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Sector · Pharma, health and cosmetics

Pharma, health and cosmetics: the list price, the CEST and single-stage taxation decide the tax on every box that leaves the stock

The same medicine can be sold with ICMS-ST, with an exemption for a public buyer and with PIS and Cofins concentrated on the producer, all in the same month. ICMS is Brazil's state value-added tax, and ST is tax substitution, where one party withholds the tax for the next ones in the chain. Perfumery and hygiene follow a similar logic, with their own ST list and their own contribution rate. Whoever books these invoices answers to one rule on regulated price and another on batch records.

This page gathers what DFSpro read in official sources about ST for medicines and perfumery, exemptions, single-stage taxation, EFD records and the Tax Reform, and points to where the SAP setup usually differs. The tax decision always belongs to the client.

Versão em português
Tax map

What weighs in medicines and cosmetics, topic by topic

The direct answer

For a medicine, the tax depends on who sells, to whom and by which price list. Two almost identical items can be taxed differently because the CEST, the buyer or the health registration is different.

To start the conversation: does your CEST master data already separate, material by material, who is on the positive, negative and neutral list of Annex XIV on the date of the invoice?

The short answer: if it separates them, ST comes out right by item and by state. If it does not, the starting point is the matrix of material, NCM, CEST and list, tested on a sample of invoices.

TopicThe rule that hits the sector mostLegal basis readWhere it usually breaks
ICMS-ST on medicinesIn interstate operations among the 18 states (each one a UF) that signed Agreement 234/17, the sender withholds the ICMS on the items of Annex XIV of Agreement 142/18. The destination state may use as the base the PMC, from a specialized magazine or set by the CMED, adjusted to the average retail price.Conv. ICMS 234/17, clauses first and third; Conv. ICMS 142/18, Annex XIVCEST of the positive, negative or neutral list swapped; old PMC in the master data; a state outside 234/17 treated as if it were inside.
ICMS-ST on perfumery, hygiene and cosmeticsAnnex XIX of Agreement 142/18 lists perfumes, colognes, makeup and other items, with CEST of group 20. Interstate ST exists only where the states have signed a specific agreement (clause second of 142/18).Conv. ICMS 142/18, clause second and Annex XIXNew line with no CEST and withholding done for a state with no agreement.
ICMS, medicine exemptionsThere is an exemption for drugs and medicines sold to public bodies, with conditions on PIS, Cofins, Import Tax and IPI (Conv. 87/02), an exemption for a list of medicines (Conv. 140/01) and an authorization for the states to exempt cancer medicines (Conv. 162/94).Conv. ICMS 87/02, 140/01 and 162/94Benefit applied to the product and not to the operation with the right buyer, and a term ending 31/12/2026 with no alert.
Single-stage PIS and CofinsThe producer and the importer pay a concentrated rate: 2.1% and 9.9% on pharmaceutical products and 2.2% and 10.3% on perfumery, toiletries and personal hygiene. Whoever resells, without being a producer or importer, has a zero rate, except if it is in the Simples regime.Law 10.147/2000, arts. 1, I and 2; LC 214/2025, art. 542, XISale from the producer to the wholesaler treated as a reseller sale, or the reverse, and the output CST swapped.
PIS and Cofins on imports and inputsDecree 6.426/2008 sets PIS and Cofins at zero, including on imports, for chemicals of Chapter 29 and hospital-use items, and sets PIS and Cofins-Import at zero for pharmaceutical products of headings 30.01, 30.03, 30.04 and others.Decree 6.426/2008, arts. 1 and 2Imported input without the right annex classification, with the contribution charged on entry.
IPIThe producer and the importer are IPI taxpayers. The rate by NCM of headings 30 and 33 depends on the TIPI, which was not read for this page.Decree 7.212/2010 (RIPI), arts. 24 and 35NCM rate that was reclassified and does not reach the master data.
Regulated priceThe price of a medicine is a ceiling: the CMED sets price criteria, and Anvisa publishes the PMC and PMVG lists on its portal. That price becomes the ST base and a reference for benefits.Law 10.742/2003, arts. 4 and 6; Anvisa portal, CMED pageInvoice price different from the list price and with no trace of which list was used.
IBS, CBS and Selective TaxA medicine has a zero rate in defined lines of care and a 60% reduction in the other registered ones. Single-stage taxation ends in 2027, and the Selective Tax does not reach medicines or cosmetics.LC 214/2025, arts. 133, 146, 381 and 409; LC 227/2026Master data that does not know which rate regime applies to each health registration.
Index

Choose your entry point by role

Four entries, one for each role, straight to the block that answers your question.

01Tax and fiscal

What the agreements say about ST on medicines and perfumery.

Go to the section

02IT and SAP integrator

Eight setup points that often fail in medicines and cosmetics.

Go to the section

03Management and decision

Where the tax process becomes a project in medicines, health and cosmetics.

Go to the section

04Health regulation

Registration, price and traceability: what health law changes on the invoice.

Go to the section
Direct links
ICMS-ST

ST on medicines and perfumery: what the agreements say, in the text we read

Agreement 142/18 holds the general rules and the product annexes. Agreement 234/17 covers only the ST of medicines for human use and other pharmaceutical products of Annex XIV.

