Regulatory Compliant Sourcing of RLDs and Biologics From Italy

Introduction

Italy is a key player in the pharmaceutical industry, with a robust regulatory framework and a strong focus on research and development. Sourcing Reference Listed Drugs (RLDs) from Italy can offer numerous benefits, including access to high-quality products, a favorable regulatory environment, and a wealth of research expertise. In this blog post, we’ll explore sourcing RLDs from Italy and the role of Invimeds in procuring the RLD.

Italy’s Pharmaceutical Market

The forecasted period anticipates significant growth in Italy’s biologics and Reference Listed Drugs (RLDs) market size. As per the Mordor Intelligence report, Italy’s Pharmaceutical Market is currently estimated at USD 37.70 billion in 2024, with projections to reach USD 44.80 billion by 2029.

This suggests a Compound Annual Growth Rate (CAGR) of 3.51% during the forecasted period (2024-2029). The positive trajectory reflects various factors, including the rising prevalence of chronic and infectious diseases, heightened demand for pharmaceutical products, and notable industry advancements.

Regulatory Authorities in Italy’s Pharmaceutical Sector

The regulatory landscape governing the sourcing and procurement of reference-listed drugs (RLDs) in Italy is primarily overseen by two key entities: the Italian Medicines Agency (AIFA) and the National Health Service (SSN). AIFA is entrusted with tasks such as authorizing medicines, setting prices, and managing reimbursement, while the SSN handles the procurement and distribution of medicines to the public sector.

Italy’s healthcare system, organized under the National Health Service (Servizio Sanitario Nazionale/SSN), operates across three tiers: central government, regional governments (including autonomous regions), and local health units (Aziende Sanitarie Locali, ASL) and Independent Hospitals (Aziende Ospedaliere, AO).

Responsibility for healthcare is shared between the central government and the Regions, with ASLs overseeing healthcare provision within their areas. Funding for the SSN primarily comes from national and regional taxes, with patient co-payments for outpatient medicines in some regions.

Classification and Distribution Channels of Medicines in Italy

The classification of medicines, distinguishing between prescription and non-prescription (farmaci senza obbligo di prescrizione medica), includes over-the-counter (OTC) medicines (farmaci di automedicazione / AM) and those requiring pharmacist intervention for purchase. The liberalization of non-prescription medicine distribution channels, introduced by the “Bersani law” in 2006, allows for broader retail availability, with pharmacies, para-pharmacies, and designated sections within supermarkets serving as major distribution points.

Risk Factors Associated with RLD Sourcing from Italy

Sourcing of RLD from Italy offers access to high-quality products and proximity to European markets, yet entails risks like regulatory compliance, quality control, logistics challenges, cultural differences, financial fluctuations, and environmental concerns.

Compliance with Italian and EU laws is crucial, alongside thorough supplier vetting and quality audits. Addressing logistics challenges requires careful planning, while cultural sensitivity and clear communication mitigate misunderstandings. Proactive financial monitoring and sustainable sourcing practices are essential to manage risks effectively.

Invimeds Is a Pioneering Excellence in Pharmaceutical Logistics

Strategic Collaborations for Global Reach:

Invimeds, a prominent player in the pharmaceutical realm, strategically collaborates with esteemed firms from Italy to navigate the complexities of the sector. Through coordinated efforts worldwide and reliable partnerships across various regions like the USA, EU, Korea, Latam, and Japan, Invimeds ensures a seamless supply chain for Reference Listed Drugs (RLDs) globally.

Upholding EU domestic product standards, Invimeds prioritizes transparent communication and strategic planning to swiftly address any distribution challenges that may arise. With access to a diverse portfolio of high-quality RLDs spanning multiple therapeutic areas, Invimeds adheres to stringent quality and regulatory standards.

Commitment to Quality Assurance:

Quality assurance remains paramount for Invimeds as a leading network of RLD suppliers in Italy. Employing rigorous selection criteria and quality control measures, Invimeds ensures that RLDs sourced from Italy meet stringent safety, efficacy, and authenticity standards. This steadfast commitment fosters trust among pharmaceutical companies regarding the reliability and integrity of RLDs procured through Invimeds.

Additionally, Invimeds provides comprehensive certifications, including Certificates of Analysis (COA), Batch Reports, and Certificate of Origin (COO), demonstrating compliance with WHO EU guidelines, FDA, and EMA regulations. By adhering to these regulatory standards and offering transparent documentation, Invimeds reaffirms its dedication to delivering only the highest-quality RLDs to its esteemed clients.

Expertise in Logistics and Shipping:

In addition to sourcing and procurement expertise, Invimeds excels in logistics and shipping, ensuring secure and efficient transportation of pharmaceuticals. Prioritizing product safety, Invimeds strictly adheres to global regulations and provides comprehensive licensing support for regulatory compliance. State-of-the-art warehousing facilities prioritize medication safety through advanced temperature controls, robust security measures, and continuous 24/7 monitoring via data loggers. From inventory management to secure shipment handling, Invimeds emphasizes efficiency while upholding rigorous quality standards.

Timely Delivery and Customer Satisfaction:

At Invimeds, timeliness is paramount. We prioritize efficiency from procurement to delivery, ensuring prompt processing and dispatch of orders. Our dedicated logistics team collaborates closely with clients, ensuring seamless communication and timely updates at every stage. Recognizing the critical importance of timely delivery in the pharmaceutical industry, Invimeds goes above and beyond to meet clients’ timelines, showcasing an unwavering commitment to excellence in timeliness and service reliability.

Conclusion

In conclusion, when seeking to source RLD from Italy or any other part of the world, Invimeds emerges as a key player and a trusted source for procurement. With its commitment to authenticity, reliability, and stringent quality standards, Invimeds ensures a seamless process for RLD sourcing, mitigating risks effectively.

By partnering with Invimeds, pharmaceutical companies can rest assured that they are accessing genuine and high-quality RLDs not only from Italy but from around the globe. With a dedicated content team ensuring a smooth process and proactive risk management strategies in place, Invimeds stands as a beacon of excellence in the pharmaceutical procurement industry, offering unmatched reliability to our clients.