On July 20, 2026, ANVISA published the 1st edition of the Questions & Answers (Q&A) document on the Sanitary Authorization (AS) for Cannabis products for human medicinal use, under RDC No. 1,015/2026 — the regulation in force since May 4, 2026, which revoked RDC No. 327/2019. The document consolidates 109 questions across 13 thematic sections.

It should be noted that the content of this Q&A applies exclusively to Cannabis products for human medicinal use. RDC No. 1,015/2026 does not cover cosmetics, tobacco products, medical devices, or food products based on Cannabis sativa L., nor any other non-medicinal uses. Some of the 109 questions address this delimitation precisely because the market has raised doubts about the scope boundaries — and ANVISA’s response is consistent: outside medicinal use, RDC No. 1,015/2026 does not apply.

Below is a structured analysis of each section, with emphasis on the most relevant regulatory and technical points.

Section 1 — General Topics

This section establishes the regulatory context of the category and clarifies transitional and classification issues that affect the entire product chain.

• Transitional nature of the AS

The Sanitary Authorization remains an exceptional and transitional instrument. It is not equivalent to a medicine registration and does not presuppose a full efficacy and safety evaluation by ANVISA. A Cannabis product may only remain on the market beyond the AS validity period if it obtains registration as a medicine, following RDC No. 24/2011 (specific medicines) or RDC No. 1,004/2025 (herbal medicines), according to the classification of the active pharmaceutical ingredient (API).

• Transition between the regulations

Petitions filed before May 4, 2026 continue to be assessed under RDC No. 327/2019. Companies may file an Amendment for full alignment with RDC No. 1,015/2026, provided:

▪ it is filed before the start of technical review; and

▪ it addresses full alignment — partial adjustments are not accepted.

• Classification for quality assessment: herbal medicine or specific medicine?

This is an essential starting point for the product’s regulatory strategy:

▪ If the API is isolated phytopharmaceutical cannabidiol with a minimum purity of 98%, the Cannabis product must comply with the complementary quality requirements of RDC No. 24/2011 (specific medicines).

▪ If the API is a plant-derived active pharmaceutical ingredient (IFAV), i.e. a Cannabis extract, the applicable requirements for herbal medicines under RDC No. 1,004/2025 apply.

To confirm classification, the following must be submitted in the AS petition:

▪ description of starting materials;

▪ steps of the manufacturing process with CBD, THC, and other cannabinoid concentrations at each step; and

▪ raw material analytical reports with chromatographic profiles.

• Outsourcing

Manufacturers may outsource one or more production steps, but not the complete manufacturing process. Contracted companies must hold a valid GMP Certificate (CBPF) for medicines issued by ANVISA.

Importers may outsource storage, transport, quality control analyses, and stability studies. Contracted companies must hold a CBPDA (storage/transport) or a GMP Certificate for medicines, or be REBLAS-accredited (release analyses and stability studies).

• Analytical validation and stability studies

RDCs No. 318/2019 (stability) and No. 166/2017 (analytical validation) apply in full. From the AS petition onwards, documentation related to analytical method validation and accelerated and long-term stability studies must already be submitted — for 3 finished product batches, under Zone IVB conditions.

Section 2 — Submission and Instruction of the Sanitary Authorization Request

This is the section with the greatest operational impact for the pharmaceutical industry. The Q&A consolidates responses on eligibility, mandatory documentation, GMP certification, timelines, and the submission workflow.

• Who may apply for the AS

Art. 12 of RDC No. 1,015/2026 defines who is eligible:

▪ companies holding AFE and AE for the manufacture of medicines and a valid GMP Certificate (CBPF) issued by ANVISA for the Cannabis product production line, according to the pharmaceutical form; or

▪ companies holding AFE and AE as medicine importers and a valid Good Distribution and Storage Practice Certificate (CBPDA) issued by ANVISA.

Distributors, patient associations, and any other entities not covered by this article are not eligible, regardless of other authorizations they may hold.

• Good Manufacturing Practice Certificate (CBPF)

The CBPF for medicines issued by ANVISA is mandatory for national and foreign manufacturers alike, with no exceptions. Not accepted:

▪ equivalent documents from other regulatory authorities (even from PIC/S member countries — this possibility was provided for under RDC No. 327/2019 but the transitional period ended on December 12, 2022);

▪ CBPF issued for other categories (food, dietary supplements, etc.); and

▪ CBPF requested by a company other than the AS applicant.

Proof of CBPF filing is accepted, with one condition: the certificate must be valid at the conclusion of technical review (365 days). Foreign companies holding a GMP certificate for dietary supplements that comply with GMP requirements for medicines may file a pharmaceutical CBPF request with ANVISA and await analysis and inspection.

