Mexican Laws in English
NOM-073-SSA1-2015, Stability of drug substances and drug products, as well as herbal remedies. 


Published DOF June 07, 2016 – effective Dec. 4, 2016


This Standard is under the oversight of the SSA = (Secretaría de Salud - Secretary of Health) Environmental Health 

LAW, REGULATION, OR NOM - what is the difference?  



NOM-073-SSA1-2015, Estabilidad de fármacos y medicamentos, así como de remedios herbolarios. NOM-073-SSA1-2015, Stability of drug substances and drug products, as well as herbal remedies.



0. Introducción.

0. Introduction

1. Objetivo.

1. Objective

2. Campo de aplicación.

2. Field of application

3. Referencias.

3. References

4. Definiciones, símbolos y abreviaturas.

4. Definitions, symbols and abbreviations

5. Fármaco nuevo.

5. New drug substance

6. Fármaco conocido.

6. Known drug substance

7. Medicamento nuevo.

7. New drug product

8. Medicamento conocido o genérico y remedio herbolario.

8. Known or generic drug product and herbal remedy.

9. Gases medicinales en envases metálicos.

9. Medicinal gases in metal containers

10. Consideraciones generales.

10. General Considerations

11. Concordancia con normas internacionales.

11. Concordance with international standards

12. Bibliografía.

12. Bibliography

13. Observancia de la Norma.

13. Observance of the Standard

14. Vigencia.

14. Validity

15. Apéndice Normativo A. Modificaciones a las condiciones de registro.

15. Obligatory Appendix A. Modifications to the registration conditions.





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