July 10, 2020
Bioseguridad

Resolution 1066 of 2020 is applied to:

  1. Establishments that produce, market, store, or transport products such as medicines, phIto-therapeutic products, medical devices, biomedical equipment, cosmetic products, and home care products.
  2. Authorized health service providers.
  3. Places for the expansion of the healthcare provision that are exceptionally authorized for the duration of the health emergency.
  4. Pharmaceutical services and establishments.
  5. The INVIMA. (May make requirements when it considers it necessary). 
  6. Departmental, district and municipal health secretariats and institutes
  • They must ensure all the quality conditions during the procedures.
  • Are responsible for the veracity of the information provided to the competent health authorities and the consequences that they may cause in users.

Health conditions for the marketing, distribution, dispensing, uninformed delivery, storage, and transport of products such as medicines, medical devices, biomedical equipment, and in vitro diagnostic testing devices, cosmetics, and household products.

  1. In general, the following document should be applied: "GIPS05 Code. Version 02. Guidelines for the production sector of pharmaceutical products, food and beverages during the coronavirus epidemic (covid-19) in Colombia".

  2. The special requirements for the marketing, distribution, dispensing, sale, storage and transport of the products, which are found in Technical Annex No. 1 of this Resolution, must be taken into account.

Operation of the pharmaceutical service in places of healthcare expansion.

  1. If there is a high demand and the qualified staff can't handle the products. The pharmaceutical service can be done by health staff with the necessary knowledge and experience.
  2. For transport, the special requirements contained in Annex 1 must be taken into account.
  3. The products must be stored in places that will guarantee their conservation  They are not allowed to be stored on the floor, it must be on pallets or stacks.
  4. To have the registration of the products. 
  5. Inform the INVIMA in case of any event or incident related to the products.
  6. The rational use of medicines must be guaranteed. 
  7. Information technologies can be used for the elaboration and transmission of the medical prescription.
     

Resolution 1066 of 2020

 

 

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