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Ministry of Health Regulates Certain Pharmaceutical and Cosmetic Products

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Newsletter #161

On December 6, 2023, Ministerial Agreement No. 357-2023 was published, by which the Ministry of Public Health and Social Assistance (MSPAS) issued the Technical Standard for the Regulation of Distribution and Commercialization of Pharmaceutical and Related Products for Aesthetic Use in Authorized Establishments.

The list of products covered by this agreement includes the following:

  • Botulinum toxin type A
  • Linear hyaluronic acid
  • Cross-linked hyaluronic acid
  • Calcium hydroxyapatite
  • Polylactic acid dermal threads
  • Polydioxanone dermal threads
  • Polylactic polycaprolactone acid

 

The provisions established in the agreement will be applicable to distributors and drugstores that commercialize and distribute pharmaceutical products and related products for aesthetic use in authorized establishments in the country.

According to these regulations, distributors and drugstores may only sell the listed products to authorized establishments that have a health license issued by the Department of Regulation, Accreditation and Control of Health Establishments of the MSPAS. Therefore, it is prohibited to sell these products to individuals, beauty salons, spas, or other unauthorized establishments. 

Distributors and drugstores must have the appropriate support for the sale of products authorized by the MSPAS. This will be verified by the commercialization Kardex, which may be in physical or digital form.

The agreement has already entered into force and is available on the Ministry of Health's website at https://medicamentos.mspas.gob.gt/index.php/legislacion-vigente/acuerdos.

For more information, please contact:

Álfaro lópez
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