Five-Year Validity and Renewal: Article 7 and the EDE’s Official Renewal Service Terms

1. Key takeaways

Article 7 of Federal Decree-Law No. 38/2024 provides that a marketing authorization is valid for 5 years and may be renewed upon expiry; the EDE service page states in step that the certificate is valid for 5 years from the date of approval by the committee. Our judgement is that the 5 years is the validity period of the certificate, not the preparation period of the company. Renewal involves the entity qualifications, the GMP certificate, labelling, vigilance records and a series of other documents that may change within the 5 years, and the lapse of any one of them will slow down the renewal. The consequence of failing to renew in time is not “paperwork pending”, but that after the certificate lapses the product falls back into the unlicensed state under Article 5.

• Article 7 provides a 5-year validity period for marketing authorizations, renewable upon expiry.
• The EDE service page states that the certificate is valid for 5 years from the date of approval by the committee.
• Entity qualifications, GMP certificates, labelling and vigilance records may all change within the five years and affect renewal.
• Failure to renew on time returns the product to the unlicensed state under Article 5.

2. Legal basis

The table below lists the validity provision, the official service terms that operationalise it, and the two independent provisions — on re-approval for major changes and on cancellation — that bound the renewal route from either side.

3. Expert insights

Insight 1: The validity period starts from the “date of approval by the committee”, not from the date of issue or the date of publication. Our judgement is that taking the approval date as the starting point means companies cannot calculate the expiry date from the date they received the certificate. The certificate ledger should record the approval date and reverse-schedule the renewal start from it. The reason is that the official review timeline is 45 working days, to which the time for internal document updates and for processing the certification chain must be added, so the lead time actually required is far longer than the last few months before the 5-year expiry.

Insight 2: The substance of renewal is a re-examination of the eight conditions of Article 6, not a paid extension. Our judgement is that the renewal review will again touch on applicant eligibility (a), the quality and traceability and vigilance systems (b), the GMP certificate (f) and labelling (g). Manufacturing site changes, MAH changes, updates of standard versions and label revisions occurring within the 5 years should therefore be self-checked and aligned before renewal. Leaving those changes to be handled together at renewal turns the renewal into a fresh application.

Insight 3: Article 15 and Article 17 are two risk lines independent of renewal. Article 15 provides that a major change to the product requires re-approval; Article 17 provides the cancellation grounds, including local products not placed on the market within 2 years and within 1 year after approval. Our judgement is that companies often equate “the certificate is valid” with “the operation is compliant”, whereas in reality failure to place the product on the market within the prescribed period likewise leads to cancellation of the certificate. The renewal plan should therefore be scheduled together with the actual sales plan.

4. Practical recommendations

• Record the committee approval date in the certificate ledger, reverse-schedule the renewal start point against the 5-year validity period, and add the official review timeline of 45 working days.
• Before renewal, complete a self-check of the eight conditions of Article 6, focusing on the manufacturing site, the GMP certificate scope and the label version.
• Budget the renewal fees separately on the basis of the official fee schedule (practical estimate: renewal fees of AED 100 + AED 2,500, in about 15 working days).
• Grade changes occurring within the 5 years in advance: major changes go through re-approval under Article 15 and are not folded into the renewal.
• Establish a contingency plan for certificate lapse, specifying the trigger conditions for stopping distribution, display and sale during the unlicensed period.
• Track the Cabinet’s decision on extending the transition period, and treat the extension or non-extension as one of the preconditions of the renewal schedule.

5. Verification checklist

• □ The renewal start time has been reverse-scheduled from the committee approval date, with a 45-working-day review window reserved.
• □ Manufacturing site, MAH, standard-version and labelling changes occurring within the 5-year period have been verified.
• □ It has been confirmed that the GMP certificate remains valid throughout the renewal review and its scope covers the products.
• □ It has been confirmed that vigilance records and post-market follow-up materials can be produced on request.
• □ The grading and handling of major changes under Article 15 have been completed.
• □ The actual market status of the products has been verified under Article 17, ruling out cancellation risk.
• □ The official renewal fee basis has been confirmed and included in the budget (practical estimate: AED 100 + AED 2,500).

Further reading: Article 09 “From Federal Law No. 8/2019 to Decree-Law No. 38/2024: Repeal, Amendment and the Validity of Existing Certificates”; Article 07 “The Eight Statutory Conditions for Obtaining Marketing Approval: Article 6 (a)–(h) Broken Down Item by Item”; Article 45 “Change Management: Notification of Minor Changes and Re-Approval of Major Changes (Article 15)”.

Regulatory information verified as of October 29, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the United Arab Emirates. Our team manages MOHAP registrations and free-zone (DHCC) pathways, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com