Conditional Marketing Authorization and Emergency Use Authorization: Scope of Articles 8-13

1. Key takeaways

Articles 8 to 10 provide for conditional marketing authorizations, and Articles 11 to 13 provide for emergency use authorizations. Both are entry points outside the regular route, but their natures differ. Our judgment is that the conditional marketing authorization serves products whose evidence is still incomplete but whose clinical value is clear, at the price of a validity period of only 1 year under Article 10(1), with the evidence gap having to be closed within that period. The emergency use authorization serves states of emergency; it is not a regular commercial channel, and companies should not treat it as the default way to shorten time to market.

• Articles 8 and 9 define the situations in which a conditional marketing authorization applies and the mechanism for its approval.
• Under Article 10(1), the validity period of a conditional marketing authorization is 1 year, in sharp contrast with the 5-year validity of a regular marketing authorization.
• Articles 11, 12 and 13 govern the granting, conditions and termination of emergency use authorizations, which are tied to public health emergencies rather than commercial scheduling.
• Vigilance duties under Article 21(6) apply to both routes once the product enters use, alongside the Article 22 entity arrangements.

2. Legal basis

The conditional and emergency routes rest on Articles 8 through 13 of Federal Decree-Law No. 38/2024, together with the downstream obligations in Articles 21 and 22, summarised below.

3. Expert insights

Insight 1: A 1-year validity period means the route must carry its own conversion plan. Article 10(1) sets the validity of the conditional marketing authorization at 1 year, in sharp contrast with the 5-year validity of a regular marketing authorization. We therefore require clients to lay out a timetable for closing the evidence gaps at the application stage itself: if the 1-year term expires with the conditions unmet, the product faces the real risk of being withdrawn from circulation, and inventory and signed orders are affected in a chain reaction.

Insight 2: Conditional does not mean discounted conditions. Among the conditions for obtaining an authorization listed in Article 6(1)(a) through (h), applicant eligibility, the quality and traceability system, the GMP certificate and labelling compliance are not waived or reduced because the route is conditional; what is reduced or deferred is the completeness of the evidence. Our judgment is that reading conditional as a discount on the full set of conditions is a common misreading, and in practice filings more often stumble over applicant eligibility under item (a) and the GMP certificate under item (f).

Insight 3: The downstream obligations of an emergency use authorization are easily underestimated. Articles 11 to 13 are designed for emergency situations, but once the product enters use, the vigilance obligations of Article 21(6), the lead responsible entity arrangements of Article 22 and the whole-lifecycle management requirements apply immediately. On our projects we hold to one principle: before taking the emergency route, confirm that the lead responsible entity and the vigilance contact are already in place, because without them an authorization in hand still cannot be used to supply the market lawfully. The Executive Regulations have not yet all been issued, and the specific conditions and procedures should be confirmed in writing with EDE.

4. Practical recommendations

• Judge the applicable entry point first: products with incomplete evidence but clear value take Articles 8 to 10; only public health emergency situations should consider Articles 11 to 13.
• When applying for a conditional authorization, submit the evidence completion plan at the same time, fixing the completion date of each data item in line with the 1-year validity period.
• Prepare in advance the material bridge for converting to a regular marketing authorization, including the Article 6(1)(c) reference-country evidence and the Class III and IV safety and effectiveness data.
• Designate the lead responsible entity before applying, and write the vigilance and post-market follow-up responsibilities into the written arrangements with importers and distributors.
• Obtain written confirmation from EDE on the conditions, procedures and specific requirements for conversion to the regular route, rather than waiting for the Executive Regulations to be issued and remedying afterwards.
• Design inventory and supply plans around the 1-year validity period, so that goods still in transit do not face clearance problems when the certificate expires; import licences are valid for 2 months from the date of issue.

5. Verification checklist

• □ It has been confirmed whether the product falls under Articles 8 to 10 or Articles 11 to 13, with the reasons stated clearly in the filing explanation.
• □ The evidence completion plan for the conditional marketing authorization is scheduled, with completion dates falling before the 1-year validity period expires.
• □ Evidence is in place item by item for the conditions of Article 6(1)(a) through (h) that are not waived.
• □ The lead responsible entity has been designated, and the responsibility interfaces for vigilance and post-market follow-up are agreed in writing.
• □ A written response from EDE has been obtained on the conditions of the route and the conversion procedure.
• □ Inventory, orders and import licence arrangements are matched to the certificate validity, with import licences valid for 2 months from the date of issue.

Regulatory information verified as of 29 October 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 registration applications, prepares reference-approval dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com