Type IAs: The Latest Dos and Don’ts of ‘Do-and-Tell’ 

Type IA variations, often known as “do-and-tell” procedures, represent the process in the European Union (EU) and UK for making ‘minor’ changes to the dossiers of marketing authorisations (MAs). Pharmaceutical companies implement these changes before notifying regulatory authorities, and while straightforward on the surface, these variations have always required close attention to ensure compliance. From 2025 onwards, important regulatory changes are shifting how Type IA variations must be managed and reported. A new model of annual reporting and an imminent update to the existing variation guideline will require pharmaceutical companies to adapt their regulatory strategies and processes.

Understanding all of the latest requirements is critical for marketing authorisation holders (MAHs) to help ensure Type IA success, and mitigate against compliance issues, significant business disruption, or, in the most extreme cases, patient safety concerns and/or product recalls.

Understanding Type IA variations

In theory, Type IA variations should have minimal impact on the quality, safety, or efficacy of a medicinal product. The European Commission publishes a list of variations and their classifications (the variation classification guideline) that defines precisely which changes are acceptable as Type IA variations. Examples include minor changes to manufacturing processes, updates to administrative information, or minor adjustments to quality control methods. For this reason, Type IA variations are commonly viewed as “entry-level” submissions that require minimal oversight and that can be prepared by any Regulatory professional, including those with less experience. This perception has led many to underestimate their finer details.

While the changes may appear inconsequential, they must still meet strict regulatory criteria to be classified correctly as Type IA. In reality, the “do-and-tell” nature of these variations carries inherent risks precisely because companies implement changes before receiving regulatory ‘approval’. Beyond basic errors in classification, unmet conditions, and insufficient documentation, several pitfalls can lead to non-compliance or the non-acceptance of Type IA variations. This can include the following examples:

• Timing issues, such as late submissions or non-compliant implementation dates.
• The deletion of ‘non-significant’ test specification parameters can have shades of grey as the meaning of ‘significant’ can be subjective (although general ‘rule of thumb’ examples exist).
• Incorrect super grouping when changes aren’t completely identical across affected products.

In the event of rejection or ‘non-acceptance’ as it’s known, MAHs must immediately cease applying the rejected changes, potentially leading to complicated remediation processes. These outcomes occur relatively frequently, with European Regulatory Authorities we spoke to disclosing rejection rates of up to around 20% in their latest reporting years, although rejection rates varied significantly between the authorities.

Consequences of ‘non-acceptance’

DLRC recently assisted a client with a challenging non-acceptance due to the variation grouping being deemed incorrect. The situation was complicated by the variation impacting the EU Product Information* of a highly active product with multiple ongoing procedures. Procedural guidance on variations states that when Type IA variations impact Product Information, the implementation date and the ‘Date of Revision of the text’ for the Summary of Product Characteristics (SmPC) and Patient Leaflet is determined by the date that the company internally approves the revised Product Information. The revised Product Information will then be used in the next packaging run.

Where a variation has been rejected, there may be a need to reverse the change. Previous guidance had suggested that non-accepted changes only need to be immediately removed/reverted prior to resubmission if there was an impact on quality, safety or efficacy of the medicinal product. In the client’s case, this was not agreed by the Regulatory Authority. The client was therefore asked to revert the Product Information to the previous version and make the change again only with the resubmission. A headache for version control, but a positive resolution was eventually reached!

Companies could face compliance issues, business disruption, and reputational damage from a Type IA variation non-acceptance. The sudden reversion to previous processes can disrupt supply chains, create quality control challenges (as discussed above), and require corrective and preventive actions (CAPAs). In extreme scenarios, incorrect regulatory decisions by the MAH (e.g. misclassifying a bigger change as a Type IA variation) could result in public safety concerns and product recalls.

The expertise needed to navigate Type IA variations successfully from start to finish represents a critical regulatory skill which is even more vital with the introduction of the latest changes and the additional layers of complexity this brings.

New to 2025 – compulsory annual reporting

Regulation (EU) 2024/1701, which amended variation procedures with the aim of introducing a simpler, clearer, and more flexible legal framework, entered into force on July 7th, 2024, with implementation beginning on January 1st, 2025. This regulation has updated the historical approach of submitting individual Type IA variations within 12 months of implementation, now enforcing a consolidated annual reporting system (previously optional) – more akin to that used in the US. Type IA variations (not needing immediate notification) implemented after 1st January 2025, may no longer be submitted individually as they occur but must be collected in a single ‘Type IA Annual update’. Submission should be no earlier than 9 months after implementation of the first variation in that package. It should be clearly identified in the cover letter as a Type IA annual update.

