Regulatory advice and registrations before AGEMED

We help you open your company, register your products and manage your imports in an orderly way.

Advisory services

Opening an importer

Medicines and other products recognized by law

What it is

Registration of your importing company with AGEMED to import medicines and other products recognized by the Medicines Law (Law 1737).

Who it is for

Companies and entrepreneurs who want to import pharmaceutical, cosmetic, medical device or hygiene products into Bolivia.

Opening industrial laboratories

Pharmaceutical, cosmetic and device labs, among others

What it is

Licensing of industrial laboratories with AGEMED, according to the type of product to be manufactured.

Who it is for

Companies that will manufacture pharmaceutical or other regulated products in Bolivia.

Registration of micro and small enterprises (MyPE)

Producers of cosmetics, household hygiene and personal hygiene absorbents

What it is

Registration with AGEMED of micro and small enterprises that produce cosmetics, household hygiene products and personal hygiene absorbent products (Supreme Decree 5279; Administrative Resolutions 48 and 50 of 2024).

Who it is for

Micro and small producers of cosmetics and hygiene products who need to regularize their production unit.

Pharmaceutical product registration

Health registration of medicines

What it is

Health registration of the medicine before it is marketed: preparing and filing the dossier under the Health Registration Manual (RM 0909/2005) and its amendments.

Who it is for

Laboratories and importers that want to register a medicine.

NSO registration

Cosmetics and hygiene products

What it is

Mandatory Health Notification (NSO): the code that cosmetics, household hygiene products and personal hygiene absorbents need in order to be marketed.

Who it is for

Manufacturers and importers of cosmetics and hygiene products.

Medical device registration

Health registration under Manual RM 0010/2006

What it is

Health registration of medical devices. The manual establishes registration by device group.

Who it is for

Importers and manufacturers of medical devices.

Customs clearance

Customs Clearance Authorization Certificate (CADA)

What it is

Management of the Customs Clearance Authorization Certificate with AGEMED, the document that accompanies the import of medicines recognized by law and other regulated products.

Who it is for

Companies registered with AGEMED that import regulated products.

Expert advice sessions

Discuss your case with a regulatory specialist

What it is

Personalized guidance sessions on the procedure that applies to your activity and product, and how to organize it before AGEMED.

Who it is for

Anyone starting out, or who already has a company and does not know where to go next.

Report on your case

You present your case and we deliver a report

What it is

You present your case and we deliver a written report on the applicable regulations, with the rules cited and their validity verified.

Who it is for

Companies that need to support a decision or present the analysis to their team or agent.

Requirements are subject to the current AGEMED regulations. We give you the list that applies to your case during the consultation.

Expert advice: a session or a report on your case

If your case does not fit a standard procedure, or you need clarity before deciding, you can choose how to work with us.

Advice session

We discuss your case with a specialist in AGEMED regulations and registrations and guide you on the path that applies.

Request a session

Report on your case

Present your case and we deliver a written report with the applicable rules, cited and with their validity verified.

Present my case

Scope, cost and timing are confirmed once we receive your inquiry.

How we work

  1. 1

    We review your case and tell you the path that applies.

  2. 2

    We prepare the file with you.

  3. 3

    We file the procedure and follow up with AGEMED.

  4. 4

    We stay with you until AGEMED responds.

Which procedure do I need?

Answer 4 questions and we will guide you. We do not store your answers.

Frequently asked questions

Do I need an incorporated company?

The application starts from a legally incorporated company. If you do not have one yet, we guide you on the order of the steps.

Is opening the laboratory the same as registering a product?

No. Opening the laboratory licenses the company; registering each product is a separate procedure.

Am I a MyPE or do I need an industrial laboratory?

It depends on the size of your production unit and on what you produce. We review it during the consultation.

Is registration done only once?

Health registration has a renewal. We tell you when it applies in your case.

Does my product need an NSO?

Cosmetics, household hygiene products and personal hygiene absorbents must have an NSO code in order to be marketed.

Is each device registered separately?

The manual establishes one health registration for each group of devices. We help you identify the right group.

Who can apply for it?

Mainly companies registered with AGEMED as importers. The AGEMED directive also covers other cases, such as donations and patients.

When is a consultation worthwhile?

Before importing, manufacturing or registering: it helps organize the path from the start.

What does the report contain?

The rules that apply to your case, with their source and the verified validity of each one.

Can you guarantee approval or a deadline?

No. Approval and timing depend on AGEMED. We work so that your file is submitted complete and in order.

Get a quote for our services

Requirements are subject to the current AGEMED regulations. We give you the list that applies to your case during the consultation.

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