient insofar as it only allows public comments to cases of re-certification. It fails to allow the public to comment in cases where a reproductive drug or device is being subject to the certification process for the first time. This is clearly in contravention of the 4/21/2020, 9:19 AM