• Several exceptions exist, e.g. as part of a grouping with other variation types (as long as they are related), a so-called ‘super grouping’ across multiple MAs, a resubmission of a rejected variation for the purposes of complying with the 12-month deadline, shortage mitigation (with Regulatory Authority agreement), and others.
• In case of a negative outcome of a Type IA variation, there is no option to resubmit a corrected application without ceasing to apply the change in the registered documents. The applicant should provide a consolidating sequence within 15 days to revert the dossier to the latest approved version. Note, the applicant may resubmit a new application for the same change, still within the original 12-month implementation timeframe.

Practical implications

The shift to mandatory annual reporting brings important practical implications and the need for careful planning. Most notably, companies could face a compressed submission window for some of the variations to be included in the annual report. With submissions required no earlier than 9 months after implementation of the first change but still within 12 months, regulatory teams must prepare and submit consolidated applications within the correct timeframe.

A particular challenge emerges when attempting to group two or more variations implemented nearly a year apart. For instance, if one variation is implemented in January and another in December, both might be included in the same annual report. This creates potential challenges in documentation preparation and submission management. Companies must therefore have developed robust tracking systems to ensure all variations are properly ‘saved up’, front-loaded and planned for in the appropriate annual report after change implementation.

Contingency plans also need to be in place for potential rejections, including the capability to rapidly revert to previous processes within the mandated 15-day window. As always, regulatory teams must also coordinate closely with manufacturing, quality, and supply chain functions to ensure operational readiness for both implementations and potential reversions.

Fees

On the plus side, the new fee regulation (Regulation (EU) 2024/568 on fees and charges payable to the European Medicines Agency) came into effect on 1st January 2025. Minor variations of Type IA (and IB) are now included in the annual fee levied for medicinal products authorised in accordance with the centralised procedure to cover the costs connected with the overall post-authorisation supervision and maintenance activities for those medicinal products.

New to 2026 – updated variation classification guidelines

Aside from annual reporting, the regulatory landscape will continue to develop and change for Type IA variations (amongst all other variation types) into next year. In January 2026, the European Commission plans to issue an updated guideline which will redefine the variation classification list. An initial draft of this guideline was released in mid-2025. One notable change is that some biological CMC* updates could become Type IAs where previously they defaulted to a ‘higher’ classification. It is understood that further publication will be stepwise on a potentially annual basis. The European Medicines Agency (EMA) is also preparing Q&As and technical guidelines to support this planned release (e.g. guidance on the additional regulatory tools; complex manufacturing, changes for drug-device combinations).

Like with the annual reporting regulation, the introduction of the revised variation classifications will be subject to a watershed date depending on the timing of their implementation. Variations implemented before the proposed date (currently 15th January 2026) will follow the ‘old’ variation classification guidelines, whilst those implemented after will follow the new. This means that MAHs may plan strategically, implementing certain changes after the new guideline is in force in order to access the revised classifications. Regulatory professionals should monitor draft versions of these materials closely to prepare for these changes. Understanding the differences will be essential for regulatory compliance during the transition period and will require careful navigation and planning.

How can DLRC help?

The ongoing changes to Type IA variations (and variations overall) represent an important shift in our ways of working in the EU. With an evolving regulatory landscape and stricter, less familiar requirements, MAHs must invest in thorough preparation, appropriate decision-making and proactive submission building in these areas of lifecycle management.

The emphasis on having experienced regulatory professionals available to prepare “right first time” submissions has never been more essential. These specialists can navigate the multitude of technical and procedural requirements, anticipate potential issues, and develop robust strategies for implementation and submission. Their expertise directly translates to protecting patients, ensuring business continuity and maintaining company reputation.

Whether you want to navigate the regulatory requirements or are planning your approach to regulators, our regulatory affairs experts at DLRC can help you succeed.

Contact us at hello@dlrcgroup.com to discover how our experienced team can support your adaptation to these new regulatory requirements and ensure your continued compliance in this evolving regulatory landscape.

Footnotes

* The EU Product Information includes the detailed prescribing information (known as the SmPC), Manufacturing sites, conditions of the MA, product labelling and the Patient Leaflet text

** Chemistry, Manufacturing, and Controls refers to the processes and procedures used to ensure a drug product is consistently produced with the same quality, safety, and efficacy as demonstrated in clinical trials.