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Resolution about the Medicine Control Integral System

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. 39,971 of July 25, 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 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 the national territory, as well as the special regime in bordering States.

The SICM has the purpose of controlling and monitoring the importation of the raw material for the manufacture of medicines, the importation of finished products, the inventories, receipt and dispatch in all the chain of commercialization or 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 in all of the national territory.

This Resolution is applicable to the establishments that take part in the process of importation, transformation, transportation, distribution, and commercialization of medicines or other pharmaceutical products.  Likewise, all public or private legal persons, duly registered with the Ministry of the Popular Power for Health, that perform activities of transportation of medicines intended for commercialization and distribution in the national territory, are imposed the obligation, as applicable, to request from FARMAPATRIA, C.A., the relevant Single Guide for Transportation, Monitoring, and Control of Medicines; said request is to be made using the format and complying with the requirements to that end prescribed in the Resolution.

As to the penalties, the Resolution provides that any person carrying out activities of dispatch, transportation and moving of medicines or other pharmaceutical products, intended for commercialization or distribution, without the corresponding authorizing Single Guide for Transportation, Monitoring, and Control of Medicines, shall be penalized by the competent health authority, in accordance with the provisions of the Organic Law on Health and the Law on Medicines.

The Resolution became effective upon its publication in the Official Gazette. However, the military authorities shall refrain from requiring the Single Guide for Transportation, Monitoring, and Control of Medicines in the national territory for a period of thirty (30) business days - extendible for equal, shorter, or longer periods - after the publication of the Resolution in the Official Gazette.

Finally, the Resolution repeals the Joint Resolution issued by the Ministries of the Popular Power for Health, for Commerce, for Science, Technology, and Innovation, and for Nourishment, published in Official Gazette No. 39,930, dated May 25, 2012

In order to access said Resolution, 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.”