Who joined

Clause first of Agreement 234/17 lists Acre, Alagoas, Amapá, Bahia, Espírito Santo, Maranhão, Mato Grosso, Mato Grosso do Sul, Pará, Paraíba, Paraná, Pernambuco, Piauí, Rio de Janeiro, Rio Grande do Norte, Rio Grande do Sul, Sergipe and Tocantins. Santa Catarina left through Agreement 119/20, with effect from 01/01/2021. The other states: not checked.

What stays out

Products for veterinary use are not included (clause second, I). CEST 13.012.00 stays out when the origin or destination is Paraná, Rio Grande do Norte or Rio Grande do Sul, and 13.013.00 when it is Rio Grande do Norte. Since 01/08/2024, a list of 20 CEST of group 13 also stays out when the destination is Paraná (Agreement 92/24).

Calculation base

The destination state may use the Maximum Consumer Price published in a large-circulation specialized magazine or set by the CMED, adjusted to reflect average retail prices, by the same survey criteria as Agreement 142/18 (clause third).

Price list to the SEFAZ

The PMC list from the magazines goes to the destination tax authorities within 30 days after a price is added or changed, in XML in the format of the single Annex of the agreement (clause fourth).

How Annex XIV and Annex XIX organize the items

Medicine by type and by list

Annex XIV separates reference medicines, generics, similars and others, and each type appears three times, in the positive, negative and neutral lists, with its own CEST (for example 13.001.00, 13.001.01 and 13.001.02). The meaning of each list was not read in this round.

Other products of Annex XIV

It includes hormone-based contraceptive preparations (CEST 13.005.00 to 13.005.05) and provitamins and vitamins (13.006.00), among others. The Annex also covers pharmaceutical products for veterinary use, which Agreement 234/17 excludes.

Perfumery in Annex XIX

Perfumes (3303.00.10, CEST 20.007.00), colognes, makeup products for the lips and eyes, powders and manicure preparations appear with CEST of group 20. The full list of items was not opened.

Agreement by state

Agreement 142/18 says that interstate ST depends on a specific agreement between the states involved, and that the destination state may require an act of the Executive Branch to bring it into its rules (clause second). The perfumery and hygiene protocols were not read.

Official source, read on 19/10/2026

ICMS Agreement 234/17, clauses first to fourth, and ICMS Agreement 142/18, clauses first and second and Annexes XIV and XIX, in the texts published on the CONFAZ portal. History read in the page notes: Agreement 76/94 (ST on pharmaceutical products) was repealed by Agreement 228/17, with effect from 01/01/2018 (clauses first and second, read on 22/10/2026), and Protocol 105/09, between Bahia and São Paulo, appears as repealed and rejected by Protocol 79/25, with effect from 01/01/2026.

DFSpro judgment

The master data question that weighs most is which list each item comes from: positive, negative or neutral, and by which PMC. A wrong CEST changes the base and the withholding of the whole box, and the mismatch only shows up when the destination state rejects or recalculates the invoice.

Exemptions and single-stage taxation

Public buyer exemption, concentrated PIS and Cofins: what holds and until when

A medicine has ICMS benefits that depend on who buys and a concentrated PIS and Cofins taxation that depends on who sells.

Sale to a public body

Agreement 87/02 exempts from ICMS the operations with the drugs and medicines of its single Annex sent to bodies of the direct and indirect federal, state and city administration and their public foundations. The exemption requires that the products have an exemption or zero rate of Import Tax or IPI and that the revenue be relieved of PIS and Cofins (clause first, § 1, I and II).

Term of agreements 87/02 and 140/01

ICMS Agreement 21/26 (27/01/2026, published in the DOU on 29/01/2026), clause first, items LIV and LV, extends until 31/12/2026 the provisions of Agreements 140/01 and 87/02. What holds after that date: not checked. Agreement 140/01 exempts ICMS on a list of medicines, such as those based on imatinib mesylate and the interferons.

Cancer medicine

Agreement 162/94 authorizes the states and the Federal District to grant an exemption on operations with medicines for cancer treatment, listed in the single Annex, now amended up to Agreement 90/25. Each state decides whether to grant it, and by which act.

Concentrated PIS and Cofins

Art. 1, I, of Law 10.147 sets, on the revenue of the producer and the importer, 2.1% PIS and 9.9% Cofins on pharmaceutical products, and 2.2% and 10.3% on perfumery, toiletries and personal hygiene (headings 33.03 to 33.07, with code exceptions). Art. 2 sets at zero the rates of whoever is neither a producer nor an importer, but not for companies in the Simples regime.

Official source, read on 19/10/2026

Law 10.147/2000, arts. 1 and 2, in the compiled text of the Planalto site, where the successive wordings (Law 10.865/2004, Provisional Measure 609/2013 and Law 12.839/2013) appear together on the page. The reading here follows the wording that carries the exception of heading 33.06. Decree 6.426/2008 sets PIS and Cofins at zero on the domestic sale and on the import of Chapter 29 chemicals and hospital-use items, and PIS and Cofins-Import of the pharmaceutical products listed in art. 2. Law 10.147 leaves the legal order completely on 01/01/2027, by repeal in LC 214 (art. 542, XI).

