How to Successfully Update Your Dossier: A Guide to Post-Approval Variations 

So, you’ve got the Marketing Authorisation (MA) for your medicinal product! But, let’s be real, it’s not a one-and-done deal. As your product’s lifecycle progresses, you’ll need to make updates to its dossier to ensure it remains compliant with regulatory requirements. 

What’s a Variation, Anyway?  

A variation is any change to a medicinal product’s registered dossier, decision granting MA, Summary of Product Characteristics, Package Leaflet, or labelling. This includes changes to product formulation, manufacturing process, site of manufacture, specifications, and more. 

Types of Variations  

There are several types of variations, classified based on their potential impact on product quality, safety, and efficacy: 

Type IA (Do and Tell): Minor changes with minimal risk, implemented immediately and notified to authorities within 14 days. 

• Example: Changing the font size on your product’s packaging (B.IV.1.a)  
• Example: Updating the address of your marketing authorisation holder (B.IV.1.b)  

Type IB (Tell, Wait, and Do): Changes with moderate risk, requiring approval before implementation. 

• Example: Changing the supplier of a starting material (B.I.a.1)  
• Example: Updating the shelf life of your product (B.II.d.1)  

Type II (Tell, Wait, and Do): Major changes with significant impact, requiring thorough assessment and approval. 

• Example: Changing the manufacturing process of your active substance (B.I.a.2)  
• Example: Adding a new indication for your product (B.II.e.1)  

Line Extension: Significant changes that alter the product’s fundamental characteristics, requiring a new application. 

• Example: Changing the dosage form of your product (e.g., from tablet to capsule)  
• Example: Adding a new strength or route of administration for your product  

How to Classify Your Variation  

To classify your variation, consider the following: 

• Impact on product quality, safety, and efficacy 
• Changes to manufacturing process, site, or specifications 
• Updates to product information or labelling 

Steps for Successful Dossier Update  

1. Assess the change: Determine the type of variation and its potential impact. 
2. Gather documentation: Collect required documents, including Module 2 and supporting data. 
3. Classify the variation: Use the Classification Guideline to determine the variation type. 
4. Submit the variation: File the variation with the regulatory authority. 
5. Implement the change: Once approved, implement the change and update your dossier. 

Best Practices  

• Keep your dossier up-to-date and accurate. 
• Avoid unnecessary variations by providing precise data. 
• Ensure proper classification and documentation. 
• Engage with regulatory authorities when needed. 

 Updating your dossier with post-approval variations is a critical aspect of product lifecycle management. By understanding the types of variations, classification, and steps for successful regulatory submission, you can ensure compliance and maintain product quality.