{
“@context”: “https://schema.org”,
“@type”: “Article”,
“mainEntityOfPage”: {
“@type”: “WebPage”,
“@id”: “https://www.clinicalstudies.in/sop-for-eu-imp-device-labelling-annex-13-annex-vi-specifics”
},
“headline”: “SOP for EU IMP/Device Labelling (Annex 13/Annex VI) Specifics”,
“description”: “This SOP outlines EU-specific labelling requirements for Investigational Medicinal Products (IMPs) and devices under Annex 13 and Annex VI. It ensures compliance with EMA regulations, multilingual label requirements, batch control, and inspection readiness in clinical trials.”,
“author”: {
“@type”: “Organization”,
“name”: “ClinicalStudies.in”
},
“publisher”: {
“@type”: “Organization”,
“name”: “ClinicalStudies.in”,
“logo”: {
“@type”: “ImageObject”,
“url”: “https://www.clinicalstudies.in/logo.png”
}
},
“datePublished”: “2025-08-26”,
“dateModified”: “2025-08-26”
}
Published on 22/12/2025
Standard Operating Procedure for EU IMP/Device Labelling (Annex 13/Annex VI) Specifics
| SOP No. | CR/OPS/139/2025 |
| Supersedes | NA |
| Page No. | 1 of 80 |
| Issue Date | 26/08/2025 |
| Effective Date | 01/09/2025 |
| Review Date | 01/09/2026 |
Purpose
The purpose of this SOP is to define standardized procedures for labelling Investigational Medicinal Products (IMPs) and medical devices
Scope
This SOP applies to sponsors, packaging and labelling vendors, QA, CROs, and investigators involved in EU clinical trials. It covers IMP and device label content, multilingual translations, expiry date handling, blinding/unblinding, batch-specific labelling, and archiving.
Responsibilities
- Sponsor: Ensures compliance of IMP and device labels with Annex 13/Annex VI and provides approved templates.
- Packaging Vendor: Prints and applies labels as per sponsor’s approved design and regulatory requirements.
- Investigator: Ensures labelled products are stored and dispensed appropriately at site.
- CRO: Oversees vendor activities and supports regulatory submissions of label templates.
- QA: Conducts label verification, audits, and ensures inspection readiness.
Accountability
The Sponsor’s Regulatory Affairs and QA leads are accountable for compliance with EU IMP and device labelling requirements.
Procedure
1. Label Design and Approval
1.1 Draft label templates in accordance with Annex 13 (IMPs) or Annex VI (devices).
1.2 Include mandatory elements: trial reference code, batch/lot number, expiry date, storage conditions, “For Clinical Trial Use Only.”
1.3 Obtain sponsor and QA approval prior to printing.
1.4 Record in Label Template Approval Log (Annexure-1).
2. Multilingual Requirements
2.1 Translate label text into official languages of Member States where trial is conducted.
2.2 Verify translations by certified linguists.
2.3 Document in Translation Verification Log (Annexure-2).
3. Printing and Application
3.1 Print labels with secure, legible fonts and tamper-proof adhesive.
3.2 Apply labels under controlled packaging conditions.
3.3 Document in Label Printing Log (Annexure-3).
4. Batch-Specific Labelling
4.1 Apply batch/lot numbers and expiry dates at packaging stage.
4.2 Maintain traceability in Batch Labelling Log (Annexure-4).
5. Blinding/Unblinding
5.1 For blinded studies, apply labels without disclosing allocation.
5.2 Unblinding procedures must be defined in trial protocol.
5.3 Document in Blinding Control Log (Annexure-5).
6. Quality Control and Verification
6.1 QA verifies label content, alignment, and compliance before release.
6.2 Document verification in Label QC Log (Annexure-6).
7. Archiving
7.1 Archive sample labels, approvals, and batch records in TMF.
7.2 Retain for minimum 25 years per EU CTR requirements.
7.3 Document in Label Archiving Log (Annexure-7).
Abbreviations
- SOP: Standard Operating Procedure
- IMP: Investigational Medicinal Product
- EMA: European Medicines Agency
- EU CTR: Clinical Trials Regulation
- CRO: Contract Research Organization
- QA: Quality Assurance
- TMF: Trial Master File
- MDR: Medical Device Regulation
Documents
- Label Template Approval Log (Annexure-1)
- Translation Verification Log (Annexure-2)
- Label Printing Log (Annexure-3)
- Batch Labelling Log (Annexure-4)
- Blinding Control Log (Annexure-5)
- Label QC Log (Annexure-6)
- Label Archiving Log (Annexure-7)
References
- Annex 13 of Directive 2001/20/EC
- Annex VI of EU MDR 2017/745
- European Medicines Agency (EMA)
- ICH GCP E6(R2)
Version: 1.0
Approval Section
| Prepared By | Ravi Kumar, Regulatory Affairs Specialist |
| Checked By | Sunita Reddy, QA Officer |
| Approved By | Dr. Anil Sharma, Head Clinical Operations |
Annexures
Annexure-1: Label Template Approval Log
| Date | Template ID | Reviewed By | Approved By | Status |
|---|---|---|---|---|
| 01/09/2025 | IMP-LAB-001 | QA | Reg Affairs | Approved |
Annexure-2: Translation Verification Log
| Date | Language | Verified By | Status |
|---|---|---|---|
| 02/09/2025 | German | Linguist | Confirmed |
Annexure-3: Label Printing Log
| Date | Batch No. | Quantity Printed | Printed By | Status |
|---|---|---|---|---|
| 05/09/2025 | B2025-01 | 500 | Packaging Vendor | Completed |
Annexure-4: Batch Labelling Log
| Date | Batch No. | Expiry Date | Applied By | Status |
|---|---|---|---|---|
| 06/09/2025 | B2025-01 | 12/2026 | QA | Released |
Annexure-5: Blinding Control Log
| Date | Study ID | Blinding Status | Controlled By | Status |
|---|---|---|---|---|
| 07/09/2025 | CTR-2025-01 | Double Blind | QA | Active |
Annexure-6: Label QC Log
| Date | Batch No. | Checked By | Status |
|---|---|---|---|
| 08/09/2025 | B2025-01 | QA Officer | Accepted |
Annexure-7: Label Archiving Log
| Date | Batch No. | Archived By | Location | Status |
|---|---|---|---|---|
| 10/09/2025 | B2025-01 | QA Officer | TMF | Archived |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 26/08/2025 | 00 | Initial version | New SOP creation | Head Clinical Operations |
For more SOPs visit: Pharma SOP