National Licensing with ANMAT

We handle your company's national licensing (habilitación, the health authorization required to operate) with ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, Argentina's national regulator for medicines, food and medical devices) and other regulatory authorities, covering every stage of the procedure through to approval.

Our work includes:

Analysis of the national regulations that apply to your sector.
Preparation of the technical file (legajo técnico) and required documentation.
Representation of your company before the regulatory authority.
Post-licensing support and help with future renewals.

Specific procedures

Licensing of medical device manufacturers and importers

We handle national licensing for companies that manufacture or import medical devices.

Licensing of a new site

We process the licensing of a new address when your company adds or relocates a plant or warehouse.

GMP certificate renewal

We manage the renewal of your Good Manufacturing Practice certificate (certificado de BPF) before it expires.

Licensing of distributors of medical devices and/or in vitro diagnostic products (interprovincial distribution)

We process the licensing required to distribute medical devices or in vitro diagnostics across different jurisdictions in the country (tránsito interjurisdiccional).

Scope extension (ampliación de rubro)

We add new product categories to an existing national license, without having to start the process from scratch.

Facility modification (modificación de estructura)

We update your national license when your company modifies its building or production structure.

RNE for household cleaning products

We manage the National Establishment Registration (Registro Nacional de Establecimiento, RNE) for household cleaning product companies (domisanitarios).

Need a national license?

Tell us about your case and we'll advise you on the next steps.

National licensing