Peru Registration Holder and D.S. N° 020-2024-SA: Holder and Distribution Decoupling Outlook

Regulatory information verified as of October 29, 2026

1. Key takeaways

Until the original text published in El Peruano is obtained, the record of D.S. N° 020-2024-SA concerning the decoupling of registration ownership from commercial distribution can only be treated as pending verification industry information and cannot serve as the sole legal basis for transaction structuring. What can currently be confirmed about holder-import arrangements remains governed by D.S. N° 016-2011-SA (Reglamento para el Registro, Control y Vigilancia Sanitaria de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios, published on 2011-07-27): the registration holder (Titular del Registro Sanitario / Peru Registration Holder, PRH) holds the registered status over the sanitary registration (Registro Sanitario, RS), while import and distribution rely on the respective facility authorizations of qualified pharmaceutical establishments (Establecimientos Farmacéuticos). This separation of registered ownership from physical import capability is precisely why distribution agreements in Peru must be drafted with attention to both the registry layer and the facility-authorization layer, because control of one layer does not automatically deliver control of the other. Any commercial model built on the reported decree should therefore be structured in two independent layers: a registry layer anchored on D.S. N° 016-2011-SA, and a contractual layer that remains valid regardless of how the administrative framework evolves.

2. Legal basis

Regulatory information verified as of October 29, 2026. The number, publication date, and article content of D.S. N° 020-2024-SA have not been retrieved from the official registry in original text and are marked pending verification.

3. Expert insights

Insight one: the so-called decoupling, when unpacked, consists of two separate things. Secondary sources describe D.S. N° 020-2024-SA as a 2024 Supreme Decree amending D.S. N° 016-2011-SA, with the effect of allowing an independent PRH to hold the registration while other qualified Droguerías (wholesale distributors) may separately obtain a Certificado de Registro Sanitario (CRS) to import the same registered product. Mechanically, it changes the default structure of one product mapped to one licensing chain: registration ownership stays with the brand owner or its designated PRH, while commercial distribution rights can be deployed in parallel across multiple importing entities. GRZAN stresses that this description is pending verification and must not be written into project documents as a settled conclusion.

Insight two: if the decoupling holds, the legal basis of exclusivity shifts from registry exclusivity to contractual exclusivity. Under the current framework, controlling the import pathway mainly means controlling the registration record itself. Once multiple Droguerías can each obtain a CRS for the same registered product, exclusivity can only be maintained through distribution agreements, trademark licenses, and supply terms. This moves the negotiation focus forward from who holds the license to how the contract locks in protection, and it makes remedies for breach depend more on civil avenues than on administrative registration.

Insight three: the decoupling does not change the qualification threshold for the holding entity. Even if importing entities diversify, the entity applying for the sanitary registration must still be a pharmaceutical establishment holding a Droguería or Laboratorio license. The restriction that foreign manufacturers cannot hold registrations directly has not been lifted by the changes described in secondary sources. What is being decoupled is the relationship between the registration holder and the distribution entities; the entity-qualification threshold itself is not relaxed.

Insight four: registry data provide a real-world reference point. According to statistics derived from the official DIGEMID registry (Category C data, extracted on 2025-02-14), 28,819 valid registrations correspond to 1,688 registration holders from 68 countries of origin. Holder concentration is higher than manufacturer concentration (6,316 manufacturers), which indicates that a small number of entities carrying a large number of products remains the mainstream structure. This is consistent with the direction described by the decoupling reports, but it cannot conversely be used as proof that the reports are accurate. Concentration of this kind also has an operational side effect: a single holding entity’s compliance failure can simultaneously affect a large portfolio of products from unrelated manufacturers, which is why entity-level due diligence matters more in Peru than in markets with higher holder fragmentation.

4. Practical recommendations

1. For any transaction structure involving D.S. N° 020-2024-SA, mark the relevant provisions as pending verification in contracts and filing documents, and simultaneously verify the current text through the official DIGEMID platform.
2. Design transfer and holding arrangements for current projects under Art. 8 of D.S. N° 016-2011-SA, without presuming parallel holding by multiple entities.
3. In distribution agreements, tie exclusivity, channel allocation, remedies for breach, and changes in registration status together, so that commercial exclusivity does not rest on administrative registration alone.
4. When selecting a PRH, prioritize the stability of its facility license and the compliance record of the pharmaceutical establishment over price comparisons alone.
5. If a second importing entity is planned, first confirm its Droguería license and sanitary operating authorization, then assess whether an independent sanitary registration certificate is required.

5. Verification checklist

□ Statements related to D.S. N° 020-2024-SA in project documents have been marked pending verification.

□ Current transfer and holding pathways have been checked against Art. 8 of D.S. N° 016-2011-SA.

□ The Droguería or Laboratorio license of the intended holding entity has been verified as currently valid.

□ The distribution agreement contains clauses addressing changes in registration status.

□ The official platform of DIGEMID has been searched for the original text of the 2024 Supreme Decree (not yet obtained).

□ Regulatory information verified as of October 29, 2026.

Regulatory information verified as of October 29, 2026.

GRZAN provides medical device registration support in Peru for manufacturers, importers, and authorized representatives. For inquiries, contact info@grzanglobal.com.

*GRZAN Regulatory Affairs Team*