Armenia Shelf Life, Stability and Transport Validation: EAEU Evidence Requirements

1. Key takeaways

Shelf life, stability and transport validation are not optional items under the union rules; they are direct demonstrations of the general requirements. Article 5 of Decision No. 27 (no impairment of performance during transport and storage), Article 7 (no degradation of characteristics within the service life) and the labelling requirements (the period must be stated as year and month) together form three hard constraints. The GRZAN conclusion is that rejection reasons cluster around 3 points: the validity period is not stated in the required format, the stability data do not cover the claimed period, and the transport validation scenarios do not match the declared storage conditions.

2. Legal basis

3. Expert insights

Insight one: Article 5 is the substantive legal basis for transport and storage validation. The article requires that the design, manufacture and packaging of a medical device be such that its characteristics and performance are not impaired during transport and storage carried out as instructed. The GRZAN observation is that this clause binds transport validation to the instructions for use: the validation scenarios must cover every transport and storage condition declared in the instructions. If a cold chain is declared, cold chain validation must be performed; if protection from light is declared, corresponding validation must exist.

Insight two: Article 7 is the substantive legal basis for shelf-life and stability validation. The article requires that, within the service life determined by the manufacturer, the performance characteristics and effectiveness of the device do not change to a degree that endangers the life or health of users or third parties, on the premise that the device is subject to the influences that may occur under normal working conditions and is maintained as instructed. The GRZAN observation is that Article 7 also pulls maintenance into the equation: for devices declared to require periodic maintenance or calibration, the stability argument must cover the maintenance intervals.

Insight three: the validity period on the label carries a precise format requirement. Under the labelling requirements of Decision No. 27, the label must state the period during which the device can be used safely, as year and month; where that period is not stated, the year of manufacture must be stated, and it may be embedded in the batch code or serial number provided the year is easily identifiable as part of the number. The GRZAN observation is that stating only the year without the month, or using a batch code in which the year cannot be identified, are both common format-based rejection reasons.

Insight four: special storage conditions must appear on the label. The label must also state information on special storage and/or handling conditions where needed. The GRZAN observation is that whenever the instructions for use declare special storage conditions — a range of 2 to 8 degrees Celsius, a relative humidity ceiling, protection from light — the label must reflect them; otherwise the dossier contains an inconsistency between the label and the instructions.

Insight five: these three documents carry the highest cost of a mid-review rejection. Under Article 14 of Decision No. 46, the time the applicant takes to respond to a request for corrections is not counted within the authority’s review clock. The GRZAN observation is that stability and transport validation are long-cycle, non-compressible studies; if they must be performed after a review request, the total project timeline can extend by several months. All three items must therefore be finished before submission (practical estimate: the remediation period depends on the product and the test plan).

4. Practical recommendations

1. Map every declaration to a validation: build a cross-reference table pairing each storage and transport declaration in the instructions for use with the corresponding section of the validation report.
2. Format the validity period correctly: always state the period as year plus month on the label, and where the year of manufacture is folded into the batch number, make sure it remains identifiable.
3. Cover the claimed period with stability data: the duration covered by real-time stability data must not be shorter than the claimed shelf life.
4. Bring maintenance into the argument: for devices requiring periodic maintenance or calibration, cover the maintenance intervals and post-maintenance performance in the stability argument.
5. Finish before submission: keep stability and transport validation off the complete-it-later list, so the review clock never stops on these grounds.

5. Verification checklist

1. □ Transport and storage validation under Article 5 is complete, with scenarios covering every declared condition in the instructions for use.
2. □ Shelf-life and stability validation under Article 7 is complete, with data covering the claimed period.
3. □ The safe-use period is stated in the year-plus-month format.
4. □ The label states special storage and/or handling conditions where applicable.
5. □ The storage conditions on the label and in the instructions for use are consistent.
6. □ For devices needing maintenance or calibration, the stability argument covers the maintenance intervals.
7. □ All three document sets are complete before submission and none is on the remediation list.

Regulatory information verified as of October 30, 2026.

GRZAN supports manufacturers and authorised representatives with shelf-life, stability and transport validation documentation for the Armenian market, from declaration-to-validation mapping and label format audits to pre-submission readiness reviews. For tailored assistance with your Armenia medical device documentation, contact us at info@grzanglobal.com.