BRAZIL Law and Practice Contributed by: Priscila Kashiwabara, Viviane Trojan, Gustavo Vicenti and Giovanna Mezher, Kasznar Leonardos Intellectual Property
registration regimes, labelling requirements and usage instructions for medical devices. Addi- tionally, RDC 18/2014 regulates communication to ANVISA regarding temporary or permanent discontinuation or reactivation of medicine man- ufacture or import. Import Authorisation (AI) requirement: • commercial imports typically require an AI from ANVISA; • importers must apply for the AI before the shipment reaches Brazil; and • ANVISA assesses applications and support- ing documents to ensure product registration, technical compliance and adherence to GMP. Exemptions may apply in certain cases. • Donations – importing for public health pro- grammes as donations may be exempt from AI, subject to specific ANVISA procedures and documentation. • Emergency situations – temporary authorisa- tions may be granted during public health emergencies. • Clinical trials – authorised trials have specific import procedures for investigational drugs and medical devices. • Personal use – limited exemptions may exist for small quantities for personal use, but trav- ellers should verify guidelines with ANVISA or Brazilian customs to avoid penalties. 7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports Brazil’s non-tariff regulations and restrictions (NTRs) for imports, including pharmaceuticals and medical devices, ensure product safety,
• Harmonised System (HS) Tariff Code – deter- mines NTR requirements based on product classification; • technical description – product characteris- tics can dictate NTRs; eg, medical devices may need extra certifications; and • regulatory category – ANVISA’s classification influences NTRs, with high-risk products fac- ing stricter regulations. Laws and regulations listing products subject to NTRs: • Law 13,097/2015 – governs import/export of health products, outlining ANVISA’s role; • ANVISA resolutions and directives – specify technical requirements, registration and import processes for different product cat- egories; and • other legislation – additional regulations from ministries such as MAPA or INMETRO may apply. 7.5 Trade Blocs and Free Trade Agreements Brazil engages in trade agreements with provi- sions for trade and regulatory facilitation. Some include the following. Trade Bloc Mercosur was formed in 1991 with Argentina, Uruguay, Paraguay and associate members such as Bolivia, Chile, Peru, Suriname and Guy- ana. Mercosur promotes trade integration via tariff reductions and regulatory harmonisation. Free Trade Agreements (FTAs)
Brazil has FTAs with various countries: • Uruguay and Paraguay (Mercosur); • Argentina (Mercosur); • Bolivia (Mercosur);
quality and compliance. Basis for imposing NTRs:
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