AVIDARA · COMPLIANCE INTELLIGENCE · ARTWORK REVIEWCardivex 5 mg [2941657892]
Artwork Review Report
Cardivex 5 mg
Amlodipine besylate 5 mg tablets · Novus Pharma (Pty) Ltd · S3
⚠ Findings Identified — Not Approved for Release
Doc ref: 2941657892Date: 11 April 2026Version: 1.0 — Initial ReviewPI: CARD-PI-2024/01
PRODUCT
Cardivex 5 mg
Amlodipine besylate 5 mg tablets
ARTWORK REVIEWED
Patient Leave-Behind A5
Ref 2941657892 · 2 pages
REFERENCE PI
CARD-PI-2024/01
SAHPRA-approved
REVIEW OUTCOME
Not Approved for Release
2 critical · 4 major · 2 minor
01Executive Summary
This Artwork Review Report was prepared by Avidara for Cardivex 5 mg (Document Reference: 2941657892). The artwork was reviewed against the SAHPRA-approved Professional Information (PI, CARD-PI-2024/01).
A total of 8 findings were identified: 2 Critical, 4 Major, and 2 Minor. Critical findings require immediate correction before this artwork may be released.
Avidara's role is to flag, analyse, and report. The client team reviews all findings, makes them their own, and bears full regulatory accountability for everything acted upon.
This artwork is NOT APPROVED FOR RELEASE in its current form. All Critical and Major findings must be corrected and the revised artwork resubmitted to Avidara for formal re-review before any distribution to healthcare professionals.
02Finding Summary
| # | Severity | Finding | PI Reference | Location |
|---|---|---|---|---|
| 1 | CRITICAL | Scheduling Declaration Absent from Front Cover | PI §5 / GN R510 Reg 11(1)(a) | Front cover — scheduling box area |
| 2 | CRITICAL | INN Prominence Ratio Non-Compliant — 1:4 vs Required 1:2 | PI §5.1 / GN R510 Reg 9(1) | Front cover — product name area |
| 3 | MAJOR | Storage Temperature Deviates from Registered PI | PI §6.4 | Back panel — storage section |
| 4 | MAJOR | Missed Dose Instruction Absent | PI §4.2 | Page 2 — Dosage and directions section |
| 5 | MAJOR | Pregnancy Contraindication and Category Omitted | PI §4.3 / §4.6 | Page 2 — Contraindications section |
| 6 | MAJOR | Disposal Instruction Absent | GN R510 Reg 18 / National Environmental Management | Back panel — general information |
| 7 | MINOR | Batch Number and Expiry Date Order Reversed | GN R510 Reg 11(1)(g)–(h) | Back panel — batch/expiry area |
| 8 | MINOR | Registration Number Format Non-Standard | SAHPRA Labelling Guidelines §3 | Back panel — registration details |
03Document Overview
| Artwork Document | Cardivex 5 mg — Promotional Patient Leave-Behind A5 Leaflet |
| Document Reference | 2941657892 |
| Product | Cardivex 5 mg (Amlodipine besylate 5 mg tablets) |
| Scheduling Status | S3 |
| Registration Number | 35/4.2/0098 |
| Format | A5 leave-behind, 2 pages (front and reverse) |
| MAH / PI Holder | Novus Pharma (Pty) Ltd, 14 Acacia Road, Sandton, Johannesburg, 2196, RSA |
| Reference PI | CARD-PI-2024/01 — SAHPRA-approved (March 2024) |
| Intended Audience | Healthcare professionals (HCPs) — promotional leave-behind |
| Review Date | 11 April 2026 |
| Review Version | 1.0 — Initial Review |
04Detailed Findings
F1
Scheduling Declaration Absent from Front CoverCRITICAL
Front cover — scheduling box area
Observation
The front cover does not display the S3 scheduling declaration. Schedule 3 medicines must carry the scheduling statement prominently on the front face in the prescribed box format per GN R510 Reg 11(1)(a). Omission constitutes a fundamental labelling non-compliance that blocks regulatory approval.
PI / PIL Reference
PI §5 / GN R510 Reg 11(1)(a): The scheduling status must be displayed on the front panel in the prescribed box.
Recommendation
Add the scheduling declaration "S3 PHARMACIST ONLY MEDICINE" to the front cover in the required box format with the prescribed minimum dimensions. Artwork cannot be approved for distribution without this element.
F2
INN Prominence Ratio Non-Compliant — 1:4 vs Required 1:2CRITICAL
Front cover — product name area
Observation
The proprietary name "Cardivex" appears at 24pt while the INN "amlodipine" is rendered at 6pt — a ratio of 1:4. SAHPRA regulations (GN R510 Reg 9(1)) require the INN to appear at a minimum prominence ratio of 1:2 relative to the proprietary name.
PI / PIL Reference
PI §5.1 / GN R510 Reg 9(1): The non-proprietary name must appear with at least half the prominence of the proprietary name.
Recommendation
Increase "amlodipine" to a minimum of 12pt, or reduce the proprietary name until both are at equal prominence. Confirm final sizes with the regulatory team before artwork sign-off.
F3
Storage Temperature Deviates from Registered PIMAJOR
Back panel — storage section
Observation
The leaflet states "Store below 30°C in a dry place." The SAHPRA-approved PI §6.4 specifies "Store below 25°C. Protect from light and moisture." Both the temperature ceiling and the light-protection requirement deviate from the registered storage statement.
