{"id":1143,"date":"2026-08-06T09:26:18","date_gmt":"2026-08-06T12:26:18","guid":{"rendered":"https:\/\/www.vitapharmaconsulting.com\/en\/?post_type=noticias&#038;p=1143"},"modified":"2026-08-06T09:28:56","modified_gmt":"2026-08-06T12:28:56","slug":"anvisa-questions-answers-on-the-sanitary-authorization-of-cannabis-products-rdc-no-1015-2026","status":"publish","type":"noticias","link":"https:\/\/www.vitapharmaconsulting.com\/en\/news\/2026\/08\/06\/anvisa-questions-answers-on-the-sanitary-authorization-of-cannabis-products-rdc-no-1015-2026\/","title":{"rendered":"ANVISA \u2013 Questions &#038; Answers on the Sanitary Authorization of Cannabis Products: RDC No. 1,015\/2026"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">On July 20, 2026, ANVISA published the 1st edition of the Questions &amp; Answers (Q&amp;A) document on the Sanitary Authorization (AS) for Cannabis products for human medicinal use, under RDC No. 1,015\/2026 \u2014 the regulation in force since May 4, 2026, which revoked RDC No. 327\/2019. The document consolidates 109 questions across 13 thematic sections.<\/span><\/p>\n<p><!--more--><\/p>\n<p><span style=\"font-weight: 400;\">It should be noted that the content of this Q&amp;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 <\/span><i><span style=\"font-weight: 400;\">Cannabis sativa<\/span><\/i><span style=\"font-weight: 400;\"> 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 \u2014 and ANVISA\u2019s response is consistent: outside medicinal use, RDC No. 1,015\/2026 does not apply.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Below is a structured analysis of each section, with emphasis on the most relevant regulatory and technical points.<\/span><\/p>\n<h2><b>Section 1 \u2014 General Topics<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">This section establishes the regulatory context of the category and clarifies transitional and classification issues that affect the entire product chain.<\/span><\/p>\n<ul>\n<li aria-level=\"1\"><b>Transitional nature of the AS<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">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).<\/span><\/p>\n<ul>\n<li aria-level=\"1\"><b>Transition between the regulations<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">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:<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa it is filed before the start of technical review; and<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa it addresses full alignment \u2014 partial adjustments are not accepted.<\/span><b><\/b><\/p>\n<ul>\n<li aria-level=\"1\"><b>Classification for quality assessment: herbal medicine or specific medicine?<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">This is an essential starting point for the product\u2019s regulatory strategy:<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa 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).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa 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.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">To confirm classification, the following must be submitted in the AS petition:<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa description of starting materials;<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa steps of the manufacturing process with CBD, THC, and other cannabinoid concentrations at each step; and<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa raw material analytical reports with chromatographic profiles.<\/span><b><\/b><\/p>\n<ul>\n<li aria-level=\"1\"><b>Outsourcing<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">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.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">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).<\/span><\/p>\n<ul>\n<li aria-level=\"1\"><b>Analytical validation and stability studies<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">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 \u2014 for 3 finished product batches, under Zone IVB conditions.<\/span><\/p>\n<h2><b>Section 2 \u2014 Submission and Instruction of the Sanitary Authorization Request<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">This is the section with the greatest operational impact for the pharmaceutical industry. The Q&amp;A consolidates responses on eligibility, mandatory documentation, GMP certification, timelines, and the submission workflow.<\/span><\/p>\n<ul>\n<li aria-level=\"1\"><b>Who may apply for the AS<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Art. 12 of RDC No. 1,015\/2026 defines who is eligible:<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa 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<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa companies holding AFE and AE as medicine importers and a valid Good Distribution and Storage Practice Certificate (CBPDA) issued by ANVISA.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Distributors, patient associations, and any other entities not covered by this article are not eligible, regardless of other authorizations they may hold.<\/span><b><\/b><\/p>\n<ul>\n<li aria-level=\"1\"><b>Good Manufacturing Practice Certificate (CBPF)<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">The CBPF for medicines issued by ANVISA is mandatory for national and foreign manufacturers alike, with no exceptions. Not accepted:<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa equivalent documents from other regulatory authorities (even from PIC\/S member countries \u2014 this possibility was provided for under RDC No. 327\/2019 but the transitional period ended on December 12, 2022);<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa CBPF issued for other categories (food, dietary supplements, etc.); and<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa CBPF requested by a company other than the AS applicant.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">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.<\/span><\/p>\n<ul>\n<li aria-level=\"1\"><b>CBPF for the active ingredient manufacturer<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">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.<\/span><\/p>\n<ul>\n<li aria-level=\"1\"><b>Good Distribution and Storage Practice Certificate (CBPDA)<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">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.