19.1. General considerations
The activities of extraction, production, manufacture, conversion, synthesis, purification, fractioning, packing, repacking, import, export, storing and shipment of medicines, drugs, pharmaceutical raw material and correlatives are subject to the sanitary surveillance rules in Brazil.
For the purposes of this work, there shall be understood as related all substances, products, apparatus or accessories which cannot be characterized as drug, medicine and pharmaceutical raw material, the use or application which is related to the defense and protection of individual or collective health, personal hygiene or environments, or for diagnosis and analysis purposes, the cosmetics and perfumes as well as dietetic, optical, medical acoustic, dental and veterinarian products.
Bear in mind that the sanitary surveillance rules, which are part of the sanitary legal system in Brazil, are of public order and are grounded in the police power granted to the sanitary authority in all aspects, especially in the federal ambit.
Likewise, the health actions and services are considered of public relevance, and the Public Power should be involved with its regulation, inspection and control. Even though health constitutes a right of all and duty of the State, the performance of health actions and services is incumbent not only to the State, but shall also be implemented by means of private law legal entities. This is therefore a complex and highly regulated area.
19.2. National Sanitary Surveillance System
The National Sanitary Surveillance System has federal, state and municipal units and is comprised of the following entities: Ministry of Health, National Health Surveillance Agency – ANVISA, National Council of State Health Secretaries (CONASS), the National Council of Municipal Health Secretaries (CONASEMS), the State Sanitary Surveillance Centers of the Federal District and Municipal Sanitary Surveillance Centers (VISAS), the Central Public Health Laboratories (LACENS), the National Institute of Quality Control in Health (INCQS), Oswaldo Cruz Foundation (FIOCRUZ) and the State, District and Municipal Health Boards.
Within the Federal ambit, the main assignments of the National Sanitary Surveillance System consists in defining the national sanitary surveillance policy, issue rules, control and inspect products, substances and services of interest to health; exercise sanitary surveillance of Ports, Airports and Borders – which assignment may be complementarily exercised by the States, by the Federal District and by the Municipalities – accompany and coordinate state, district and municipal sanitary surveillance actions; provide technical and financial cooperation to the States, to the Federal District and to the Municipalities; act in special circumstances of health risk and maintain sanitary surveillance information system in cooperation with the States, the Federal District and the Municipalities.
The activities assigned to the National Sanitary Surveillance System are exercised at the federal ambit by the Ministry of Health – regarding the formulation, follow up and appraisal of the national sanitary surveillance policy and the general guidelines of the National Sanitary Surveillance System – by the National Health Surveillance Agency – ANVISA and by the other bodies and entities of the Federal Executive Power, the action areas of which relate to the system.
Let us thus consider the actions of ANVISA – National Health Surveillance Agency, responsible for the regulation of the pharmaceutical market in Brazil.
19.3. ANVISA – National Health Surveillance Agency
ANVISA, a Governmental agency under special regime – regulatory agency characterized by administrative independence, stability of its management during their mandate and financial independency – is subordinated to the Ministry of Health and has as its institutional mission to promote the health protection of the population, by means of the sanitary control of the production and sale of products and services subject to the sanitary surveillance, including of the environments, processes, raw material and technologies related thereto, as well as the control of ports, airports and borders.
ANVISA action inserted in the context of administrative decentralization of a typical service of the public administration is specially justified by the necessity of expertise in the public service provision of such magnitude, aiming at the achievement of better results.