• CBPF for the active ingredient manufacturer

The regulation does not require a CBPF issued by ANVISA for the API or IFAV manufacturer. A declaration or proof of GMP compliance is required (RDCs No. 654/2022, No. 658/2022 and IN No. 130/2022). There is no requirement to register the active ingredient in Brazil.

• Good Distribution and Storage Practice Certificate (CBPDA)

For importers, the CBPDA for medicines issued by ANVISA must be submitted in the petition. GMP compliance declarations or equivalent documentation are not accepted. The CBPDA must belong to the AS holder itself, not to a third-party distributor.

• AS number and Official Gazette publication

Each commercial presentation receives an individual AS number published in the Official Gazette (DOU). Commercialization is only permitted after that publication.

• Analysis timelines

▪ AS: 365 days* 

▪ Post-AS changes: 180 days*

* no tacit approval

Analysis queue tracking available at: https://consultas.anvisa.gov.br/#/filas/ (select “Medicamento” as “Área de interesse” and “Registro” as “Fila”).

• One Sanitary Authorization per Cannabis product

A company holding an AS may not submit a new application for the same already-authorized product. A product is considered “the same” when it does not differ in terms of the technical nature of the API or IFAV and the pharmaceutical form. Companies in the same economic group may also not seek AS for the same product. 

The Q&A also mentions the possibility of requesting a new AS for a product with the same pharmaceutical form but a demonstrably different IFAV. Although not explicitly stated in the document, it is worth clarifying that for two IFAVs to be considered equivalent, a set of requirements must be met, as detailed in Guide No. 85/2025, which governs the registration of herbal medicines.

Section 3 — Commercial Names

Sanitary Authorizations with commercial names cannot be granted until the subject is specifically regulated. Products must be identified by the name of the active ingredient (“Cannabidiol” or “Cannabis sativa extract”) followed by the name of the AS holder, in standardized format.

Section 4 — Advertising

Advertising is permitted, but restricted to:

▪ prescribers (physicians and dental surgeons) and dispensing pharmacists;

▪ information approved by ANVISA in the package insert and labelling.

The distribution of free samples is prohibited.

Section 5 — Composition

This is one of the most relevant sections of the document. It defines which products may be authorized under RDC No. 1,015/2026 and is fundamental for product development and AS dossier preparation.

• Permitted active ingredients

▪ Phytopharmaceutical CBD: cannabidiol with a minimum purity of 98% on an anhydrous basis, complying with a pharmacopoeia recognized by ANVISA.

▪ Cannabis sativa L. extract: obtained exclusively from the CBD-dominant chemotype (chemotype III), with CBD in a concentration at least five times higher than that of THC.

• What is not permitted

▪ Synthetic or semi-synthetic cannabidiol.

▪ Mixture of phytopharmaceutical CBD with Cannabis extract: the two active ingredient types cannot be combined.

▪ Other chemotypes: only chemotype III may be used as the source of the extract. Accordingly, extracts with a THC content exceeding the 5:1 ratio (CBD:THC) must follow the registration pathway as a medicine.

• Presence of other cannabinoids and concurrent constituents in the Cannabis sativa extract

When the product is formulated with extract as IFAV, other cannabinoids (CBC, CBG, THCV, etc.), flavonoids, and terpenes may be present as components of the extract. The petition must include the qualitative and quantitative profile of THC and of other cannabinoids present at concentrations above 1.0%, together with the justification for the choice of active ingredient.

• THC: limits and use restrictions

The regulation does not establish maximum THC content, but there is an important regulatory distinction:

▪ Products with THC ≤ 0.2%: Special Control Prescription applies (red label). Contraindicated for children under 2 years of age.

▪ Products with THC > 0.2%: permitted only for patients with serious debilitating conditions (RDC No. 38/2013) or life-threatening conditions. Require Prescription Notification “A” (black label). Contraindicated for persons under 18 years of age, pregnant women, and breastfeeding mothers. The petition must include technical-scientific data on the safety and biological plausibility of potential therapeutic applications.

ANVISA also clarifies in this document that the 0.2% THC limit does not conflict with the 0.3% limit for plant material from cultivation in Brazil, as provided for in RDC No. 1,013/2026. That regulation permits and governs the cultivation of Cannabis sativa in Brazil, provided that inflorescences obtained after harvesting and drying present a maximum THC content of 0.3%. The 0.2% limit refers to the threshold in the finished product for classification purposes as described above, serving as a control parameter rather than a prohibitive ceiling.

• Total THC value: acidic forms included

The reported THC value must include THCA (the acidic form). This total value must be used for labelling, package insert, use restrictions, and prescription requirements.

Section 6 — Routes of Administration and Pharmaceutical Forms

This section is relevant from the product development phase onwards, as it defines the boundaries of what may be authorized via the AS pathway.

