The Dominican General Directorate of Pharmaceutical, Foods and Sanitary Health Products (“DIGEMAPS”) was created under Decree 82-2015 of April 6, 2015, under the dependency of the Dominican 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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ABOUT THE AUTHOR: Dr. Felipe Isa Castillo is a Partner leading the Foreign Investment, Real Estate & Tourism areas at Arthur & Castillo Law Firm and Attorneys in the Dominican Republic. He specializes in foreign investment, real estate and international business (International Legal Studies LLM in Georgetown University Law Center in Washington, D.C. & Masters in International E- Business in Universitat Pompeu Fabra in Barcelona) with more than 20 years of experience in Foreign Investment, Free Trade Zones, International Business and Cross Border Real Estate practice. Dr. Castillo is a Certified Bankruptcy Conciliator and Liquidator and Legal Interpreter.

Email: [email protected]

Disclaimer: This publication is not intended to provide legal advice or suggest a guaranteed outcome as individual situations will differ and the law may have changed since publication. For specific technical or legal advice on the information provided and related topics, please contact the author.

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