Guideline for processing variations to marketing authorisations for veterinary medicinal products approved through EAC mutual recognition procedures

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dc.contributor.authorEast African Community
dc.date.accessioned2023-07-18T12:42:41Z
dc.date.available2023-07-18T12:42:41Z
dc.date.issued2020
dc.descriptionGuideline for processing variations
dc.description.abstractThe Mutual Recognition Procedure (MRP) for registering veterinary medicinal products through a harmonised process in East African Community (EAC) Partner States (PSs) was developed in 2015 and introduced in 2016 in accordance with the direction from the EAC Council of Ministers on 26 September 2016 for National Regulatory Authorities (NRAs) of the EAC Partner States to implement MRP (EAC/CM34/Decision 35). Following the issue of a Marketing Authorisation (MA), the Applicant may wish to make changes or improvements to the way that a veterinary medicine is manufactured or sold. Such changes are known as Variations. Any Variations to a Marketing Authorisation must be notified to the relevant National Regulatory Authority (NRA) and in some cases they must be reviewed and approved before the change can be introduced.
dc.description.sponsorshipEast African Community; Busitema University
dc.identifier.citationEast African Community. (2020). Guideline for processing variations to marketing authorisations for veterinary medicinal products approved through EAC mutual recognition procedures. East African Community
dc.identifier.urihttps://doi.org/10.60682/tjan-aq16
dc.language.isoen
dc.publisherEast African Community
dc.relation.ispartofseriesREF: GL14 ; Processing MRP Variations Guideline; CODE: PSS/1/1/21/98
dc.titleGuideline for processing variations to marketing authorisations for veterinary medicinal products approved through EAC mutual recognition procedures
dc.typeOther
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