10.07.2015 Views

1E9Ct5D

1E9Ct5D

1E9Ct5D

SHOW MORE
SHOW LESS

Create successful ePaper yourself

Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.

individually or in association vitamins, minerals, electrolytes, amino acids, or fattyacids, in concentrations greater than those of natural foods and they are also presentedin a defined pharmaceutical form and the indication of use contemplatestherapeutic, preventive, or rehabilitative effects;b) Farmaco. Any natural, synthetic, or biotechnical substance that has any pharmacologicalactivity and that is identified by its physical, chemical, or biologicalaction properties, that is not presented in a pharmaceutical form, and that meetsconditions to be used as a medicine or ingredient of a medicine;c) Raw material. Substance of any origin that is used for the preparation of natural orsynthetic medicines or farmacos;d) Additive. Any substance that is included in the formulation of a medicine that actsas a vehicle, preservative, or modifier of any of its characteristics to improve its efficacy,safety, stability, appearance, or acceptability;e) Materials. The products necessary for the containing and packaging of medicine.The SSA will only grant authorization for medicines when it is shown that the substancesthey contain meet the safety characteristics required by the LGS.In addition, the LGS establishes that laboratories, as well as deposit and distributionwarehouses, for medical products may only distribute them to establishments that havea sanitary license that certifies them as drug stores or pharmacies authorized to supplyto the public drugs that contain narcotics or psychotropic substances. For the sale ortrade of narcotics in the interior of Mexico, the SSA will set requirements that must besatisfied and issue special acquisition or transfer permits.The LGS classifies establishments that engage in the processing of medical products,including their importation and exportation, in the following manner:a) Factory or laboratory of raw materials engaged in the preparation of medicines orbiological products for human use;b) Factory or laboratory preparing medicine or biological products for human use;c) Factory or laboratory working with herbal remedies;d) Laboratory engaged in chemical, biological, pharmaceutical, or toxicological controlfor the study or testing of medicines and raw materials, or else involved in sanitaryregulation;__________b) Homeopathic. Any substance or mixture of substances of natural or synthetic origin that has a therapeutic,preventive, or rehabilitative effect and that is prepared according to the manufacturing proceduresdescribed in the homeopathic pharmacopoeia of the United Mexican States, in those of other countries,or in other sources of national and international scientific information;c) Herbal. The products prepared with plant material or some derivative thereof, whose principal ingredientis the above-ground or subterranean part of a plant or extracts, as well as juices, resins, oils, andessences, presented in a pharmaceutical form, whose therapeutic efficacy and safety have been confirmedscientifically in the national or international bibliography.185Special Regulations for the Sale of Products

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!