Angola Pharmaceutical and Healthcare Technologies
A presidential decree created the Regulatory Agency for Medicines and Healthcare Technologies (ARMED). Under the auspices of the Ministry of Health of the Republic of Angola, ARMED inherits more responsibilities, and will regulate and supervise the sector, license pharmaceuticals and health technologies for human use, ensure quality healthcare products and services are entering Angola, and guarantee healthcare safety, security, and wellbeing for all. ARMED’s main objective is to elevate the standards, quality, and protection of public health for Angola.
Under its mission ARMED provides licenses and certificates to approved importers, and to new players in their roles as local distributors, retailers, or manufacturers. ARMED assures that locally registered companies active in the sector import healthcare products and services directly from overseas manufacturers to permit quality and price control.
The licensing of distributors is governed by Presidential Decree No. 202/21 of 26 August 2021, accommodating a reduction of the bureaucracy around the licensing process of distributions points. ARMED has plans for the liberalization of the market to allow increased access of new entrants in the distribution, retailing and manufacturing of medicines and equipment. The idea is to reduce barriers to market entry and permit increased importation and local manufacturing.
ARMED also commits to register and license new products entering Angola. The registration of medicines and health technologies is governed by Presidential Decree No. 315/20 of 17 December 2020. Incoming products for healthcare must be submitted to laboratory tests to appraise compliance with established norms, standards, procedures and regulations. Those also must be labelled in Portuguese Language, same as for the consumer medicine information (CMI) leaflet, and the instructions for medical devices.
In the spectrum of pharmacovigilance ARMED strengthens capacity to avoid medicines from losing their therapeutic properties and from provoking adverse reactions to patients, and traces medical products across the entire supply cold chain. Presidential Decree No.253/21 of 14 October 2021 statutes on the scope of pharmaceutical surveillance in Angola.
Presidential Decree No. 426/21 of 16 September 2021 enforces the establishment of a list of pharmaceuticals considered priority, essential and necessary to Angola based on the epidemiologic status of the country. ARMED determines a list of essentials pharmaceuticals and medicinal plants approved for human consumption.
Potential areas for Public Private Partnership collaboration with ARMED:
- Protocols to combat the trafficking and counterfeiting of drugs
- Policy reforms and restructuring leading to harmonized standards for cross border and regional exchanges
- Interagency cooperation with multilateral banks and organizations (WHO, UNDP, UNICEF, WB Global Fund, AfDB)
- Construction of manufacturing plants to establish a pharmaceutical industry in-country
- Construction of a public laboratory which will analyze the quality of pharmaceuticals as they are entering Angola
- Health IT (data processing and storage)
- Specialized training and education on pharmaceuticals and health technologies
- Consumer education on pharmaceutical quality and consumer behavior
Regulatory Agency for Medicines and Healthcare Technologies (ARMED): https://armed.gov.ao/
For more information contact Clemência Nogueira, Commercial Specia list at (+244) 932 572 822 | (+244) 222 641 076 or Clemencia.Nogueira@trade.gov.