Exceptional Authorisation for Urgent Public Health Needs: Article 21

1. Key takeaways

Article 21 of Law No. 84-12 provides that where public health requires it and the circumstances are urgent, the competent health authorities may grant exceptional authorisation for medical devices to be placed on the market and put into use without waiting for the registration procedure of Article 14 to be completed, provided that the manufacturer or importer can demonstrate that the device has been verified for efficacy, quality and safety under the conditions of its normal use. This is a release-first, register-later channel: the trigger sits with the government, and the burden of proof sits with the company.

The article is best understood as an emergency valve rather than a market entry route. Because the triggering conditions are assessed by the authorities and cannot be self-declared, the only element a company can genuinely control is the quality of its evidence package. Preparation therefore concentrates on that single controllable element.

The evidence requirement deserves particular attention. Verification of efficacy, quality and safety under normal use conditions is not satisfied by marketing brochures or by the mere existence of a certificate elsewhere. It calls for documented verification against defined performance claims, quality system evidence and safety data that reflect real conditions of use. Because the exceptional authorisation, if granted, will later be examined alongside the conventional registration file, the same evidence should be prepared once and reused in both procedures, with consistent wording and consistent scope. Companies that assemble the package in advance also protect themselves against the most dangerous scenario under this article: being asked to demonstrate verification after the devices are already needed, when there is no time left to collect it.

2. Legal basis

3. Expert insights

Insight 1: Three conditions must all be present. The structure of the provision is: where the needs of public health so require, plus in urgent circumstances, plus subject to the manufacturer or importer demonstrating that the device has been verified for efficacy, quality and safety under the conditions of its normal use. The first two are judgments made on the government side; the third is an evidentiary burden borne by the company. Since the company controls only the third element, all preparation should be concentrated on it.

Insight 2: Article 21 and the specific authorisations of Article 13 are not the same road. Article 13 addresses six defined situations (research, individual patients, refurbishment for export, custom-made devices, evaluation samples and exhibition samples), with conditions and procedures fixed by regulation. Article 21 addresses urgent public health needs and is decided case by case by the government authorities. The former is predictable, the latter is not. Companies should never treat Article 21 as a routine acceleration tool for commercial timelines.

Insight 3: Exceptional authorisation does not waive subsequent registration. The provision authorises placing on the market and putting into use while awaiting completion of the registration procedure laid down in Article 14. Exceptional authorisation is therefore a temporary status, and the conventional registration obligation continues to exist. After obtaining an exceptional authorisation, the company must still push the registration forward and cannot remain in the temporary state.

Insight 4: Breach of Articles 21 and 22 is among the heavily sanctioned offences. Article 44 includes placing on the market or putting into use in violation of Articles 21 and 22 among the infringements sanctioned as a percentage of turnover. A company that decides for itself that circumstances are urgent and markets a device without government authorisation does not enjoy the protection of Article 21 at all.

Insight 5: The evidence can be prepared in advance. What must be demonstrated is the verification of efficacy, quality and safety, expressly under the conditions of normal use. Existing CE certificates, ISO 13485 certificates, third-party test reports, marketing approvals in the country of origin and usage records can all form part of the evidentiary basis. GRZAN recommends assembling these in advance into a single emergency authorisation evidence package that can be submitted immediately when needed.

Insight 6: Article 21 and Article 22 form the emergency perimeter of the law. Article 44 groups breach of Article 21, the exceptional authorisation, together with breach of Article 22, the donation regime, in the same tier of turnover-based sanctions. Both provisions carve out limited, tightly conditioned side doors from the ordinary registration system built on Articles 12 and 14. The pairing is deliberate: emergency releases and humanitarian donations both operate outside the certificate, and both depend on dated filings, documented verification and traceable records to stay on the lawful side of the perimeter. A company operating in Morocco should treat these clauses as narrow exceptions to be used with care and full documentation, never as alternative market entry strategies running alongside a conventional launch plan.

4. Practical recommendations

1. Do not rely on Article 21 for commercial scheduling. Treat it as a supplementary channel for sudden public health needs, and keep conventional projects moving under the registration procedure of Article 14.
2. Prepare the evidence package in advance. Assemble verification materials on efficacy, quality and safety into a single document set that can be submitted at once, including versions in French or Arabic.
3. Apply through the licensed site. The evidentiary subjects under Article 21 are the manufacturer or the importer; in practice, the Moroccan licensed site should submit the application, attaching the manufacturer evidence.
4. Push the conventional registration in parallel after approval. Set internal milestones so that the exceptional authorisation does not expire before registration is completed.
5. Archive the complete chain of approval documents. The exceptional authorisation is key evidence of compliance going forward and must be filed completely.

5. Verification checklist

• □ It has been confirmed that the situation genuinely combines public health need and urgent circumstances
• □ Verification materials on efficacy, quality and safety have been prepared
• □ The evidence covers verification under the conditions of normal use
• □ The licensed site has been designated as the submitting entity
• □ The conventional registration procedure of Article 14 has been initiated in parallel
• □ The exceptional authorisation documents have been archived completely
• □ The risk under Article 44 of marketing without authorisation has been assessed

GRZAN support for the Moroccan market. GRZAN helps manufacturers assess whether an emergency situation could engage Article 21, assembles emergency authorisation evidence packages, and manages the transition from exceptional authorisation to conventional registration in Morocco. For support with registration pathways and classification strategy, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of 30 October 2026