Chile Pharmaceutical Licensing

This record covers only pharmacy retail, droguería wholesale and pharmaceutical manufacturing of human medicines in Chile; it is not a guide to financial licensing. Decree No. 466 covers the health requirements for pharmacies, droguerías and related pharmaceutical establishments, including storage, distribution, dispensing/repackaging and retail; Decree No. 3 separately covers the full medicines-control framework, including product registration, manufacture, storage, distribution, import/entry and export.

Article 4 of Decree No. 466 permits natural or legal persons to establish or acquire the establishments listed in that decree, subject to the rules specific to each establishment. This provision must not be interpreted as automatic approval of all foreign-investment structures, shareholding arrangements or post-transaction licence succession; no uniform foreign ownership restriction applicable to all pharmaceutical businesses was identified in this review.

— Retail pharmacy: supply of medicines to the public, subject to both pharmacy-establishment authorisation and technical-director requirements.

— Wholesale droguería: storage, distribution and declared activities such as import/export are controlled according to the authorised scope.

— Manufacturing laboratory: premises authorisation, GMP, product registration and cross-border controls must be assessed separately.

Swipe horizontally to view all items

The Ministry of Health, through the Undersecretariat of Public Health, is responsible for pharmaceutical policy and regulations. ISP is the national authority for sanitary control of medicinal products and is responsible for authorising the establishment and operation of pharmaceutical laboratories, product authorisations/registrations, imports/entry, exports, manufacturing, and control of controlled substances. Decree No. 3 also provides that SEREMI is responsible, within its legally applicable scope, for enforcing and supervising the distribution, storage, and possession of authorised pharmaceutical facilities.

The division of responsibilities by region must be preserved. Decree No. 9 states that SEREMI in each region has authorisation/inspection functions for pharmacies, mobile pharmacies, droguerías, and medicine cabinets, and expressly provides that compounding rooms for sterile preparations in pharmacies remain under ISP control. The document does not group all droguería or manufacturing laboratory procedures under a single regional office; therefore, confirm the actual filing channel based on the type and address of the facility.

— ISP/ANAMED: Laboratories, product registration, and national-level control of medicinal products/controlled substances.

— SEREMI: Authorisation, inspection, and sanitary administrative procedures for regional pharmacies and other retail facilities.

— Ministry of Health: Policy, regulations, and technical standards for medicinal products.

A pharmacy follows a separate retail-facility route. Decree No. 466 requires an on-site inspection before authorisation to establish, operate, or relocate is issued; the application is submitted to the SEREMI for the region where the facility is located, and the text of the decree provides that a decision must be made within fifteen working days of submission, with reasons given for any refusal. This provision does not guarantee approval where documents are incomplete, an inspection is pending, local supplementary information is required, or other specific conditions apply.

The ISP pharmacy authorisation guide, updated in 2025, requires the application materials to cover the legal status of the entity and site, the technical director, architectural plans, business/practice hours, pest control, and repackaging arrangements. The specific office address and payment method stated in the guide should not be treated as the sole nationwide filing rules for every region.

— Confirm with the relevant SEREMI, for the proposed address, the current form, submission method, and inspection arrangements for the pharmacy establishment and operation application.

— Appoint a chemical pharmacist as technical director and prepare evidence of qualifications, appointment, and actual working hours.

— Complete the site, plans, local use/completion documentation, storage, and repackaging arrangements, and undergo an on-site inspection.

In Chile, pharmaceutical wholesale activity should generally be assessed under the droguería facility route. The ISP/ANAMED unified application form lists droguería as a separate application category and requires applicants to declare the types of products handled and activities such as storage, import, export, distribution, and repackaging of raw materials. The actual authorised scope must be determined from the formal sanitary authorisation; activities listed as options on the form are not automatically authorised.

The form also lists establishment and operation of a droguería, facility modifications, operation following modifications, expansion of activities, temporary/permanent closure, resumption of operations, and changes of name or ownership as separate items. Therefore, before adding cold-chain products, controlled products, imports, exports, or repackaging of raw materials, first determine whether an expansion or another separate procedure is required.

— Select a droguería category and scope of activities consistent with the actual product types and business flows.

— Prepare materials on the technical director, site, process flow diagrams, plans, equipment, and quality procedures.

— Map storage, import, export, distribution, temperature control, and repackaging of raw materials individually against the proposed application scope.

