Legislation
Administrative Order

Administrative Order nº 110, of March 10, 1997

The Surveillance Secretary of the Ministry of Health, vested in the legal attributions and considering the texts of the "direction for use" of the medicines with the same active principle(s), must present have the same therapeutic indications and other fundamental information;

WHEREAS,

that fundamental information, related to an active principle and respective therapeutic class, must guide adequately the patient and the doctor;

WHEREAS,

the existence of "direction for use" with insufficient information available in the market;

WHEREAS,

Law No. 6.360/76 and Decree No. 79.094/77, Administratvive Order No. 65/86 and the "Consumer Defense Code", decides:

Article 1 - to establish guidelines for the text of the "direction for use" of medicines, whose items must be strictly followed, as to order and content.

Article 2 - without jeopardizing articles 93, 94, 95 and 96, including paragraphs and items of Decree No. 79.094/77, the "directions for use" of the medicines must contain the following:

I) Identification of the Product
a. Name of the product
b. Generic Name
c. Pharmaceutical forms and presentation
d. PEDIATRIC OR ADULT USE (in prominence)
e. Complete composition

II) Information to the Patient

Compulsory and uniform, written in easily understandable language for the consumer in general.

a. Medicine's expected action
b. Storage care - specific guidelines must be mentioned as for keeping and storage care before and after opening of the package and/or preparation.
c. Expiry date - inform date. Warn against hazards caused by taking the medicine after its expiry date.

d. Pregnancy and breast-feeding - include the sentences "Inform your doctor about the occurrence of pregnancy during the treatment or after its end (establishing a date, when necessary). "Inform your doctor if you are breast-feeding".
e. Management care - Mention specific care and include: "follow your doctor's directions, always following schedules, doses and length of the treatment".
f. Treatment interruption - Include the sentence "do not interrupt the treatment without your doctor's knowledge". Mention consequences whenever the case be.
g. Side Effects - Include the sentence "inform your doctor about the occurrence of unpleasant reaction" (mention the most important ones, by frequency or seriousness, whenever the case).
h. "KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN"- in prominence and on the external side of the package.
i. Ingestion concomitantly with other substances - (alcohol, food, etc...).
j. Cautions - inform the patient about the items whenever the case. Include the sentence "Inform your doctor about any medicine you have been taking, before or during the treatment".
k. Whenever the case, include the sentence (s):

- do not use during pregnancy and breast-feeding;

- during treatment, the patient should not drive or operate machines, due to possible impairment.

l. Self-medication risks: warning of self-medication risks in general: "DO NOT TAKE MEDICINE WITHOUT YOUR DOCTOR'S KNOWLEDGE, CAN BE HAZARDOUS TO YOUR HEALTH".

III) Technical Information
a. Characteristics - chemical and pharmacological of the medicine based on technical report.
b. Prescribed Use - based on pharmacological and non-diagnostic actions or symptoms (diagnosis may be used upon agreement of the Sanitary Surveillance Secretariat of the Ministry of Health (SVS/MS) .
c. Cautions - based upon clinical entities in which the medicine can not be used.
d. Warnings - highlight restrictive items, whenever the case.
e. Medicamental Interactions - and other interactions, mentioning substances or groups of substances rather than pharmaceutical specialties.
f. Adverse Reactions/ Side Effects and alterations of laboratory tests - mention according to severity (if possible mention incidence) all proven side effects, always using technical language; replace the phrase "does not produce side effects" for "intensity and frequency of adverse reactions have not been established yet" (mention the most common situations in INFORMATION TO THE PATIENT).
g. Dosage - dose and length of treatment, means of administration; whenever the case, detail dosage for specific diseases and especial situations (kidney or liver failure, etc...) always in technical language.
h. Overdose - procedure in overdose and whenever the case, in serious adverse reactions - general and specific procedures.
i. Elderly patients - warning and recommendations about the adequate use of the medicine by elderly patients.
j. New product - when the product is new the following statements must be added : THIS PRODUCT IS A NEW MEDICINE AND ALTHOUGH RESEARCH HAS INDICATED EFFICIENCY AND SAFETY, WHEN CORRECTLY PRESCRIBED, UNPREDICTABLE ADVERSE REACTIONS, STILL NOT DESCRIBED OR KNOWN, MAY OCCUR. IN CASE OF SUSPECTED ADVERSE REACTION, THE DOCTOR IN CHARGE MUST BE NOTIFIED.
k. Products restricted to hospitals - remove the item TO THE PATIENT, except for information related to storage and expiry date. The phrase: USE RESTRICT TO HOSPITAL must be included.

IV) Legal Statements

a. Registration number in the Ministry of Health.
b. Pharmacist in charge and CRF(Pharmaceutical Registration Certificate).
c. Name (s) of the company(ies) (registration holder and manufacturer).
d- Company (ies) address (es) ( registration holder and manufacturer).
e- Number of the CGC (Tax Payers Registration) .
f- Prescription (sale with or without prescription, with prescription retention, with notification, etc...).
g- Other legal statements.

Article 3 The SVS/MS shall elaborate "directions for use" statements regarding each active principle or associations and respective therapeutic class, classified as: essential minimum for items II (and all sub-items) and III (sub-items c, d, e, f, h, i) of Article 2, the company not being allowed to omit such information in its "directions for use", however, it shall be allowed to incorporate, to the proposed text, new information resulting from scientific knowledge; essential maximum for sub-items b and g of item III, of Article 2, the company not being allowed to add information other than the one proposed. The company shall be responsible for the elaboration of the other items on the "directions for use" which depend on products specifications.

Article 4 The "directions for use", as described in the previous item, shall be published in the Official Journal of the Union - D.O.U., and interested parties shall must present plea within 30 (thirty) days.

Article 5 - The plea shall only be submitted to study provided that fundamental reasoning is pointed out, originated from known bibliographic references.

Article 6 - After publication of the definite text, companies must adapted "directions for use" of products already registered to the new statements within 180 (one hundred) days.

Article 7 The new "directions for use" referred to in the previous article, once adopted, must be sent to the SVS/MS within the length of time established in the previous article, as approval of the fulfillment of provisions established in this Administrative Order .

Article 8 Additional information as to chemical and pharmacological characteristics, as to warnings, cautions, adverse reactions, medicamental interactions, precautions and new care in overdose, may be included in the "directions for use", even if it is not mentioned in the text published in the Official Journal of the Union - D.O.U., regardless of previous approval by the SVS/MS.

Article 9 The company must inform SVS/MS, within a 30 (thirty) day term, the restrictions mentioned in article 8, to allow immediate updating of texts published in the Official Journal of the Union - D.O.U..

Article 10 The information mentioned in article 8, may also be sent to SVS/MS by scientific societies.

Article 11 While text is not published in compliance with article 3 the approved "directions for use" of medicines already registered remain in force, complying, however, with the items described in article 2 of the present Administrative Order as to order and content.

Article 12 The non-observance of the present Administrative Order constitutes sanitary infraction and shall be subject to penalties provisioned for in the Legislation in force.

Article 13 This Administrative Order shall be enforced on the date of its publication, Administrative Order Nos. 65/84-SNVS, 59/90-DTN and 10/97-SVS being hereby revoked.

ELISALDO L. A. CARLIN