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

An insight into marketing, manufacturing, packaging & labeling, advertising in Panama. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 75.

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

To obtain authorization to develop and market a product, each product must obtain a sanitary registration before the Ministry of Health.

STEPS

A. Drugs and Biological and medicinal products

1. Before the application for registration, a quotation for the product analysis must be obtained before the Specialized Analysis Institute.
2. File the petition with the correspondent forms before the Pharmaceutical and Drug Department for the registration accompanied of the documentation and samples required. This form must be signed by the Attorney and certified by a Panamanian Chemical Pharmacist, which signature must be certified by the Panamanian Pharmaceutical Bar.
3. Once admitted, the application passes to be technically evaluated by the authority to verify the compliance with the sanitary standards.
4. Once evaluated, the authority proceeds to issue a payment order for the government fees and post-registration analysis.
5. After the settlement of the payment, the authority grants the product the sanitary registration and issues the corresponding certificate.

B. Over-the-counter medications:

1. File the petition with the correspondent forms before the Pharmaceutical and Drug Department for the registration accompanied of the documentation and samples required. This form must be signed by the Attorney and certified by a Panamanian Chemical Pharmacist, which signature must be certified by the Panamanian Pharmaceutical Bar.
2. Once admitted, the application passes to be technically evaluated by the authority to verify the compliance with the sanitary standards.
3. Once evaluated, the authority proceeds to issue a payment order for the government fees and post-registration analysis.
4. After the settlement of the payment, the authority grants the product the sanitary registration and issues the corresponding certificate.

C. Medical devices:

1. File the petition with the correspondent forms before the Ministry of Health for the registration accompanied of the documentation that can prove that the Device complies with the security, quality and efficiency required by the International regulations.
2. The authority proceeds to issue a corresponding certificate of technical criteria to market the Medical Devices.

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

The authorization process for marketing of generic version is the same as mentioned in Question 1.

3. What are the typical fees for marketing approval?

Please refer to Question 4 in Chapter 1.

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

The authorization is granted for a period of 5 years. The renewal process is the same as the application for the authorization and the documentation will depend on the type of product.

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

There is no requirement for post-approval pharmacovigilance.

6. Are foreign marketing authorizations recognized?

A foreign marketing authorization for a product can be used for importation and commercialization by a different applicant and owner provided that the product is identical in all aspects: name, brand, formula, pharmaceutical form, dosage and composition of the authorized product (same excipient); originated in the same manufacturer laboratory and country; manufactured by the legal owner of the trademark or patent or by an authorized entity, fulfilling all the documented approved specifications for the marketing authorization.

This procedure only applies to products which country of origin be: Canada, United States of America, Japan, Finland, Island, Norway, France, Spain, Sweden, Australia, Belgium, Switzerland, Austria, Germany, Denmark, New Zealand, United Kingdom, Netherlands, Ireland, Italy and other that according with the Ministry of Health are recognized as countries that are recognized as high standard manufacturing countries. This list may vary by the Ministry of Health discretion.

7. Are parallel imports of medicines or devices allowed?

Parallel imports are allowed. However, to import drugs and devices, the importer and distributor must be declared in the Department of Drugs and Pharmacy.

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?

According to the Doctor Code of Ethics by Colegio de Medicos de Panama it is strictly prohibited to receive any financial benefit or any other type of incentive for recommending patients or prescribing medicines/drugs/devices,

See the Directory Local Institutions below for more information available on the website.

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

Regulated by Law No. 1 of 2001 and supervised by The Ministry of Health.

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?

Our local manufacturing requirements use the GMPs as defined by the U.S. Food & Drug Administration and the European Medicine Agency as a guidance, consequently the requirements can be compatible.

11. What is the inspection regime for manufacturing facilities?

During the process and post approval, The Ministry of Health has the faculty to perform an inspection to the factory in order to ensure that the requirements are being complied.

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

No.

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

For storage, packaging and handling of medicines the requirements are the following:

1. Good storage practices
2. Organizational manual
3. Personal Training
4. Care for design, internal and external environments
5. Humidity and temperature controls
6. Receipt and dispatch conditions
7. Waste handling care
8. Compliance with transport requirements
9. Queries and complaints systems
10. Self-inspection process

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

The label must include: Commercial name of the product, name of the manufacturer, origin country, pharmaceutical form, active ingredient according to international common denomination, batch code, expiration date, quantity or volume of the product or package, name and concentrations of active ingredients, warning claims, selling conditions, sanitary registration number.

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

Please refer to Question 14.

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

It is not possible to indicate qualities that do not have the product or words that incentive the use or consumption.

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

It is only allowed advertising for OTC products and medical devices. The advertising needs the previous approval by the Publicity and Propaganda Commission of The Ministry of Health.

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

Drugs and devices may be sold at any authorized pharmaceutical or non-pharmaceutical facility. It is mandatory to previously obtain a License to store and sell medicines and devices.

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

The same mentioned in Question 17.

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

Please see Question 17.

21. How is compliance monitored?

Compliance is monitored through the different departments from The Minis-try of Health as well as ACODECO

22. What are the potential penalties for noncompliance?

The potential penalties for noncompliance through the administrative channel include fines from USD 500 to USD 25,000 according to the gravity of the infraction and without disregarding possible civil or criminal actions.