Legal & Regulatory > Bolivia > Marketing, Manufacturing, Packaging & Labeling, Advertising

All you need to know about Marketing, Manufacturing, Packaging & Labeling, Advertising in Bolivian pharma. Prepared in association with Indacochea & Asociados, a leading Bolivian law firm, this is an extract from The Pharma Legal Handbook: Bolivia, available to purchase here for USD 99.

1. What is the authorization process for the marketing of new drugs, biologics, medical devices, non-prescription medications, and other medicinal products?

The first step in order to obtain the corresponding authorization to commercialize products in Bolivia is to go through the evaluation and qualification of the products efficiency and security. If this is met the Pharmacological Commission authorizes that the authorization process continues. Once authorization of the product is met and therefore authority gives a heath registration number (registro sanitario), sampling and quality control phase must be met.

2. What is the authorization process for the marketing of generic versions of these products?

Under law, only generic pharmaceutical can be promoted through massive communication (television, radio, press, public spaces, etc.). All marketing information must be previously authorized by the public institution. Non generic pharmaceuticals can only be promoted amongst doctors and health professionals.

3. What are the typical fees for marketing approval?

Costs will vary. It´ll depend if they are imported products or locally manufactured. Therefore, costs can be between US$ 300 and US$ 140.

4. What is the period of authorization and the renewal process?

Under law, it can take up to thirty business days. In practice it takes around 6 months.

5. What are the requirements, if any, for post-approval pharmacovigilance?

Patients can notify pharmacies of any adverse effects. The professional must fill out a form and immediately inform the Departmental Pharmacovigilance Center.

6. Are foreign marketing authorizations recognized?

Only in the case of cosmetics and when they are members of the Andean Community.

7. Are parallel imports of medicines or devices allowed?

They are permitted if deemed necessary and exceptional in order to facilitate a rapid import and commercialization of products.

8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?

Bolivian law states that any gifts, sponsorships, consulting agreements, trips, entertainment and other benefits must be informed previously. Any receptions or hospitality gestures as well as gifted made to health professionals must occupy a secondary objective of the conference, meeting, etc. and must be modest.

9. How is the manufacturing of medicines and devices regulated and by which agencies?

Product manufacturing is regulated under Ministerial Resolution No. 0296 dated June 2, 1996 and is regulated by the State Agency (Agencia Estatal de Medicamentos y Tecnología en Salud –AGEMED).

10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the U.S. Food & Drug Administration and/or the European Medicines Agency?

Yes, they are compatible.

11. What is the inspection regime for manufacturing facilities?

It’ll depend of the authority’s objective. They can be either:

1. Frequent: making sure that Good Manufacturing Practices are complied with.
2. Concise: in order to verify a specific aspect.
3. Follow up: making sure that observations were complied with.
4. Special: aleatory.

12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?

These inspections are not required by local law. Therefore, if companies are open to them, they must state so in their internal procedures.

13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?

The basic elements in order to comply with Good Manufacturing Practices are:

• Personnel
• Infrastructure
• Equipment and materials
• Documentation
• Materials, packages and labels
• Returned products
• Product recalls
• Transportation
• Claims

14. What information must be included in medicine and device labeling?

The information that must be included for medical products:

a. Primary packaging:

• Commercial name
• Generic name
• Principle components
• Pharmaceutical means
• Lot/batch number
• Expiration date
• Content
• Name of manufacturer or licensee
• Instructions

b. Secondary packaging

• Commercial name
• Generic name
• Pharmaceutical means
• Instructions
• Health registration number
• Expiration date
• Prescription
• Conservation and storage conditions
• Therapeutic action
• Dosage
• Warnings
• Instructions of preparation
• Name of manufacturer or licensee
• Manufacturer country of origin
• Labels

Labels for medical devices must contain:

• Commercial name
• Lot/batch number
• Expiration date
• Name of manufacturer or licensee

15. What additional information may be included in labeling and packaging?

16. What items may not be included in labeling and packaging?

Because authority must review and authorize labels and packing, any information not required by law will be revised and approved by the authority.

17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?

In order to commercialize and distribute products in Bolivia, products must have the corresponding health registration number (registro sanitario).

18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?

Medical products must be handled and disposed by health professionals under their responsibility. Products can be sold in pharmacies, drugstores and other stores authorized to do so.

19. What are the restrictions and requirements for electronic marketing and advertising via email, by internet, social media, and other channels?

Although there is no specific regulation in this respect, the health authority includes this type of advertising as marketing directed for public in general and therefore must meet said requirements.

20. May medicines and devices be advertised or sold directly to consumers?

Only specific products can be sold directly to the public. For example for cancer treatment. In order to do so, the company must have special authorization.

21. How is compliance monitored?

AGEMED revises all documents and information in order to verify that the company is complying with all regulations. If not, AGEMED will ask the company to provide additional information/documents or amend them. Also, AGEMED can randomly inspect pharmacies or company’s warehouse to make sure that law is complied with.

22. What are the potential penalties for noncompliance?

Possible sanctions can include monetary sanctions as well as temporary closings or confiscation of products in the market.