Distributor Authorisation by the Certificate Holder under Law 84-12

1. Key takeaways

Article 1, item 11, of Law No. 84-12 defines a medical device distribution establishment as an establishment engaged in the bulk purchase and storage of devices already registered under the Law, for wholesale distribution or retail sale, on condition that it holds the authorisation of the holder of the registration certificate issued under Article 12. In other words, the source of distribution rights in Morocco is the certificate-holder’s authorisation, not an independent licence. Without that authorisation, a distributor’s purchasing and storage activities lack a legal basis, no matter how complete its commercial paperwork may be.

For Chinese manufacturers, this definition converts distributor management into a legal-design exercise rather than a purely commercial one. The appointment letter that grants distribution rights is not just a sales contract attachment; it is the instrument on which the distributor’s regulatory standing depends. Any gap between the commercial reality of the relationship and the written authorisation — unwritten sub-dealers, products outside the authorisation scope, activities after the authorisation has lapsed — creates compliance exposure that surfaces at exactly the wrong time, usually during an inspection or a shipment check.

2. Legal basis

3. Expert insights

Insight 1: The authorisation chain is a single chain running from holder to distribution establishment. The statute embeds the authorisation into the very definition of a distribution establishment, which shows that the legislator views distribution as an extension of the registration certificate. This gives certificate-holders a legal instrument for managing their channels: withdrawing the authorisation cuts off the distributor’s compliance foundation. For manufacturers, the same mechanism cuts both ways — it gives the holder leverage over the channel that the manufacturer does not directly control, which is why authorisation terms need to be addressed in the underlying cooperation agreement.

Insight 2: What a distribution establishment purchases must already be registered. The definition limits the distribution establishment’s activity to the bulk purchase and storage of devices that have been registered under the Law and its implementing texts. Distributing unregistered devices falls outside the definition and contradicts Article 12. This is not a technicality: it means every batch a distributor handles must be traceable to a valid registration certificate, and a distributor that knowingly deals in unregistered product exposes itself to the penalty regime while also undermining the manufacturer’s market position.

Insight 3: Retail of non-medicinal medicinal products remains exclusive to pharmacies. The final paragraph of Article 1, item 11, provides that dispensing to the public of non-medicinal medicinal products within the meaning of Article 4 of Law No. 17-04 (which are treated as devices) is reserved to pharmacists in pharmacies under Article 30 of that Law. This is an overlapping restriction: even with a certificate-holder’s authorisation in hand, the channel for public-facing dispensing remains governed by Law No. 17-04. Consumer-oriented devices in this category cannot simply be routed through ordinary retail; they must follow a pharmacy-based design.

Insight 4: Operating beyond scope triggers Article 43. Article 43 lists among punishable conduct the retail sale to the public, outside pharmacies, of devices falling within the scope of Law No. 17-04, and it expressly states that this does not affect the application of Article 134 of Law No. 17-04 on illegal practice. A distributor that crosses this line therefore faces pressure from both statutes simultaneously. For the manufacturer, the practical consequence is that channel design must respect the statutory boundary between distribution and pharmacy dispensing from the outset, rather than discovering the limit through an enforcement action.

Insight 5: Distribution authorisation and import authorisation are two different things. Import establishments (Article 1, item 9) and distribution establishments (Article 1, item 11) are two distinct declaration types. The same company may declare both, but a company that declared only distribution and then imports is operating beyond its declared scope. When mapping a channel, manufacturers must check which declaration types each partner actually holds, because commercial capability does not substitute for the declared activity type in the AMMPS system.

4. Practical recommendations

1. Design a written authorisation chain document. Have the certificate-holder issue an authorisation letter to each distribution establishment, stating the authorised product scope, term, and territory, signed and retained by both parties.
2. Tie the authorisation letter to the registration certificate. Reference the certificate number in the letter, and update the authorisation in step with any change or expiry of the certificate.
3. Verify the distributor’s declaration type. Confirm in the AMMPS register that the distributor’s declared activities include distribution, and decline cooperation with undeclared parties.
4. Include vigilance and recall cooperation duties in the authorisation letter. Reporting and recall obligations under Articles 25 and 29 require channel cooperation, and the authorisation letter is the instrument that binds it.
5. Route public-facing products through pharmacies. For products constituting non-medicinal medicinal products, design the dispensing channel in line with Article 30 of Law No. 17-04.

5. Verification checklist

• □ A written authorisation letter has been issued by the certificate-holder to the distribution establishment
• □ The authorisation letter states the product scope, term, and territory
• □ The authorisation letter references the registration certificate number with a synchronised update mechanism
• □ The distributor’s declaration type has been confirmed as including distribution in the AMMPS register
• □ The authorisation letter sets out cooperation duties under Articles 25 and 29
• □ Public-facing non-medicinal medicinal products have been channelled per Article 30 of Law No. 17-04
• □ The penalty risk of out-of-scope operation under Article 43 has been assessed

Regulatory information verified as of 30 October 2026

GRZAN supports medical device manufacturers entering the Moroccan market with authorisation chain documentation, distributor vetting against the AMMPS register, and cost budgeting for registration, distribution, and maintenance obligations. For support on the requirements described above, contact info@grzanglobal.com.