Company in the Simples Nacional regime

Under LC 123, art. 13, § 1, XIII, item a, the single payment of the Simples does not cover the ICMS due on operations under tax substitution, single-stage taxation and advance payment that closes the taxation, involving, among other products, medicines and other pharmaceutical products for human or veterinary use, cosmetics and perfumery and personal hygiene products. Item XII also leaves out of the single payment the PIS, Cofins and IPI due on the import of goods and services. How this applies to the case of each company: not checked, it is the client's reading.

State ICMS benefit

LC 160/2017, art. 1, allows the states and the Federal District, by agreement, to forgive the credits of benefits created without Confaz approval and to create again those still in force. ICMS Agreement 190/17, clause first, covers the forgiveness of benefits created by legislation published until 08/08/2017. Which medicine and medical device benefits each state registered: not checked.

Official source, read on 22/10/2026

LC 123/2006, art. 13, § 1, items XII and XIII, and LC 160/2017, arts. 1 to 3, in the compiled text of the Planalto site; ICMS Agreements 190/17, 21/26 and 228/17, on the CONFAZ portal.

DFSpro judgment

The public buyer benefit and the single-stage rate look at the operation, not the product: the same item leaves a producer under one rule and a distributor under another. SAP needs to know who the seller is, who the buyer is and which agreement authorizes it, at the moment of the invoice.

Health and price regulation

Registration, price and traceability: what health law changes on the invoice

Four laws define the regulated environment of the sector. None is a tax law, but all of them appear in the tax master data.

Registration before sale

Law 6.360/1976 places medicines, drugs, pharmaceutical inputs, related products, cosmetics, perfumes and hygiene products under health surveillance (art. 1). None of them may be produced, offered for sale or delivered for consumption before being registered with the federal health body (art. 12), and only authorized companies and licensed establishments may produce, store or ship them (art. 2).

Anvisa and Health Surveillance

Law 9.782/1999 defines the National Health Surveillance System and creates Anvisa. The agency's portal holds the CMED page, with the PMC and PMVG price lists in spreadsheet form.

CMED and price ceiling

Law 10.742/2003 creates the CMED and sets that the price adjustment of medicines follows a ceiling model based on an index (the IPCA), a productivity factor and a relative price adjustment factor (art. 4). The CMED is responsible for setting price criteria and trade markups (art. 6).

National Medicine Control System

Law 11.903/2009 created the system, and Law 14.338/2022 gave art. 3 the wording of control by a medicine identification system, with electronic data capture. Anvisa decides by rule which categories are included. Art. 1, in the wording of Law 13.410/2016, extends the control to production, distribution, sale, dispensing and prescription. The Anvisa traceability page, with no update date, mentions tests, validation and implementation with a deadline ending on April 28, 2022, and the two-dimensional barcode as the capture technology. The health rule in force and the current status of the system: not checked.

Official source, read on 19/10/2026

Laws 6.360/1976, 9.782/1999, 10.742/2003 and 11.903/2009 on the Planalto site, and the CMED page on the Anvisa portal (last change marked on 24/08/2026). The Anvisa traceability page was read on 22/10/2026. The Anvisa and CMED resolutions, including the annual adjustment and the tracking rules in use, were not read.

DFSpro judgment

Registration, batch and expiry are health data that the EFD also asks for in the medicine records. When the material master and the batch master do not talk to the tax side, the same information is typed twice and never matches.

Law

Sector rules, with status and source read on 19/10/2026

Each line was opened in the official source. The sources section gives the address of each one.

RuleSubjectStatus
ICMS Agreement 234/17ST on operations with medicines and other pharmaceutical products of Annex XIV of 142/18; PMC as the baseIn force, amended (Convs. 103/18, 46/19, 119/20 and 92/24). Text read on the CONFAZ page
ICMS Agreement 142/18ST and advance-payment regimes; Annex XIV (medicines) and Annex XIX (perfumery, hygiene and cosmetics)In force, amended (last change listed: Conv. 107/26)
ICMS Agreement 76/94ST on operations with pharmaceutical productsRepealed by Conv. 228/17 (clause first), with effect from 01/01/2018 after national ratification (clause second). Text of 228/17 read on 22/10/2026
ICMS Protocol 105/09ST on pharmaceutical products, sera and vaccines between Bahia and São PauloRepealed (page note); rejected by Prot. 79/25, effect from 01/01/2026
ICMS Agreement 87/02ICMS exemption on drugs and medicines sent to public bodiesIn force, amended many times; extended until 31/12/2026 by Conv. 21/26 (page note)
ICMS Agreement 140/01ICMS exemption on a list of medicinesIn force, extended until 31/12/2026 by Conv. 21/26 (page note)
ICMS Agreement 162/94Authorizes ICMS exemption on cancer treatment medicinesIn force, amended up to Conv. 90/25. Act of each state: not checked
Complementary Law 204/2023Non-incidence rule on the output to an establishment of the same owner (art. 12, § 4 of LC 87), with the taxpayer's option to tax (§ 5)In force since 01/01/2024. Form and deadline of the option: not checked
EC 87/2015 and LC 190/2022; ICMS Agreement 236/21DIFAL on a sale to a final consumer in another state, taxpayer or notIn force. Read in the manufacturing round; practical start of LC 190: not checked
Law 10.147/2000Concentrated PIS and Cofins on pharmaceutical products and on perfumery, toiletries and hygieneIn force until 31/12/2026; repeal by art. 542, XI, of LC 214
Decree 6.426/2008PIS and Cofins at zero on Chapter 29 chemicals, hospital-use items and imports of pharmaceuticalsText read with no repeal mark in arts. 1 and 2; amendments: not checked
Non-cumulative PIS and Cofins regimeEach of Laws 10.637/2002 and 10.833/2003 governs the credits in its art. 3In force, amended. Read in the manufacturing round
Law 6.360/1976Health surveillance of medicines, cosmetics, perfumes and hygiene products; prior registrationIn force, amended
Law 9.782/1999National Health Surveillance System and creation of AnvisaIn force, compiled text
Law 10.742/2003CMED and economic regulation of the pharmaceutical sectorIn force. Note for Provisional Measure 933/2020
Law 11.903/2009National Medicine Control SystemIn force, amended by Laws 13.410/2016 and 14.338/2022
Ajuste SINIEF 07/05Creates the NF-e, model 55In force, amended several times
Ajuste SINIEF 02/09EFD; Block C records used in medicinesIn force, amended
Constitutional Amendment 132/2023Consumption tax reform and transitionIn force
Complementary Laws 214/2025 and 227/2026IBS, CBS, Selective Tax, reduced health rates and transitionIn force. Law 214 was amended by 227, including art. 146
Complementary Law 123/2006Simples Nacional; art. 13, § 1, items XII and XIIIIn force, with cross-reference notes to LC 214/2025. Read on the Planalto site on 22/10/2026
Complementary Law 160/2017 and ICMS Agreement 190/17Forgiveness and re-creation of ICMS tax benefits created without Confaz approvalIn force (LC 160 refers to LC 186/2021). Read on 22/10/2026
ICMS Agreement 21/26Extends until 31/12/2026 tax benefit agreements, among them 140/01 and 87/02In force. Read on 22/10/2026; what holds after 31/12/2026: not checked
Not checked in this round