Decree No. 3 gives ISP the nationwide authority to authorise the establishment and operation of pharmaceutical laboratories. The official unified application form distinguishes manufacturing, packaging/compounding, and quality control laboratories, and lists assessment of plans/processes, establishment and approval of plans, commencement of operations, expansion, facility modifications, and operation following modifications as separate applications. A manufacturer should not extend the status of an authorised facility to dosage forms, production lines, analytical activities, or sites that have not been declared.

Application materials should reflect the actual capabilities of the proposed manufacturing scope: plans and personnel/material flows, equipment and critical support systems, applicable calibration/qualification/temperature mapping, documented procedures, and professional responsibilities. GMP technical standard NT 127 is listed in the ISP regulations directory; its applicability is not automatically waived because a company describes itself as a small-scale manufacturer.

— First distinguish manufacturing, packaging/compounding, quality control, and contract activities; do not use one manufacturing authorisation as a substitute for other categories.

— Apply for establishment/approval of plans first, then apply for commencement of operations and an on-site inspection in accordance with the approved arrangements.

— For changes to a new production line, product category, critical area, or scope of activities, first assess modifications or expansion against the ISP list of application items.

The pharmacy technical director is a professional role with specific documentation requirements. The 2025 ISP guide requires submission of the chemical pharmacist’s proof of identity, degree certificate or certificate from the health supervisory authority and/or evidence of degree recognition by the Ministry of Foreign Affairs, employment contract, practice hours, and declaration. The pharmacy owner/representative must also formally appoint the person as technical director. For 24-hour pharmacies or pharmacies with specific assistance arrangements, the guide requires schedules covering all relevant professionals.

The unified application form for droguerías and manufacturing laboratories requires details of the technical director or the professional responsible for the relevant sanitary duties, together with qualifications, a declaration of responsibility, and applicable training materials. The official materials reviewed for this guidance did not establish uniform qualifications, nationality, or minimum-years-of-experience requirements applicable to all wholesale or manufacturing positions; none are therefore asserted.

— Pharmacy: Chemical pharmacist as technical director, with evidence matching the business hours.

— Droguería: Submit technical director information in accordance with Decree No. 466 and the application form.

— Manufacturing laboratory: Submit evidence of professional responsibility, training, and qualifications in accordance with Decree No. 3, the scope of activities, and sanitary-role requirements.

A pharmacy application should provide evidence of lawful occupancy and use of the premises, local address documentation, completion or change-of-use certificates, and functional architectural plans drawn to scale. The official guide also requires disclosure of whether repackaging will be carried out in the pharmacy; if repackaging is performed by a third party, a service contract and corresponding authorisation documents must be provided. The fact that the materials specify a plan scale does not justify assuming any nationwide minimum business area.

For a droguería/laboratory, plans should show personnel and material flows and the necessary support systems. Materials for commencement of operations or expansion may include equipment/instruments, critical support systems, calibration or qualification, temperature mapping, and procedural documents. Basic wholesale-facility procedures should at least cover receiving, sampling, storage, dispatch, cleaning, pest control, temperature and humidity, returns, expired/rejected/recalled/counterfeit products, complaints, inventory, destruction, training, self-inspection, transport, and document management.

— Retail: Lawful use of the site, functional plans, repackaging, and pest control arrangements.

— Wholesale: Quality protection, segregation, temperature and humidity, returns/recalls, and transport records.

— Manufacturing: Premises, equipment, support systems, and GMP documents suited to the authorised process.

Pharmacies are generally prepared in stages for “establishment” and “operation,” subject to confirming the current filing process with the SEREMI for the proposed site. Decree No. 466 requires prior inspection; the ISP 2025 guide places information on the company/representative, technical director, site, plans, pest control, business and professional schedules, and repackaging arrangements within the same review framework.

For droguerías and laboratories, the ISP unified form separates establishment, plans/processes, operation, expansion, facility modification, operation following modification, closure, and resumption. Legal documents are first reviewed for admissibility; an on-site visit is scheduled after the legal-document review is satisfactory. The form states that if the facility cannot operate according to the proposed activities at the time of the visit, the application may be considered withdrawn.

— Confirm the business category, address, and proposed activities, and select the correct authorisation item.

— Prepare materials on the entity/representative, ownership or lease, technical director, plans/processes, equipment, and quality procedures.

— Submit the application, provide supplementary documents, and undergo inspection as required by the competent authority; do not conduct the relevant activities before formal operating authorisation is granted.

