Cape Verde Drug Product Registration

Marketing Authorization

Drugs that are imported or produced domestically require authorization from the Independent Health Regulatory Entity (ERIS) before they may be introduced or sold. To ensure the efficacy, caliber, and safety of the medications on the market, rigorous legal and scientific standards are used throughout the marketing permission procedure, which involves a technical-scientific examination of the marketing authorization dossier. 

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) guidelines must be followed in the structure of the Marketing Authorization application dossier by complete procedure.

If a State recognized by ERIS has awarded marketing authorization, it is likewise possible to seek marketing authorization for pharmaceuticals intended for human use in Cape Verde. Requests for marketing authorizations, renewals, and changes can be delivered by email, or hard copies can be mailed to the ERIS address or the ERIS office. 

Regulation nº09/2014 of October 6th, Decree-Law nº59/2006 of December 26th, and its annex Regulation of Marketing Authorization introduction (MAI) by recognition of MAI issued by other countries govern marketing authorization.

The process entails a technical and scientific evaluation of the MA dossier to determine the safety, effectiveness, and quality of medications sold using stringent legal and scientific standards. According to article 24 of Decree-Law nº 59/2006, of September 26, and Resolution nº 09/CA/2014, of October 6, if the medicinal product intended for sale in Cape Verde had a previous marketing authorization in a Country recognized by ARFA for this purpose, the marketing authorization is granted in Cape Verde by recognition of the marketing authorization issued in the State of reference.

To be accepted as an MA from another state, the following minimal requirements must be met:

• Being an official body (a Ministry of Health service, an agency, or an institute) that ensures the quality of medications placed on the market by evaluating and authorizing them while considering the appropriate laws and regulations.
• Verify that manufacturers are adhering to Good Manufacturing Practices guidelines by conducting inspections.

The marketing permission application must be submitted digitally (by CD-ROM, DVD-ROM, or pen drive); however, it may also be filed on paper. The application form and requirement must be submitted on paper and must also be included in the digital dossier. The Delivery can be done by mail or directly to the ARFA (Agência de Regulação e Supervisão dos Produtos Farmacêuticos e Alimentares) records.

The application for marketing permission is made up of the following documents:

• Cover letter
• MA Application form
• Copy of SmPC, PIL, and Labeling materials in the country of origin and, if relevant, translation into Portuguese
• Declaration certifying that the data in the dossier matches that which has been approved in the origin country (in the language of Portugal) from which MA recognition is requested
• List of variants approved in the origin state (in the languages of Portugal, England, or France)
• Declaration made by the applicant that ARFA would be informed of any modifications to the status of the drug, such as formal decisions to remove it from the market made by competent authorities in other member states (in Portuguese)
• WHO certificate completed in the PT, EN, or FR language, or its translation by a qualified body, if appropriate, by the competent authority of the nation from which MA recognition is requested.
• A statement regarding the presence of marketing data released by the nation’s competent authority for which a request for marketing authorization is made (in the languages of PT, EN, or FR, or if necessary, through translation by a competent organization).
• A declaration in the language of PT, EN, or FR, or its translation by a competent body, if appropriate, declaring that there have been no revisions to the benefit/risk balance completed by the competent authority from the nation where the MA was issued.
• A list of safety alerts about the medication, released in the PT, EN, or FR languages, or translated into those languages by a qualified body, if appropriate, by the nation’s responsible authority for whom a request for marketing permission is made.
• Analytical techniques and specifications utilized for final product quality control (in either PT, EN, or FR language)

The following annexes, which should be provided with the application form in the same sequence and numbering as specified in the order form, must be included:

• Evidence of payment
• Evidence of establishment of the applicant in the country where it is located.
• Letter of authorisation for communication on behalf of the applicant/MAH.
• Authorisation to exchange confidential information between ARFA and competent
• Manufacturing Authorisation
• Flowchart displaying every production and control location involved in producing the active ingredient and pharmaceutical product.
• GMP statement(s) or certificate(s); if relevant, a list of additional GMP inspections.
• Certificate(s) of appropriateness for transmissible sporadic encephalopathies from the European Pharmacopoeia.
• written approval(s) from the relevant authorities for the release of genetically modified organisms into the environment.
• Copy of Marketing authorization certificate granted in other(s) state(s) Correspondence with European Commission regarding multiple applications.
• List of Mock‐ups or Samples/specimens.
• A list of the holders of marketing authorizations and suggested (created) names in the relevant member states.
• Copy of European Pharmacopoeia certificate of suitability (CoS), Active Substance master File or Drug Master File Copy of EMA certificate for a Vaccine Antigen Master File (VAMF). Copy of EMA certificate for a Plasma Master File (PMF).