Por: Andrea Castillo, Ruth Olivares, Olga Torres.

On June 28, 2022, the Department of Regulation and Control of Pharmaceutical and Related Products issued Version 06 of Technical Standard 77-2022 “Homologation of the Sanitary Registration of Medicines and Vaccines”.

The previous one had been defined to enter into force on August 5th of this year, however, currently on the official website of the Ministry of Health the entry into force has been changed to “PENDING”.

Additionally, the College of Pharmacists and Chemists of Guatemala (COFAQUI) published the first week of August in its social networks, an announcement where they announced that the Technical Commission of Regulatory Affairs of the College of Pharmacists and Chemists of Guatemala (CTAARR) conducted a review of the standard in question and held a meeting with various units of the Department of Regulation and Control of Pharmaceuticals and Related Products.

With the above, the Technical Commission of Regulatory Affairs of Pharmaceutical Chemicals requests that an update to the Technical Standard 77 be managed and that version 06 does not enter into force until modifications are made to it.

The changes proposed by the Technical Commission on Regulatory Affairs are as follows:

The definition of “country of origin” be modified, as they indicate that in version 06 this is related to other terms such as “manufacture or packaging of the product”, in order to coincide with the purpose and scope of the standard.

The term “issuance” should be replaced by “receipt or notification”, and mechanisms should be guaranteed so that the Pharmaceutical Chemist can obtain a physical or formal notification of the objection or resolution, and that from the next working day after the receipt is confirmed, the deadline to respond should start to be calculated.

The Technical Standards Unit of the Department of Regulation and Control of Pharmaceutical and Related Products has indicated that version 06 of Technical Standard 77-2022 is not in force due to internal processes and that version 05 remains in force until further notices are issued.