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ProjTitle.icon P.II.A.1 Related guidelines

GVP P.II is intended to be used in conjunction with the Saudi GVP Modules I to XVI and does not replace these modules or introduce additional regulatory requirements beyond those already covered in the existing modules.

The effects of medicines on fertility and the use of medicines in neonates are out of scope of GVP P.II; guidance on these areas is provided in GVP Module V on “RISK MANAGEMENT SYSTEMS".​​

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