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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.

Important data in Mexico.

  • 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.

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.

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

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

  • 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.

See here the list of reference drugs:

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