Missing: Anvisa and CMED resolutions (tracking, annual adjustment, price rules in use). The ST protocols and agreements on perfumery and hygiene by state. The full lists of Annexes XIV and XIX. The TIPI for headings 30 and 33. The EFD-Contributions. State special regimes for producers and distributors. Decree 12.955/2026. None of this enters here as fact.

Sector situations

Where the tax process becomes a project

These are typical situations of the sector, described as a pattern and not as a client case. Here DFSpro steps in on the design, the setup and the proof of how SAP behaves, and the tax decision stays with the company.

15

situations where the process becomes a project

Fixed assets, stock, credits, withholdings and migration: where volume and rules make the work heavy, and where a well-proven design takes the process out of the spreadsheet.

01

Validated production line: requalification, capitalization and depreciation

What weighsFactory equipment goes through qualification and periodic revalidation.

What DFSpro changesValidation cost kept apart from maintenance, with a record by line.

See the situation, the basis and the proof

The situationThe factory qualifies each piece of equipment and revalidates the line from time to time. The requalification spend can be an expense or a cost of the asset, depending on what changes in use and useful life.

Legal basisRIR arts. 317 to 321; RDC 658/2022

The proof deliveredRequalification scenario with record, ledger and CIAP reconciled.

02

Equipment on loan at the customer: an asset outside the house

What weighsThe asset is yours, sits in the hospital or lab, and depreciates.

What DFSpro changesControl by serial number, with outbound, return and depreciation.

See the situation, the basis and the proof

The situationThe company lends an analyzer or an infusion pump to a hospital and sells the supplies. The equipment stays outside, with a contract, maintenance and a term.

Legal basisState rule on loan for use; Ajuste SINIEF 02/09

The proof deliveredEquipment report by serial number, customer and asset record.

03

Recall and return by batch: the way back of the document

What weighsA whole batch must come back, with invoice and stock.

What DFSpro changesBatch traced from the sales document to the returned stock.

See the situation, the basis and the proof

The situationA batch is recalled from the market. Distributors and pharmacies return parts of it, with different invoices, and the returned stock stays blocked until its destination is set.

Legal basisLaw 11.903/2009; EFD Record C173

The proof deliveredSimulated batch: list of sales invoices, returns and blocked balance.

04

Expired product, destruction and reverse logistics

What weighsWriting off an expired product requires a record, an invoice and handling of the credit.

What DFSpro changesDestruction flow with document and a reversal decided by the client.

See the situation, the basis and the proof

The situationExpired or recalled product is destroyed by a specialized company. The write-off needs a record, an output invoice to the destroyer and handling of the original credit.

Legal basisLC 87 art. 21

The proof deliveredScenario tested with block, invoice to the destroyer and write-off.

05

Sale to a public body: discount on the invoice and conditional exemption

What weighsThe price to the government has a ceiling and a discount that must appear on the invoice.

What DFSpro changesPublic sale scenario tested, with the value and the benefit in the document.

See the situation, the basis and the proof

The situationA sale by tender to a public hospital or health department leaves with a conditional exemption and a limited price. If the discount is not on the invoice, the condition does not close.

Legal basisICMS Agreements 87/02 and 140/01

The proof deliveredMatrix of scenarios with value, discount and expected and obtained tax.

06

Research and development: lab equipment and full depreciation

What weighsResearch machinery can be depreciated in one year, with separate control.

What DFSpro changesRecord by R&D project, with the accelerated charge and the tax adjustment traced.

See the situation, the basis and the proof

The situationIndustry invests in labs and innovation projects. New equipment used in research can have accelerated depreciation, and development spend can become an intangible asset.

