Legal and Regulatory Framework - Brazil

The project covering the areas of regulation of pharmaceutical and food products aims to strengthen the work of the Agency for Regulation and Supervision of Pharmaceutical and Food Products (ARFA) in the scope of the economic and sanitary regulation of medicines and foodstuffs in Cape Verde, and the creation of institutional management tools. In the pharmaceutical sector, the project will enable (i) the creation of instruments for the economic and sanitary regulation of medicines, (ii) formulation of instruments for the operationalization of the National Pharmacovigilance System, (iii) establishment of the drug registration process, and (iv) the preparation of strategic plans for intervention in the aftermarket (quality, safety, efficacy and use). In the food sector, it intends to operationalize sanitary regulation and surveillance in Cape Verde, through (i) the creation of a technical and methodological regulation for the incorporation of CODEX ALIMENTARIUM in the Cape Verdean order, (ii) creation of instruments for the operationalization of the National Food Control System and Sanitary Licensing, and (iii) elaboration of methodology for investigation of outbreaks of food and waterborne diseases. In the area of institutional management, the Regulatory Agenda for Medicines and Foods of Cape Verde and the "Guide to Good Regulatory Practices" will be elaborated and the Institutional Communication Plan of ARFA will be operationalized.

The project provides training and consulting for the technical staff of the Bank of Cape Verde (BCV) in the areas of information technology, internal audit, human resources, strategic planning, monetary policy, international relations, communication, supervision / Financial System Regulation, technical advice to the BCV for the development of tools related to the payment system and the preparation of a supervisory action plan. In this sense, the second phase of the project aims to contribute to the institutional and operational strengthening of the BCV, through training and exchange of experiences with the following objectives: (i) creation of new management tools, (ii) improvement of accounting procedures and the quality of financial information, (ii) strengthening risk management, (iii) improved management of reserves and Improvement of the Cape Verdean payment system, and (iv) migration from supervision to the risk-based model.

Mozambique has achieved a progressive increase in international markets due to its consistent economic growth. To secure exports, the Mozambican private sector needs to comply with the international quality standards. Additionally, revitalization of legal metrology is necessary for all districts and municipalities to provide an effective basis for consumer protection. To ensure compliance with these requirements, the Mozambican government has chosen to strengthen the National Institute for Standards and Quality (INNOQ).

The strengthening of INNOQ is supported by ABC, the National Institute of Metrology, Standardization and Industrial Quality (INMETRO), the German International Cooperation (GIZ) and the German Institute of Metrology (PTB). The principal tasks of INNOQ are the promotion of standardization and quality in product manufacturing and service execution and cooperation with international and regional organizations in these areas. Furthermore, the aim of this project is to enable INNOQ to respond to the growing demand for quality infrastructure (QI) services from the economic sector and to be capable of protecting the rights of Mozambican consumers. The objective of INNOQ is to ensure compliance with the growing demand for quality standards required by the export industry and Mozambican consumers.

One of the results of the triangular pilot project with Brazil, Germany and Mozambique in 2008 and 2009 was the elaboration of a Law on Metrology, approved by the Mozambique Parliament in 2010. Building the legal basis for activities in the areas of quality services related to metrology, certification and standardization is gradually growing and getting attention and support from the government. In the following years, the organizational framework of INNOQ was modernized, and the technical and management were extended. The Institute tripled the amount of its technical personnel to approximately 80 employees.

Contribution of the Partners

The National Institute for Standards and Quality (INNOQ) is responsible for the implementation of the project. Its support includes:

• Provision of professional staff in the areas of metrology, quality, standards, as well as internal and external communication
• Construction of laboratories and provision of services
• Conduction of trainings and other courses
• Management of the local logistics of the project

The Brazilian Cooperation Agency (ABC) coordinates the Brazilian contribution. The National Institute of Metrology, Standardization and Industrial Quality (INMETRO), the Brazilian National Standards Organization (ABNT) and the National Institute of Technology (INT) provide technical assistance in the following areas:

• Legal metrology and decentralization
• Industrial metrology
• Product certification
• Quality management system
• Normalization
• Overcoming the technical barriers to trade

The Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) and the Physikalisch-Technische Bundesanstalt (PTB) provide expertise in the following areas:

• Business and market plan
• Internal and external communication and marketing
• Communication network with Municipal Councils
• Industrial metrology
• Quality management system
• Normalization