URUGUAY

On October 13, the Executive Branch published a resolution that adds exceptional cases of entry and commercialization of medicines to the Regulation for the registration, production, export, import and commercialization of medicines for human use. The update adds that, exceptionally, the National Drug Regulatory Authority may authorize the entry and marketing of drugs that are not registered when the Executive Branch declares it essential or when there is a court ruling that justifies the entry.

Specifically, the measure enables the entry of unregistered drugs in the following scenarios:

• When, within the framework of a sanitary state of emergency declared by the Executive Branch, the Ministry of Public Health considers it essential the entry or temporary commercialization, in order to combat the disease or guarantee the availability of the drug in the market.
• When a judicial sentence so provides, in which case the patient must accompany his/her request with the corresponding medical prescription and the requirements established by the condemned state agency.

The Executive Branch indicated that “it is essential to guarantee greater speed in the purchase of unregistered medicines whose supply is ordered by judicial sentence, to the extent that the State is obliged to comply with the jurisdictional order and therefore must establish an administrative procedure in which the purchase is not conditioned to the fulfillment of the requirements set forth in the Regulation for the registration, production, export, import and commercialization of medicines for human use”.

On the other hand, the Executive Branch published the incorporation into the national legal system of the MERCOSUR resolution that establishes the “Good Practice Requirements for the Organization and Operation of Clinical Analysis Laboratories.” These good practices include criteria relating to organization, facilities, laboratory supplies and equipment, personnel, and analytical procedures, among others.