Among the assignments of the Governmental agency there are the coordination of the National Sanitary Surveillance System; the development and performance of studies and research within its assignment area; the bringing, follow up and implementation of policies, guidelines and sanitary surveillance action; the establishment of rules and standards on contaminant limitations, toxic residues, disinfectants, heavy metals and other which involve health risk; the temporary intervention in the administration of producing entities, whether they are financed, subsidized or maintained with public resources, as well as rendering of services and/or exclusive or strategic producers for the supply of the national market; the administration and collection of the sanitary surveillance inspection fees; the concession and cancellation of operational authorization of manufacturing, distribution and importation of products subject to the sanitary surveillance, the issue of import and export licenses for such products; the grant of product registration for sale; the concession and cancellation of good manufacturing practices certificate; the interdiction as sanitary surveillance measure of manufacturing sites, control, importation, warehousing, distribution and sale of products and rendering of services related to health, in case of infringement of the related legislation or of imminent risk to health; the prohibition of manufacturing, importing, warehousing, distribution and sale of products and components in case of infringement of the relevant legislation or imminent risk to health; the monitoring and audit of the state, district and municipal bodies and entities comprising the National Sanitary Surveillance System, including the official quality control laboratories acting in the health area; the coordination and performance of the quality control of assets and products subject to the control and sanitary inspection; the regulation, control and inspection of products and services which involve risk to the public health or of special monitoring programs of the quality in the health area; summoning and imposition of penalties in case the sanitary judicial order infringement; and also, the exercise of control health through supplementary analysis of patent applications examined by the Brazilian Patent and Trademark Office (INPI) in order to ensure the quality, efficacy and safety of products and processes subject to such requests.
There are inserted within the ANVISA control and inspection ambit the human use drugs, their active principles and other raw material (drug or additional or supplementary raw material of whatever nature, destined for use in medicines, should it be the case, and its containers), processes and technologies; food products, including beverages, bottled water, its components, packages, food additives, limits of organic contaminants, pesticide and vet medicines residues; cosmetics, personal hygiene products and perfumes; sanitation products destined to the hygienization, disinfection or disinfestations within household environments, hospital and collective environments; sets, reagents and components destined to diagnosis; medical-hospital equipment and materials, dental, hemotherapic and lab diagnosis products, image diagnosis equipment; immunobiologicals and its active ingredients, blood and hemoderivatives, organs, human and vet tissues for use in transplantations or reconstitutions; radioisotopes for in vivo diagnosis; radiopharmaceutical and radioactive products used for the diagnosis and therapy; cigarettes, cigars, cheroots and any other smoking product, whether or not derivatived from tobacco, and any products involving the possibility of health risk, obtaining through genetic engineering or by another procedure or subject to radiation sources.
For legal purposes, a pharmaceutical product with prophylactic, cure, reductive or diagnosis purpose is deemed a medicine.
19.4. Sanitary Surveillance Fees
The individuals and legal entities exercising activities in the manufacturing, distribution and sale of products and the rendering of services subject to sanitary surveillance are shown as passive subjects of such fees.
The generation fact of the Sanitary Surveillance Inspection Fee is the practice of acts under the competence of the National Health Surveillance Agency, such as the concession of sale registration, working authorizations, consents, inspections, certificates and slips issue, among other.
The collection and charge of the Sanitary Surveillance Fee may be delegated to the States, the Federal District and the Municipalities, at the discretion of ANVISA, it being certain that the tax which is not timely paid will be charged, under the administrative or judicial system, with interest, fine and substitutive charges of the debtor condemnation to pay legal counsel fees.
19.5. Marketing approval for pharmaceutical products
The manufacture, sale or display for sale of medicines, drugs, pharmaceutical raw material and the like shall be preceded by the sale authorization consubstantiated by the sanitary registration granted by the Ministry of Health, through ANVISA, it being certain that any modification to the formula, change of composition elements or its quantities, addition, subtraction or innovation introduced during the preparation of the product shall be previously submitted to the sanitary authority for prior and express authorization, under the penalty of register cancellation.
It is important to emphasize that the import, sale, display for sale, warehousing and distribution of product without registration, when required; in disagreement with the formula shown in the registration; without the characteristics of identity and quality accepted for its sale; with reduction of its therapeutical value or of its activity; of ignored origin or acquired from premises with no sanitary authority license typify crime against the public health, also considered as heinous crime.
Drugs which contain substances not recognized as beneficial from the clinical and therapeutic point of view shall not be registered.
The drugs, medicines and pharmaceutical raw material containing narcotic substances or which determine physical or psychological attachment and the medicines in general shall only be registered or shall have their registrations renewed if their packages are in accordance with the standards approved by the Ministry of Health.
