Vitamin and Supplement Submissions

Not all vitamins and supplements are classified as simple food products—some require MHRA approval as medicines due to their ingredients, dosage levels, or health claims. At eCTD Pharma, we specialize in managing the full regulatory submission process for medicinal supplements, ensuring compliance with MHRA, EMA, FDA, and global health authorities.

When Do Supplements Require an eCTD Submission?

A supplement may be classified as a medicinal product if it:

Contains high-dose vitamins that exceed standard nutritional levels.
Makes explicit medicinal claims, such as treating or preventing diseases.
Includes herbal extracts that have pharmacological effects.
Falls under Traditional Herbal Registration (THR) or requires a Marketing Authorization Application (MAA)

In these cases, companies must submit a full eCTD dossier to the MHRA or other relevant regulatory agencies to gain approval before marketing the product.

Our Expertise in Medicinal Supplement eCTD Submissions

At eCTD Pharma, we handle every stage of the eCTD submission process, ensuring your medicinal supplement meets all

regulatory requirements for approval. Our services include:

1. Marketing Authorization Applications (MAA) for Medicinal Supplements

Preparation of the complete eCTD dossier in line with ICH and MHRA guidelines.
Compilation of Module 1 (administrative documents), including cover letters, application forms (eAF), and national requirements.
Submission of Modules 2–5, covering quality, safety, and clinical data.
Handling regulatory interactions, responding to MHRA questions, and managing amendments.

2. Life Cycle Management & Compliance Updates

Post-approval variations, renewals, and updates to maintain compliance.
Submission of Periodic Safety Update Reports (PSURs) and pharmacovigilance updates.
Management of any required labelling and formulation changes.

3. Regulatory Gap Analysis for Medicinal Supplements

Before submission, our team conducts a comprehensive gap analysis to:

Identify missing or weak data that could lead to rejection.
Ensure all scientific evidence and justifications meet regulatory expectations.
Assess whether your supplement’s classification is correct to avoid unnecessary delays.
Provide a detailed roadmap to strengthen your submission and improve approval chances.

Why Choose eCTD Pharma for Medicinal Supplement Submissions?

Extensive regulatory expertise in medicinal supplement approvals.
Proven success with MHRA, EMA, and FDA eCTD submissions.
Efficient submission process using world-class Freyr Submission Pro software.
Dedicated support for regulatory compliance and post-market updates.

With eCTD Pharma, your medicinal supplement submission is in expert hands. We ensure a smooth, compliant, and efficient regulatory process, helping you bring your product to market without unnecessary delays.