<\/span><b><\/b><\/p>\n<ul>\n<li aria-level=\"1\"><b>AS number and Official Gazette publication<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Each commercial presentation receives an individual AS number published in the Official Gazette (DOU). Commercialization is only permitted after that publication.<\/span><\/p>\n<ul>\n<li aria-level=\"1\"><b>Analysis timelines<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u25aa AS: 365 days*\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa Post-AS changes: 180 days*<\/span><\/p>\n<p><span style=\"font-weight: 400;\">* no tacit approval<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Analysis queue tracking available at: <\/span><a href=\"https:\/\/consultas.anvisa.gov.br\/#\/filas\/\"><span style=\"font-weight: 400;\">https:\/\/consultas.anvisa.gov.br\/#\/filas\/<\/span><\/a><span style=\"font-weight: 400;\"> (select \u201cMedicamento\u201d as \u201c\u00c1rea de interesse\u201d and \u201cRegistro\u201d as \u201cFila\u201d).<\/span><b><\/b><\/p>\n<ul>\n<li aria-level=\"1\"><b>One Sanitary Authorization per Cannabis product<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">A company holding an AS may not submit a new application for the same already-authorized product. A product is considered \u201cthe same\u201d 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.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The Q&amp;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.<\/span><\/p>\n<h2><b>Section 3 \u2014 Commercial Names<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">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 (\u201cCannabidiol\u201d or \u201c<\/span><i><span style=\"font-weight: 400;\">Cannabis sativa<\/span><\/i><span style=\"font-weight: 400;\"> extract\u201d) followed by the name of the AS holder, in standardized format.<\/span><\/p>\n<h2><b>Section 4 \u2014 Advertising<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">Advertising is permitted, but restricted to:<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa prescribers (physicians and dental surgeons) and dispensing pharmacists;<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa information approved by ANVISA in the package insert and labelling.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The distribution of free samples is prohibited.<\/span><\/p>\n<h2><b>Section 5 \u2014 Composition<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">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.<\/span><\/p>\n<ul>\n<li aria-level=\"1\"><b>Permitted active ingredients<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u25aa Phytopharmaceutical CBD: cannabidiol with a minimum purity of 98% on an anhydrous basis, complying with a pharmacopoeia recognized by ANVISA.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa <\/span><i><span style=\"font-weight: 400;\">Cannabis sativa<\/span><\/i><span style=\"font-weight: 400;\"> 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.<\/span><\/p>\n<ul>\n<li aria-level=\"1\"><b>What is not permitted<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u25aa Synthetic or semi-synthetic cannabidiol.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa Mixture of phytopharmaceutical CBD with Cannabis extract: the two active ingredient types cannot be combined.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa 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.<\/span><\/p>\n<ul>\n<li aria-level=\"1\"><b>Presence of other cannabinoids and concurrent constituents in the <\/b><b><i>Cannabis sativa<\/i><\/b><b> extract<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">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.<\/span><b><\/b><\/p>\n<ul>\n<li aria-level=\"1\"><b>THC: limits and use restrictions<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">The regulation does not establish maximum THC content, but there is an important regulatory distinction:<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa Products with THC \u2264 0.2%: Special Control Prescription applies (red label). Contraindicated for children under 2 years of age.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa Products with THC &gt; 0.2%: permitted only for patients with serious debilitating conditions (RDC No. 38\/2013) or life-threatening conditions. Require Prescription Notification \u201cA\u201d (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.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">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 <\/span><i><span style=\"font-weight: 400;\">Cannabis sativa<\/span><\/i><span style=\"font-weight: 400;\"> 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.<\/span><b><\/b><\/p>\n<ul>\n<li aria-level=\"1\"><b>Total THC value: acidic forms included<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">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.<\/span><\/p>\n<h2><b>Section 6 \u2014 Routes of Administration and Pharmaceutical Forms<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">This section is relevant from the product development phase onwards, as it defines the boundaries of what may be authorized via the AS pathway.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Permitted routes: inhalation, oral, buccal, sublingual, and dermatological. The inhalation route replaces the nasal route provided in RDC No. 327\/2019 and encompasses:<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa inhalation (nasal and oral simultaneously);<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa nasal inhalation (exclusively nasal); and<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa oral inhalation (exclusively oral).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Prohibited forms: modified-release, nanotechnological, and pegylated pharmaceutical forms. Products with these characteristics must follow the medicine registration pathway.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">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\u2019s 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.<\/span><\/p>\n<h2><b>Section 7 \u2014 Quality Control<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">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:<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa Products containing isolated cannabidiol (&gt; 98% purity): must comply with the quality control requirements of RDC No. 24\/2011.