Currently, the ALMBIH has officially accepted two electronic submission formats: NeeS and eCTD. Among them, eCTD is gradually being enforced and will become the mainstream direction for future drug registration.
This article integrates the latest Bosnia and Herzegovina eCTD specifications (Version 1.3, effective date: December 4, 2025), and breaks down the core points one by one, including the eCTD implementation plan, scope of coverage, differences from EU eCTD, document requirements, submission methods, and baseline submission requirements，etc.
I. Bosnia and Herzegovina eCTD Implementation Plan
The implementation of Bosnia and Herzegovina eCTD is carried out in phases, with the following clear timelines:
• August-October 2025: Launch a pilot project, select some pharmaceutical companies to test the eCTD submission process, collect internal and external feedback for system optimization;
• January 2026: Complete system updates and officially put it into operation to ensure the smoothness of the eCTD submission portal;
• Starting from February 1, 2026: eCTD format is mandatory for initial registration;
• February 1, 2026 - January 31, 2031: Transition period. For already approved drugs, or drugs for which initial registration applications were submitted before February 1, 2026, either NeeS or eCTD format can be used for submission. During the transition period, pharmaceutical companies must complete eCTD baseline submission (once submitted, it is no longer allowed to revert to NeeS format), which must be completed by January 31, 2031 at the latest, or simultaneously during the renewal procedure within the transition period.
II. Scope of Coverage and Exemption Types of eCTD Technical Specifications
Scope of Coverage
Applicable only to human medicinal products, covering all types of human medicinal products (prescription/non-prescription, innovative/generic drugs, chemical drugs, biotechnological, herbal medicines, homeopathic medicinal products, vaccines, blood and plasma-derived medicinal products, etc.);
Covers all types of applications related to drug regulation, including initial marketing authorization, renewal, variation, transfer, withdrawal/revocation, Periodic Safety Update Report (PSUR), Active Substance Master File (ASMF), etc.
Exemption Types
The following documents are not applicable to the eCTD format, and ALMBIH will not accept eCTD submission of such documents: scientific advice documents, clinical trial-related documents, Paediatric Investigation Plan (PIP) submission documents, and other contents that do not constitute CTD documents.
III. Key Differences from EU eCTD
Bosnia and Herzegovina eCTD is based on EU eCTD specifications with additional exclusive requirements. The core differences are as follows:
• Additional Codes: New exclusive country code for Bosnia and Herzegovina "ba" (ISO-3166-1-alpha-2), language codes "bs (Bosnian)" and "sr (Serbian)" (ISO 639-1), and agency code "BA-ALMBIH" (Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina);
• File Naming: The prefix of core XML, DTD, MOD and other files is changed from "eu-" in EU specifications to "ba-", such as ba-regional.xml, ba-regional.dtd, ba-envelope.mod, etc.;
• Validation Rules: On the basis of EU eCTD Validation Criteria v8.2, additional exclusive validation rules for Bosnia and Herzegovina are added (including file checksum requirements);
• Root Folder Naming: Must be named with the "Internal SZL Application Reference Number" (Serbian: Interna šifra SZL zahtjeva). The SZL number must be obtained from the corresponding application on the ALMBIH e-Portal.
IV. Requirements for Working Documents Folder
The specifications clearly define the requirements for working documents, as follows:
• Content to be Stored: Including documents related to legal status (court registration certificate, representation agreement, approval document from the Ministry of Foreign Trade and Economic Relations, insurance policy, documents related to responsible persons, etc.), editable format (Microsoft Word) Summary of Product Characteristics (SmPC), Package Leaflet (PIL), and packaging mock-ups, etc.;
• Folder Naming: The format is "000N_workingdocuments", where "000N" corresponds to the eCTD sequence number;
• Subfolder Requirements: Documents representing legal status must be placed in the "ba/legalnost_zastupnika" (Serbian, meaning "Legal Status of Representative") subfolder, and the file name must clearly identify the content of the document (for example, regentproof-var.pdf is the applicant's court registration certificate);
• Special Requirements: Editable format documents such as SmPC and PIL must be submitted separately and shall not be included in the eCTD sequence. If the same document includes multiple dosage forms/pack sizes, the file name must clearly distinguish the corresponding drug information (for example, smpc-wonderpil30mgtablete.doc).