The Sanitary registration is valid for ten years throughout the national territory and may be revalidated for equal and successive periods (except for the dietetic products – those destined to oral ingestion, technically prepared to cover the dietetical requirements of persons in special physiological condition – not to be confused with dietetic food – the validity and revalidation of which is of two years). A product that has not been commercialized during the time corresponding to the final two thirds of the expired registration period cannot be revalidated. Further, for the revalidation of registers that were prioritized during their examination phase, the commercialization period is up to 365 days.
Both the registration and its revalidation will only be done as of their publications in the Official Federal Gazette.
It is necessary to pay attention to the fact that, under the penalty of caducity, the register revalidation shall be required by its holder during the first semester of the last year of the validity five years, being deemed automatically revalidated if no decision has been issued by the sanitary authority up to the expiry of its validity.
The registration of drugs, medicines, pharmaceutical raw material and related products, in addition to the observance of specific requirements, is conditional to the scientific and analytical evidence that the product is safe and effective for the proposed use and it has the identity, activity, quality, purity and innocuity required.
Likewise, the claimant of the registration may be required to submit pharmacoeconomics information to the sanitary authority, such as the product price performed by the company in other countries, the acquisition value of the active ingredient, the treatment cost per patient with the product use, the potential number of patients to be treated, the price list intended to be used in the internal market – with the separation of the tax burden – the details of the product sales proposal, including expenses foreseen with the sales effort and with publicity and advertising, the price of products subject to changes – in case of formula or form change – and all substitution products list existing in the market, accompanied by their corresponding prices.
The evidence that a given product, up to then deemed safe, is prejudicial to the health or is in disagreement with the sanitary legislation shall imply its withdrawal of the market and the changing requirement of its formula and labels wording, package insert and packages, under the penalty of the register cancellation and product seizure.
19.6. Approval for new drugs
The medicines with unregistered API shall be deemed as new or innovative, as well as its new salts, isomers or isomers mixture, esters, ethers, complexes or other derivatives that also are not registered.
The company interested in obtaining sanitary registration for a new drug shall offer to the sanitary authority, for assessment of its nature and determination of the degree of safety and effectiveness, wide information on its composition and use.
The new drugs, destined exclusively for experimental use, under medical control are exempt from registration and may also be imported by express authorization of the Ministry of Health. It should however be emphasized that such exemption shall only be valid for a three years term, after which the product will have to be registered, under penalty of seizure ordered by the Ministry of Health.
In Brazil, the registration of new drugs is done by the Office of New Drugs, Research, and Clinical Trials (GEPEC) of ANVISA. The appraisal of a registration dossier is generally divided into three steps: Pharmacotechnical analysis, effectiveness analysis and safety analysis.
The pharmacotechnical analysis – which involves the analysis of the documents and technical report – consists on the checking of all product manufacturing steps, from the acquisition of materials, production, quality control, release, warehousing, shipment of finished products and related controls.
The effectiveness and safety analysis performed through the analysis of pre-clinical studies (or not clinical) and clinical, these subdivided into steps I, II, III and, eventually, IV, in case of medicines already registered in other countries, for which the post market pharmaco-surveillance data area already available.
It should be noted that the approval of studies involving new drugs or health products which have not yet been registered in Brazil, developed and manufactured within the national territory will occur through the submission of the document required by the specific regulatory act, accompanied with a notice of special lots manufacture destined exclusively to clinical research when the study involves drugs not yet approved in Brazil.
19.7. Approval for non-branded generic (“GENERICS”) drugs
A non-branded generic drug (ou just generic drug) may be described as a similar medicine to the innovative or reference-listed drug, that intends to be interchangeable with the reference-listed drug, generally produced after the expiry or waiver of the patent protection or other proprietary rights, with proven effectiveness, security and quality, being always named according to the DCB (Brazilian Common Denomination – name of the pharmaceutical product or pharmacological active ingredient approved by the federal sanitary authority) or, in its absence, by the DCI (Brazilian International Common Denomination – name of the pharmaceutical product or pharmacological active ingredient recommended by OMS – Worldwide Health Organization).
It is important to note that it will not be admitted for purposes of registration as a generic or similar drugs: biological products, immunotherapies, plasma derivatives and human blood; herbal medicine; specific drugs; dynamized drugs; simplified notification medicine; antiseptics for hospital use; products for diagnostic purposes and radiological contrasts; radiopharmaceuticals; and medicinal gases.