Permitted routes: inhalation, oral, buccal, sublingual, and dermatological. The inhalation route replaces the nasal route provided in RDC No. 327/2019 and encompasses:

▪ inhalation (nasal and oral simultaneously);

▪ nasal inhalation (exclusively nasal); and

▪ oral inhalation (exclusively oral).

Prohibited forms: modified-release, nanotechnological, and pegylated pharmaceutical forms. Products with these characteristics must follow the medicine registration pathway.

The correct classification of route and pharmaceutical form must be defined from the outset of development, as it determines the type of GMP Certificate required, the applicable quality control tests, and the stability requirements. The reference for identifying pharmaceutical forms is ANVISA’s Controlled Vocabulary of Pharmaceutical Forms, Routes of Administration, and Medicine Packaging. Products with routes not provided for in the regulation must follow the medicine registration pathway.

Section 7 — Quality Control

Quality control of Cannabis products follows the same standards required for medicines. This is one of the most critical points for preparing the AS dossier:

▪ Products containing isolated cannabidiol (> 98% purity): must comply with the quality control requirements of RDC No. 24/2011.

▪ Products containing plant-derived API (Cannabis extracts): subject to the provisions of RDC No. 1,004/2025.

▪ Analytical methods must be validated in accordance with RDC No. 166/2017.

• Pharmacopoeial monograph — mandatory compliance

When a monograph exists in the Brazilian Pharmacopoeia or another pharmacopoeia recognized by ANVISA (per RDC No. 511/2021), compliance is mandatory for raw materials and finished product. This currently applies primarily to purified cannabidiol (≥ 98% purity). Although not mentioned in the document, we would add that there is also a pharmacopoeial monograph for Cannabis extract in the German Pharmacopoeia. What must be submitted in the AS petition:

▪ quality control reports for raw materials and finished product, by manufacturing site;

▪ analytical validation protocols and reports (RDC No. 166/2017); and

▪ results and specifications with maximum and minimum limits, including chromatographic profiles.

• Required tests

▪ Identification and assay of CBD (mandatory for any product).

▪ Total THC (including THCA), CBN, and other cannabinoids above 1.0%.

▪ Microbiological testing per the most recent edition of the Brazilian Pharmacopoeia.

▪ For liquid pharmaceutical forms: appearance, relative density, viscosity, pH (where applicable), volume, and ethanol determination.

▪ Residual solvents: depending on formulation, may be analyzed in the API or IFAV with appropriate justification. 

Some tests may not apply to oily solutions; additional tests may be required depending on the pharmaceutical form.

• Where the analyses should be performed

All batches must be analyzed in a laboratory located in Brazil, even if already analyzed in the country of origin. Analyses may be conducted by the manufacturer (holding a valid GMP Certificate for medicines) or by a third-party laboratory accredited in REBLAS or holding a GMP Certificate for medicines. Outsourcing must comply with RDC No. 234/2018.

Section 8 — Stability Studies

Stability studies follow the same requirements applicable to medicines, with the specificities detailed below.

• Regulations and conditions

▪ RDC No. 318/2019 and Guide No. 28/2019: main references. Studies must be conducted as provided in these instruments.

▪ Zone IVB mandatory: 40°C ± 2°C / 75% RH for accelerated; 30°C ± 2°C / 65% RH for long-term.

▪ 3 finished product batches: minimum required. Submitting studies with only 1 batch is not accepted.

• Minimum data required in the AS petition

▪ completed accelerated stability study;

▪ long-term stability data (minimum 6 months), provided the accelerated study is complete;

▪ in-use stability study; and

▪ photostability study.

• API or IFAV equivalence between batches

When the batches used in stability studies differ from the final product batches, API or IFAV equivalence must be demonstrated. For extracts, equivalence must follow Guide No. 85/2025.

• Stability of the API or IFAV

Although not required in the AS petition, API or IFAV stability must be conducted as part of GMP obligations (RDC No. 654/2022).

• Impact on the dossier and lifecycle

Stability studies are living documents: data must be updated throughout the validity period of the AS. Changes to the shelf life require a post-AS change protocol with updated data.

Section 9 — Labelling and Package Insert

Labelling and package inserts have their own rules, distinct from those of medicines. 

Product identification: until commercial names are regulated, the product is identified by the name of the active ingredient followed by the name of the AS holder, in standardized format.

• Expressly prohibited terms in labels, packaging, package insert, and advertising:

▪ “full spectrum” and “broad spectrum”;

▪ “Cannabis oil”, “cannabidiol oil”, or “CBD oil”; and

▪ any variation of these terms, in any language.

Claims about the absence or concentration of cannabinoids beyond what is prescribed by the regulation are also not accepted — phrases such as “contains no THC” or “THC-free” are prohibited.

