Question 1

What regulatory advisory services do you offer in Bolivia?

Accepted Answer

We provide specialised advice on managing and meeting the regulatory requirements that apply to medicines recognised by law, from the initial product assessment to obtaining and maintaining the corresponding authorisations.

Question 2

What is a medicine recognised by law?

Accepted Answer

For regulatory purposes, Article 4 of Law 1737 establishes that the medicines recognised by law are: generic medicines (International Nonproprietary Name, INN); branded medicines; official preparations; magistral formulas; homeopathic medicines; products of plant, animal or mineral origin with medicinal properties; special medicines; biologicals; blood products; dietary products; dental products; cosmetics; radiopharmaceuticals; medical devices; diagnostic substances and clinical laboratory reagents.

Question 3

What kind of companies do you work with?

Accepted Answer

We work with pharmaceutical laboratories, manufacturers, importers, distributors, legal representatives and companies that want to bring regulated products to the Bolivian market.

Question 4

Can you advise us before we import a product into Bolivia?

Accepted Answer

Yes. We carry out a prior regulatory assessment to identify the requirements that apply to the product and guide you on the documentation and procedures needed before starting to import or sell it.

Question 5

What documentation do I need to register a pharmaceutical product?

Accepted Answer

The requirements depend on the product's characteristics and category. We carry out an initial assessment to identify the technical, legal and administrative documentation that applies in each case.

Question 6

Can you help me sell an imported cosmetic in Bolivia?

Accepted Answer

Yes. We can guide you on the regulatory requirements, documentation and procedures needed to import and sell the product.

Question 7

How can I find out which regulatory requirements apply to my medical device?

Accepted Answer

The requirements depend on, among other factors, the device's characteristics, intended use and classification. We carry out a regulatory assessment to determine the procedure that applies.

Question 8

How long does a regulatory procedure take?

Accepted Answer

The timeframe depends on the type of product, the procedure, the documentation submitted and the competent authority's review times. That is why we recommend a prior assessment before setting a schedule.

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