The company intending to obtain authorization for sale of a generic drug, in addition to the documents required for the registration of new drugs, must submit a pharmaceutical equivalence certificate, dissolution profile certificate and report on the development of the dissolution method to the health authority. In addition, a bioequivalence study should be presented.
Based on the legal concept of reference-listed drug – which consists on the innovative drug duly registered and sold in the Country, the effectiveness, safety and quality of which were scientifically evidenced upon the registration, we have that, as a rule, the innovative drug corresponds to the reference-listed drug, however, in its absence, ANVISA is responsible for indicating it.
The bioequivalence study consists in the statement of pharmaceutical equivalence between products submitted under the same pharmaceutical form, containing identical qualitative and quantitative composition of active ingredients and which have comparable bioavailability, when studied under the same experimental design and which shall be realized, mandatorily, with the same lot used in the pharmaceutical equivalence study.
19.8. Approval for branded generic (“SIMILAR”) drugs
The branded generic drug (or just similar drug) is that containing the same active ingredient(s), the same concentration, pharmaceutical form, administration means, dosage and therapeutical or preventive indication, or diagnosis, of the reference-listed drug registered with the federal office in charge of the sanitary surveillance, which may differ only in characteristics related to size and form of the product, duration, package, label, excipients and vehicles, and must always be identified by brand.
Similar drugs are deemed registered after one hundred and twenty days, counted as of the submission of the corresponding petition, if it has not been rejected by then. However, the similar drug, manufactured in or outside Brazil, must have its effectiveness, security and quality proven in an equivalent way to the one adopted by the generic drug.
The registration of a similar drug, as well as that of other drugs, will be declared void if it is not requested to be renewed in its last semester of validity. Also, the absence of commercialization for at least the time corresponding to the final two thirds of the validity period, will not be revalidated.
In case registration validity loss, a new registration request may be filed two years after the occurrence of the fact giving cause to the validity loss of the previous grant, except if it is attributed to the interested company.
The company intending to obtain sanitary registration for a similar drug shall submit to the sanitary authority a pharmaceutical equivalence certificate, a dissolution profile certificate and a dissolution method development report, as required for the registration of generic drugs. However, such documents are exempted from being presented if the similar drug is manufactured in the same place, with the same formulation, production process and equipment as those used in the manufacture of the reference drug.
In order to obtain the registration, it is also necessary to present bioequivalence studies, which must be carried out with the same batch used in the pharmaceutical equivalence study.
Should the pharmacokinetic standards between the test and reference-listed drug indicate necessity of adjustments, the product formulation may be changed until such time when they are compatible. Should the company choose not to change the formulation, it shall propose a dose assuring the safety and effectiveness if the pharmacokinetic curves be below the safety limit and above the therapeutical limit. In this case, the drug will be a product resulting from change of pharmacokinetic properties, will be exempt from submission of clinical study and shall not be a reference product.
Should a similar drug be comprised by association of drugs, or two or more presentations in one same package for simultaneous or sequential use, the evidence of relative bioavailability of each active ingredient of the formula will be demanded in relation to the reference-listed drug.
With the implementation of the obligation to submit bioequivalence studies also for similar drugs, the main difference now existing between generic and similar drugs is that, whilst those are identified solely by DCB or, in its absence, the DCI, these are identified by the brand.
19.9. Operation authorization
The obtention of the marketing approval for the product before ANVISA does not constitute the sole legal requirement for companies intending to develop any type of economic activity related to products subject to sanitary surveillance. Actually, in addition to the sanitary registration, such companies shall obtain operation authorization before ANVISA and shall be licensed by the sanitary office of the Federative Units where they are located.
The registration refers to the product, whilst the license is destined to the premise and the authorization is for the company’s operation. The operation authorization constitutes discretionary and precarious act, and, in such step, may be revoked by the sanitary authority whenever the public interest so demands.
Therefore, the Operation Authorization (also known by its monogram in Portuguese, AFE) is an act of competence of ANVISA, incurring in the authorization for the operation of companies or establishments, institutions and agencies granted upon the compliance with the technical and administrative requirements of the current sanitary standards.
