Dominican Food and Drug Product Registration

By Maria Arthur (marthur@aclaw.com)

On April 6th of 2015, the Executive Branch enacted Decree 82-2015, which creates the General Directorate of Pharmaceutical, Foods and Sanitary Health Products (“DIGEMAPS” for its Spanish acronym), under the dependency of the Ministry of Public Health and Social Assistance.

According to Article 2 of said Decree, DIGEMAPS is and will be, henceforth, the competent entity in matters of regulation, control, auditing and vigilance of medicines, sanitary products, food, beverages, cosmetics, products for personal hygiene, housing and for industrial and technological processes, and materials for human use, that are consumed or used in the rendering of health services and/or in the diet, as well as of the control of the establishments, activities and processes derived therefrom.

For its entry into force, the Decree 82-2015 establishes the transfer to DIGEMAPS of the competencies and functions, of the General Directorate of Drugs and Pharmacies and the Department of Risk Control on Food and Beverages and provides for the transfer to DIGEMAPS of its assets, human resources and any other type of request corresponding to their functions that is in process within a period of sixty days.

The Decree 82-2014 foresees the possibility of applying for medicine registration simplified procedures to amendments of the facilities, technical file, bottling and improvement materials, information system, fabrication processes and control, recipients under certain conditions and for new registers and renewals of existing registrations.

Finally, DIGEMAPS is instructed to define and propose the classification of the new registration and renewal processes subject to apply to simplified procedure and determine, by resolution, the requirements for each case in a period no longer than 60 days, counted from the issuance of the Decree.

In view of the above, it is important to consider that DIGMAPS will review the current requirements and will amend and establish new requirements for the processes of registration and renewal of medicines, deciding over those registrations and renewals that may apply to the simplified procedure.

 

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