Variations EU - Techsol Life Sciences

Life Cycle Management

Variations EU

Our regulatory experts ensure precise determination of variation type, appropriate documentation, and adherence to procedural requirements, whether changes are administrative, quality-related, or impact the safety or efficacy of the product.

Variations (Type IA, IB, II for EU, CP/MRP/DCP/National)

Effective lifecycle management of medicinal products within the EU requires a structured and compliant approach to handling regulatory variations. Changes to the terms of a marketing authorization (MA) are classified by the European Medicines Agency (EMA) and national competent authorities into Type IA, Type IB, and Type II variations, based on the potential impact on product quality, safety, and efficacy.

Each variation type is governed by specific regulatory guidelines, defined timelines, and procedural requirements. Regulatory strategies must align with the applicable submission routes Centralized (CP), Decentralized (DCP), Mutual Recognition (MRP), or purely National procedures to ensure timely implementation and uninterrupted product availability.

At Techsol, we provide end-to-end regulatory support for the classification, preparation, and submission of variations in accordance with the European Union (EU) regulatory framework, enabling Marketing Authorization Holders (MAHs) to maintain ongoing compliance while efficiently managing post-approval product changes.

Techsol Expertise Across EU Variation Types

We provide regulatory support across all categories of EU variation submissions:

Type IA Variations: Minor changes with no significant impact on quality, safety, or efficacy. These are submitted as post-implementation notifications, without requiring prior approval from the competent authority
Type IB Variations: Moderate changes that are not classified as Type IA or Type II. These require prior notification and regulatory assessment. Techsol ensures accurate variation scope definition and timely submission to avoid review delays
Type II Variations: Major changes that may significantly affect product quality, safety, or efficacy. These require a comprehensive scientific evaluation, and we support dossier preparation, justification development, and authority engagement for favorable outcomes

Support Across All EU Regulatory Procedures

Techsol manages variation submissions through all applicable EU regulatory pathways:

Mutual Recognition Procedure (MRP): For products authorized in one Member State, we coordinate submission to the RMS, manage communication with CMS, and support responses to regulatory questions for recognition across additional Member States.
Decentralized Procedure (DCP): For new products seeking parallel approvals in multiple EU Member States, we manage dossier preparation, procedural timelines, and regulatory interactions to ensure a harmonized review and approval process.
National Procedure: For country-specific variations, we adapt submission strategies to meet national requirements and maintain close coordination with local health authorities to secure timely approvals.