V. Validation Requirements
Technical validation is a necessary link for eCTD submission, and the core requirements are as follows:
• Validation Basis: Based on EU eCTD Validation Criteria v8.2, combined with exclusive validation rules for Bosnia and Herzegovina;
• Mandatory Requirement: Applicants must complete technical validation on their own before submission to ensure that the documents comply with all specifications;
• Submission of Validation Report: The technical validation report must be placed in the "000N-validationreport" folder (where "000N" corresponds to the eCTD sequence number), supporting PDF, RTF, HTML, and MHTML formats;
• Key Validation Points: File naming compliance, file checksum matching, validity of DTD/stylesheet references, consistency of sequence numbers, etc.
VI. Special Requirements for File Naming
In addition to following the relevant naming rules of EU eCTD, Bosnia and Herzegovina eCTD has the following exclusive requirements:
• Module 1 Files:
- Cover Letter: Placed in the "m1/eu/10-cover/ba/" folder, named in the format of ba-cover.pdf;
- Application Form, Proof of Payment, etc.: Placed in the "m1/eu/12-form/ba/" folder, named in the format of ba-form-annex-xxx.pdf (xxx is the file type, such as application form requestform, proof of payment proofpayment, etc.);
• Additional Documents (such as DMF Authorization Letter, CEP Certificate, etc.): Placed in the "m1/eu/additional-data/ba/" folder, named in the format of ba-additionaldata-xxx-var.pdf (xxx is the file type suffix, such as DMF Authorization Letter dmfletter, CEP Certificate cosas, etc.);
• Bosnia and Herzegovina Exclusive Files: Must be named with the "ba-" prefix (such as ba-regional.xml, ba-envelope.mod), and the file checksum must be consistent with the value specified in the specifications (for example, the checksum of ba-regional.dtd is becaf0ff98f817421936c0c939168abf).
VII. Submission Method
eCTD submission must strictly follow the following processes and requirements:
• Exclusive Submission Channel: Submitted through the ALMBIH e-Portal;
• Submission Specifications: A single ZIP file can only contain one eCTD sequence, and the sequence number must be consecutive (0000, 0001, 0002...), and no number may be skipped;
• Pre-requisite: The electronic documents must be scanned for viruses before submission to ensure no security risks;
• Other Requirements: The application form, cover letter, and proof of payment must be submitted in paper form at the same time, and the content of the electronic version must be consistent with the paper version. It should be noted that if NeeS or other non-eCTD formats were used for previous submissions, the baseline submission must be completed first when transitioning to the eCTD format. The specific requirements are as follows.
VIII. Requirements for Baseline Submission
Baseline Submission is a core link in transitioning from NeeS format to eCTD format, which must strictly comply with ALMBIH specifications. The specific requirements are as follows:
• Submission Pre-requisite: When transitioning from NeeS or other non-eCTD formats to eCTD format, the baseline document must be submitted first as the new starting point of the drug's eCTD life cycle. Once submitted, it is no longer allowed to revert to NeeS format;
• Content Requirements: The baseline document must include the complete file previously submitted for the drug, ensuring that all documents are approved and valid versions, and no new or unapproved content is included;
• Submission Specifications: The baseline submission must be submitted as an independent sequence. In the envelope, the submission unit type must be set to "reformat", the submission type to "none", and the sequence number must follow the consecutive rule;
• Submission Time Limit: The baseline submission must be completed within the transition period (February 1, 2026 - January 31, 2031), at the latest by January 31, 2031, or simultaneously during the renewal procedure within the transition period, to ensure smooth connection with subsequent eCTD sequences and avoid affecting subsequent application submissions.
💡 Summary: Bosnia and Herzegovina eCTD Update: Version 1.3 Now Effective
To ensure smooth submissions and avoid delays, please align with the latest Bosnia and Herzegovina eCTD specification (Version 1.3). Prepare your dossier structure early and complete technical validation to prevent non-compliance issues.
📢 Professional Support for Compliant Submissions
BrilliantMed brings more than ten years end-to-end experience in EU eCTD and Bosnia and Herzegovina NeeS to help you submit with confidence. Our core team - drawn from Fortune 500 companies such as Bayer - has over 15 years of industry expertise and deep knowledge of Bosnia and Herzegovina and EU regulatory requirements.
Our one-stop compliance services include:
eCTD document formatting and lifecycle management
Technical validation and error resolution
Baseline submissions and transition planning
Submission process guidance and publisher support
With BrilliantMed, you can:
Rapidly adapt to Bosnia and Herzegovina eCTD v1.3 requirements
Minimize compliance risks and avoid application delays
Accelerate registration timelines and market access
Whether you’re converting during the transition period, filing an initial registration, or managing post-approval variations, BrilliantMed provides end-to-end support to keep your Bosnia and Herzegovina regulatory pathway on track.
Ready to streamline your submission? Contact BrilliantMed for tailored guidance and a compliant, efficient path to approval.