Dossier Writing
- Clinical and Nonclinical Overviews/Summaries (Modules 2.4/2.5/2.6/2.7)
- Quality Overall Summaries (Module 2.3) and Module 3 sections
- Active substance master file (ASMF) and drug master file (DMF)
- Addendums to Clinical Overview
- Clinical Overviews / Expert Reports to support classification change (Rx to OTC switch)
- Summaries of product characteristics (SPCs) and Package Leaflets (PL)
- Package Leaflet Readability User Testing (RUT) or Bridging Reports (Module 1.3.4)
- Risk Management Plans (1.8.2)
- CMC Amendments
- Normative documents (for CIS countries)
- 50+ Clinical/Nonclinical overviews written
- 50+ Quality overall summaries written
- 50+ PL Readability user tests/bridging reports performed
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What are the timelines for developing Clinical and Nonclinical Overviews/Summaries (Modules 2.4/2.5/2.6/2.7)?
We can typically develop Clinical and Nonclinical Overviews and Summaries (Modules 2.4/2.5/2.6/2.7) within 3-5 weeks. This timeline ensures thorough analysis and high-quality documentation that meets regulatory standards while being efficient to support your product's development and submission schedule.
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What is required for an Rx to OTC Classification Change?
To succeed in an Rx to OTC classification change, you need to ensure that the product is suitable for self-diagnosis, has a strong safety profile, and poses minimal risk for misuse. Sufficient post-marketing experience, appropriate packaging, clear patient information, and an easy-to-use dosage form are also critical. Thoroughly analyzing market conditions, local policies, and preparing robust clinical documentation can increase the chances of a successful switch. Engaging experienced professionals can further enhance your submission's success.
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When can I use a Bridging Report (Module 1.3.4) and not do a full Package Leaflet Readability User Testing (RUT)?
We can prepare Bridging Reports (Module 1.3.4) when minor changes have been made to a previously tested leaflet, helping you avoid the need for full Readability User Testing. The Bridging Report should demonstrate that the differences between the two leaflets do not impact the readability and comprehension of the new leaflet. This approach can save time and resources (and cost) if the changes are minor and do not affect user understanding.
For more details, please contact us for advice. -
What is the deadline for EAEU MAA upgrade (bringing dossiers into compliance) procedure?
Effective January 1, 2026, all registration certificates for medicinal products registered under national legislation will be annulled if they do not comply with the Eurasian Economic Union (EAEU) requirements. Currently, a transitional period is in effect in EAEU countries, concluding on December 31, 2025. During this period, medicinal products registered under the legislation of EAEU member states must be brought into alignment with the Union's requirements and regulations.
Perpetual registration certificates issued under national procedures will also remain valid only until December 31, 2025. By this date, the registration dossiers for medicinal products, which were prepared according to member states' legislation, must be updated to comply with the Union's requirements.