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“headline”: “SOP for EU IMP/Device Labelling (Annex 13/Annex VI) Specifics”,
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Standard Operating Procedure for EU IMP/Device Labelling (Annex 13/Annex VI) Specifics

Purpose

The purpose of this SOP is to define standardized procedures for labelling Investigational Medicinal Products (IMPs) and medical devices in compliance with European Union requirements under Annex 13 of Directive 2001/20/EC and Annex VI of the EU Medical Device Regulation (EU MDR 2017/745). This ensures subject safety, trial integrity, and regulatory compliance.

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

1. Label Template Approval Log (Annexure-1)
2. Translation Verification Log (Annexure-2)
3. Label Printing Log (Annexure-3)
4. Batch Labelling Log (Annexure-4)
5. Blinding Control Log (Annexure-5)
6. Label QC Log (Annexure-6)
7. 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

Annexures

Annexure-1: Label Template Approval Log

Annexure-2: Translation Verification Log

Annexure-3: Label Printing Log

Annexure-4: Batch Labelling Log

Annexure-5: Blinding Control Log

Annexure-6: Label QC Log

Annexure-7: Label Archiving Log

Revision History

For more SOPs visit: Pharma SOP