SmPC (Summary of Product Characteristics) and Electronic Product Information (ePI) for EU Regulatory Compliance

Regulatory Operations Updates

Understanding the Importance of SmPC and ePI in EU Regulatory Submissions

The Summary of Product Characteristics (SmPC) is a key document in the marketing authorization process for medicinal products in the European Union (EU). It provides detailed, scientifically validated information about the drug, such as its indications, dosage, contraindications, side effects, and more. The SmPC serves as the basis for other regulatory documents, including the Patient Information Leaflet (PIL) and labeling, and it is intended to provide healthcare professionals with essential information for the safe and effective use of the product.

At Techsol Life Sciences, we specialize in ensuring that your SmPC and other product information documents comply with the latest EU regulatory requirements and standards. Our approach incorporates the electronic product information (ePI) format to align with the EMA’s digital transition efforts and EU guidelines.

SmPC Preparation for EMA Compliance

Techsol’s approach to SmPC preparation includes comprehensive support from document creation to submission for EU market authorization.

Key SmPC Guidelines and Resources

Introduction to SmPC:

The SmPC is a core document that outlines essential information about the medicinal product for healthcare professionals, including indications, dosage, side effects, and interactions. It must meet strict regulatory requirements defined by the EMA and aligned with EU Directive 2001/83/EC.

Electronic Product Information (ePI):

The ePI is part of the EMA’s initiative to digitize product information, enabling easier access to up-to-date drug information. It replaces traditional printed materials with digital formats that can be accessed in real-time. Techsol Life Sciences supports ePI creation and submission, ensuring that your product information is in line with the EU’s digital transformation strategy.

EU ePI Common Standard:

The EU ePI Common Standard is the technical standard for developing electronic product information for human medicines. It provides guidelines for creating SmPCs and PILs in electronic formats that are compliant with EMA’s requirements. Techsol utilizes this standard to ensure that product information is structured in a way that facilitates its approval and accessibility across all EU member states.

Key Principles of ePI for Human Medicines:

The ePI system aims to enhance accessibility, consistency, and real-time updates of product information for both healthcare providers and patients. These principles emphasize secure data management, harmonization across member states, and seamless integration with digital platforms.

Regulatory Guidelines for ePI in the EU:

The EMA guidelines for ePI detail the procedural and technical requirements for electronic submissions, including the use of structured data formats, validation processes, and submission standards.

Review of Package Leaflet (PIL):

The Package Information Leaflet (PIL) is a critical component of the product information that must be included in the product packaging. The PIL provides patients with essential details about the drug, such as usage instructions, warnings, and potential side effects. Techsol ensures that the PIL complies with both content and regulatory standards.

Piloting ePI Creation for EU Medicines:

The EMA is piloting ePI systems to improve the accessibility and distribution of product information across the EU. Techsol follows the latest industry practices to implement ePI formats that are compatible with EU regulatory standards and healthcare providers’ needs.

Techsol Life Sciences Approach to SmPC and ePI Preparation

SmPC Creation and Review: We begin the process of SmPC creation by collecting all necessary clinical and non-clinical data. This information is compiled into the SmPC, with careful attention to detail to meet EMA’s regulatory standards. Our experts review each section, ensuring accurate scientific data, appropriate warnings, dosage instructions, and other necessary information for healthcare professionals.
ePI Compliance: Techsol is committed to helping clients transition to ePI. We ensure that the SmPC, PIL, and other product documents are formatted according to the EU ePI common standard, making them compliant with the EMA's digital and regulatory framework. This enables faster updates, easier access, and seamless integration with the EU’s digital infrastructure.
Gap Analysis and Regulatory Alignment: We conduct a thorough gap analysis of existing SmPCs and related product information, ensuring alignment with the latest EMA guidelines. This includes the review of clinical data, regulatory updates, and any other modifications required by the EU regulatory body.
ePI Submission and Integration: After the preparation and review of the SmPC and other product documents, we handle the ePI submission process, ensuring that all electronic submissions follow the correct format and submission procedures. Our team manages everything from data validation to final submission to ensure your product information is compliant and up-to-date.

Techsol Life Sciences Expertise

Expert Regulatory Knowledge: Techsol Life Sciences has a team of regulatory affairs professionals with in-depth knowledge of EU regulations for SmPC and ePI preparation. We stay current with changes in the regulatory landscape to ensure your documents are always compliant.
Comprehensive Support: From the creation of SmPC documents to the transition to ePI formats, we offer end-to-end support, ensuring a seamless process that meets all regulatory standards.
Electronic Format Expertise: We specialize in ePI preparation, leveraging the EU ePI Common Standard and ensuring compatibility with digital platforms. This enables easier access to updated product information for healthcare professionals and patients.
Efficient, Timely Delivery: Techsol’s structured approach to SmPC and ePI preparation ensures timely submission, reducing the time to market for your products.

Contact Techsol Life Sciences for SPL Conversion Services

If you need expert help with SPL creation, updating, or delisting, Techsol Life Sciences is here to guide you through every step of the process. Our experienced team ensures that your SPLs are fully compliant with FDA, EMA, and other regulatory standards, helping you meet your regulatory goals.

Get in touch today to learn how our SPL Conversion Services can support your global regulatory strategy.