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For Industry

No, at this time, all dossier/packaging/labelling materials must be submitted in English.

WHO’s prequalification program has guidance on this (http://apps.who.int/prequal/info_general/documents/guidelines/Storage_June2015.pdf) and the CRS follows this approach. Generally, zone IVb stability data (data generated at 302C/75 5%RH) on the primary or production batches of the product in the same packaging as approved for marketing of the finished product in the Reference Authority (RA) country, should be provided.

If these zone IVb data are not available at the time of submission, applicants should initiate as soon as possible long-term stability testing at these conditions in the same packaging as approved by the RA. When complete, the full long term data (at minimum 12 months) should be submitted to the CRS team. Questions regarding this matter can be directed to CRSregistration@CARPHA.org

The CRS team has compiled procurement data for select priority medicines from sample Member States and procurers in the region. It can be downloaded here.

A positive CRS review is posted on the CARPHA/CRS website, and triggers a process whereby the CRS notifies CARICOM Member States and Associate Member States, as well as regional and national procurers, of the recommendation. Pertinent dossier information, such as the assessment report compiled by the CRS, is then shared with focal points in each of these entities, and the clock begins to tick for sovereign countries to turn the recommendation into a marketing authorization. The goal is 90 calendar days.

After products are favorably reviewed, a certificate of CRS Recommendation for market authorization is issued to the sponsor. The product’s information (name, manufacturer details, contact information, regulatory authority of reference, market authorization reference number) is addeAfter products are favorably reviewed, a certificate of CRS Recommendation for market authorization is issued to the sponsor. The product’s information (name, manufacturer details, contact information, regulatory authority of reference, market authorization reference number) is added to the list of Recommended Medicines, which is posted on the CRS website (here).  Representatives of Ministries of Health in CARICOM are also informed of the newly recommended product.d to the list of Recommended Medicines, which is posted on the CRS website (here).  Representatives of Ministries of Health in CARICOM are also informed of the newly recommended product.

The CRS team has compiled procurement data for select priority medicines from sample Member States and procurers in the region. It can be downloaded here.

For Governments and CRS Focal Points

The CRS has requested countries/territories to provide officially nominated government focal points to engage with the CRS. The following are terms of reference for focal point responsibilities. Click here to read terms of reference.

Resources

Caribbean Pharmaceutical Policy

Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) Products

Regionalization as an approach to regulatory systems strengthening: a case study in CARICOM member states.