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa Products containing plant-derived API (Cannabis extracts): subject to the provisions of RDC No. 1,004\/2025.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa Analytical methods must be validated in accordance with RDC No. 166\/2017.<\/span><\/p>\n<ul>\n<li aria-level=\"1\"><b>Pharmacopoeial monograph \u2014 mandatory compliance<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">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 (\u2265 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:<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa quality control reports for raw materials and finished product, by manufacturing site;<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa analytical validation protocols and reports (RDC No. 166\/2017); and<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa results and specifications with maximum and minimum limits, including chromatographic profiles.<\/span><b><\/b><\/p>\n<ul>\n<li aria-level=\"1\"><b>Required tests<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u25aa Identification and assay of CBD (mandatory for any product).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa Total THC (including THCA), CBN, and other cannabinoids above 1.0%.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa Microbiological testing per the most recent edition of the Brazilian Pharmacopoeia.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa For liquid pharmaceutical forms: appearance, relative density, viscosity, pH (where applicable), volume, and ethanol determination.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa Residual solvents: depending on formulation, may be analyzed in the API or IFAV with appropriate justification.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Some tests may not apply to oily solutions; additional tests may be required depending on the pharmaceutical form.<\/span><\/p>\n<ul>\n<li aria-level=\"1\"><b>Where the analyses should be performed<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">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.<\/span><\/p>\n<h2><b>Section 8 \u2014 Stability Studies<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">Stability studies follow the same requirements applicable to medicines, with the specificities detailed below.<\/span><\/p>\n<ul>\n<li aria-level=\"1\"><b>Regulations and conditions<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u25aa RDC No. 318\/2019 and Guide No. 28\/2019: main references. Studies must be conducted as provided in these instruments.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa Zone IVB mandatory: 40\u00b0C \u00b1 2\u00b0C \/ 75% RH for accelerated; 30\u00b0C \u00b1 2\u00b0C \/ 65% RH for long-term.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa 3 finished product batches: minimum required. Submitting studies with only 1 batch is not accepted.<\/span><\/p>\n<ul>\n<li aria-level=\"1\"><b>Minimum data required in the AS petition<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u25aa completed accelerated stability study;<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa long-term stability data (minimum 6 months), provided the accelerated study is complete;<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa in-use stability study; and<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa photostability study.<\/span><b><\/b><\/p>\n<ul>\n<li aria-level=\"1\"><b>API or IFAV equivalence between batches<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">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.<\/span><b><\/b><\/p>\n<ul>\n<li aria-level=\"1\"><b>Stability of the API or IFAV<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Although not required in the AS petition, API or IFAV stability must be conducted as part of GMP obligations (RDC No. 654\/2022).<\/span><\/p>\n<ul>\n<li aria-level=\"1\"><b>Impact on the dossier and lifecycle<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">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.<\/span><\/p>\n<h2><b>Section 9 \u2014 Labelling and Package Insert<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">Labelling and package inserts have their own rules, distinct from those of medicines.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">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.<\/span><\/p>\n<ul>\n<li aria-level=\"1\"><b>Expressly prohibited terms in labels, packaging, package insert, and advertising:<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u25aa \u201cfull spectrum\u201d and \u201cbroad spectrum\u201d;<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa \u201cCannabis oil\u201d, \u201ccannabidiol oil\u201d, or \u201cCBD oil\u201d; and<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa any variation of these terms, in any language.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Claims about the absence or concentration of cannabinoids beyond what is prescribed by the regulation are also not accepted \u2014 phrases such as \u201ccontains no THC\u201d or \u201cTHC-free\u201d are prohibited.<\/span><\/p>\n<ul>\n<li aria-level=\"1\"><b>Mandatory cannabinoid information<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u25aa CBD content in mg\/mL or mg\/mg.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa THC content (mg\/mL or mg\/mg) when above 0.2%.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa Qualitative and quantitative profile of other cannabinoids above 1.0% (for products with extract as IFAV).<\/span><b><\/b><\/p>\n<ul>\n<li aria-level=\"1\"><b>Anti-doping warning \u2014 mandatory for all products<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">All products \u2014 regardless of THC content \u2014 must carry: \u201cThis product contains substance(s) prohibited in sporting competitions.\u201d This obligation stems from Law No. 14,806\/2024 and includes other cannabinoids on the WADA prohibited list beyond THC.<\/span><\/p>\n<ul>\n<li aria-level=\"1\"><b>Mandatory phrases by THC content<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u25aa For THC \u2264 0.2%: \u201cThis product should not be used by children under 2 (two) years of age.\u201d<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa For THC &gt; 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 \u201cUse of this product may cause physical or psychological dependence.\u201d<\/span><\/p>\n<ul>\n<li aria-level=\"1\"><b>Transitional period and timelines<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u25aa Deadline to file the labelling and package insert change petition: by August 1, 2026.