1. June 11th 2009 FEDERAL OFFICIAL GAZETTE (FIRST SECTION))
MINISTRY OF HEALTH
Decree Adding Article 222 Bis on Biotechnological Medicinal Products to the General Law of Health.
To the margin a seal with the National Shield, that says: The Mexican United States. - Presidency of the
Republic.
FELIPE DE JESÚS CALDERÓN HINOJOSA, President of the Mexican United States The Mexican United
States, to its inhabitants you know:
That the Honorable Congress of the Union, has used to send the following
DECREE
"THE GENERAL CONGRESS OF THE MEXICAN UNITED STATES, DECREES:
An article 222 BIS to the General Law of Health is added.
Sole Article.- Article 222 Bis is added to the General Health Law, as follows:
Article 222 Bis.- For the purposes of this Law, biotechnological medicinal product is
considered to be any substance that has been produced through molecular
biotechnology, that has a therapeutic, preventative or rehabilitative effect, is found in a
pharmaceutical form, is identified through its pharmacological activity and physical,
chemical, and biological properties. Innovative biotechnological medicinal products
may be used as a reference for non-innovative biotechnological medicinal products,
which will be referred to as biosimilars. The form of identification of these products
will be determined by the corresponding regulations.
In order to obtain the marketing license for biotechnological medicinal products, the
applicant shall comply with the requirements and tests that demonstrate the quality,
safety and efficacy of the product, in conformity with the provisions of this Law, its
regulations and the other applicable legal provisions and once the biotechnological
medicinal product is placed on the market, pharmacovigilance of it shall be performed
in conformance with the corresponding regulations.
The applicant for the marketing license of a biosimilar medicinal product that supports
its application on a reference biotechnological medication, shall present the clinical and,
if applicable, in-vitro studies necessary to demonstrate the safety, efficacy and quality of
the product.
In the event that the regulations regarding the necessary studies and their characteristics
referred to in this article have not been issued, the regulations will be defined on a case-
by-case basis, taking into account the opinion of the New Molecules Committee, which
for the purpose of the provisions of this article will have a Subcommittee for Evaluation
of Biotechnological Products which will be made up of specialists and scientists in
biotechnological pharmacology.
The biotechnological medicinal products shall include on their labels the drug substance
manufacturer and its origin, the packaging site and in if it is the case its importer. The
International non-proprietary name shall correspond to the referenced medicinal
product, this without implying a separation in the codes of the Basic Chart and of the
catalogues of medicines of the health institutions assigned for these.
TRANSITORY PROVISIONS

2. June 11th 2009 FEDERAL OFFICIAL GAZETTE (FIRST SECTION))
First. The present Executive Order will enter into effect 90 days after its publication in
the Federal Official Gazette.
Second. The Ministry of Health will have 180 days after its publication in the Federal
Official Gazette to issue the legal provisions necessary for the application of the present
Executive Order.
Third. The Ministry of Health under the terms established by the Federal Measurement
and Standardization Law, shall adjust the related official Mexican standards to that
which is established by this Executive Order.
Fourth. The Subcommittee for Evaluation of Biotechnological Products referred to in
article 222 Bis, will have at least five members among which must be included one
representative from each of the following institutions: National Institute of Genetic
Medicine, National Autonomous University of Mexico and National Polytechnic
Institute, as well as representation of the health authority and the Council on General
Health, and shall be established within 90 days after publication in the Federal Official
Gazette.
Fifth. The Regulations of the New Molecules Committee shall be issued within 90 days
after the publication of the present Executive Order.