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Angola
Regulation Regarding Pharmacovigilance (Presidential Decree No. 253/21)
This Presidential Decree establishes the legal framework for Angola’s National Pharmacovigilance System, covering medicines for human use, traditional medicines, and other health products. Coordinated by the Regulatory Agency for Medicines and Health Technologies, the system defines the roles and responsibilities for all stakeholders, including public and private health units, pharmaceutical establishments, and healthcare professionals. The regulation mandates good pharmacovigilance practices, establishes mandatory reporting procedures for adverse reactions, and details a methodology for data collection and evaluation. It also imposes a duty of confidentiality and outlines administrative violations and fines for non-compliance.
Use Cases
- Regulatory Agency for Medicines and Health Technologies – Coordinate the National System: The agency is responsible for ensuring the system’s effectiveness, establishing technical standards, analyzing notifications, and applying measures to ensure the safe use of medicines.
- Pharmaceutical Establishments – Establish a Pharmacovigilance Service: They must have a dedicated service led by a qualified professional, immediately report serious or unexpected undesirable effects for their products, and prepare risk management plans when requested.
- Public and Private Health Units – Conduct Continuous Surveillance: They are required to monitor the safety of medicines used in their clinical practice and make mandatory reports on suspected adverse reactions to the competent authorities.
- Healthcare Professionals – Report Suspected Adverse Reactions: Professionals who diagnose, prescribe, dispense, or administer medicines must notify their pharmacovigilance organization of any serious or unexpected undesirable effects as soon as possible.
- Provincial, Municipal, or District Health Services – Manage Local Pharmacovigilance: These services must collect local notifications, report serious effects to the next level within 24 hours, provide training, and report their activities regularly to the national agency.
- Users of the National Health System – Provide Information on Adverse Reactions: Patients are encouraged to report any adverse reaction to the professional who prescribed or dispensed the product or to the nearest pharmacovigilance stakeholder.
Key takeaways you'll learn
The resource’s purpose is to create a structured and comprehensive National Pharmacovigilance System in Angola to ensure the quality, efficacy, and safety of medicines and health products. It aims to identify, assess, and prevent risks associated with their use by defining the responsibilities of all actors within the national health system.
- Centralized National Coordination: The entire system is coordinated by a central body, the Regulatory Agency for Medicines and Health Technologies, which is responsible for setting standards, making decisions on product safety, and communicating with international bodies like the WHO.
- Hierarchical Reporting Structure: The regulation establishes a clear, multi-level reporting structure, from municipal/district services up to provincial services and finally to the national regulatory agency, with strict timelines (e.g., 24 hours for serious effects) for escalating critical information.
- Mandatory Participation for Industry and Professionals: All Pharmaceutical Establishments are required to have their own Pharmacovigilance Service, and individual healthcare professionals have a legal duty to report any suspected adverse reactions they observe.
- Inclusion of Traditional Medicine: The scope of pharmacovigilance explicitly includes not only conventional medicines but also traditional medicines, and it assigns reporting responsibilities to Traditional and Complementary Healers.
- Enforcement Through Penalties: The decree enforces compliance by defining specific administrative violations and applying monetary fines for non-compliance with key articles, such as those related to good practices, confidentiality, and mandatory reporting.