Legal basisRIR art. 326; Law 11.196/2005 art. 17

The proof deliveredReport by project with the accounting charge, the tax charge and the adjustment, reconciled with the ledger.

07

Hospital and clinic: withholdings across dozens of providers

What weighsEach provider has a different withholding rule.

What DFSpro changesWithholding calculated at payment, checked against the EFD-Reinf.

See the situation, the basis and the proof

The situationA hospital and a clinic network pay medical providers, labs and cleaning and maintenance companies. Withholdings vary by service and by city.

Legal basisLaw 10.833 art. 30; Law 8.212 art. 31

The proof deliveredReconciliation of payment, withholding and EFD-Reinf event.

08

Free samples to doctors: shipment in volume and write-off by representative

What weighsThousands of samples leave with no sale, under packaging and destination rules.

What DFSpro changesSample stock kept apart, with a balance by representative and batch.

See the situation, the basis and the proof

The situationIndustry hands out samples to doctors through representatives. The sample leaves with no price, with identification, and the balance stays in the hands of each representative.

Legal basisRIPI, product samples

The proof deliveredSample balance by representative and batch, reconciled with the invoices.

09

Stock of 31/12/2026 by batch and by case

What weighsLarge stock, by batch, with a different tax origin for each item.

What DFSpro changesInventory by item, batch and case, frozen and reconciled.

See the situation, the basis and the proof

The situationOn January 1, 2027 the pharmaceutical stock will hold items that came in under single-stage taxation, under ST or in the cumulative regime.

Legal basisLC 214/2025 art. 381

The proof deliveredReport by item, batch and case reconciled with the ledger.

10

Controlled products: stock balance against the health book

What weighsThe SAP balance must match the book required by surveillance.

What DFSpro changesPeriodic reconciliation of balance, invoice and book.

See the situation, the basis and the proof

The situationControlled medicines have their own bookkeeping, with entries, outputs and losses. The system balance and the book balance must match.

Legal basisPortaria SVS/MS 344/1998

The proof deliveredReconciliation report by batch.

11

Export and accumulated ICMS credit in industry

What weighsWhoever exports builds up ICMS credit that must be used.

What DFSpro changesCalculation of the accumulated balance with proof by establishment.

See the situation, the basis and the proof

The situationIndustry exports and buys inputs with ICMS, and the accumulated credit balance grows with no taxed output to offset it.

Legal basisLC 87 art. 25 § 1

The proof deliveredCredit balance by establishment and period, reconciled with the EFD.

12

Migration of the health product master and the batch

What weighsHealth registration, batch and NCM must survive the migration.

What DFSpro changesMaster data and batch checked before go-live.

See the situation, the basis and the proof

The situationThe pharmaceutical master carries the Anvisa registration, therapeutic class, batch and expiry. In the migration to S/4HANA, the historical batch must arrive intact.

Legal basisICMS Agreement 142/18

The proof deliveredReport of batches and materials before and after the load.

13

Sale to a public body and the earlier operations in the chain

What weighsThe exemption covers the sale to the government, but the earlier chain has its own rule.

What DFSpro changesScenario by link in the chain, with the state rule applied on each invoice.

See the situation, the basis and the proof

The situationThe distributor buys from the lab and resells to a public hospital. The exemption in the agreement covers the operation sent to the body, and the treatment of the earlier operations depends on the state.

Legal basisICMS Agreement 87/02; SEFAZ-SP query 22706/2020

The proof deliveredMatrix by link in the chain and state with expected and obtained tax.

14

Medicine serialization and reporting to the national system

What weighsEach serialized pack must be reported on every movement.

What DFSpro changesStock movement and tax document tied to the traceability event.

See the situation, the basis and the proof

The situationA medicine under the national control system has a code per pack, and each entry, output or return creates an event for the agency.

Legal basisAnvisa, IN 100/2021

The proof deliveredSimulated batch with invoice, movement and event reconciled.

15

Updated good manufacturing practice (GMP, BPF) and the equipment record

What weighsThe GMP rule changed and the equipment record must follow.

What DFSpro changesEquipment master with qualification status tied to the asset record.

See the situation, the basis and the proof

The situationThe factory qualifies and revalidates equipment under the health rule in force, which was updated. The qualification status and the asset record must talk to each other.

Legal basisAnvisa, RDC 658/2022

The proof deliveredEquipment report with status, asset record and last qualification.

Which of these situations is yours? The Tax Diagnostic shows how each one stands today in your SAP and what needs to be designed and proven first.

Learn about the Tax Diagnostic
What DFSpro solves

Time and proof gained in medicines, health and cosmetics

Six points where the sector rule does not fit the standard SAP master data, and what DFSpro does on each. The tax thesis of each case stays with the client.

Medicine

The 60% reduction depends on who supplies

Art. 133 of LC 214 cuts the IBS and CBS on a medicine by 60%, but only for whoever signed a commitment with the Union and the IBS Management Committee or follows the CMED system. Registering only by NCM does not solve it. DFSpro takes the supplier condition to the master data and tests the calculation in SAP.

Stock of 01/01/2027

Inventory by item and by batch

Art. 381 of LC 214 provides a presumed credit on the stock of January 1, 2027 for items that came in under ST or single-stage taxation. Without an inventory by item and by batch, the company does not know if it has the credit. DFSpro builds the stock by case; whether to take the credit or not is the client's decision.

