Snapshot
The Verification Review of Medicines and Vaccines pathway has been developed by the Caribbean Public Health Agency (CARPHA) of CARPHA-CRS.
This pathway can be used where This FRP can be used for medicines and vaccines. To be eligible for verification review, each product submitted to the CRS for verification should meet the following criteria: 1. Essential Medicine: The product is an essential medicine, vaccine, or biotherapeutic product as listed on the most recent Model List of Essential Medicines by the World Health Organization (WHO EML). 1.1 The active pharmaceutical ingredient and the route of administration/dosage form must be the same as the listed medicine. Note: the dose strength does not have to be the same (e.g. 250mg vs 100mg). 1.2 Products that are not listed on the WHO EML may be considered for CRS verification based on the public health need. In these instances, the CRS will consult with CARICOM’s Expanded Committee for Pharmaceutical Policy (TECHPHARM), comprised of Member State representatives for approval. 2. Market Authorization by Regulatory Authorities of Reference 2.1 Medicines a. The product has valid market authorization from one of the CRS reference authorities (RAs) for medicines, and is on the market of the respective country, or there is no objection to the product being on the market; or b. The product has been favorably assessed by WHO and is included in the WHO list of prequalified medicines (WHOPQ). 2.2 For innovative biotherapeutic products and similar biotherapeutic products (including insulins) a. The product has valid market authorization from one of the CRS reference authorities for innovative and similar biotherapeutic products, and is on the market of the respective country; or b. The product has been favorably assessed by WHO and is included in the WHO list of prequalified medicines (WHOPQ). 2.3 Vaccines a. The product has been favorably assessed by the WHO prequalification team for medicines and vaccines, and is included in the WHO list of prequalified vaccines, and b. The sponsor agrees to the use of the WHO Collaborative Registration Procedure by the CRS on behalf of CARICOM for review of the vaccine..
It is a verification review (a recognition pathway).
Regional regulatory initiatives can help optimize the efficient use of an agency’s resources. The following countries participate in this initiative/pathway: Belize Guyana Haiti Jamaica Suriname Trinidad and Tobago
When relevant, the agency relies on prior decisions from Argentina Australia Brazil Canada Chile Colombia Cuba EU-EMA Europe Iceland Japan Liechtenstein Mexico Norway Switzerland United Kingdom United States
After payment of the CRS user fee, the verification review takes approximately 4-8 weeks once the dossier satisfies the eligibility criteria. The review time may be reduced if new applicants hold in-person, telephone, or on-line meetings with CRS staff to familiarize themselves with requirements before making a dossier submission. Following favorable verification of an applicant’s submission, the CRS issues a recommendation certificate and an assessment report is shared with CARICOM governments via official CRS focal points. The recommended product is published in the list of recommended products on the CRS webpage http://carpha.org/What-We-Do/Programmes-and-Projects/CRS/Caribbean-Regulatory-System. National regulatory authorities are then encouraged to make a decision regarding market authorization of the product in their countries within 60 calendar days of receiving an application from the applicant, which can be the local importer or the manufacturer. The applicant will be required to satisfy local requirements such as: 1) payment of a local user fee, 2) completion of any additional local administrative forms for record-keeping, and 3) identification of an importer/distributor. Applicants are advised to contact the regulatory authorities of the relevant countries to confirm the local requirements. The CRS may assist applicants by making available upon request, lists of licensed importers operating in CARICOM Member States.