E-Library - Information At Your Fingertips: Printer Friendly 19 of 48 http://elibrary.judiciary.gov.ph/thebookshelf/showdocsfriendly/1/63027 [9] c. Regulatory Powers, Duties and Functions: xxx [10] Step 1. Identify contraceptive products in the database. Create another database containing the following details of contraceptive products: generic name, dosage strength and form, brand name (if any), registration number, manufacturer, MAH, and the period of validity of the CPR. Step 2. Identify contraceptive products which are classified as essential medicines in the Philippine Drug Formulary. Step 3. Retrieve the contraceptive product's file and the CPR duplicate of all registered contraceptive products. Create a database of the contraceptive product's history, including its initial, renewal, amendment, and/or variation applications. Step 4. Conduct a preliminary review of the following: a. general physiology of female reproductive system, including hormones involved, female reproductive cycle, and conditions of the female reproductive system during pregnancy. b. classification of hormonal contraceptives; c. regulatory status of the products in benchmark countries; and 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 4/21/2020, 9:19 AM