Snapshot

The Non-Routine Assessment of Products for Public Health Emergencies pathway has been developed by the Botswana Medicines Regulatory Authority of Botswana.

This pathway can be used where Vaccines and therapeutics each have specific requirements to be eligible for evaluation under the EUL procedure. In order to qualify for assessment under this procedure, the following criteria must be met: (a) The disease for which the product is intended is serious or immediately life threatening, has the potential of causing an outbreak, epidemic or pandemic and it is reasonable to consider the product for an EUL assessment, e.g., there are no licensed products for the indication or for a critical subpopulation (e.g., children); (b) Existing products have not been successful in eradicating the disease or preventing outbreaks (in the case of vaccines and medicines); (c) The product is manufactured in compliance with current Good Manufacturing Practices (GMP)..

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from ASEAN Algeria Argentina Armenia Australia Azerbaijan Brazil Canada China Colombia Cuba EU-EMA East African Community (EAC) Egypt GHC-GCC India Indonesia Iran, Islamic Republic of Israel Japan Jordan Kazakhstan Lebanon Malaysia Mexico Moldova, Republic of Russia Saudi Arabia Singapore South Africa South Korea Switzerland Taiwan (Chinese Taipei) Tunisia Turkey Ukraine United Kingdom United States WHO Zazibona

The Authority shall finalise review of the information received within 3 months.