The Pharma Legal Handbook: Panama

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The Pharma Legal Handbook: Panama answers essential questions about the legal and regulatory environment for pharmaceuticals in Panama. It is a must-have for any company operating in the country or looking to enter the market.

Prepared in association with Alfaro, Ferrer & Ramírez (AFRA), one of Panama’s leading full service law firms, it should answer any questions linked to regulation, pricing, clinical and preclinical trials, marketing, manufacturing, trademarks and patents, cannabinoid medicines, medical cannabis and opioid drugs.

February 2024

1. Biosimilars & Biologics: Panama

The key facts about biosimilars & biologics in Panamanian Pharma. 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 99.

BIOSIMILARS AND BIOLOGICS in Panama are regulated by Law 1 January 10, 2001, Executive Decree No. 95 of May 14, 2019.

1. Are biosimilar medicines considered the same as generic medicines in your country?

No. Generic medicines are defined as medicines distributed or sold that are marked with the generic name of the active principle.

Biosimilar medicines are neither defined nor regulated by Panamanian Law, however, in general terms biosimilar medicines are biologic medical products highly similar to another already approved biological or biotechnological medicine.

Therefore, they are not considered the same, since generic medicines are derived from a pre-existing active principle and biological or biotechnological products must evidence a better or superior effectiveness, quality and safety from the reference product from which they are derived.

2. Are all biologic medicines, including biosimilar medicines patentable in your country?

Biological medicines can be patentable provided that are a new invention, resulting from an inventive activity that is susceptible of industrial application.

3. Is there a specific regulatory framework for the marketing authorization of biosimilar medicines in your country? If yes, what is the regulatory framework for the authorization of biosimilar medicines?

No. Biosimilar medicines are neither defined nor regulated by Panamanian Law.

N/A

4. What kind of data package is needed to obtain approval for a biosimilar drug? Is this any different to the requirements for the original Biologics drug?

Please refer to Question 3.

5. What are the requirements for the choice of the reference comparator product?

Please refer to Question 3.

6. Can the comparator product be sourced from another regulatory jurisdiction? If yes, what are the data needed to support this approach?

Please refer to Question 3.

7. How are the prices of biosimilar medicines regulated? Is this any different to the requirements for the original Biologics drug?

Please refer to Question 3.

8. What is the reimbursement policy for biosimilar medicine? Is this any different to the requirements for the original Biologics drug?

Please refer to Question 3.

9. Does biosimilar competition impact the reimbursement policy of the originator reference products?

Please refer to Question 3.

10. What is the legal framework for biosimilar medicines prescribing (clinical decision maker) and dispensing (pharmacy level, hospital or retail)? Is this any different to the requirements for the original Biologics drug?

Please refer to Question 3.

11. Is the system considering physician-led switching and/or pharmacy-level substitution (without involvement of the clinical decision maker)?

Please refer to Question 3.

12. What are the post – authorisation requirements (including pharmacovigilance, risk management plans, post-approval studies) for biosimilar medicines? Is this any different to the requirements for the original Biologics drug?

Please refer to Question 3.

13. Are there specific policies and requirements in terms of biosimilar medicines labelling in the event of second medical use patents? Is this any different to the requirements for the original Biologics drug?

Please refer to Question 3.

14. Have there been any significant legal/judicial developments in relation to biosimilars in your country? (Including but not limited to IP, procurement, competition, misleading information campaign, access to reference comparator product)

No to the best of our knowledge.

15. Are there proposals for reform or significant change to the legal, regulatory, procurement of biosimilars? If yes, when are they likely to come into force?

No to the best of our knowledge.

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2. Orphan Drugs & Rare Diseases: Panama

Keen to learn more about orphan drugs & rare diseases in Panama? Read on! 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 99.

Orphan Drugs in Panama are regulated by Law 1 January 10, 2001, Executive Decree No. 95 of May 14, 2019 and Executive Decree 1217 of December 7, 2015; Rare Diseases are regulated by Law 28 of October 28, 2014.

