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FORM 20-F Grupo Casa Saba, S.A.B. de C.V.

FORM 20-F Grupo Casa Saba, S.A.B. de C.V.

FORM 20-F Grupo Casa Saba, S.A.B. de C.V.

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Table of Contents<br />

Risk Factors Relating to Regulations to Which Our Business is Subject<br />

Mexican Antitrust Law and Regulations May Affect Our Ability to do Business. Mexico’s Fe<strong>de</strong>ral Antitrust Law, or Ley Fe<strong>de</strong>ral <strong>de</strong> Competencia Económica, and<br />

its Regulations, or Reglamento <strong>de</strong> la Ley Fe<strong>de</strong>ral <strong>de</strong> Competencia Económica, may affect some of our activities. In particular, such laws and regulations may adversely affect our<br />

ability to acquire and sell businesses or to enter into joint ventures with competitors due to our market share in some of the industries in which we operate and the reduced number of<br />

participants in those markets.<br />

The most recent amendments to Mexico’s Fe<strong>de</strong>ral Antitrust Law are in full force as of May 11, <strong>20</strong>11. Such amendments, among other things, have significantly<br />

increased monetary fines and provi<strong>de</strong>d for changes in the actions to be taken by the Mexican Antitrust Commission or Comision Fe<strong>de</strong>ral <strong>de</strong> Competencia, with respect to illegal<br />

conduct. In addition, Mexico´s Fe<strong>de</strong>ral Antitrust Law and related regulations or conditions imposed by the Mexican Antitrust Commission may adversely affect our ability to <strong>de</strong>termine<br />

the manner in which we provi<strong>de</strong> our products and services. Approval of the Mexican Antitrust Commission is required for us to acquire certain businesses or enter into certain joint<br />

ventures. There can be no assurance that in the future the Mexican Antitrust Commission will authorize certain acquisitions or joint ventures related to our businesses, the <strong>de</strong>nial of<br />

which may adversely affect our business strategy, financial condition and results of operations.<br />

Changes in Mexican Legislation May Adversely Affect Our Operations and Revenue. Existing laws and regulations could be amen<strong>de</strong>d, the manner in which laws<br />

and regulations are enforced or interpreted could change, and new laws or regulations could be adopted. The implementation of such amendments or changes in interpretation or<br />

enforcement of existing Mexican laws and regulations or any other future laws or regulations could materially and adversely affect our operations and revenue. During <strong>20</strong>11 and the first<br />

quarter of <strong>20</strong>12, different reforms were implemented to the General Health Law in Mexico. As a result of these reforms, as of June <strong>20</strong>11 cosmetic products are goods regulated by the<br />

General Health Law. The regulation of the cosmetic products impacts its marketers due to the imposition of requirements on the importation and exportation processes, and publicity. In<br />

addition, as of September <strong>20</strong>11, all cosmetics products that contain hormones, vitamins and in general, substances with a therapeutic effect are consi<strong>de</strong>red as drugs, therefore its<br />

producers, distributors and marketers must comply with the dispositions and legal requirements applicable to drugs.<br />

At the beginning of <strong>20</strong>12, the General Health Law was modified in or<strong>de</strong>r to implement the term “orphan drugs”, which are <strong>de</strong>fined as those medicines inten<strong>de</strong>d for the<br />

prevention, diagnosis or treatment of uncommon conditions. Such conditions have a frequency of no more than 5 persons per each 10,000 people. The scarcity of these products is a<br />

concern to the Ministry of Health, the legislative reform allowed said authority to implement the necessary measures and actions to boost and promote the availability of orphan drugs.<br />

In addition, on January 19, <strong>20</strong>12, the Regulations of the General Health Law were amen<strong>de</strong>d to regulate the publicity of “Miracle Products”. Miracle products were a<br />

controversial topic during <strong>20</strong>11 due to the strict measures adopted by the authorities in or<strong>de</strong>r to withdraw different herbal remedies, dietary supplements and cosmetic products that<br />

were publicized and commercialized as drugs or products with a therapeutic quality or effective for preventive treatments, rehabilitation or healing of one or more conditions from the<br />

market.<br />

As a consequence of amendments to the fe<strong>de</strong>ral Income Tax Law (Ley <strong>de</strong>l Impuesto Sobre la Renta), <strong>Grupo</strong> <strong>Casa</strong> <strong>Saba</strong> <strong>de</strong>ci<strong>de</strong>d to drop out of the tax consolidation<br />

regime and during the fiscal year <strong>20</strong>10 filed the relevant application. During fiscal year <strong>20</strong>11, the Company and its subsidiaries filed its tax return for the Single Rate Business Tax<br />

(Impuesto Empresarial a Tasa Única) and the Income Tax, individually.<br />

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