For the introduction or commercialization of drugs imported or manufactured in the country, the Independent Health Regulatory Entity (ERIS) needs to grant authorization. The marketing authorization process includes technical-scientific evaluation of the Marketing Authorization dossier, to guarantee the effectiveness, quality, and safety of the drugs available on the market, based on the application of strict legal and scientific criteria.
The structure of the Marketing Authorization application dossier by complete procedure must follow the guidelines of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) for the Common Technical Document For The Registration Of Pharmaceuticals For Human Use (CTD).
The dossier must have 5 modules which includes the Regional Administrative Information, the overall quality summary, non-clinical overview and summary, and a clinical overview and summary: the quality report, non-clinical study reports and the clinical study reports.
The Marketing Authorization for medicinal products for human use in Cape Verde can also be obtained if Marketing Authorization has been granted by an ERIS recognized State. Marketing Authorization requests, renewals and amendments can be sent via email or physical documents can be sent to the ERIS office or by post to the ERIS address.

Adverse drug reaction reports can be made on the ERIS website. Cabo Verde is a member of the WHO Programme for International Drug Monitoring. Cabo Verde has a system called Integrated Pharmaceutical Market Monitoring System (SIMFAR) which is an integrated approach to the technical and economic aspects of drugs, namely by monitoring access, price and stock and also by assessing the quality, safety, efficacy and effectiveness. The aim of SIMFAR is to:
·       Collect, process, and make available information on the market for medicines and pharmaceutical products for the purpose of monitoring and supporting the preparation of studies and opinions on accessibility and consumption of medicines.
·       Provide information capable of contributing to the execution of inspection and inspection actions.
·       Support policy formulation, decision-making and impact assessment.
·       Integrate the support instruments needed to implement systems to prove the quality, safety and efficacy of medicines and pharmaceutical products.

Inspection of manufacturers focuses on the following aspects of GMP and GDP: Quality Assurance System, folks, facilities and equipment, documentation, production, quality control, contracts; complaints and collections and self-inspections. The regulatory body also conducts inspections on pharmacy and drug outlets to ensure that they are complying with Good Pharmacy Practices (GPP).

Medicines collected under the quality assurance programme are tested in a reference laboratory of the European network of Official Medicines Control Laboratories, under an existing collaboration protocol. The monitoring of the quality of medicines existing in the national market is done by analyzing several aspects, namely:
Physio-chemical - identification and measurement of the active substance, determination of related substances / impurities / degradation products, density, pH, heavy metals, sulphur ash, loss on drying, among others.
Pharmacotechnics - dissolution test, breakdown test, hardness, friability, mass uniformity, uniformity of dosage / content, aspect of the pharmaceutical form, among others.
Biological - determination of biological potency, among others.
Microbiological - evaluation of microbiological contamination, test of sterility, test of bacterial endotoxins, microbiological measurement of antibiotics, test of the effectiveness of preservatives, among others.

Cabo Verde authorizes drugs unregistered in the country that are not in the national drug list or the list of essential medicines to be brought into the country through the Simplified Special Import Procedure. The simplified special import request must be accompanied by a Medical declaration, applicable for the initial order, doctor's prescription, and a user identification document.

None mentioned in relation to drug regulation on the website. The ERIS website. However, Cabo Verde’s National Pharmacovigilance Centre collaborates with other National Pharmacovigilance centres in other countries.