Pharmaceutical manufacturing is becoming increasingly global: a significant share of medicines available on the European market is produced using active pharmaceutical ingredients (APIs) manufactured outside the EU.
This scenario has made global sourcing a common practice for many pharmaceutical and nutraceutical companies. However, it is a process that requires strict standards to ensure quality, safety, and traceability across the entire supply chain.
The European Union has introduced specific regulations for ingredients imported from third countries, covering production, distribution, and documentation.
Understanding how these requirements apply to APIs sourced from outside the EU is essential for anyone involved in raw material procurement or supply chain management.
What is meant by an extra-EU API?
When referring to APIs of extra-EU origin, this means active pharmaceutical ingredients produced in facilities located outside the European Union and subsequently imported for use in the manufacture of medicines intended for the European market.
Since the quality of ingredients is a key factor in ensuring the safety and efficacy of the final product, European regulations require that components sourced from outside the EU meet conditions equivalent to those applied within the Union.
The European regulatory framework
European guidelines for medicinal products for human use are based on several directives that have been updated over time, strengthening controls across the supply chain and introducing specific requirements for the import of active substances. Among the most important standards are Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).
Good Manufacturing Practices (GMP)
Good Manufacturing Practices define the standards for the production of pharmaceutical active ingredients and cover several aspects of the manufacturing process, including:
- design and management of facilities and equipment;
- organization of documentation and operating procedures;
- supervision of production activities;
- testing and batch control.
Compliance with GMP is essential not only during manufacturing, but also throughout subsequent sourcing and usage phases. Competent authorities verify manufacturers’ compliance and oversee authorization and registration procedures related to import activities, ensuring that each active substance is clearly linked to its manufacturing site.
Good Distribution Practices (GDP)
Good Distribution Practices govern the management of procurement, storage, and supply activities for APIs sourced from outside the EU, establishing criteria to ensure:
- traceability of products throughout the supply chain;
- appropriate transport and storage conditions;
- standardized operating procedures;
- qualification and monitoring of involved partners.
These requirements must be supported by systems that enable operational control and risk mitigation. The goal is to ensure that the active ingredient’s characteristics are preserved throughout all stages, from production to final use.
Sustainability criteria: EcoVadis and carbon footprint
Alongside regulatory and quality aspects, sustainability criteria are becoming increasingly important. Although they are not yet part of specific regulatory requirements for active substances, recent European initiatives, such as the Corporate Sustainability Due Diligence Directive (CSDDD), are placing greater emphasis on environmental and social impacts across the supply chain.
Assessment tools such as EcoVadis – an ESG (environmental, social, and governance) performance rating platform – and indicators related to carbon footprint, which measure greenhouse gas emissions associated with products and processes, are increasingly used to monitor supplier performance and support more responsible sourcing practices.
Who can import APIs into Europe? Requirements, stakeholders, and responsibilities
Companies established in the European Union that manufacture, import, or distribute active substances must comply with European regulations and register their activities with the relevant national competent authority. When these activities involve the import of APIs from non-EU countries, additional requirements apply under EU pharmaceutical legislation to ensure that substances meet quality standards equivalent to those within the Union.
Among these requirements is the Written Confirmation, a declaration issued by the competent authority of the exporting country, confirming that the manufacturing site complies with GMP and is subject to regular inspections.
In certain cases, the Written Confirmation may not be required, for example, when the European Commission recognizes the regulatory framework of the exporting country as equivalent.
In this context, the importer is responsible for verifying compliance with these provisions and is directly accountable. It must also hold the relevant Import License for the substance being handled.
Best practices for importing APIs from non-EU countries
International API sourcing requires careful management of regulatory compliance. Issues with documentation or activities along the supply chain can lead to operational delays or additional regulatory checks. To reduce these risks, it is important to adopt a set of best practices, including:
- verifying that manufacturers comply with GMP;
- ensuring that all required documentation is available;
- maintaining full supply chain traceability;
- working with logistics partners and distributors operating in accordance with GDP standards;
- ensuring that suppliers are qualified through periodic audits and operate in line with European regulatory requirements.
A structured approach to supply chain management helps improve supply reliability and production continuity. For this reason, many pharmaceutical companies rely on specialized partners for API sourcing and distribution.
Flarer: a strategic partner for API sourcing and distribution
Sourcing raw materials from non-EU countries requires expertise beyond simple procurement, encompassing regulatory, logistical, and supply chain control considerations. For this reason, the support of qualified partners becomes a strategic asset for improving operational efficiency.
To meet these needs, Flarer offers integrated support covering all stages of the process, from supplier selection to the distribution of pharmaceutical, nutraceutical, and cosmetic substances within the European market.
The company operates through a network of qualified manufacturers, subject to continuous and periodic auditing, to ensure compliance with European standards and the quality of the materials distributed. In addition to supplier selection, Flarer supports organizations in verifying requirements and documentation throughout the entire supply chain.
From an operational perspective, Flarer provides solutions for importing APIs from non-EU countries through a logistics structure certified according to GMP and GDP standards. This model ensures that products already introduced into the European territory are readily available, simplifying sourcing processes. Contact us for more information or to request a consultation, our team is always available.