COMMITMENT

AMELAF promotes the consolidation of the pharmaceutical industry that is 100% Mexican- owned. This industry, the main supplier of medicines in the public sector, has two major challenges:

1. The tendency of the large transnational corporations to continue monopolizing the pharmaceutical market with high-priced products, and to block the entry of generic medicines that are now more attractive and profitable due to their rapid growth in Mexico.

2. Health regulations in Mexico, which are constantly modified to comply with the best international practices of health authorities.

PRESENCE

AMELAF maintains communication and presence with authorities and institutions in Mexico's health and economic sector, in order to address topics of interest and impact for the domestic pharmaceutical industry. Permanent dialogue and communication have also been established with the health commissions of the Chamber of Deputies and Senate.

ACTIVITIES

1. POINT OF CONTACT
AMELAF serves as its members' point of contact with the authorities and institutions of the nation's health sector, as well as with the health commissions of the Chamber of Deputies and Senate.

2. INFORMATION

Information is transmitted in a daily compilation of the most important news items in the health sector, with emphasis on pharmaceutical topics and the news stories that present AMELAF's viewpoints and opinions.

To health and regulatory authorities, AMELAF provides information about regulations and information generated daily (Official Mexican Standards, reforms to laws and regulations, and notifications from COFEPRIS).

AMELAF reports on the bidding processes for purchasing health sector inputs.

It provides timely information on any topic that is considered relevant and may be of interest for its member laboratories.

3. ORGANIZATION

AMELAF offers courses, workshops, and working groups of interest for Mexico's pharmaceutical industry, to provide Association members with training.

4. ANALYSIS

AMELAF reviews and analyzes the regulations published daily in Mexico's Official Gazette, on the COFEPRIS website, the CONAMER website, the IMPI Gazette of Medical Patents, and other standards of the domestic pharmaceutical industry.

Through a group of professionals specialized in international law and the pharmaceutical industry, AMELAF prepares the legal analysis of topics that affect corporate decisions in copyrights, and the regulations of international treaties and agreements, including United States-Mexico-Canada Agreement (USMCA), and the Free Trade Agreement between Mexico and the European Union (FTA EU-MX).

5. GUIDANCE

AMELAF provides guidance on the registration of medicines, health licenses, certification of good manufacturing practices, import permits, and advertising, with relation to COFEPRIS.