IMPORTATION OF PHARMACEUTICAL PRODUCTS – COMPANIES NOT DOMICILED IN VENEZUELA

 

Resolution No. 075, issued by the Ministry of the Popular Power for Health (Ministerio del Poder Popular para la Salud – “MPPPS”), was published in Official Gazette No. 41.610 of April 4, 2019 (the “Resolution”). The Resolution established a special temporary regime through the implementation of measures directed to pharmaceutical companies not domiciled in the Republic of Venezuela (the “Republic”), for the importation and commercialization of pharmaceutical products not registered in the country and not approved as medicines of service in the national territory, in order to opportunely attend to problems of availability and access within the Republic’s sanitary control standards.

The Resolution is applicable to the legal persons not domiciled in the territory of the Republic, which will have the following options:

a. Strategic alliances with State-owned companies; they must file with the MPPPS, through the Vice-ministry of Resources, Technology and Regulation, a Letter of Intent to enter into a Strategic Alliance with the State-owned company assigned to the MPPPS.
b. Establishment and operation of a Representative Office, which will be requested through the Autonomous Service of Sanitary Comptrollership (Servicio Autónomo de Contraloría Sanitaria – “SACS”), in accordance with the requirements established by said entity.

The companies interested in entering into a Strategic Alliance must take into account, among others, the conditions established in the Resolution, such as: (i) the importation, commercialization, and distribution of pharmaceutical products will be made by means of the Sanitary Permit of Importation and Commercialization of Pharmaceutical Products (“Sanitary Permit”), granted by the SACS, (ii) the contributions and benefits individually and jointly contributed by the parties to the Strategic Alliance must be set, (iii) the necessary actions must be determined in order to designate the executing entity on the part of the Republic as Representative Office of the pharmaceutical products of the pharmaceutical company not domiciled in the Republic, (iv) the commercialization and distribution percentages of the pharmaceutical products will be fixed, (v) the products intended for the public sector will be stored inside the storehouses assigned to the MPPPS, (vi) the prices of the products in the private market must meet the cost standards established by the National Executive or by strategic associations authorized by the National Executive through the MPPPS. The legal persons not domiciled in the Republic that carry out the establishment and operation of a Representative Office will be exempt from these conditions.

The Resolution establishes the requirements, conditions, and procedure in order for the Pharmaceutical Companies not domiciled in the Republic to obtain the Sanitary Permit. The Sanitary Permit will be valid for one (1) year and extendible for one year only.

The pharmaceutical products imported and commercialized with the Sanitary Permit must bear the following, printed in Spanish in the minimum distribution unit: permit number, name of active ingredient, pharmaceutical form, concentration, lot number, manufacturing date, expiration date, and sanitary registry number in the country of origin. If the printing may not be made or the label may not be attached in the country of origin, the importer must request an authorization from the SACS to label the products in the national territory.

According to the Resolution, type A and type B proprietary drugs and type A1, A2, B1, and B2 biological products, defined in the rules of the Board of Review of Pharmaceutical Products, are excluded from the application of the same, as well as the products of the category: Psychotropics, Narcotics, and Precursors.

The Resolution became effective upon publication of the same in the Official Gazette and will be in effect until December 31, 2019. It may be extended for one (1) year.

In order to access the Resolution, please click here.

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