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Regulation on Prescription of Medicines for Human Beings

Resolution No. 049 of the Ministry of the Popular Power for Health was published in Official Gazette No. 40.163 of May 9, 2013. The purpose of said Resolution is to regulate the prescription of medicines for human beings in the territory of the Bolivarian Republic of Venezuela.  The Resolution establishes that the prescription of medicines must be obligatorily made by indicating the active principle or International Common Denomination (“ICD”) of the pharmaceutical product, indicating its concentration, pharmaceutical form, route of administration, and posologic dose/unit.  Also, the ICD has to be obligatorily declared in the texts of the packages and labels of the primary, secondary containers or posologic unit and information pamphlets, as well as in the general promotion or advertising of the medicines.

The Resolution prohibits the use of medical prescriptions with names, advertising logos or tag lines of pharmaceutical laboratories, medicines, or trademark printed in the same. Likewise, said Resolution contains a prohibition against accompanying medical prescriptions with any type of promotional or advertising material relating to pharmaceutical products. The Resolution prescribes that the establishments authorized to sell medicines must obligatorily publish, in a visible place, the list of equivalence between medicines with a commercial name and ICD.

The Resolution became effective upon its publication in the Official Gazette. It repealed Resolution No. 028, published in Official Gazette No. 40.131 of March 19, 2013, amended by Resolution No. 031, published in Official Gazette No. 40.136 of March 26, 2013, whereby the Complementary Sanitary Rules for the Regulation of Prescription and Sale of Medicines were issued.

In order to access the 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.”