1. What is the definition of Rare Diseases in your country?

Rare, less common and orphan diseases are defined by Law as those that are chronically debilitating or severe diseases that are life-threatening and endangering to the human life that may be genetically originated or for unknown causes, that require specialized and permanent therapy, with a dominance lower than 1 per every 2,000 individuals.

2. Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition of Rare Diseases?)

Yes, our legislation defines Orphan Drug as the drug or biologic product use for the treatment of rare conditions or diseases that affects only a small proportion of the population. It refers to potential active principles wherein there is no interest from the manufacturing laboratories for the commercial development of the drug, since it does not represent an economic incentive, even though it may satisfy health needs.

The following products are included in this definition:

Drugs indicated for the diagnostic, treatment or prevention of rare conditions or diseases.
Antidotes indicated for unusual intoxications.
Active principles excluded from the market due to adverse effects but useful for other diseases.
Active principles that do not have commercialization sponsors or that are no longer commercialized despite their therapeutically efficiency and being products that are withdrawn from the market due to low selling price, inefficient consumption or because they are not patentable since are natural products.

Therefore, in Panama the definition of Rare Diseases does not correspond to the definition of Orphan Drug, but they are related.

3. What is the regulatory framework for the authorization of an Orphan Drug? (Is this regulatory framework based on Rare Disease status or can it alternatively be based on Orphan Drug foreign status?)

Law No. 1 of January 10, 2001 which regulates Drugs and other Human Health related products.
Executive Decree No. 95 of May 14, 2019 whereby the Law No. 1 of January 10, 2001 is regulated.

The regulatory framework is based on Rare Diseases status.

4. Does your country have provisions for relaxed clinical trial/scientific evidence requirements in respect of Orphan Drugs as compared to other drugs?

No. The clinical trial and scientific evidence for Orphan drugs are the same as for other drugs.

5. Is there an expedited pathway for Orphan Drugs?

The only regulated expedited pathway is if the Orphan Drug is under the process of authorization and if for humanitarian reasons is required, the Ministry of Health will approve the exception of the sanitary registration for importation purposes.

6. Are foreign marketing authorizations recognized in your jurisdiction for Orphan Drugs? If yes, marketing authorizations from which countries are recognized?

Foreign marketing authorizations are not recognized for authorization purposes.

However, part of the requirements for the obtention of the authorization certificate is to file a Notarial Declaration wherein the manufacturer of the Orphan Drugs must include the countries where the Orphan Drug is registered and the year of registration or, in absence of this information, a certification issued by Foreign Sanitary Authorities from the origin or manufacturing country.

7. Can Orphan Drugs be reimbursed? If so, is there a specific reimbursement procedure for Orphan drugs?

To the best of our knowledge to date there is no specific regulation for the reimbursement of Orphan Drugs.

8. How are the prices of Orphan Drugs regulated?

Prices of Orphan Drugs are not specifically regulated. However, it is established that due to the nature of the Orphan Drug, the commercialization cannot generate high dividends for the company.

9. In case of reference price based on a basket of countries, what countries are included?

N/A

10. Have there been any significant legal/judicial developments in relation to Orphan Drugs in your country?

No to the best of our knowledge.

11. Are there proposals for reform or significant change to the regulation of Orphan Drugs? If yes, when are they likely to come into force?

No to the best of our knowledge.

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3. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs: Panama

The low-down on the situation regarding cannabinoid drugs, medicinal cannabis and opioid drugs 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 99.

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

Cannabinoids are substances subject to national control for therapeutic, medical, veterinary, scientific and research use.

2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?

The regulatory authorities are the Pharmaceutical and Drug Department from the Ministry of Health and the Ministry of Agricultural Development.

3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?

Yes, the Law No. 14 of May 19, 2016 modified by Law 242 of October 13, 2021 Executive Decree No. 183 of June 8, 2018 and Resolution No. 410 of July 12, 2018 whereby is regulated the evaluation, monitoring and control of import, export, cultivation, production, manufacturing, laboratory analysis, acquisition in any capacity, storage, transportation, marketing, distribution, final disposal, use of duly authorized seeds for sowing. cannabis plant, as well as medicinal cannabis derivatives, for medical, veterinary, therapeutic, scientific and research purposes.