Public body

Contract that crosses 31/12/2026

ICMS Agreements 87/02 and 140/01 were extended until 31/12/2026 by Agreement 21/26. A contract with delivery in 2027 and a price fixed in 2026 is at risk. DFSpro sets the condition and date by contract and makes the turn of the year visible on the tax calendar.

ST by state

The same box, different rules

ICMS Agreement 234/17 applies to 18 states in clause first, and the others stay out. A rule copied from one state to another calculates ST where it should not. DFSpro keeps the rule by state and CEST and proves each one in a scenario.

Medical device

Regular registration with Anvisa

The 60% reduction of art. 131 of LC 214 only applies to a device regularized with Anvisa (reading of 19/10/2026). Without control, an expired registration does not stop the invoice from being issued. DFSpro takes the registration validity to the material and designs the block.

Batch and expiry

One batch, two processes

Health traceability and tax traceability look at the same batch and meet in the master data. DFSpro handles the tax side, with batch and expiry on the invoice item and in the EFD, and leaves serialization to the project the client already has.

Where the client starts

Each point above ends in a choice that only the client makes. We deliver the setup and the proof that SAP behaves as the company chose.

What breaks in SAP

Eight setup points that often fail in medicines and cosmetics

DFSpro judgment, not a measurement: these are the points where the setup tends to drift from the rule. For each one, the symptom is what the tax team sees on the invoice or in the EFD, and the proof is the test that ends the doubt.

CEST and Annex XIV list by material

Symptom: ST withheld too low, too high, or an invoice rejected because the item fell on the wrong positive, negative or neutral list. Proof: matrix of material, NCM, CEST and list against Annex XIV on the date of the invoice.

State outside Agreement 234/17 and exclusions by CEST

Symptom: withholding for a destination that did not join, or no withholding for a destination that did, and exceptions for Paraná, Rio Grande do Norte and Rio Grande do Sul missing from the master data. Proof: matrix of state by CEST tested on a sample of invoices for each destination.

ST base by PMC

Symptom: base calculated with an old list price or without the average retail price adjustment. Proof: recalculation of the base by presentation, with the PMC list and the date used kept with the invoice.

EFD record C173

Symptom: batch, expiry or ST reference type flag blank or different from what goes on the invoice, with the maximum price field at zero. Proof: reconciliation between the stock batch, the invoice and the C173 line of the month.

Single-stage PIS and Cofins by type of seller

Symptom: a producer applying a reseller rate, or a distributor applying the concentrated rate, and a Simples company treated as if it had a zero rate. Proof: classification by issuer, NCM and CST against arts. 1 and 2 of Law 10.147.

Public buyer exemption

Symptom: Agreement 87/02 exemption applied without checking the PIS, Cofins and Import Tax conditions, or after 31/12/2026 without the new term. Proof: report by public recipient CNPJ, item and agreement, with the validity date read.

ST refund and return

Symptom: C176 without the matching entry invoice, or a batch return that does not reverse the ST withheld. Proof: reconciliation between the output key, the return key and the amount withheld, by batch.

Cosmetics: Free Trade Zone and DIFAL on direct sale

Symptom: perfumery sold to a Free Trade Zone destination without the art. 441 treatment of LC 214, and a direct sale to a consumer in another state without DIFAL. Proof: rule by NCM (headings 3303 to 3307) and destination against the text of LC 214 and Agreement 236/21.

Ancillary obligations

What the producer, the distributor and the pharmacy file and who requires it

ObligationWhat it reportsFrequency and requirement
NF-e, model 55Document for each sale, with CEST, ST base and amount, and the batch and expiry data of the medicine.Ajuste SINIEF 07/05, clause first. Batch fields on the invoice and the deadlines of each state: not checked.
EFD ICMS/IPIBookkeeping of ICMS and IPI. In Block C, record C173 carries the medicine operations: batch, quantity, manufacture, expiry, reference type of the ST base and maximum list price.Monthly. Mandatory for ICMS and IPI taxpayers since 01/01/2009 (Ajuste SINIEF 02/09). The deadline comes from state law (EFD ICMS/IPI Practical Guide in force, to check on the SPED portal).
ST records in the EFDC176 (refund of ICMS on an ST operation), C180 and C185 (entries and outputs of goods under ST), C181 and C186 (returns).Monthly, inside the EFD, according to the states that require the record. The Guide notes that C176 is not used by all states.
GIA/ST and DeSTDAST withheld and paid to the destination state.GIA/ST for the substitute and DeSTDA for the Simples company, according to Agreement 142/18. Frequency: not checked.
PMC listList of prices from specialized magazines, sent to the SEFAZ in XML.ICMS Agreement 234/17, clause fourth, within 30 days after a price is added or changed. The duty belongs to whoever publishes the list.
Medicine trackingIdentification of the medicine by a system with electronic data capture.Law 11.903/2009, art. 3. The Anvisa rule that puts it into practice: not checked.
EFD-Contributions, ECD and ECFPIS and Cofins calculation, plus the company's accounting and tax books.Not checked: rules not yet opened in the source for this page.

To read each obligation in more detail: ancillary obligations and SPED in SAP, SPED Fiscal and EFD ICMS/IPI, law on SPED and ancillary obligations and the tax calendar.

