Distribution and commercialization distribution of pharmaceutical and related products for esthetic use in authorized establishments.
By: Andrea Castillo
The Draft Technical Standard 89 version 1-2023 public consultation on the Pharmaceutical and Related Products Distribution and Commercialization for Aesthetic Use, has been opened. It should be highlighted that it does not have an effective date, since it is a regulation under construction.
This Technical Standard would be applicable to pharmaceutical, cosmetic, medical-surgical, and medical device products. In addition, it indicates that the list of products to which this regulation would apply would be published in the Department of Regulation and Control of Pharmaceutical and Related Products official web page.
It is established that it is the distributors’ and drugstores’ responsibility to sell the mentioned products only to establishments with a Sanitary License, according to their category, issued by the Department of Regulation, Accreditation and Control of Health Establishments (DRACES). It is proposed to prohibit the sale of such products to unauthorized establishments.
Distributors and drugstores must have the required support on the distribution and commercialization activities since they would be subject to control requested and supervised by the Surveillance, Monitoring & Control Unit.
Public consultation
The deadline for public consultation was established until June 24, 2023. If you have any observations, you may send your Physical proposals or comments to the Regulation and Control of Pharmaceutical and Related Products Department; or by e-mail: jefaturadrcpfa@mspas.gob.gt and normativadrcpfa@mspas.gob.gt.
Also, if you wish to participate in the Technical Committee, you must attach the following application form: Entity you represent, full name, and position held, considering that will be accepted a maximum of 02 representatives per entity.
Additionally, I attach the official document published by the Department of Regulation and Control of Pharmaceutical and Related Products.