Pharma Serialization requirements for Rwanda

Key dates in Rwanda:

2024 – Master data reporting to the Rwanda Ministry of Health (MOH)

2025 & beyond – Serialization & aggregation reporting to be mandated.

Introduction

The Government of Rwanda (GOR), through the MOH, has underwritten its commitment to ensuring access to quality, affordable and sufficient medicines to its population through the development of key policy and strategic documents to guide the national pharmacy sector. The vision of the Health Sector is to pursue an integrated and community-driven development process through the provision of equitable, accessible, and quality health care services.

In 2016, the government published the National Pharmacy Policy (NPP) and was developed in support of the goals of The National Pharmaceutical Sector Strategic Plan (NPSSP) to address challenges in the pharmaceutical sector. The plan includes a series of strategic initiatives such as establishing the Rwanda Food and Drug Authority (RFDA), incentivizing, and enabling local manufacturing of pharmaceuticals, regulating pricing for health commodities, and increasing use of technologies in the private sector.

In support of these NPSSP goals, in June 2018, the Rwanda Ministry of Health (MOH) hosted a collaborative workshop to launch the pharmaceutical traceability initiative. The workshop was attended by government and private sector stakeholders involved in the pharmaceutical sector in Rwanda. This multi-disciplinary team established the vision, objectives, and activities for implementing pharmaceutical traceability in Rwanda through the use of global standards.

The NPSSP outlines priority issues to be addressed in the areas of policy, legislation and governance, regulation and quality assurance (QA), rational medicines use and pharmacovigilance, supply chain, antimicrobial resistance (AMR), access to pharmaceutical products and health technologies, public private partnership, human resources and pharmaceutical information systems. The strategic objective of the NPSSP seeks to address the following issues:

• Establish overarching process(es) to ensure that any quality failures are detected, and systematically shared with central authority and addressed.
• Address poor compliance with pharmacy code of ethics policy especially in private pharmacies in districts, operating without presence of pharmacist and dispensing prescription-only medicines without prescriptions.
• Build capacity to track and trace health commodities from manufacturers, storage locations down to end users. This impacts the recall process as well as monitoring quality compliance in ensuring quality products flow through the supply system.
• Regularly collect data and develop key performance indicators (KPIs) for monitoring adherence to medicine quality standard operating procedures (SOPs).
• Enforce ethical advertising procedures for all products regulated by Rwanda FDA.
• Availability of pharmaceutical products and health technologies in private health facilities not meeting acceptable packaging.

Traceability Model & Vision

There are still discussions ongoing around the model for traceability to be used in Rwanda. However, the Ministry of Health (MOH) has defined the three types of models which are commonly seen worldwide:

• Centralized: All event data from all supply chain parties is stored in one central repository.

The repository will manage the data authentication between a user and/or a system, the authorization of the user or system and the access control for the user or system, for all supply chain parties. All event-storing and event-retrieving is managed by a separate service of the central repository. This model is being implemented in Turkey, Argentina, and China.

• Semi-centralized: All event data for a given item and its instances is stored in one repository. The repository will be populated with data from the item owner, who is commonly the brand owner/manufacturer. Only events and event data identified to be important for other supply chain partners are stored in the repository. Each supply chain party may operate their own repository, which may contain data about more events as well as more data about a shared event. This model is being implemented in the European Union.
• Distributed: The event data is stored by each data owner of the event data in its own repository. The data owner then decides which event data they want to share with other The data owner will then make information available for other supply chain parties. The data owner will also be able to control which supply chain party can see what data, putting the data owner in control of the data. This model is being implemented in the United States.

Each model comes with its own benefits and limitations that are often based on the structure of the national supply chain and role of different partners in trading health commodities and delivering health services. These IT infrastructure models need to be considered in context and evaluated based on traceability goals and feasibility of implementation.

The Rwanda NPSSP outlines interventions to increase and ensure access to quality and affordable pharmaceutical products and health technologies in Rwanda. This includes building and enforcing a quality assurance system that ensures safety, effectiveness and efficacy of health commodities and technologies from manufacturers to consumers. To meet this objective, Rwanda seeks to implement pharmaceutical traceability that is supported by the use of GS1 global standards. The implementation of pharmaceutical traceability policies, processes, and systems will create an environment that:

• Decreases the presence of SF medications.
• Ensures the quality and desired efficacy of pharmaceuticals.
• Promotes trust in the pharmaceutical sector and healthcare system.
• Provides visibility of product status across the supply chain.
• Creates supply chain efficiencies from manufacturers to patient receipt.
• Increases patient safety.

How can CosmoTrace help?

We provide serialization consulting, implementation & integration services to help our clients with managing the end-to-end serialization projects and preparing them for the existing and upcoming regulations across the globe.
We are well versed with the compliance regulations for various markets and can help you with implementing the Rwanda pharmaceutical serialization requirements.

Our team of experts strategize and plan end-to-end solutions using a combination of years of knowledge in product serialization, pharmaceutical supply chains, life sciences and brand integrity.

Disclaimer
This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just one possible interpretation of information available in the public domain or through membership organizations, and that interpretation is subject to change. This information does not constitute legal advice. Users must refer to the source material for the complete requirements and form their own interpretation before making business decisions. Please use the references below to follow the updates at the source.

References

Government of Rwanda (www.gov.rw)

Regulation and Guidelines (rura.rw)