PI / PIL Reference
PI §6.4: Store below 25°C. Protect from light and moisture.
Recommendation
Replace with the verbatim PI storage statement: "Store below 25°C. Protect from light and moisture." Do not paraphrase or approximate registered storage conditions.
F4
Missed Dose Instruction AbsentMAJOR
Page 2 — Dosage and directions section
Observation
No instruction is provided for a missed dose. The SAHPRA-approved PI §4.2 includes a specific missed dose statement. Its absence may lead patients to double-dose or to seek incorrect guidance at point of dispensing.
PI / PIL Reference
PI §4.2: If you forget to take Cardivex, take the next dose at the usual time. Do not take a double dose.
Recommendation
Add the missed dose instruction verbatim from PI §4.2. Ensure it is placed immediately after the standard dosage directions, in the same typeface and prominence.
F5
Pregnancy Contraindication and Category OmittedMAJOR
Page 2 — Contraindications section
Observation
Pregnancy is listed as a contraindication in the SAHPRA-approved PI §4.3, and Pregnancy Category C appears in §4.6. Neither element appears in the leaflet. Omission of pregnancy risk information from a patient-facing document is a safety concern and a regulatory gap.
PI / PIL Reference
PI §4.3 / §4.6: Cardivex is contraindicated in pregnancy. Pregnancy Category C.
Recommendation
Add the pregnancy contraindication per PI §4.3 and include the Pregnancy Category C notation per §4.6. Wording must be reviewed by the MAH medical/regulatory team before approval.
F6
Disposal Instruction AbsentMAJOR
Back panel — general information
Observation
No instruction for disposal of unused or expired medicine is included. GN R510 Reg 18 requires patient-facing materials to carry a disposal statement. Its absence may attract a SAHPRA deficiency query.
PI / PIL Reference
GN R510 Reg 18 / National Environmental Management: Waste Act Reg 30.
Recommendation
Add: "Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need."
F7
Batch Number and Expiry Date Order ReversedMINOR
Back panel — batch/expiry area
Observation
The expiry date field is printed before the batch number field. GN R510 Reg 11(1)(g)–(h) places the batch number before the expiry date. SAHPRA reviewers may raise this as a query during formal review.
PI / PIL Reference
GN R510 Reg 11(1)(g)–(h): Batch number precedes expiry date in the prescribed order.
Recommendation
Swap to place "Batch No:" before "Expiry Date:" in the back panel layout. No other changes to the panel are required.
F8
Registration Number Format Non-StandardMINOR
Back panel — registration details
Observation
The registration number is displayed as "REG NO: CARD5/2022" rather than the standard SAHPRA format (e.g., 35/4.2/0098). The "REG NO:" prefix is not part of the approved registration number.
PI / PIL Reference
SAHPRA Labelling Guidelines §3: Registration numbers must appear in the approved format without prefix.
Recommendation
Remove the "REG NO:" prefix and display the number as "35/4.2/0098" only. Verify against the current registration certificate.
05Recommendations
The following actions are required before this promotional material may be approved for distribution to healthcare professionals.
Critical Findings — Mandatory Corrections (must resolve before release)
- →F1: Add the scheduling declaration "S3 PHARMACIST ONLY MEDICINE" to the front cover in the required box format with the prescribed minimum dimensions. Artwork cannot be approved for distribution without this element.
- →F2: Increase "amlodipine" to a minimum of 12pt, or reduce the proprietary name until both are at equal prominence. Confirm final sizes with the regulatory team before artwork sign-off.
Major Findings — Required Corrections (must resolve before release)
- →F3: Replace with the verbatim PI storage statement: "Store below 25°C. Protect from light and moisture." Do not paraphrase or approximate registered storage conditions.
- →F4: Add the missed dose instruction verbatim from PI §4.2. Ensure it is placed immediately after the standard dosage directions, in the same typeface and prominence.
- →F5: Add the pregnancy contraindication per PI §4.3 and include the Pregnancy Category C notation per §4.6. Wording must be reviewed by the MAH medical/regulatory team before approval.
- →F6: Add: "Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need."
Minor Findings — Recommended Improvements
- →F7: Swap to place "Batch No:" before "Expiry Date:" in the back panel layout. No other changes to the panel are required.
- →F8: Remove the "REG NO:" prefix and display the number as "35/4.2/0098" only. Verify against the current registration certificate.
Following correction of all Critical and Major findings, the revised artwork must be resubmitted to Avidara for formal re-review and sign-off before any distribution to healthcare professionals.
06Sign-Off
Reviewed By
Avidara (Pty) Ltd
Compliance Intelligence
Review Date
11 April 2026
Version 1.0 — Initial Review
Outcome
Not Approved for Release
2 critical · 4 major · 2 minor
The findings and recommendations herein are based solely on the SAHPRA-approved PI (CARD-PI-2024/01) as provided for this review. Avidara flags, analyses, and reports. The client team reviews all findings, makes them their own, and bears full legal and regulatory accountability for everything acted upon. This report does not constitute legal or regulatory advice.
This is a sample report for demonstration purposes only. The product name, findings, and references are fictitious and do not represent a real regulatory submission.
Confidential · Avidara (Pty) Ltd · Compliance IntelligenceSample Report — AVI-DEMO-2026
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