The official materials reviewed confirm that pharmacy, droguería, and laboratory procedures involve relevant fees or proof of payment, but no uniform amount applicable nationwide to all categories and modifications was obtained; accordingly, no fee is invented or listed. Applicants should confirm the amount with the actual competent authority, application item code, and latest fee schedule.

For applications to establish, operate, or relocate the facilities listed in Decree No. 466, the decree sets out a SEREMI processing provision of fifteen working days from submission, and authorisations are valid for three years with automatic successive extensions subject to statutory conditions. Do not apply this period to manufacturing laboratory authorisations without checking the specific provisions individually. A 2020 ISP form listed on-site visit schedules of 10 to 15 working days in the Metropolitan Region and 30 to 40 working days in other regions; this should be treated only as information from a historical form, not as a current nationwide total approval timeline.

— Fees: Confirm them against the competent authority, authorisation category, establishment/operation/modification item, and current fee schedule.

— Facilities covered by Decree No. 466, such as pharmacies: Note the difference between the statutory processing provision and actual completeness review/inspection.

— Manufacturing laboratories: Do not automatically extend the three-year provision for retail/wholesale facilities to laboratory authorisations.

Licensed operations are not a one-time submission. Pharmacies should continuously maintain their approved premises, technical director, and operating conditions, and are subject to regional sanitary inspections. A droguería’s procedures should cover receiving, storage, transport, temperature and humidity, returns, expired products, rejected products, recalled products, counterfeit medicines, complaints, inventory, destruction, training, self-inspection, and document records; this is consistent with the regulatory direction of NT 147 on good storage and distribution practices.

Pharmaceutical laboratories should continuously maintain their quality systems, equipment status, personnel responsibilities, and technical documentation in accordance with GMP and their authorised scope of activities. Quotas, certificates, monthly reports, transport, destruction, and cancellation of records for theft/loss of controlled drugs are additional ongoing obligations and cannot be replaced by general facility maintenance.

— Retail: Maintain the technical director, site status, business arrangements, and inspection readiness.

— Wholesale: Implement storage, transport, traceability, returns, recalls, and document controls consistent with NT 147.

— Manufacturing: Implement GMP, equipment/support-system status management, quality records, and change control.

A change in pharmacy ownership is not a silent continuation. The 2025 ISP guide defines “cambio de dominio” as the transfer of a pharmacy from one legal entity owner to another resulting in a change to the owner’s RUT, and requires a separate change application, pharmacy documents, the existing authorisation resolution, legal entity materials, and information on the new technical director/schedules. A change of name without a change to the RUT is a separate application item.

The ISP unified form likewise lists changes of company name or ownership, facility modifications, operation following modification, expansion of activities, closure, and resumption as separate items for droguerías and laboratories. For a pure shareholding or control change that does not alter the RUT, the materials reviewed do not establish a conclusion on automatic continuation that can safely be applied to every type of facility; before closing, confirm with the competent authority whether a change application, supplementary documents, inspection, or reauthorisation is triggered.

— Pharmacy: First determine whether the change constitutes a cambio de dominio involving a change to the owner’s RUT, and apply under the separate procedure.

— Droguería/laboratory: Assess changes to name, ownership, address, facilities, equipment, activities, or product scope individually.

— Transaction documents should make closing conditional on obtaining necessary regulatory confirmation and maintaining technical director/operating conditions.

Product sanitary registration is distinct from authorisation of business premises. Decree No. 3 includes product registration, import/entry, export, manufacture, storage, and distribution in a single national control system, and gives ISP responsibility for product authorisations/registrations and cross-border controls. Therefore, even where a pharmacy, droguería, or laboratory has operating authorisation, the sanitary status of each medicinal product intended for marketing and the applicable import/export procedures should still be verified.

Controlled narcotic drugs, psychotropic substances and precursor substances follow a separate pathway. ISP states that, after annual estimates/quotas have been approved, a laboratory or droguería must obtain an official certificate for the import or export of each product or active ingredient; separate document or reporting requirements also apply to domestic distribution, dispensing, transport, destruction, and the cancellation of records for stolen or lost items.

— Products: verify the sanitary registration, authorised holder, labels/package inserts, and applicable variation status.

— General cross-border trade: confirm application or control requirements with ISP according to the goods, origin, import/entry, or export stage.

— Controlled substances: obtain separate annual quotas, official certificates for each product, and the relevant transport/record/reporting approvals.