4. Which are the cannabinoid drugs that have received market approval to date?

To the best of our knowledge up to date the Panamanian Authority has not received an application for approval of any the cannabinoid drug.

5. Who can prescribe Cannabinoid Drugs?

Doctors
Veterinarians
Dentist
Nurses
Pharmacy

6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?

To the best of our knowledge up to date there is no special list.

7. What approvals or notifications are required to prescribe Cannabinoid Drugs?

It must be done through the authorized prescription book or vouchers.

Voucher for Controlled Substances are specifically for distribution. These vouchers must be compiled by the distribution agencies, laboratories, drugstores and filed it before the Pharmaceutical and Drug Department for evaluation and authorization according to the establish format.

Specifically, for National and Regional Hospitals Pharmacies that purchase directly from distribution agencies, laboratories, drugstores are required to be previously authorized by the Pharmaceutical and Drug Department.

8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?

It is necessary to have a special License of operations for marketing the Cannabinoid Drugs Pharmaceutical Regent.

9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?

To the best of our knowledge to date there is no special list.

10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?

No, because the regulations (Law 242 of October 13, 2021, Executive Decree No. 183 of June 8, 2018 and Resolution No. 410 of July 12, 2018) were recently approved.

11. When are they likely to come into force?

The Law No. 14, came into force since May 24, 2016 and Law 242 came into force on October 16, 2021.

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

Yes, Law 242 of October 13, 2021 regulates the medicinal and therapeutic use of cannabis and its derivatives and dictates other provisions.

13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?

N/A

14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?

N/A

15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?

Any product derived from cannabis for medical, therapeutic, veterinary, scientific and research purposes, which is grown, imported, manufactured, exported, marketed, and researched in the territory of the Republic of Panama will be subject to a system of surveillance and supervision by the Ministry of Health, which is the competent control authority to comply with the process of approval and cancellation of licenses.

16. What approval or notifications are necessary to produce or import Medicinal Cannabis?

A licensing system is established, which will be mandatory and will be subject to compliance with special requirements prior to its issuance. The licenses issued in accordance with this Law may not be transferred or assigned under any title.

Two types of licenses are recognized:

1. Medical Cannabis Derivatives Manufacturing License.

2. License for the Scientific Research of Medicinal Cannabis.

17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?

N/A

18. How can patients obtain Medicinal Cannabis?

Prescription by an authorized Health Care Provider.

19. Who can prescribe Medicinal Cannabis?

N/A

20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?

To the best of our knowledge to date there is no special list.

21. What approvals or notifications are required to prescribe Medicinal Cannabis?

N/A

22. Where is Medicinal Cannabis available?

Authorized licensed legal entities and Health Care providers.

23. Is there a list of retailers authorized to sell Medicinal Cannabis?

N/A

24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?

Please refer to Question 10.

Opioid Drugs

25. Are Opioid Drugs authorized in your country?

Yes, opioid drugs are authorized but only for medical or scientific use.

26. What are the regulatory authorities with jurisdiction over Opioid Drugs?

The regulatory authority is the Pharmaceutical and Drug Department from the Ministry of Health.

27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?

Please refer to Question 3.

28. Which are the Opioid drugs that have received market approval to date?

This is not public information.

29. Who can prescribe Opioid Drugs?

Please refer to Question 5.

30. Is there a list of doctors authorized to prescribe Opioid Drugs?

Please refer to Question 6.

31. What approvals or notifications are required to prescribe Opioid Drugs?

Please refer to Question 7.

32. Which organizations are authorized to sell/distribute Opioid Drugs available?

Please refer to Question 8.

33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?

Please refer to Question 9.

34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?

No to the best of our knowledge.

35. When are they likely to come into force?

Please refer to Question 11.

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4. Regulatory Reforms: Panama

All legal aspects surrounding regulatory reforms 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 99.

1. Are there proposals for reform or significant change to the healthcare system?

Currently enforced new healthcare related regulations are due to Covid19 preventions, extraordinary and temporary measures enacted until the state of emergency is declared by the Panamanian Government.

2. When are they likely to come into force?

N/A

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5. Patents and Trademarks: Panama

All about patent and trademarks in Panamanian Pharma. 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 99.

