Module 6

04/10/2024

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Recommended References

• EU Guideline on Changing the Classification for the Supply of a Medicinal Product for Human Use ❑ https://health.ec.europa.eu/system/files/2016 11/switchguide_160106_en_0.pdf

● Items in your handouts for this lecture... (in additional to links provided)

The Organisation for Professionals in Regulatory Affairs

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Recommended references

• FDA guidance pages: ● Prescription to non-prescription (Rx to OTC) Switches ❑ https://www.fda.gov/drugs/drug-application-process nonprescription-drugs/prescription-nonprescription-rx-otc switches ● Small Business Assistance: Frequently Asked Questions on the Regulatory Process of Over-the-Counter (OTC) Drugs ❑ https://www.fda.gov/drugs/cder-small-business-industry assistance-sbia/small-business-assistance-frequently-asked questions-regulatory-process-over-counter-otc-drugs

The Organisation for Professionals in Regulatory Affairs

116

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