June 11th 2009 FEDERAL OFFICIAL GAZETTE (FIRST SECTION)) MINISTRY OF HEALTHDecree 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 theRepublic.FELIPE DE JESÚS CALDERÓN HINOJOSA, President of the Mexican United States The Mexican UnitedStates, 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 isconsidered to be any substance that has been produced through molecularbiotechnology, that has a therapeutic, preventative or rehabilitative effect, is found in apharmaceutical form, is identified through its pharmacological activity and physical,chemical, and biological properties. Innovative biotechnological medicinal productsmay be used as a reference for non-innovative biotechnological medicinal products,which will be referred to as biosimilars. The form of identification of these productswill be determined by the corresponding regulations.In order to obtain the marketing license for biotechnological medicinal products, theapplicant 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, itsregulations and the other applicable legal provisions and once the biotechnologicalmedicinal product is placed on the market, pharmacovigilance of it shall be performedin conformance with the corresponding regulations.The applicant for the marketing license of a biosimilar medicinal product that supportsits application on a reference biotechnological medication, shall present the clinical and,if applicable, in-vitro studies necessary to demonstrate the safety, efficacy and quality ofthe product.In the event that the regulations regarding the necessary studies and their characteristicsreferred 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, whichfor the purpose of the provisions of this article will have a Subcommittee for Evaluationof Biotechnological Products which will be made up of specialists and scientists inbiotechnological pharmacology.The biotechnological medicinal products shall include on their labels the drug substancemanufacturer and its origin, the packaging site and in if it is the case its importer. TheInternational non-proprietary name shall correspond to the referenced medicinalproduct, this without implying a separation in the codes of the Basic Chart and of thecatalogues of medicines of the health institutions assigned for these.TRANSITORY PROVISIONS
June 11th 2009 FEDERAL OFFICIAL GAZETTE (FIRST SECTION))First. The present Executive Order will enter into effect 90 days after its publication inthe Federal Official Gazette.Second. The Ministry of Health will have 180 days after its publication in the FederalOfficial Gazette to issue the legal provisions necessary for the application of the presentExecutive Order.Third. The Ministry of Health under the terms established by the Federal Measurementand Standardization Law, shall adjust the related official Mexican standards to thatwhich is established by this Executive Order.Fourth. The Subcommittee for Evaluation of Biotechnological Products referred to inarticle 222 Bis, will have at least five members among which must be included onerepresentative from each of the following institutions: National Institute of GeneticMedicine, National Autonomous University of Mexico and National PolytechnicInstitute, as well as representation of the health authority and the Council on GeneralHealth, and shall be established within 90 days after publication in the Federal OfficialGazette.Fifth. The Regulations of the New Molecules Committee shall be issued within 90 daysafter the publication of the present Executive Order.