RESOLUTION - RDC No. 61 OF 12 DECEMBER 2012. Sets forth the procedures under ANVISA changes to drug labeling and other matters .

RESOLUTION - RDC No. 61 OF 12 DECEMBER 2012

Sets forth the procedures under ANVISA changes to drug labeling and other matters .

The Board of the National Health Surveillance Agency , in exercise of the powers conferred on it by sections III and IV , Art.15 of the Law n . 9.782 , of January 26, 1999 , Item II , and § § 1 ° and 3 of art. 54 of the Bylaws approved in accordance with Annex I of Ordinance No. 354 of ANVISA , of August 11, 2006 , republished in the Official Gazette of August 21, 2006 , and its updates , in view of the provisions of sections III , art. 2, III and IV , art. 7 of Law no . 9782 , 1999 , and Program Improvement Process Regulatory Agency , established by Decree No. 422 of 16 April 2008 , at a meeting held on December 11, 2012 , adopted the following Board Resolution and I , the Chairman , determine its publication :

Article 1 The changes in drug labeling may be subject to notification to ANVISA for companies owning their health records , and they may be immediate implementation without prior approval of the Agency.

Sole Paragraph . Notification of objects may be mentioned herein, the following labeling changes :

I. Inclusion of data security .

II . The following changes "layout " :

a. Color ;

b . source ;

c . size and dimensions of labeling;

d. diagramming information , including changing the text direction , and ,

and . alteration, addition or deletion of graphics that comes to art. 17 of Resolution RDC No. 71 of December 22, 2009 .

III . Inclusion of information on approved labeling or exclusion of non-mandatory information .

Article 2 . For labeling changes contemplated in this Resolution , whose petitions have already been protocolizadas atAnvisa until the date of its publication , the companies holding the records of their medications that are interested in their conversion in the notification object of this resolution will have a term of up to 30 ( thirty) days to docket the completed form as a model appearing in Annex I, provided it has not been drawn up and any requirement by the ANVISA .

Article 3 . Notifications of labeling changes made ​​pursuant to this Resolution and protocolizadas atAnvisa after the date of its publication , must be accompanied by all required documentation to the subject , as well as the completed form as the model in ANNEX II .

Article 4 . Any changes notified to ANVISA and implemented in accordance with the provisions of this Resolution shall contain,
obligatorily in History Product Change whose labeling was changed together with the number of hours of their notifications made .

Article 5 . The immediate implementation of labeling changes related to this Resolution does not hinder the analysis , at any time, the documentation required by ANVISA .

Article 6 . The authenticity and veracity of the information provided to ANVISA are the responsibility of the owner of record, and any irregularity detected by ANVISA , in contradiction to the provisions of sanitary legislation , constitutes a health violation , pursuant to Law No. 6437 of 20 August 1977 and may result in cancellation of the registration of the drug to be notified defined in this Resolution

Article 7 . This Resolution shall take effect on the date of its publication.

DIRCEU BRÁS APARECIDO Barbano
Chief Executive Officer

ANNEX I

DECLARATION FORM FOR REFERRING TO HALFTIME NUMBERS RELATED TO THE SUBJECT MATTER OF THE NOTICE OF CHANGE OF DRUG LABELING

Considering the provisions of RDC 61 RDC No. 61 of December 12, 2012 , the company ________________________________________________________ , CNPJ _________________ declares below the numbers of expedients related to the matters of the standard for which will be granted immediate implementation from this notification.

The company declares that it has complied with the legislation in force that provides change drug labeling with regard to the documentation required for each subject, as well as maintaining the quality characteristics of the product.

No. EDITORIAL PRODUCT SUBJECT DATE OF PROTOCOL
The company is aware that the authenticity of the information provided is the responsibility of the owner of record and any irregularities detected by ANVISA , in contradiction to the provisions of sanitary legislation , constitutes a health violation , pursuant to Law No. 6437 , of August 20, 1977 .

REPRESENTATIVE TECHNICAL REPRESENTATIVE
ANNEX II

FORM DECLARATION PURSUANT TO APPLICABLE LAW ON AMENDMENT OF DRUG LABELING

Considering the provisions of the RDC No. 61 of December 12, 2012 , the company ________________________________________________________ , CNPJ ___________________ , declares to have complied with the law in force that provides change drug labeling with regard to the documentation required for this change pósregistro , as well as maintaining the quality characteristics of the product.

The company is aware that the authenticity of the information provided is the responsibility of the owner of record and any irregularities detected by ANVISA , in contradiction to the provisions of sanitary legislation , constitutes a health violation , pursuant to Law No. 6437 , of August 20, 1977 .

REPRESENTATIVE TECHNICAL REPRESENTATIVE