Brazil Pharmaceutical Licensing

Brazilian Federal Decree No. 8,077/2013 provides that activities involving products under its regulation are subject both to ANVISA's establishment authorisation and to a premises licence issued by the state, Federal District or municipal health authority. Authorisations and licences should specify the establishment's actual activities and product categories; therefore, retail, distribution, storage, manufacturing, import, export, packaging and transport must not be grouped indiscriminately under a single scope of operations.

The AFE service page for medicines and pharmaceutical active ingredients lists activities including storage, distribution, packaging, export, manufacturing, import and transport. Each operating location under the same company must also be considered separately: the Decree expressly states that premises health licences are independent of one another, even when the locations are in the same municipality or Federal District.

The federal ANVISA/government materials reviewed for this page do not state a uniform foreign shareholding limit, statutory corporate form, minimum capital or premises area applicable to all pharmaceutical retail, wholesale and manufacturing projects. This must not be taken to mean that foreign investment is either permitted or prohibited; where a foreign entity is to invest, hold shares or form part of the import chain, the requirements should be verified for the specific project against those of the relevant municipal/state Visa, company registration and tax authorities.

— Check the AFE, local health licence and product procedures separately for each CNPJ, address, activity and product category.

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Brazil's national health surveillance system is implemented jointly by different levels of government. Decree No. 8,077/2013 assigns responsibility for national health surveillance policy to the Ministry of Health, statutory functions to ANVISA, and corresponding health surveillance responsibilities to the competent state, Federal District and municipal health authorities. For applicants, ANVISA does not replace the local premises-licensing authority, and the local Visa does not replace the AFE or medicine registration.

ANVISA's AFE/AE pages list "manufacturing, distribution, storage, transport, import or export" and "pharmacies and drugstores" as separate topics for operating authorisations. Local health authorities may also issue inspection reports for use in AFE applications and carry out premises licensing, inspections and renewals under local procedures.

— Manage ANVISA, local Visa and CRF matters separately by subject, entity and address.

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Law No. 13,021/2014 defines a pharmacy as an establishment providing pharmaceutical services, health assistance and health guidance. Within this definition, a non-compounding pharmacy/drugstore (drogaria) is a premises for dispensing and selling medicines, pharmaceutical active ingredients and related products in their original packaging, while a compounding pharmacy also prepares medicines to prescription. Retail models should first distinguish between these two types of activity; general drugstore authorisation does not cover compounding.

Pharmacy operations require authorisation and a licence from the competent authority. ANVISA’s pharmacy AFE FAQ describes the AFE as a licence allowing a company to commercialise industrially manufactured medicines, and refers to the scope of specially controlled medicines. However, ANVISA also provides an AE application pathway, and the specific authorisations, record-keeping and storage requirements for specially controlled medicines must be checked item by item against the product/substance and the latest service checklist.

RDC 44/2009 sets out good pharmacy practices for the operation of pharmacies and drugstores, dispensing, product commercialisation and pharmaceutical services. Where prescription compounding is performed, ANVISA separately lists RDC 67/2007, the good practices for compounding in pharmacies.

— First determine whether the pharmacy will compound and whether it will offer additional services; verify controlled products, compounding and online business separately.

— Maintain an on-duty pharmacist, suitable premises and good pharmacy practices on an ongoing basis.

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ANVISA includes distribution, storage, transport, import and export among the activities covered by the AFE for medicines/active pharmaceutical ingredients. ANVISA’s distribution FAQ defines “distribution” as transactions between legal entities or with professionals for use in their professional activities; this differs from dispensing, which may be carried out only by pharmacies/drugstores to consumers.

Wholesale is not determined solely by ownership of the goods. Decree No. 8,077/2013 requires technical and operational capacity, suitable premises and equipment, quality assurance measures, trained personnel and control of environmental risks to be verified at the local licensing stage. It also provides that entities throughout the supply chain bear corresponding responsibility for product quality, safety and efficacy.

ANVISA states that RDC 430/2020 sets good practice requirements for the distribution, storage and transport of medicines, and that the relevant provisions took effect from 3/2022 following the transition period. Owned warehouses, third-party warehouses, logistics service providers and transport arrangements should all be included within the quality system and inspection preparations according to their actual scope.

— Apply for authorisation based on the actual distribution, storage, transport, import and export activities; include warehousing, logistics and traceability in the quality system.

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Activities involving medicines and active pharmaceutical ingredients—including manufacturing, production, packaging, subdivision into smaller packs, repackaging, purification and synthesis—are covered by the AFE. Manufacturers must also obtain a local health licence for each specific manufacturing site; authorisation and inspection of the relevant site cannot be replaced by the group’s compliance record, product registration or compliance record for another factory.

