Guidelines on variations to a registered veterinary pharmaceutical product (VPP) approved through EAC mutual recognition procedure (MRP)

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dc.contributor.authorEast African Community
dc.date.accessioned2023-07-18T07:53:29Z
dc.date.available2023-07-18T07:53:29Z
dc.date.issued2021
dc.descriptionGuidelines on variations
dc.description.abstractA registered Veterinary Pharmaceutical Product (VPP) Marketing Authorization Holder (MAH) is responsible for the registered product throughout its life-cycle irrespective of the regular reviews by NRAs. The MAH is required to consider technical and scientific progress and therefore changes may be required to the registered VPP over time. The MAH may also wish to alter or to improve the VPP or to introduce an additional safeguard. Regulation of pharmaceutical products is, therefore considered dynamic, taking into account that changes to the original dossier that was used for registration of the VPP may become necessary during the lifetime of the product. Any changes to a registered VPP, i.e., variations, whether administrative or substantial, are subject to approval by NRAs.
dc.description.sponsorshipEast African Community, Busitema University
dc.identifier.citationEast African Community. (2021). Guidelines on variations to a registered veterinary pharmaceutical product (VPP) approved through EAC mutual recognition procedure (MRP). East African Community.
dc.identifier.urihttps://doi.org/10.60682/43qn-4337
dc.language.isoen
dc.publisherEast African Community
dc.relation.ispartofseriesREF: GL15 ; Variation Guidelines for Registered Pharmaceutical Products; CODE: PSS/1/1/21/104 Ver. 1
dc.titleGuidelines on variations to a registered veterinary pharmaceutical product (VPP) approved through EAC mutual recognition procedure (MRP)
dc.typeOther
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