Notification of costs and prices of medicines
Administrative Ruling No. 187 (the “Ruling”), issued by the National Superintendence of Costs and Prices (Superintendencia Nacional de Costos y Precios - SUNDECOP) was published in the Official Gazette No. 39,986 of August 15, 2012. Said Ruling establishes the obligation to give notice of the costs and prices of medicines.
According to said Ruling, the entities/individuals that produce, import, distribute, and/or commercialize medicines that have been registered with and/or authorized by the Ministry of the Popular Power for Health as Brand-name Drug (Especialidad Farmaceutica – E.F.), Generic Brand-name Drug (Especialidad Farmaceutica Genérica – E.F.G), and Biological Product (Producto Biólogico - P.B.), pursuant to the Law on Medicines, and are actually being commercialized at the time of publication of the Ruling, are under the obligation to notify SUNDECOP through two (2) loading processes (i) the accounting information about the production, importation, distribution, and/or commercialization costs corresponding to the closing of the last fiscal period of year 2011 and the first semester of the fiscal period of year 2012, and (ii) the prices of sales to their different distribution or commercialization channels in effect on the date of publication of the Ruling.
The Ruling imposes on the aforesaid entities/individuals subject to the application of the Ruling the obligation to provide, through the Price Administration Automated System (Sistema Automatizado de Administración de Precios - SISAP), the information required concerning general information of the company, notification of costs and prices, and other data required.
The notification of sales prices and production, importation, distribution and/or commercialization costs of the medicines subject to this regulation must be given by the entities/individuals subject to the application of the Ruling, from the date of entry into force of the Ruling up to and including FRIDAY, AUGUST 31, 2012.
The entities/individuals subject to the application of the Ruling that fail to perform the above-described obligations shall be penalized in accordance with the Decree with the Status, Value, and Force of Law on Fair Costs and Prices (the “Decree”).
The Ruling establishes that the entities/individuals subject to the application of the Ruling that produce, import, distribute, and/or commercialize the medicines governed by this regulation are bound to provide the SUNDECOP officers duly authorized to conduct inspections and audits with all the information, documentation, and other facilities required by them, in order to complement the information subject matter of the Ruling, when they deem it necessary under the Decree.
The Ruling became effective upon 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.”