The AFE is required from each company that carries out the activities of storage, distribution, packaging, shipping, export, extraction, manufacturing, fractionation, import, production, purification, repackaging, synthesis, transformation and transportation of medicines and pharmaceutical supplies intended for human use, cosmetics, personal care products, sanitizing perfumes and filling of medical gases. The AFE is different for each of the activities and the company is not allowed to operate in an activity not covered by the registration obtained.
Companies that carry out the activities listed above, but with substances subject to special control or with drugs that contain them, must obtain Special Authorization (also known by its monogram in Portuguese, AE). The technical requirements to be met by drug manufacturers, for granting the authorization for operation are: (i) facilities, equipment and technical equipment necessary and in conditions appropriate to the purpose for which they will be used, including qualifications and calibrations; (ii) established quality system; (iii) clearly defined qualification and validation policy, in cases where required by the standard of good manufacturing practices; (iv) utility systems to support the production process under conditions appropriate to the purpose for which they are proposed; (v) conditions of hygiene, storage and operation appropriate to the needs of the product, in order to reduce the risk of contamination or changes in its characteristics; (vi) human resources trained to perform production activities, quality control, quality assurance and other support activities; (vii) means for the inspection and quality control of products that industrialize, including specifications and analytical methods; (viii) standard operating procedures and other necessary documents completed and approved; (ix) means capable of eliminating or reducing elements of pollution resulting from industrialization, which cause harmful effects to health; and (x) evidence of compliance with the project development plan up to, at least, the project input data definition phase, for manufacturers of healthcare products.
Importing, distributors, warehousing, transporters, exporters and fractionators companies must comply with the following technical requirements: (i) necessary facilities, equipment and technical equipment under conditions suitable for the purpose for which they will be used, including qualifications and calibrations; (ii) existence of qualified human resources and duly trained to perform the activities of the company or establishment, including, in the case of an importer of medicines, the guarantee of the quality of medicines, the investigation of quality deviation and other support activities; (iii) conditions of hygiene, storage and operation adequate to the needs of the product, in order to reduce the risk of contamination or alteration of its characteristics; (iv) standard operating procedures for receipt, identification, inventory controls and storage of finished products, returned or collected; (v) self-inspection program, with scope, frequency, execution responsibilities and actions resulting from non-conformities; (vi) separate, identified and restricted access area for the storage of products or substances subject to special control; (vii) inventory control system that allows periodic inventories to be issued; (viii) formal system for investigating quality deviations and preventive and corrective measures adopted after identifying the causes; (ix) established quality system; (x) waste management plan; (xi) receiving and shipping areas that are adequate and protected against climatic variations; (xii) mechanisms that ensure that suppliers and customers are duly regularized with the competent health authorities, when applicable; and (xiii) for transporters, a list of the quantity and identification of their own or third party vehicles under their responsibility, made available for transportation, which must be equipped with the necessary equipment to maintain the specific transport conditions required for each product subject to health surveillance.
Moreover, the licensing, by the local authority, of the industrial or commercial premises exercising such activities will depend on whether the operation of the company has been authorized by the Ministry of Health – through ANVISA – and on the observance, by each premise, of the technical and sanitary demands established through the regulations and instructions of the Ministry of Health, including in relation to the effective assistance of the technicians in charge qualified for the many areas of activity. Additionally, each premise must have a specific and independent license, even if there is more than one in the same place, belonging to the same company.
It should be noted that the operation authorization issued by the Federal sanitary authority will qualify the Company to operate throughout the national territory and shall be renewed upon the occurrence of the specific activity for which it was granted.
It should also be reminded that the acts of extracting, producing, manufacturing, converting, preparing, manipulating, purifying, fractioning, pack or repack, import, export, warehouse, ship, carry, acquire, sell, assign or use food products, medicines, drugs, pharmaceutical raw material, dietetic products, hygiene products, cosmetics, related products, packages, sanitizing products, fixtures and apparatus of interest to the public or individual health without registration, license or authorizations of the relevant sanitary office or violating the provisions of the related sanitary legislation constitute sanitary infringement. Upon the incidence of the theoretical infract practice, there may be imposed penalties of warning, seizure and destruction, interdiction, cancellation of registration and/or fine.
