Establishment Registration with COFEPRIS
Una parte importante para comenzar el proceso regulatorio de cualquier producto o servicio ante la COFEPRIS es dar de alta el establecimiento.
Existen dos vías para dar el alta.
1. Sanitary License
LEGAL BASIS
Health authorization is required for establishments dedicated to:
I. The process of drugs containing narcotic and psychotropic drugs; vaccines; toxoids; sera and antitoxins of animal origin, and blood products
II. The elaboration, manufacture or preparation of drugs, pesticides, plant nutrients or toxic or dangerous substances
III. The application of pesticides
IV. The use of radiation sources for medical or diagnostic purposes
V. Establishments where surgical or obstetric acts are performed and those that provide hemodialysis services.
SAW. Mixing centers for the preparation of parenteral nutritional and drug mixtures.
2. Notice of Operation
LEGAL BASIS
Establishments that do not require sanitary authorization and which, by agreement, shall be determined by the Ministry of Health must give notice of operation.
Differences between both processes:
1. Risk level of the establishment
2. Cost before COFEPRIS
3. Visit of COFEPRIS to begin operation
4. Processing time
Sanitary license
Operation Notice
Tall
It depends on the turn
Yes
Default according to the homoclave of the procedure
Under
Free of charge
DO NOT
Righ now
PROCEDURES WITH WHICH REGULATE CAN SUPPORT YOU
1. Establishment registration
2. Product registration
Food
Alcoholic drinks
Non-alcoholic beverages
Cosmetics
Food supplements
Cleaning and cleaning products
1. Establishment registration
2. Registration of the sanitary manager
Pharmacy
Apothecaries
Medical Device Factory
Factory of Herbal Remedies
Deposit or Warehouse of Medical Devices
Warehouse of medicines (that do not contain biological nor controlled)
1. Establishment registration
2. Product registration
General office
Specialized medicine office