Regulatory Compliance

In Genomma Lab Internacional we maintain a strict adherence to the regulations that govern us to ensure that our products comply with all the regulatory requirements of the countries where we have a presence. The legal framework that regulates us consists of rigorous standards, resolutions and decrees among which the following stand out.

Regulatory framework in Mexico

  • General Health Law
  • Regulation of Health Supplies
  • NOM-059-SSA1-2013: Good manufacturing practices for medicinal products
  • NOM-072-SSA1-2012: Labeling of medicines and herbal remedies
  • NOM-073-SSA1-2005: Stability of drugs and medications
  • NOM-137-SSA1-2008: Labeling of medical devices
  • (NOM-141-SSA1, SCFI-2012): Labeling for pre-packaged cosmetic products. Health care and commercial labeling.
  • NOM-177-SSA1-2013: Procedures to demonstrate that a drug is interchangeable.
  • NOM-220-SSA1-2012: Installation and operation of pharmacovigilance.
  • NOM-240-SSA1-2012: Installation and operation of technovigilance.
  • NOM-241-SSA1-2012: Good manufacturing practices for establishments engaged in the manufacture of medical devices.
  • Supplement for establishments dedicated to the sale and supply of medicines and other health ingredients FEUM

International Regulatory Framework

  • RTCA 11.03.59:11 Pharmaceutical products. Medicinal products for human use. Health Registration Requirements
  • RTCA 11.03.47:07 Pharmaceutical products. Medicinal products for human use. Quality verification
  • RTCA 11.03.39:06 Pharmaceutical products. Validation of analytical methods for the quality of medicines.
  • RTCA 11.01.02:04  Pharmaceutical products. Labeling of pharmaceutical products for human use
  • RTCA 11.01.o4:10 Pharmaceutical products. Stability studies of medicinal products for human use.
  • Ministerial Resolution No. 0909 Manual for Health Registration
  • Decree Number 677 of 1995 (April 26) which partially regulates the Regime of Registrations and Licenses, the Quality Control, as well as the Regime of Health Surveillance of Medicines, Cosmetics, Pharmaceutical Preparations based on Natural Resources, Toiletries, Hygiene and Cleaning and other products for domestic use and enacting other provisions on the subject.
  • Technical Standard No. 129 Guide for the completion and submission of stability studies of pharmaceutical products in Chile and its annex.
  • Decree 3 regulation of the national system for the control of pharmaceutical products for human use.
  • Technical Standard No. 127 Good manufacturing practices, related with the Supreme Decree No. 3, 2010, of the Ministry of Health, by which the regulation of the National System was approved for the control of pharmaceuticals for human use.
  • Agreement No. 00000586 Substitute regulation for health registry for medicines in general.
  • Decree 246-06 Regulation of drugs
  • Law 1 of 10 January 2001 on medicines and other products for human health
  • Executive Decree No. 178 That regulates the Law 1 of 10 January 2001, on medicines and other products for human health.
  • Provision 3554/2002 ANMAT.
  • Supreme Decree (S.D.). No. 002-2010-SA Single Text of Administrative Procedures for registration and re-registration approved with S.D. 013-2009-SA modified by S.D. No. 002-2010-SA.
  • CFR – Code of Federal Regulations Title 21
  • Manual of Procedures for registration of Specific Medicines ANVISA.

In addition, we comply with the guidelines and regulations of the agencies that regulate the products we sell. One of the main institutions to whose requirements we follow is the Federal Commission for the Protection against Health Risks (COFEPRIS), which protects the population against health risks and establishes measures for the regulation, control and prevention of health risks.

Also, at international level we are in line with the provisions of the following agencies.

  • National Health Surveillance Agency (ANVISA)
  • National Administration of Medicines, Food and Medical Technology (ANMAT)
  • National Institute of Food and Drug Surveillance (INVIMA)
  • European Medicines Agency (EMA)
  • National Center of Documentation and Information of Medicines (CENADIM)
  • National Agency of Regulation, Control and Sanitary Surveillance (ARCSA)
  • National Directorate of Medicines (DNM)
  • Institute of Public Health (ISP)
  • US Food and Drug Administration (FDA)

The bodies and provisions that regulate us may differ between countries. As an example, some of our OTC products may be marketed in certain countries by prescription only, while in other countries no prescription is required to purchase them.

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Reporte de Sustentabilidad 2016 de Genomma Lab Internacional

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