Reform

The transition to IBS and CBS in medicines and in cosmetics

The direct answer

For the sector, the Reform starts in 2027, when single-stage taxation ends and the credit on stock is born, and then the rate of each registration changes, among zero, 60% and the general rule.

2026, a transition year

For 2026 LC 214 sets IBS at 0.1% and CBS at 0.9% (arts. 343 and 346), but a taxpayer up to date with the ancillary obligations does not need to pay (art. 348, § 1), and PIS and Cofins stay in full (§ 2). Whoever pays offsets it against PIS and Cofins or gets a refund within 60 days, and a Simples company is left out (art. 348, III, c). The EFD ICMS/IPI does not calculate CBS, IBS or IS (Practical Guide, section 10).

2027, end of single-stage taxation and credit on stock

The repeal of Law 10.147 applies from 01/01/2027 (LC 214, arts. 542, XI and 544, III). Under art. 381, there is a presumed CBS credit on the stock existing on 01/01/2027, bought under the single-stage taxation of art. 1, I, of that law: 9.25% of the value of the stock of goods bought in Brazil, calculated and taken until the last day of June 2027, used in 12 monthly installments and only to offset CBS. Under art. 383, the term to use these credits is 5 years from the end of the calculation period in which each one was taken.

Medicine: zero and 60%

Under art. 146, in the wording of LC 227, the rate is zero for medicines registered with Anvisa for rare diseases, neglected diseases, oncology, diabetes, HIV and other STIs, cardiovascular diseases and the Farmácia Popular Program, and for sera and vaccines, plus those bought by public bodies and health entities with Cebas. The other registered ones get a 60% reduction (art. 133), as long as the producer or importer has an agreement with the Union and the Management Committee or follows the CMED.

Health, devices and hygiene

Health services of Annex III get a 60% reduction (art. 130). Medical devices of Annex IV get 60% (art. 131) and those of Annex XII get zero (art. 144), as long as they meet the Anvisa rule. Personal hygiene and cleaning products of Annex VIII get 60% (art. 136), and menstrual health products get zero (art. 147). The list of medicines with a zero rate is published by a joint act every 120 days.

Cosmetics and the Free Trade Zone

Perfumery, toiletries and cosmetics are left out of the favored regime of the Manaus Free Trade Zone, except headings 3303 to 3307 meant only for internal consumption in the Free Trade Zone or made with regional raw material, under the basic production process (art. 441, f).

2029 to 2033, ICMS falls until it ends

Between 2029 and 2032 ICMS is 9/10, 8/10, 7/10 and 6/10 of the set rate, and in 2033 it ends (EC 132, ADCT arts. 126 to 135, read in the manufacturing round). Meanwhile, ST on medicines and perfumery stays in ICMS. Whoever has an onerous ICMS benefit is compensated with funds from the Compensation Fund between 2029 and 2032, under the criteria and limits of arts. 384 and 385 of LC 214 (read on 22/10/2026).

Official source, read on 19/10/2026

LC 214/2025 in arts. 130, 131, 133, 136, 144, 146, 147, 343, 344, 346 to 348, 381, 409, 413, 441 and 542, in the compiled text of the Planalto site, with the amendment notes of LC 227/2026. Art. 409, § 1, lists the goods of the Selective Tax (vehicles, vessels and aircraft, tobacco products, alcoholic drinks, sugary drinks, mineral goods and betting contests), and medicines and cosmetics are not on it. The general rate of IBS and CBS and Decree 12.955/2026: not checked. Arts. 383 to 385 were read again on the Planalto site on 22/10/2026.

DFSpro judgment

The practical change is that the rate comes to depend on the health registration and the purpose of the medicine, not only the NCM. The material master needs to gain this attribute and a validity date, because the lists are reviewed by joint act.

How DFSpro steps in

Diagnostic, AMS Fiscal and GUEPARDO Tax in the sector

Tax diagnostic

It maps the ICMS, ST, CEST, PIS and Cofins and credit setup at each plant and each distribution center, compares it with the rule read and ranks by risk: critical, high, medium or monitor.

Project and AMS Fiscal

It builds in SAP the setup of the rule the client chose and tests the result. In AMS Fiscal, it follows the changes in agreements, annexes and price lists through the year, such as states joining and leaving ST on medicines.

GUEPARDO Tax

DFSpro sells the license of GUEPARDO Tax, from NTT DATA, as an Authorized Channel, and also implements and provides governance. In pharma, the ST and single-stage taxation rule the client defined is tested in this environment.

To go deeper

Related blog articles

Limit of our role

The tax decision is the client's: for example, whether to apply the public buyer exemption, how to handle the credit on stock in 2027 or what thesis to adopt when the states differ. After the client decides, DFSpro configures the rule in SAP and delivers the evidence that the system follows it.

Frequently asked questions

Questions from the tax director of the sector on ST, single-stage taxation and the reform

01Does every medicine that leaves for another state carry ICMS-ST?+

No. The ST of Agreement 234/17 applies among the 18 states that signed it, to the items of Annex XIV of Agreement 142/18, and has exceptions by CEST in Paraná, Rio Grande do Norte and Rio Grande do Sul. Products for veterinary use are left out. For the other states, the rule comes from their own law, which was not read.