19.10. Import of pharmaceutical products
The registration of drugs, medicines and pharmaceutical raw material of foreign origin will depend, in addition to the common legal requirements of national products, on the evidence that it is already registered in the origin country. Only the companies authorized by ANVISA for such activity will be able to import products subject to sanitary surveillance, being prohibited the importation of raw material and pharmaceutical raw material destined to the manufacture of medicines, by a company who does not hold the Operation Authority or Special Operation Authority, where applicable.
On November 12, 2008, according to RDC 30/2008 issued by ANVISA, all the companies that manufacture, import, export, distribute and store pharmaceutical raw-material should provide ANVISA with the names of the raw material they handle. The data will be available to the public on the website of ANVISA and the companies will be allowed to commercialize only the registered pharmaceutical raw material.
The goods pertaining to the medicine classes, food products, cosmetics, hygiene products, perfumes, sanitization products, medical products and products for in vitro diagnosis, under the form of finished product, in bulk or semi-processed, destined to the commerce, industry or direct consumption, shall have their importation authorized, provided they are formally registered before the National Sanitary Surveillance System, regarding to the mandatory requirement, where applicable, of the registration, notice, enrollment, model authorization, registration exemption or any other form of control ruled by ANVISA.
The sanitary authority for individuals or legal entities to import goods will be mandatorily occur as of the observance of the technical administrative guidelines and by means of electronic or manual petition made available and ruled by ANVISA.
Under an emergency or temporary character, taking into consideration the international epidemiological context, human, animal or vegetal or the implementation of public health programs related to the sanitary control of goods and of individuals or legal entities involved with the manufacturing processes and service provision in the import of assets and products under sanitary surveillance, the sanitary authority may prohibit the import or the entry of products subject to sanitary surveillance.
The granting of the Import License by ANVISA shall imply the inspection of the goods prior to the customs clearance or the delivery for display or human consumption, at the discretion of the sanitary authority or whenever so required.
19.11. Labeling and advertising of pharmaceutical products
The advertising, under any form of disclosure and communication means, of products subject to sanitary surveillance shall only be promoted after the authorization of the Ministry of Health. As below, the principle of transparency, which informs the customer rights, is fully privileged by ANVISA in the regulation and inspection of the advertising of pharmaceutical products.
In this sense, in case of a drug, medicines or any other product with sale requirement subject to medical or dental prescription, the advertising will be restricted to publications destined exclusively for distribution to Medical Doctors, Dental Surgeons and Pharmacists.
The labels or advertising of products subject to the sanitary surveillance shall not bear names, geographic names, symbols, pictures, drawings or any indications which may lead to false interpretation, error or confusion regarding to origin, nature, composition or quality, which attribute the product purposes or characteristics different from those it actually has.
The following practices are expressly prohibited: advertise medicines not registered by ANVISA in the cases required by the law; make direct or indirect comparisons which are not grounded on information evidenced by clinical studies disclosed in indexed publications; advertise the same drug as new, after two years of its initial sale, except new presentations or new therapeutical indications registered with ANVISA, cause fear, anguish and/or suggest that the health of a person will or may be affected by not using the drug; express prejudice on nationality, sex, race, religion and other; publish messages such as: “Approved”, “Recommended by specialist”, “Evidenced in clinical essays” or “Publicity Approved by the Sanitary Surveillance”, by the ”Ministry of Health”, or similar State, Municipal office or office of the Federal District, except in the cases specifically determined by the National Health Surveillance Agency; suggest risk reduction, in any degree, except in cases where such reduction is explicitly shown in the indications or properties approved in the registration with ANVISA and, even in such cases, only in publications addressed to health professionals; include messages, verbal or not verbal, which mask the actual indications of the drugs registered with ANVISA; attribute curing properties to the medicine when it is destined – according to the Anvisa registration – only to treat the symptoms and/or to control chronic diseases; suggest absence of collateral or adverse effects or use expressions such as: “innocuous”, “safe” or “natural product”, except for the cases registered with ANVISA.
