Legislation
Resolution

Resolution - RDC nº 78, of August 17, 2000

Regulates the presentation of monthly information referring to the production and trade of generic products.

The Collegiate Board of Directors of the National Sanitary Surveillance Agency, in the use of the attributions vested in it under Article 11, item IV, of ANVISA Internal Regulation, approved by Decree No. 3.029, of April 16, 1999, in a meeting held on August 16, 2000;

WHEREAS

provisions in Article 7, item XXV, Law No. 9.782, of January 26, 1999, and successive re-editions of Provisional Remedy No. 2.039-19/00;

WHEREAS

provisions in Article 4, of Law N. 9.787, of February 10,1999;

WHERAS
provisions in Article 4, paragraph 1, item I, and Article 13, item IV, of ANVISA Internal Regulation, approved by Decree No. 3.029, of April 16, 1999; c/c Article 7, item XV, of Law No. 9.782, of January 26, 1999;

WHEREAS

provisions in Article 150, only paragraph, of Decree No. 79.094, of February 1, 1977;

WHEREAS

provisions in Resolution - RDC No. 68, of July 20, 2000;

adopts the following Resolution of the Collegiate Board of Directors and I, the chairperson, determine its publishing.

Article 1 - To determine that the medicine manufacturing companies registered at the National Sanitary Surveillance Agency, under the terms of Law No. 6.360, of September 23, 1976; and Law No. 9.787, of February 10, 1999, present monthly, by the tenth day of the upcoming month, information referring to production and trade of their generic products pertaining to the previous month, the criteria contained in the attached form being followed.

paragraph 1 - The companies must send the information by electronic means to the address genericos@anvisa.gov.br , or by magnetic means, and record 2 (two) printed copies at the National Sanitary Surveillance Agency, one being sent to the Directorate of Finance and Administration, and the other to the Directorate of Medicaments.

Paragraph 2 - The non-forwarding of the information referred to in the Caput of this article, both by electronic or magnetic means, and by the mailing of the recorded copies to ANVISA, shall characterize non-compliance to the provisions of this resolution, the manufacturing companies being, when applicable, subject to the penalties foreseen in Law No. 9.782/99, and successive re-editions of Provisional Remedy No. 2.039-00/00, Resolution- RDC No. 68/00, and other applicable regulation.

Article 2 - In the month of September 2000, exceptionally, the companies must forward, in addition to the data pertaining to the previous month, the data pertaining to the months of June and July 2000.

Article 3 - Resolution RE No. 508, of June 15, 2000 is hereby revoked.

Article 4 - This resolution enters into force on the date of its publication.

GONZALO VECINA NETO

ANNEX

Fill-out Instructions

Heading

Company (1) - Fill out with the company's corporate name.

CNPJ (2) - Inform the number of National Private Corporation Register - CNPJ, of supplying unit.

Data pertaining to the month of (3) - Inform month to which information refers.

Table 1

Field 4 EAN Code

Fill out Product National Code (EAN Bar Code of the presentation)

Field 5 Product registration

Inform the product registration number at the Ministry of Health.

Field 6 Product discrimination

Inform the name of manufactured products. Take in account products manufactured by the company, manufactured by third parties or imported products, with all their forms in their respective presentations.

Field 7 Concentration (Dosage)

Inform the dosage of the pharmaceutical unit of the presentation (as for Field 11), for example, in a product of 500 mg fill out 500.

Field 8 Concentration (Unit)

Inform the dosage unit (mg, mg/ml, UI, etc.) of the pharmaceutical unit of the presentation (as for Field 11), for example, in a product of 500 mg fill out mg.

Field 9 Packaging

Inform the packaging of the presentation. For example: box, bottle, blister, etc.

Field 10 Quantity per Packaging

Inform the quantity present in each packaging

Field 11 Pharmaceutical Form

Inform the pharmaceutical form contained in the packaging, for example: pills, coated pills.

Field 12 Means of Administration

Inform the means of administration of the presentation, for example: oral, parenteral, local application, etc.

Field 13 Therapeutic Class

Inform the therapeutic class the product belongs to.

Field 14 Continuous Use

Inform whether the product is used in continued form in most of its directions. Answer with (Y)es or (N)o

Field 15 Factory Price

Factory Price contained in the list issued under the terms of the Administrative Order MEFP No. 37/92.

Field 16 Market share

Calculate participation percentage of product sales in relation to total sales of its respective market, indicating the period referred to. Consider as market, the total sales of products produced with the same active principle.

Field 17 Product Origin

Identify the origin of the product (described in Field 6) using (I) for imported products, (P) for products manufactured by the company and (T) for products manufactured by third parties.

Field 18 Quantity of Active Principle

Inform the total quantity of active principle used in the product/presentation.

Field 19 Installed capacity

Maximum monthly installed capacity for each product listed in Field 6.

Informed the maximum monthly installed capacity, kept in the same physical unit consigned in Field 11. In the case of multipurpose plant, it is necessary to present, in the forwarding letter, an explanatory note detailing the criterion for determining the installed capacity.

Field 20 Quantity Produced

Quantity produced during the reference month, keeping the same physical measurement unit consigned in Field 9.

Field 21 Total Manufactured Lots

Inform the total number of manufactured lots of that presentation.

Field 22 Quantity sold in the internal market

Product/presentation quantity sold in the internal market, corresponding to the reference month, keeping the same physical measure unit consigned in Field 9.

Field 23 Internal Market Billing

Billing. Inform the total amount effectively billed as per receipts (including taxes), of internal market sales, corresponding to the reference month.

Field 24 Quantity sold in the external market

Products or assembly line quantity sold in the external market, corresponding to the reference month, keeping the same physical unit consigned in Field 9.

Field 25 Sales amount in the external market

Amount of sales in dollars in the external market, using FOB price, corresponding to the reference month.

TABLE II

Field 26 EAN Code

Fill out the Product National Code (EAN Bar Code of the presentation)

Field 27 Lot Number

Inform the lot number of the product sold.

Field 28 Quantity

Inform the quantity of products sold, keeping the same physical unit of Field 9.

Field 29 Customer

Inform the corporate name of the customer to whom products have been sold.

Fields 30, 31, 32, 33, and 34 Address, Neighborhood, City, Federate Unit and Zip Code.

Inform the address of the customer who has acquired the products.

Field 35 CNPJ
Inform the National Private Corporation Register number, of the customer who has acquired the product.

Field 36, 37 and 38 Name of person in charge of filling out form

Indicate the name, telephone and contact of the person who has given the information and is able to clear up eventual doubts.

Company : (1)

CNPJ : (2)
Data Referring to month: /200_ (3)

EAN code (4)
Registration code (5)
Product (6)
Concentration
Dosage (7)
Unit (8)

Packaging (9)
Quantity per Packaging (10)
Pharmaceutical Form (11)
Means of Administration (12)
Therapeutic Class (13)
Continuous Use (14)
Factory Price (15)
Market Share (16)
Product Origin (17)
Active Principle (18)
Installed Capacity (19)
Quantity Produced (20)
Total Number of Manufactured Lots (21)
Internal Market
Quantity (22)
Amount R$ (23)
External Market
Quantity (24)
Amounts R$ (25)

EAN Code (26)
Lot No. (27)
Quantity (28)
Customer (29)
Address (30)
Neighborhood (31)
City (32)
Federate Unit (33)
Zip Code (34)
CNPJ (35)
TOTAL

Filled out by: (36)
Contact Telephone: (37)
e-mail: (38)