ANVISA lists RDC 658/2022 as the general GMP guideline for medicines and states that all manufacturers of regulated products must comply with GMP at all times. ANVISA also explains that a GMP certificate (CBPF) is not a document universally required for “normal operations”; therefore, whether a certificate application is needed should be determined according to the product, market access and specific procedure.

For domestic companies, CBPF inspections are carried out or participated in by the state, municipal or Federal District Visa. ANVISA’s official FAQ lists warehouses, utility systems, production, quality control and quality assurance among the areas that inspections may cover. Where multiple factories participate in manufacturing a medicine, the applicant should disclose every manufacturing step and the process flow.

— Manage local or overseas manufacturing arrangements using a “factory—process—product—certificate—registration” mapping.

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Decree No. 8,077/2013 requires establishments regulated by it to maintain a legally qualified technical responsible professional on an ongoing basis. This principle applies to medicine-related establishments, but the specific professional category, individual registration, dual appointments, cover arrangements and working hours should not be applied uniformly without checking the rules for the relevant activity.

For pharmacies and drugstores, Law No. 13,021/2014 sets out more specific requirements: a pharmacy must have a legally qualified pharmacist responsible for technical matters and providing technical assistance, and a pharmacist must be present throughout all opening hours. Law No. 5,991/1973 also requires the technical responsible professional to be registered with the Regional Pharmacy Council and allows an alternate technical responsible professional to be appointed. After a pharmacist leaves, the law requires the pharmacy to appoint a new pharmacist within 30 days.

A company’s technical responsible professional, its legal representative and the individual qualifications of a pharmacist are matters at different levels. An individual’s qualification/registration with the CRF does not automatically confer an AFE on the company, and the company’s AFE does not automatically confer an individual pharmacist’s licence to practise.

— Keep records of the technical responsible professional’s qualifications, responsibility documents and actual work schedule; when the responsible professional changes, check the company and local procedures in parallel.

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A local health licence is not a formality or mere filing. Decree No. 8,077/2013 requires premises seeking a licence to have technical and operational capacity, facilities suitable for the intended use, equipment and instruments, quality assurance measures, trained personnel, and the capacity to prevent, eliminate or reduce harmful environmental risks. Each premises licence is independent, even where premises belong to the same company and are located in the same municipality or Federal District.

Pharmacies must also meet requirements for a sanitary-suitable location, technical equipment and fittings; where immunobiological products are handled, suitable storage equipment is required. A manufacturing CBPF inspection may examine warehouses, utility systems, production, quality control and quality assurance areas. Wholesale/logistics operations should incorporate storage and transport quality conditions into their systems in accordance with RDC 430/2020.

This verification did not identify a minimum floor area, uniform lease term or fixed equipment list that applies generally to all medicine-related business models in Brazil. The actual design and documentation should be confirmed with the Visa for the proposed location, taking into account the product category and scope of activities.

— Prepare facilities, quality, personnel and inspection evidence for each address; confirm local Visa requirements before selecting a site.

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The AFE application for medicines and active pharmaceutical ingredients is for companies intending to conduct the relevant activities and already registered with ANVISA under a CNPJ. The government service page states that applicants must select the relevant subject as an initial application in the Solicita system, enter the information, attach the applicable documents and submit. The document list varies by application subject; consult ANVISA’s subject search and the checklist applicable at the time.

In practice, contact the Visa in the intended location as early as possible about inspections and the inspection-report procedure: the ANVISA service page expressly states that the local health surveillance authority issues the inspection report for use in the AFE application. At the same time, the decree requires the premises to have a local health permit for an AFE. These requirements reflect coordination between federal authorisation and local on-site verification, rather than a single linear process. Confirm the local sequence with both authorities.

The pharmacy/drugstore page specifies that applicants must first complete ANVISA company registration and provide size information, then apply for an AFE in Solicita using subject code 733 and for an AE using code 705, and submit the documents specified for each subject. The system generates a GRU; the application formally enters the technical review queue only after payment is confirmed. The codes above apply only to the pharmacy/drugstore route described on that page; manufacturing or wholesale applicants should select the applicable subject.

— After completing CNPJ/system registration, preparing for the local inspection and checking the checklist for the applicable subject at the time, submit through Solicita and track the application.

— Controlled products, product registration, imports and CBPF follow separate applicable procedures.

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ANVISA’s medicine AFE service page states that the health surveillance fee varies according to company size and application type; the public page does not specify a single amount for all retail, wholesale and manufacturing projects. Applicants should calculate the fee based on their CNPJ, application subject, activity and the official fee rules in force at the time, and should not treat amounts for other projects as fixed quotations.

