Post-approval changes for medicinal products in the EU

Overview:

This webinar will deal with the many different post-approval changes and describe which procedure has to be followed. Variations are either:

• An administrative change such as a change of company name and/or address
• A change to the characteristics of a product that can affect its quality, such as a change to its composition
• A change to the safety, efficacy or pharmacovigilance of the product

Changes are classified as major (type II) or minor. Minor changes are either type 1A or 1B.

The Company can apply for:

• A single change to one marketing authorization (MA)
• Multiple changes to one or more products and/or MAs

Minor variations are divided into 2 types: IA and IB. Type IA changes have little or no impact on the quality, safety or efficacy of the product, for example administrative modifications such as:

• The manufacturer’s name
• A minor change to a control method
• Deleting details of where the product is packaged

Type IAIN is a sub-type of type IA where regulatory authorities require ‘immediate notification’, within 2 weeks of the change being implemented. If the change is more significant than an IA change but is not a type 2 change or an extension, it is considered a type IB change. Regulatory Authorities must approve type IB changes before they are made to the product.

Major variations (type II) are more complex and may have a significant impact on the quality, safety and/or efficacy of the product. Regulatory Authorities need to approve major variations before they are made. One example of a major change is adding a new therapeutic indication to a product or updating the current indication (the medical needs the product is used for).

Although extensions are still considered a type of variation, their impact on a product is so significant that the Company will need to follow the application process to apply for a new MA.

Extensions can be:

• Changes to the active substance(s), including the salt/ester, isomer or biological active substance
• Changes to strength, pharmaceutical form or route of administration

If the variation (e.g. change of manufacturer) affects details of the labels, leaflets and or packaging of the product, the Company will need to include the updated versions with the submission to be assessed. A Company can apply multiple changes to a single product using the ‘grouping’ format, as long as the changes are directly related.

For example, a Company can make a change to the manufacturing site of the finished product, change in batch size and the manufacturing process to 1 product. The type of procedure (type IA, IB, II) depends on the extent of the change.

The Company can use the work-sharing format if the same type IB or type II change or group of changes to multiple Mas is submitted. Proposals for work-sharing applications should be sent to:

• The European Medicines Agency (EMA) if any of the MAs the Company wants to change were granted under the centralized procedure
• The Coordination Group for Mutual Recognition and Decentralized Procedures (CMDh) if the MAs were granted under the mutual recognition and/or decentralized procedures and the reference member states were different *the reference member state if the authorizations were granted under the mutual recognition and/or decentralized procedure and the reference member state is was the same for each MA
• The competent authorities for the relevant countries if the MAs were granted under purely national procedures.

Why should you Attend: The legislation on the new scheme came fully into effect in 2013, but many companies report that they still need time to adapt to the changes. The EU system for dealing with applications for post-authorization approvals is very complex and still in an implementation phase.

On the other hand, the importance of post-approval changes is increasing due to the increasing number of changes. The number of variations per marketing authorization has gone up by approximately 45% during the past 5 years and the EMA has seen an increase from around 150 per month in 2014 to an average of around 240 per month now. Knowing and applying the rules will ensure that you can file the variations successfully and avoid rejections

Areas Covered in the Session:

• Type IAIN Variations
• Type IA Variations
• Type IB Variations
• Type II Variations
• Extension applications
• Other types of post-approval changes
• Grouping of variations
• Work-sharing

Who Will Benefit:

• Regulatory Affairs personnel
• Senior management
• Project Managers
• Medical writers
• CRAs and CRCs
• QA / Compliance personnel
• Investigators
• Clinical Research Scientists
• QA / QC Auditors and Staff
• Consultants