Operations notices
What is an Operation and Health Responsible Notice?
Document stamped by COFEPRIS, in which you are giving full notice that you are starting a health-related business, and that you have a licensed Health Responsible, with a degree registered by the applicable education authorities.
In which situations do you need to have an Operation and Health Responsible Notice?
When you start any of the following health-related business , where no surgical or obstetric acts, or commercialization of health supplies, except controlled drugs, pesticides, plant nutrients and / or toxic substances are performed.
- Medical Devices Factory (Manufacturing)
- Herbal Remedies Factory (Manufacturing)
- Medical Devices Warehouse
- Herbal Remedies Warehouse
- Non-controlled Medicines Warehouse
- Raw Material for Non-controlled Medicines Warehouse
- Medicine Distributor
- Allopathic Pharmacy
- Homeopathic Pharmacy
- Apothecary (No sales of controlled medicines)
- Medical Devices retail trade
- Herbal Remedies retail trade
If you have a health-related business and is not listed above
There is an authorization issued by COFEPRIS called Health License, which is granted if an establishment´s health conditions are met. Any changes in facilities or a change of address implies requesting a new Health License.
The following businesses require a Health License:
- Factory or raw material laboratory for the manufacture of medicines or biological products for human use
- Factory or laboratory of medicines or biological products for human use
- Laboratory for chemical, biological, pharmaceutical or toxicology control
- Warehouse for packaging of medicines or biological Products
- Warehouse for the deposit and distribution of controlled medicines or biological products, for human use
- Mixing centers for the preparation of parenteral, nutritional and medicinal mixtures.
- Pharmacy or apothecary with sales of controlled medications
- Drugstore or homeopathic pharmacy (with preparation of homeopathic medicines)
- Establishments using radiation sources for medical or diagnostic purposes
- Establishments that perform surgical and / or obstetric acts
- Health establishments with extraction, analysis, conservation, preparation and supply services of organs, tissues and cells
- Establishments with organ, tissue and cell transplantation services
- Organs, non-blood tissues and cells bank
- Establishments with blood services
- Establishments with stem cells arrangement
- Regenerative medicine establishments
- Establishments related to pesticides
- Establishments that produce, manufacture or import tobacco products
