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Health

Cosmetics

Nutritional Supplements

Medical Divices

Generics

New Molecule

Vitamin Drugs

Biologic /

Bio-technological

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GENERICS

A generic drug is one that presents the same qualitative and quantitative composition of active substances and the same pharmaceutical form as an original drug.

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Important data in Mexico.

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  • Study of patents: This is very important since there are patents that are only acknowledged in our country. Recomendation: Carry out a study of patents.

  • Bioequivalence: our country is obliged to repeat the bioequivalences in a local laboratory to confirm the results. Said study may only be carried out by authorized third party companies for this kind of thests.

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​Without this requirement it is impossible to obtain the health register. There are some pharmaceutical forms that do not require bioequivalence.

Important data in Mexico.

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  • Brand: The brand name registration process for a generic must be authorized by Cofepris and by Impi (Mexican Institute of Industrial Property)

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This process is somehow handcraft which must be done with care to avoid errors.​

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  • Reference drug:  Any generic must have a reference drug. Said drug is used as basis for all the comparisons during the studies that are carried out and for its registration process.

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See here the list of reference drugs:​

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