1. This activity is equivalent 2 hours.

1. This activity is equivalent 2 hours. Go to: https://www.fda.gov.ph downloadables/ Expand Integrated Application Forms and Process At the end, download Integrated Application Form (XLSX Format) Fill-out the form using the scenario provided. Individually upload the excel file with the following filename: FDA SCENARIO Respond to the key questions provided Scenario • Your company would like to engage in pharmaceutical distribution. You will be sourcing your products from a manufacturer based in UK. You will also be selling products from Amherz Plant from Laguna. • Your company set-up two warehouses in two separate regions from your main office. • There is only one pharmacist in the company, heading the regulatory affairs. The pharmacist is also assigned as the Authorized Officer. There is a nurse acting as PV Officer. • Using the LTO details, fill-out an integrated application form when your company tasked your to register losartan 100mg tablet: https://www.medicines.org.uk/emc/product/7062/smpc. Assume that the marketing authorization holder indicated therein is the manufacturer you will be sourcing your product from. 2. Go to: https://verification.fda.gov.ph/Home.php. Navigate to Drug Products Search for drug products falling in the classification below: 1 Vaccine Product (branded or unbranded) 1 Branded Generic Anti-diabetes drug 1 household remedy (branded or unbranded) 1 Herbal medicine (branded or unbranded) Provide the (a) product name [i.e. generic + brand name (if any) + dosage strength and form)] and (b) link to the identified product from the verification portal. SCIENCE HEALTH SCIENCE NURSING NUR 147

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