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa 180 days after filing: start of manufacturing with new packaging, for products with 6 or more batches in the last 12 months.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa 365 days after filing: for products with up to 5 batches in the last 12 months.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa Petition subject codes: 11539 (label) and 12430 (package insert).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">During the transition, black-label packaging (manufactured before May 4, 2026) and red-label packaging may coexist on the market without regulatory violation.<\/span><\/p>\n<h2><b>Section 10 \u2014 Prescription and Dispensing<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">Cannabis products may only be prescribed to patients without a satisfactory therapeutic alternative among medicines authorized in Brazil. Key considerations:<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa THC \u2264 0.2%: Special Control Prescription (red label), valid for 30 days.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa THC &gt; 0.2%: Prescription Notification \u201cA\u201d (black label), valid for 30 days.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa Special Control Prescription: up to 60 days of treatment (or 6 months for anticonvulsants).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa Dispensing restricted to pharmacists in pharmacies or drugstores, with records in the SNGPC system.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa No therapeutic substitution between products.<\/span><\/p>\n<h2><b>Section 11 \u2014 Import and Export of Active Ingredient and Finished Product<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">Import and domestic distribution are permitted for research, development, and manufacturing purposes of:<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa <\/span><i><span style=\"font-weight: 400;\">Cannabis sativa<\/span><\/i><span style=\"font-weight: 400;\"> L. plant species;<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa <\/span><i><span style=\"font-weight: 400;\">Cannabis sativa<\/span><\/i><span style=\"font-weight: 400;\"> L. extract and phytopharmaceutical CBD; and<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa intermediate products, in bulk, and in primary packaging.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">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.<\/span><\/p>\n<h2><b>Section 12 \u2014 Post-AS Changes<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">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.<\/span><\/p>\n<ul>\n<li aria-level=\"1\"><b>Examples mentioned in the document<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u25aa Modification of the plant supplier or the finished product manufacturing process: not permitted without prior filing.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa New product with the same API\/IFAV and pharmaceutical form but a different manufacturer: considered the same product under Art. 68 \u2014 a new AS cannot be requested. The manufacturer change must be handled via Art. 31.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa Specifications and analytical methods for the active ingredient: not covered by Arts. 30 and 31 \u2014 consult ANVISA (Art. 33).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa Important reference: the batch size for change classification is the batch submitted to stability studies, not the initial pilot batch.<\/span><\/p>\n<h2><b>Section 13 \u2014 Validity, Renewal, and Cancellation of the AS<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">The management of the AS validity period is a long-term strategic matter.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Validity: 5 years from DOU publication date, renewable once for an equal period \u2014 but renewal is not automatic.<\/span><\/p>\n<ul>\n<li aria-level=\"1\"><b>Conditions for renewal<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Not every product is eligible for renewal. To apply, the company must submit:<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa an approved Clinical Development Dossier (DDCM) from ANVISA or equivalent approval from competent authorities; and<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u25aa documentary evidence of the commencement of the Clinical Development Plan, including ethics committee protocol approvals.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Companies intending to renew the AS must initiate clinical development sufficiently in advance to have the DDCM approved before the renewal request.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Renewal deadline: in the first semester of the last year of the five-year validity period. Example: AS published on April 29, 2024 \u2014 deadline is October 31, 2028.<\/span><\/p>\n<ul>\n<li aria-level=\"1\"><b>Commercialization obligation<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">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.<\/span><\/p>\n<ul>\n<li aria-level=\"1\"><b>Cancellation and expiry<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">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.<\/span><\/p>\n<p><a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/setorregulado\/regularizacao\/medicamentos\/fitoterapicos-dinamizados-e-especificos\/informes\/especificos\/p-r-rdc-1015-2026_20072026.pdf\"><span style=\"font-weight: 400;\">Access the full document here.<\/span><\/a><\/p>\n","protected":false},"author":3,"featured_media":1144,"template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"_links_to":"","_links_to_target":""},"categorias":[22],"class_list":["post-1143","noticias","type-noticias","status-publish","has-post-thumbnail","hentry","categorias-brasil-anvisa"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ANVISA \u2013 Questions &amp; Answers on the Sanitary Authorization of Cannabis Products: RDC No. 1,015\/2026<\/title>\n<meta name=\"description\" content=\"On July 20, 2026, ANVISA published the 1st edition of the Questions &amp; Answers (Q&amp;A) document on the Sanitary Authorization (AS) for Cannabis products for human medicinal use, under RDC No. 1,015\/2026 \u2014 the regulation in force since May 4, 2026, which revoked RDC No. 327\/2019. 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