Any kind of advertising, publicity or promotion of medicines directed to the general public shall be conducted in such a way as to assure that the promotional character of the message becomes evident.
The notices directed to the health professionals, published in mass communication means, verbal or not, are deemed advertising, and shall be subject to the legal requirements.
In the advertising, publicity and promotion of medicines sold without requirement of medical prescription, the following practices are prohibited: stimulate and/or induce the medicines indiscriminate use and/or doses and indications use which are not shown in the medicines registry before ANVISA; include messages of whatever nature addressed to children or teenagers, as well as use symbols or images for such purpose; promote or organize contests, promise or offer financial bonus or premiums conditional to the sale of medicines; suggest or stimulate diagnosis recommending a corresponding treatment, it only being allowed the use of phrases or images defining, in scientific or lay terms, the use of the medicine for isolated symptoms, the statement that a medicine is “safe”, “without contraindication”, “exempt of secondary effects or usage risks” or use equivalent expressions; state that the medicine is a food product, cosmetic or other consumer products, just as no food product, cosmetic or other consumer product may be shown or appear as a medicine; exploit diseases, lesions or deficiencies in a grotesque, abusive or misleading manner, whether or not they are originated from the use of medicines; to state and/or suggest that a medicine produces better effects as compared to another, using expressions such as: “more effective”, “less toxic”, be the only possible alternative within the category or yet use expressions such as: “the product”, “the best choice”, “the sole”, “the most frequently recommended”, “the best” – the expressions shall only be used if supported by scientific evidences and previously approved by ANVISA -; to state and/or suggest a medicine has an effect superior to another using expressions such as: “more effective”, “better tolerated” – the expressions may only be used if supported by scientific evidence and upon prior approval by ANVISA – ; use direct or indirect language relating the use of the medicine to the physical, intellectual, emotional, sexual performance or to the beauty of a person, except when these are properties approved by ANVISA; suggest that the medicine has pleasant organoleptic characteristics, such as: “tasty”, “good taste”, “delicious” or equivalent expressions.
In the specific case in which the name and/or image of a professional is mentioned as support to the advertised properties of the medicine, it is mandatory to include in the publicity message the name of the intervening professional, its enrollment number with the corresponding Council or other professional registration office.
The quotations, tables or other illustrations extracted from scientific publications used in any advertising, publicity or promotion shall be accurately reproduced and specify the complete bibliographical reference.
In case of generic drug, according to Law 9787/99 and its regulations, the following phrase shall be included: “generic drug – Law 9787/99”.
The lab representatives shall transmit precise and complete information on the medicines they represent during the advertising, promotion and publicity action before the health professionals qualified to prescribe and dispense.
In its promotion, advertising and publicity actions, the pharmaceutical representatives shall be limited to the scientific information and characteristics of the medicine registered with ANVISA.
The grant, offer or promise of prizes, monetary advantages or cash to health professionals qualified to prescribe or dispense medicines as well as to those exercising activities of direct sale to the customer is totally prohibited.
The sponsorship by a lab manufacturing or distributing medicines of any public or private events, symposia, congresses, meetings, conferences and the like, whether partial or total, shall be mentioned in all disclosure documents or documents resulting and consequent to the corresponding event.
The distribution of free samples shall only be done in packages, holding at least 50% of the contents of the original approved by ANVISA, destined exclusively to the professionals qualified to prescribe or dispense medicines, except for the free samples of birth control pills and medicines that are used continuously, which shall be obligatorily contain 100% of the content in the original registered and marketed. In the case of antibiotics, the minimum amount that should be sufficient for the treatment of a patient.
Author: Luiz Augusto Lopes Paulino
Av. Indianópolis, 739 – Indianópolis
04063-000 São Paulo – SP
Phone: +55 (11) 2155 9500
Fax: +55 (11) 5549 2300
E-mail: [email protected]
Dannemann, Siemsen Bigler & Ipanema Moreira
Rua Marquês de Olinda, nº 70 – Botafogo
22251-040 Rio de Janeiro – RJ
Phone: +55 (21) 2237 8700
Fax: +55 (21) 2237 8922
E-mail: [email protected]