Marketing Authorization Guidelines drawn from section 3 and 4 of the National Drug Policy and Authority (Pharmacovigilance) Regulations, 2014, Statutory instrument No.37 require that an appropriately Qualified Person for Pharmacovigilance (QPPV) be appointed for all medicinal products authorized in Uganda.
This person must be resident in Uganda and is responsible ensuring that the MAH’s pharmacovigilance system is compliant with local requirements.
Generally, the local contact person for Pharmacovigilance (LCPPV) shall be responsible for:
- Establishing and maintaining a system for collecting and reporting locally suspected ADRs and ICSRs; submitting PSURs on behalf of the appointing MAH to NDA
- Being aware of and having sufficient authority over the content of RMPs applicable to marketed products
- Promptly and effectively notify NDA of any significant safety issue(s) or regulatory action(s) taken by foreign agency or agencies, including the basis for such action(s).
To the MAH, having the LCPPV will;
- Ensure dedicated and prompt monitoring of complaints (quality or adverse events) for their products in the market
- Guarantee better implementation of any risk minimization measures because they are on the ground
For more guidance about local PPV requirements, do reach out to us on email at info@saefqconsults.com .