Ministry of Health exposes drug regulation reforms to WHO
4 julio 2018

On 28th June, the Minister of Public Health and Social Assistance (MSPAS), Carlos Soto, held a bilateral meeting with WHO officers to present the reforms made to the drugs sanitary control in Guatemala. The reforms are already in force since 4th June and are under the name “Acuerdo Gubernativo 104-2018”

With this new legal framework, both the registration of new medicines and the importation of those already registered become more flexible; the authorization issued by the corresponding health authority of the country of origin is sufficient. Likewise, new rules are established for the production, import and distribution of drugs in the national territory. A certificate is requested, among others, that authorizes the legal commercialization of the drug in the country as well as its prospectus, formula and labeling. An affidavit that proves that there is no violation of patents when marketing the drug is also required. Finally, the MSPAS will periodically take a sample of medicines in order to guarantee the safety and quality of them. It is estimated that the national pharmaceutical industry will be more competitive and imported medicines will be cheaper.

Minister Soto declared that “the best quality of national products will be favored and there will be quality international medicines at a better price”.