Registering Imported Food, Drugs and Cosmetics in the Dominican Republic: The DIGEMAPS Rules

No medicine, packaged food, cosmetic or hygiene product legally reaches a Dominican shelf, or a Dominican hospital, without passing through one office. Decree 82-15, issued April 6, 2015, created that office: the General Directorate of Pharmaceutical, Foods and Sanitary Health Products, DIGEMAPS, under the Ministry of Public Health and Social Assistance.

Article 2 of the decree makes the mandate sweeping. DIGEMAPS is the competent authority for the regulation, control, auditing and vigilance of medicines, sanitary products, food, beverages, cosmetics, personal hygiene and household products, industrial and technological process materials, and materials for human use consumed in health services or in the diet, along with the establishments, activities and processes behind them.

The decree consolidated functions that had been split between the General Directorate of Drugs and Pharmacies and the Department of Risk Control on Food and Beverages, transferring their competencies, assets, personnel and pending files to DIGEMAPS within sixty days.

The part importers should not skip

For pharmaceutical companies, the most consequential provision is procedural: the decree opened the door to simplified procedures for medicine registrations, covering amendments to facilities, technical files, packaging and improvement materials, information systems, manufacturing and control processes, and containers under certain conditions, as well as for new registrations and renewals. DIGEMAPS was instructed to classify, by resolution, which processes qualify for the fast track and what each requires.

The practical consequence, a decade on, is that DIGEMAPS requirements live in resolutions that evolve, which means the checklist that worked for your last registration may not match the current one. Importers who verify the current requirements before assembling a dossier avoid the most common cause of delay: a file built to yesterday’s rules.

Our regulatory team represents importers and manufacturers before DIGEMAPS on registrations, renewals and variations for medicines, foods and cosmetics, and keeps the checklist current so you don’t have to.

Do you want more information about registering Imported Food, Drugs and Cosmetics in Dominican Republic? Contact Us.

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

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