COVID-19

The Caribbean Regulatory System (CRS) supports CARICOM Member States’ efforts to save lives during the COVID-19 pandemic by expediting the review of COVID-19 related treatments, vaccines and diagnostic kits, to make recommendations of quality-assured products for emergency use.

The CRS will accept applications for review of medical products granted emergency use authorization or the equivalent by a trusted authority of reference: medicines, vaccines, in vitro diagnostics (test kits).

Medicines and Vaccines:

The medical product must meet one of the following criteria:

• Be included in the WHO Emergency Use List (EUL) for prevention, treatment or in vitro diagnosis of COVID-19; or
• Be granted authorization for emergency use for prevention, treatment or diagnosis of COVID-19 by one of the national regulatory authorities of reference based on type of product shown in Table 1.

Table 1: Regulatory Authorities of Reference (Reference Authorities) by Product Type

The CRS reserves the right to update the list of reference authorities in the future, including for example, factor in new assessment results by the Pan American Health Organization (PAHO) for National Regulatory Authorities of Regional Reference (NRA/RRs).

   VigiCarib Vaccine AEFI Form at: https://form.jotform.co/210037487099865

The Caribbean Regulatory System assists CARICOM and CARPHA Member States in monitoring the safety and quality of medicines and vaccines through its system of voluntary reporting. After using a COVID-19 medicine or getting a COVID-19 vaccine, persons who experience an unexpected side effect or reaction should seek medical care, and inform the health worker of the use of any recent medicines or vaccines. Health professionals, sponsors, patients, and caregivers may submit case reports to VigiCarib, which will be sent to the respective Ministries of Health of the Member State. From there the national authority will follow up according to national policies. Reporting of these events will help national authorities and global systems to identify previously unknown safety issues, or issues that may be unique to certain populations.

Please see the links to reporting forms in the list below.

• Report for Vaccine Adverse Events for the Public
• Report for Medicine Adverse Reactions for the Public
• Report for Vaccine Adverse Events for Health Professionals / Sponsors
• Report for Medicine Adverse Reactions for Health Professionals / Sponsors

• CARPHA https://carpha.org/What-We-Do/Public-Health/Novel-Coronavirus
• PAHO https://www.paho.org/en/topics/coronavirus-infections
• WHO https://www.who.int/emergencies/diseases/novel-coronavirus-2019