ANVISA’s general AFE/AE questions and answers set a maximum review period of 60 days for grants and amendments. The medicine AFE service page indicates an estimated service period of 30 days, but also expressly states that actual review times may vary depending on the application and current demand. Applicants can track the application through the review queue and document search. These figures therefore do not constitute a promise of approval or an opening date.

The AFE service page indicates that the document has “no validity period”; however, the validity period of a local premises health permit is set by the local health authority according to the sanitary risk of the activity. The AFE/AE certificate is merely an optional document evidencing that the authorisation remains in force, and is valid only while the authorisation is active and the information on the certificate has not changed. It does not replace local renewal or ongoing compliance.

— Calculate fees and timelines based on company size, subject and local risk rules at the time of application; do not promise an opening date.

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Compliance is not a one-off matter after an AFE is granted. Decree No. 8,077/2013 provides that health surveillance is an ongoing activity. Inspectors may enter regulated premises, examine documents and data, conduct routine inspections or inspections investigating violations, and take measures such as sealing premises or seizing non-compliant premises or batches. Companies must maintain product quality; manufacturers, importers and other supply-chain participants bear their respective responsibilities for quality, safety, efficacy and proper use.

Pharmacies/drugstores must continuously comply with pharmacist technical responsibility and on-duty requirements during operating hours, the operational, dispensing and service standards under RDC 44/2009, and local permit conditions. Wholesalers must continuously apply good practices for medicine distribution, storage and transport; manufacturers must always comply with GMP. Revalidation/renewal of local health permits is handled according to local risk rules and inspection arrangements.

Where a company manufactures or imports a registered medicine and plans to interrupt supply, ANVISA’s interruption guidance page lists notification points of 72 hours for unplanned interruptions or emergencies, 180 days for planned interruptions, and 12 months for interruptions that may cause a shortage. This obligation should be verified against whether the product falls within the supply-interruption circumstances covered by that page.

— Maintain authorisation information, local permits, quality systems and records available for inspection; meet reporting requirements, including those for interruptions, under the applicable product rules.

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For an AFE covering medicines and active pharmaceutical ingredients, ANVISA’s official amendment service requires an amendment application after the AFE becomes active for changes to the address of the licensed CNPJ, company name, addition or removal of AFE activities, associated legal representative, associated technical manager, and changes to the CNPJ of certain head offices. The application is submitted in Solicita as an application linked to an existing procedure, with documents attached according to the corresponding subject. The page states that changes to the legal representative and technical manager are processed automatically.

Law No. 5,991/1973 provides that a transfer of ownership of the premises and a change to the premises’ name/trade name do not interrupt the permit’s validity period, but the health authority must be notified and documents evidencing the transaction must be submitted for annotation. Relocation to a site other than the licensed address requires prior authorisation from the health authority and compliance with licensing requirements. This is a rule concerning local premises permits and does not replace an AFE amendment.

The ANVISA AFE amendment page reviewed does not separately list a “pure share transfer within the same CNPJ” as a nationally uniform circumstance for automatic succession to or amendment of an AFE. Accordingly, do not assume in a transaction that the licence transfers automatically with the shares: verify whether the transaction changes the CNPJ, legal representative, company name, address, technical manager, activities or local permit registration, and follow the written/system requirements of each competent authority.

— Before any transaction or change, review the AFE, local permits, technical manager, product registration and actual activities for each site.

— Update changes to address, name, activities or responsible persons in accordance with ANVISA and local procedures.

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A company AFE is not the same as a marketing authorisation for a medicine. ANVISA’s medicine registration service page expressly states that an initial registration with ANVISA is required for a medicine to be lawfully commercialised, used and imported in Brazil. Companies using this service must already hold an AFE for manufacturing and/or importing medicines. The registration service page states that the usual registration validity period is 10 years, but exceptions apply to initial registrations and early renewals granted by means of a commitment letter: 3 years, 5 years and, thereafter, 10 years.

Decree No. 8,077/2013 provides that activities involving regulated products may be conducted only after registration with ANVISA, and that imports are subject to ANVISA’s prior regulatory approval and specific technical requirements. Therefore, holding an AFE as a retailer, wholesaler or manufacturer does not in itself mean that the holder may import any product, sell an unregistered medicine or release goods for cross-border distribution.

ANVISA provides different application subjects for AFE and AE for pharmacies/drugstores, and the pharmacy AFE page also refers to specially controlled medicines listed in Ordinance SVS/MS No. 344/1998. The applicability of special controls for substances/medicines, import/export authorisations, product registration, manufacturing GMP/CBPF and individual professional registration must be checked separately. This page does not describe any of these as an automatic entitlement attached to ordinary business authorisation.

— Check medicine registration, import activities, prior regulatory approval and eligibility for controlled products individually; do not describe the business simply as “licensed” without qualification.

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