Guideline for processing variations to marketing authorisations for veterinary medicinal products approved through EAC mutual recognition procedures
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Date
2020
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Publisher
East African Community
Abstract
The 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.
Description
Guideline for processing variations
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Citation
East African Community. (2020). Guideline for processing variations to marketing authorisations for veterinary medicinal products approved through EAC mutual recognition procedures. East African Community