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Medicine-control-integral-system-sicm

A Joint Resolution of the Ministries of the Popular Power for Health, for Commerce, for Science, Technology, and Innovation, and for Nourishment was published in Official Gazette Nº 39.928 of May 23, 2012. Said Resolution implements the Medicine Control Integral System (Sistema Integral de Control de Medicamentos - SICM) and establishes the guidelines and criteria to govern the issue of the Single Guide for Transportation, Monitoring, and Control of Medicines. The purpose of said Resolution is to implement the SICM and to establish the guidelines that govern the requirements, conditions, process, format, issue, and registration of the Single Guide, which is required for the transportation, monitoring, and control of medicines and other pharmaceutical products intended for commercialization and distribution in Venezuela, as well as the special regime in bordering States. All persons performing activities of dispatch, transportation, and mobilization of medicines and other pharmaceutical products intended for their distribution or commercialization, without the aforementioned Guide that authorizes it, will be penalized according to the provisions of the Organic Law on Health.

 

The SICM has the purpose of controlling and monitoring the importation of raw material and finished products, inventories, receipt and dispatch in all the chain of commercialization and distribution of the medicines registered with the Ministry of the Popular Power for Health, as well as any other connected activity, and of generating the necessary indicators for the competent authorities to guarantee the continuous and timely availability of medicines.

 

The following are subject to the application of said Resolution: laboratories that manufacture pharmaceutical products, laboratories that manufacture natural products, representative offices, drugstores, commercial pharmacies, and hospital pharmacies.

 

The Resolution became effective on the day following that of its publication in the Official Gazette.

 

In order to access said Ruling, please click here

 

“NOTE: THIS INFORMATION SHOULD NOT BE CONSTRUED AS LEGAL ADVICE ON ANY SPECIFIC MATTER AND ITS CONTENT ARE INTENDED AS A MANAGEMENT ALERT AS TO CURRENT DEVELOPMENTS IN VENEZUELA, ANY SPECIFIC LEGAL QUESTIONS REGARDING THE POSSIBLE APPLICATION OF NEW OR PROPOSED LEGISLATION TO PARTICULAR SITUATIONS SHOULD BE ADDRESSED TO TRAVIESO EVANS ARRIA RENGEL & PAZ.”