Interface between the Devices Law and the Medicines and Pharmacy Code

1. Key takeaways

The interface between Loi n° 84-12 and the Medicines and Pharmacy Code (Loi n° 17-04, promulgated by Dahir n° 1-06-151 on November 22, 2006) runs along three main lines. First, the products other than medicinal products defined under Article 4 of Loi n° 17-04 are regulated as medical devices. Second, Article 51 of Loi n° 84-12 repeals Chapter III of Book I of Loi n° 17-04, the old device-registration regime. Third, the dispensing of such products to the public is reserved exclusively to pharmacists in pharmacies. For any borderline product, the routing question comes first: determine whether the item falls within the Article 4 category of products other than medicinal products, because that single determination decides whether the registration track is the device track and whether a parallel pharmacy channel must be organized for retail. A product can be perfectly registered as a device and still be unsellable through the intended retail channel if this analysis is skipped, which makes the interface one of the highest-leverage checks in the entire Moroccan project.

2. Legal basis

Two laws form the interface, and the table identifies the provisions on each side that touch one another. The device law cites the drug law by name in its own definitions, which is why both texts must be held open together.

3. Expert insights

Insight 1: Loi n° 17-04 does not exit the device field wholesale. Article 51 of the device law repeals only Chapter III of Book I, the chapter that housed the former device-registration regime; the rest of the code continues to apply. The cross-referencing runs deep: item 11 of Article 1 of Loi n° 84-12 defines the distribution establishment by direct reference to Article 4 of Loi n° 17-04, showing that the two statutes are joined at the data level, not merely at the level of subject matter. Any compliance analysis that reads the device law alone is therefore structurally incomplete, because the operative definitions and several retail-side constraints live on the drug-law side of the boundary.

Insight 2: Products other than medicinal products have a dual identity. Article 2 of Loi n° 84-12 treats the products defined under Article 4 of Loi n° 17-04 as medical devices subject to device registration; but item 11 of Article 1 simultaneously provides that the dispensing of such products to the public is reserved exclusively to pharmacists in pharmacies, as organized by Article 30 of Loi n° 17-04. The combined result is a split retail architecture: registration runs through the device track, retail runs through the pharmacy track. A company can complete device registration successfully and still find its e-commerce or general-retail plan unlawful if it has not designed the pharmacy channel that the drug law requires for public dispensing.

Insight 3: Penalties cross the boundary between the two laws. The final paragraph of Article 43 of Loi n° 84-12 provides that retail sale to the public of devices falling within the scope of Loi n° 17-04 outside pharmacies is penalized under Article 43, and that this does not affect the application of Article 134 of Loi n° 17-04 on unlawful professional practice. A company that bypasses the pharmacy channel and sells direct therefore triggers both statutes at once, facing the device-law fine structure and the drug-law offense of unlawful practice in the same transaction. Compliance design for the retail stage must clear both tests, not just the device test.

Insight 4: The routing test for combination products is hard-coded in Article 2. Where a device and a medicinal product form an integral product intended to be used solely in the manner shown and not reusable, the product is a medicinal product and follows Loi n° 17-04; otherwise the device component remains on the device track, with the parts following their respective procedures under Article 20. This two-prong test — integral use and non-reusability — determines whether the project faces one submission or two, and it should be answered in writing before budgeting begins.

4. Practical recommendations

1. Check Article 4 of Loi n° 17-04 first for every borderline product. Establishing whether the product is one of the products other than medicinal products is the first step in determining the registration path, ahead of any classification work.
2. Set up the retail channel as a separate workstream. If the product qualifies as a product other than a medicinal product, a pharmacy channel must be designed independently of the ordinary device distribution plan.
3. Apply the integral-use and non-reuse test to combination products. If both conditions are met, file as a medicinal product; if not, run the device and the drug through their respective procedures (Article 20).
4. Assess penalties across both laws. Retail-stage compliance must satisfy Article 43 of Loi n° 84-12 and the relevant provisions of Loi n° 17-04 together, and the risk register should show the two exposures side by side.

5. Verification checklist

• □ Whether the product falls within the products other than medicinal products under Article 4 of Loi n° 17-04 has been confirmed
• □ The scope of the repeal in Article 51 has been confirmed as limited to Chapter III of Book I of Loi n° 17-04
• □ Whether the retail stage is subject to the pharmacy monopoly of Article 30 of Loi n° 17-04 has been confirmed
• □ For combination products, the integral-use and non-reusability determination has been completed
• □ The combined exposure under Article 43 and Article 134 of Loi n° 17-04 has been assessed
• □ The internal regulatory map marks the interface points between the two laws
• □ It has been confirmed that the distribution establishment requires authorization from the registration certificate holder (Article 1, item 11)

Regulatory information verified as of October 30, 2026. GRZAN supports manufacturers with borderline and combination-product analysis across Loi n° 84-12 and Loi n° 17-04, registration routing, and retail-channel compliance design for Morocco. For project inquiries, contact info@grzanglobal.com.