• Mandatory cannabinoid information

▪ CBD content in mg/mL or mg/mg.

▪ THC content (mg/mL or mg/mg) when above 0.2%.

▪ Qualitative and quantitative profile of other cannabinoids above 1.0% (for products with extract as IFAV).

• Anti-doping warning — mandatory for all products

All products — regardless of THC content — must carry: “This product contains substance(s) prohibited in sporting competitions.” This obligation stems from Law No. 14,806/2024 and includes other cannabinoids on the WADA prohibited list beyond THC.

• Mandatory phrases by THC content

▪ For THC ≤ 0.2%: “This product should not be used by children under 2 (two) years of age.”

▪ For THC > 0.2%: contraindication for persons under 18 years of age, pregnant women, and breastfeeding mothers; careful assessment for elderly patients and those with a history of Cannabis dependence or non-medicinal use; and “Use of this product may cause physical or psychological dependence.”

• Transitional period and timelines

▪ Deadline to file the labelling and package insert change petition: by August 1, 2026.

▪ 180 days after filing: start of manufacturing with new packaging, for products with 6 or more batches in the last 12 months.

▪ 365 days after filing: for products with up to 5 batches in the last 12 months.

▪ Petition subject codes: 11539 (label) and 12430 (package insert).

During the transition, black-label packaging (manufactured before May 4, 2026) and red-label packaging may coexist on the market without regulatory violation.

Section 10 — Prescription and Dispensing

Cannabis products may only be prescribed to patients without a satisfactory therapeutic alternative among medicines authorized in Brazil. Key considerations:

▪ THC ≤ 0.2%: Special Control Prescription (red label), valid for 30 days.

▪ THC > 0.2%: Prescription Notification “A” (black label), valid for 30 days.

▪ Special Control Prescription: up to 60 days of treatment (or 6 months for anticonvulsants).

▪ Dispensing restricted to pharmacists in pharmacies or drugstores, with records in the SNGPC system.

▪ No therapeutic substitution between products.

Section 11 — Import and Export of Active Ingredient and Finished Product

Import and domestic distribution are permitted for research, development, and manufacturing purposes of:

▪ Cannabis sativa L. plant species;

▪ Cannabis sativa L. extract and phytopharmaceutical CBD; and

▪ intermediate products, in bulk, and in primary packaging.

Before obtaining the AS, raw materials may be imported for development and pilot batch manufacturing via an Import Authorization (RDC No. 988/2025). Quantities used in pilot batches intended for commercialization are deducted from the future Import Quota. After AS publication, the company must request the Import Quota from ANVISA, defined based on estimated consumption over the first three years. All inputs are subject to the controls of List A3 of Ministerial Order SVS/MS No. 344/1998.

Section 12 — Post-AS Changes

Changes to a Cannabis product permitted after the granting of the Sanitary Authorization are those described in Arts. 30 and 31 of RDC No. 1,015/2026. Changes not covered by these articles must be consulted with ANVISA in advance per Art. 33 and may not be implemented without that consultation.

• Examples mentioned in the document

▪ Modification of the plant supplier or the finished product manufacturing process: not permitted without prior filing.

▪ New product with the same API/IFAV and pharmaceutical form but a different manufacturer: considered the same product under Art. 68 — a new AS cannot be requested. The manufacturer change must be handled via Art. 31.

▪ Specifications and analytical methods for the active ingredient: not covered by Arts. 30 and 31 — consult ANVISA (Art. 33).

▪ Important reference: the batch size for change classification is the batch submitted to stability studies, not the initial pilot batch.

Section 13 — Validity, Renewal, and Cancellation of the AS

The management of the AS validity period is a long-term strategic matter.

Validity: 5 years from DOU publication date, renewable once for an equal period — but renewal is not automatic.

• Conditions for renewal

Not every product is eligible for renewal. To apply, the company must submit:

▪ an approved Clinical Development Dossier (DDCM) from ANVISA or equivalent approval from competent authorities; and

▪ documentary evidence of the commencement of the Clinical Development Plan, including ethics committee protocol approvals.

Companies intending to renew the AS must initiate clinical development sufficiently in advance to have the DDCM approved before the renewal request.

Renewal deadline: in the first semester of the last year of the five-year validity period. Example: AS published on April 29, 2024 — deadline is October 31, 2028.

• Commercialization obligation

The product must be commercialized within 1 year of AS publication, under penalty of cancellation. Official laboratories and companies that commercialize exclusively through public procurement may submit a justification.

• Cancellation and expiry

When the AS expires without medicine registration or renewal, there is no additional stock clearance period. Only products manufactured or imported before the expiry date may be commercialized.

Access the full document here.