02What does the PMC have to do with the ST calculation base?+

The destination state may set as the base the Maximum Consumer Price, published in a large-circulation magazine or set by the CMED, adjusted to reflect average retail prices. The adjustment criteria are those of Agreement 142/18. The magazines' price list goes to the SEFAZ within 30 days after each change.

03Do perfumery and cosmetics have ST too?+

Annex XIX of Agreement 142/18 lists perfumery, personal hygiene and cosmetics products with CEST of group 20, but interstate ST depends on an agreement between the states. Which states have an active agreement today: not checked in this round.

04Does my distributor pay PIS and Cofins on the medicine it resells?+

Under Law 10.147, the concentrated rate falls on the revenue of the producer and the importer. Whoever resells, without being a producer or importer, has a zero rate (art. 2), except if it is in the Simples regime. This law stops applying on 01/01/2027.

05Does selling to a public hospital give an ICMS exemption?+

Agreement 87/02 exempts drugs and medicines of the single Annex sold to public administration bodies and foundations, if the products have an exemption or zero rate of Import Tax or IPI and the revenue is relieved of PIS and Cofins. The page note extends the agreement until 31/12/2026.

06Do the medicine exemption agreements end in 2026?+

The CONFAZ pages mark the extension of Agreements 87/02 and 140/01 until 31/12/2026 by Agreement 21/26. The text of that agreement was not opened, and a new extension only counts with a published act. Agreement 162/94, on cancer medicines, shows no end date in the notes read.

07Does moving goods between the factory and the distribution center pay ICMS?+

As a rule, no: since 01/01/2024 the non-incidence rule applies (LC 204/2023, art. 12, § 4 of LC 87), with the credit kept, and the taxpayer may opt to tax (§ 5, enacted on 12/06/2024). Form and deadline of the option: not checked. The choice is the client's.

08What changes for stock when single-stage taxation ends?+

Under art. 381 of LC 214, the stock of 01/01/2027 bought under the single-stage taxation of art. 1, I, of Law 10.147 gives a presumed CBS credit: 9.25% of the value of the stock of goods bought in Brazil, calculated until the last day of June 2027, used in 12 installments and only against CBS. There are conditions in the paragraphs of the article.

09Will every medicine have a zero rate in the Reform?+

No. Under art. 146 in the wording of LC 227, it is zero for those registered with Anvisa meant for rare diseases, neglected diseases, oncology, diabetes, HIV and other STIs, cardiovascular diseases and Farmácia Popular, and for sera and vaccines. The other registered ones get a 60% reduction (art. 133), on condition of an agreement with the Union or joining the CMED system.

10Does the Selective Tax reach medicines or cosmetics?+

By the text read, art. 409 does not mention medicines or cosmetics; it lists as targets vehicles, vessels, aircraft, tobacco products, alcoholic or sugary drinks, mineral goods and betting contests. The rates depend on an ordinary law, which was not read.

11Does a cosmetic made in the Manaus Free Trade Zone get a benefit?+

Art. 441 of LC 214 excludes from the favored regime perfumery, toiletries and cosmetics, except headings 3303 to 3307 meant only for internal consumption in the Free Trade Zone or made with regional raw material, under the basic production process. It is for the client to decide how each product fits.

12Do the batch and expiry of a medicine go into the EFD?+

Yes, in record C173 of Block C (C172 is for ISSQN), which reports the batch number, quantity, manufacture and expiry dates, the reference type flag of the ST base and the maximum price value. The record applies to documents of code 01 and 55. According to the EFD Practical Guide (in force, check on the SPED portal), C173 must be filed by companies in the pharmaceutical segment (distributors, producers, resellers and importers), except retail trade, and the duty comes from § 26 of art. 19 of the Agreement with no number of 1970. The condition that the state defines the requirement applies to other records (C176, C180, C181, C185 and C186), not to C173. How this applies to your classification: not checked.

13I am in the Simples regime and sell medicine: does the ST ICMS enter the single payment?+

Under LC 123, art. 13, § 1, XIII, item a, no: the ICMS due on operations under tax substitution, single-stage taxation and advance payment that closes the taxation stays outside the single payment and follows the rules for other legal entities. The list of products in that item includes medicines, cosmetics and perfumery. How this applies to your classification: not checked, and the decision is yours.

14Do the ICMS exemptions on medicines end in 2026?+

ICMS Agreement 21/26 extends until 31/12/2026 the provisions of Agreements 140/01 and 87/02. What holds after that date: not checked. Agreement 162/94, which authorizes the exemption on cancer medicines, is not on that extension list.

15Is medicine tracking mandatory?+

Law 11.903/2009, in the wording of Law 13.410/2016, creates the National Medicine Control System for production, distribution, sale, dispensing and prescription. The Anvisa page speaks of implementation with a deadline on April 28, 2022. The current duty by type of agent: not checked.

16What should I bring to the first conversation?+

The list of establishments by state, the three or four destinations with the most volume, the last case where a state recalculated ST or rejected an invoice, and the SAP version. With this material, the initial scope and the order of the work streams come out of the first meeting.

Next steps

Bring the establishments, the destinations and the ST or benefit case that worries you most

Tell us where the company produces or distributes, to whom it sells and which price list it uses. With that, the first design of the work is set.

To arrive with context, it is worth going through the SAP tax diagnostic and the CBS and IBS tax reform.