1. What are the basic requirements to obtain patent and trademark protection?

The basic requirements for obtaining a patent are the following:

Power of attorney granted by the applicant; no legalization nor notarization required
Assignment Document legalized by Panamanian Consulate or Apostille
Specifications, claims, abstract and drawings (if applicable).
If the applicant is a natural person: Complete name, nationality, complete domicile and his/her ID Card Number.
If the applicant is a juridical person: Complete Name, country where constituted and complete address.
For companies with an address outside of Panama, a Panamanian Address must be designated for administrative and judicial notifications concerning the trademark application/registration.
If priority is to be claimed, indication of the country and office where the priority application was filed, its date and number.
The title of the patent is necessary

The basic requirements for obtaining a trademark registration are the following:

Power of attorney granted by the applicant; no legalization nor notarization required.
If the applicant is a natural person: Complete name, nationality, complete domicile and his/her ID Card Number.
If the applicant is a juridical person: Complete Name, country where constituted and complete address.
For companies with an address outside of Panama, a Panamanian Address must be designated for administrative and judicial notifications concerning the trademark application/registration.
Name and/or description of the mark.
Colour and elements of the mark to be claimed.
Detailed description of goods or services to be covered by the mark with its corresponding class. Our legislation accepts multi-class applications.
Information regarding the use of the mark, to determine if it has been used or will be used in the commerce in Panama or in international commerce.
If priority is to be claimed, indication of the country and office where the priority application was filed, its date and number.
Translation of the mark (when necessary)
Transliteration of the mark (when necessary)
If the mark consists of or has a design, two (2) labels thereof, exactly as it is or will be used in commerce.

2. What agencies or bodies regulate patents and trademarks?

The Ministry of Commerce and Industry through the Industrial Property Department.

Panamanian Court (District Judges) handle oppositions, cancellation actions as well as unfair use.

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

3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?

TRADEMARKS

The following elements among others may constitute trademarks:

words or combinations of words, including those that serve to identify persons;
images, figures, symbols and graphic material;
letters, figures and combinations thereof where they consist of distinctive elements;
three-dimensional shapes, including the wrappers, packaging or shape of the product, the presentation thereof and holograms;
colors in various combinations;
sounds;
odours and flavours;
any combination of the elements non-exhaustively listed in the foregoing subparagraphs.
geographical indications that consist in any sign or combination of signs that can identify a good or service as original of the territory of a country, region, or locality of said territory when a determined quality, reputation or any other characteristic of the good or service is mainly attributable to the geographical origin, notwithstanding the relative dispositions related to geographical indications contained our trademark law.

Panamanian legislation prohibits the registration as a trademark or elements thereof the following:

Reproductions or imitations of coats of arms, flags and other emblems, acronyms, names or abbreviated names of any State or national or international organization, without due authorisation; marks that together constitute descriptive indications of the nature, characteristics, use or application, type, quality, quantity, purpose, value, place of manufacture or origin or time of production of the product or rendering of the service concerned, or expressions that constitute the usual or generic designation of the product or service, with the exception of descriptive or generic marks that have become distinctive or special through use and the collective or certification marks which refer to the place of manufacture or origin and according to the legal establish terms;
figures or three-dimensional shapes or word marks capable of deceiving or misleading the public, understood as being those that convey a false impression as to the nature, components or properties of the goods and services that they are intended to cover;
marks that can mislead or confuse the public in regard to the origin or attribute of the product that intends to distinguish in Panama a geographical indication or origin indication or origin indication;
signs that are contrary to morality, public policy or proper practice;
names, pseudonyms, signatures and portraits of persons different from the one applying for registration, without the consent of those persons or, if they are deceased, that of their heirs; except for portraits or names of historical figures;
the designs on coins, banknotes, hallmarks denoting control or warranty used by the State, seals, stamps or tax imprints in general;
marks that include or reproduce medals, awards, diplomas and other elements that give the impression that recognition has been received for the corresponding goods or services, except where such awards have been genuinely presented to the applicant for registration or to the person to whom the entitlement has been assigned, and where the fact is proved when registration is applied for;
marks that are identical, similar or comparable in orthographic, graphic, phonetic, visual or design terms to another mark that is used or known and has been registered or is undergoing registration on behalf of another person to distinguish goods or services that are the same or of the same type as those to be covered by any trademark or similar to them, provided that the similarity or identity of the one and the other are liable to cause errors, confusions, unintentional substitutions or misapprehensions in the mind of the public with respect to those goods or services or the source thereof. Excluding the mark that has been authorized by the owner of a registered trademark. The goods or services are not considered to be similar to each other solely on the basis that any other registration or publication are classified under the same Nice Classification. The goods or services are not considered dissimilar to each other solely on the bases that any other registration or publication are classified under different Nice Classification. In the case of related goods or services, a person who considers himself affected may oppose registration on the basis of the provisions of this item;
marks that are identical or similar to a famous or renowned trademark in Panama, registered or not, and are intended for application to any good or service; or known or well-known signs for application to specific goods or services according to the group of consumers to which they are addressed, as well as the ones that can cause dilution to a famous or well-known mark;
proper or common geographical denominations, maps, and also nouns and adjectives, including gentilics, where they denote the source of the goods or services and are liable to cause confusion or mistakes regarding that source; however, can be subject to registration as trademark the national or foreign geographical names, as long as in its use does not mislead the true place of origin and are arbitrary enough respect the goods and services that are applied for. Excepting from the application of this item the collective and certification mark application;
marks that consist basically of the Spanish translation of another mark that is already used, known, registered or undergoing registration to distinguish identical or similar goods or services;
marks that are total or partial reproductions, imitations, translations or transcriptions liable to deceive, confuse or mislead the public of a nationally or internationally known trade name belonging to a third party and in use prior to the date of the application for registration as a trademark;
three-dimensional shapes that lack such originality as will readily distinguish them, and the usual and everyday shape of goods or that which is dictated by their nature or industrial functions;
animated or changing names, figures or three-dimensional shapes that are expressed by movement, even where they are visible;
the titles of literary, artistic or scientific works and fictional or symbolic characters, except with the author’s consent where, in accordance with the relevant law, the said author retains full possession of his rights, and characteristic human figures where their conformity is not assured;
letters, numerals or colours in isolation, except where they are combined with or constituted or accompanied by elements such as signs, designs or denominations that give them distinctive character;
words, letters, characters or signs that are used by indigenous or religious communities or associations without gainful intent to distinguish the manner of processing goods or finished goods or services and those that constitute expressions of their culture or customs, idiosyncrasies or religious practices, except where the application is formulated on their behalf by one of the communities or associations provided for in this item;
marks that use, as a basis for their design, references to national historical monuments and sites that are recognized as such by Law. Unless the authorization for its nonexclusive use is given by the correspondent government entity;
Technical or scientific denominations, the name of plant varieties, OMS recommended common denominations and the ones that indicate a therapeutically action when applied to goods or services related with the object thereof.

PATENTS

It can be patentable any new invention, resulting from an inventive activity that it is susceptible of industrial application. Panamanian legislation prohibits to be patentable the following:

theories or scientific principles;
discoveries that consist in publicizing or revealing something that already existed in nature, even where previously unknown;
plans or methods relating to mental activities, games, principles pertaining to economics or business; • computer programs per se;
methods of presenting information;
aesthetic creations and artistic or literary works;
methods of surgical, therapeutic or diagnostic treatment applicable to the human body and to animals. This provision shall not apply to the products, notably the substances or compositions, or to inventions of apparatus or instruments for the implementation of such methods;
the juxtaposition of known inventions or the mixing of known products, or the alteration of the form, dimensions or materials thereof, except if the new inventions, that are the result of an inventive step and susceptible of industrial can be proven;

The following inventions relating to live material are excluded from patentability:

plants, animals and essentially biological means of breeding thereof in so far as for them not to be non-biological or microbiological means;
plant species and animal species and breeds;
biological material as encountered in nature;
live material that forms part of the human body;
plant varieties.

4. How can patents and trademarks be revoked?

Patents can be revoked by a judicial process initiated before the Panamanian Court to declare the nullity on the following cases:

When the patent was granted to a person who is not the inventor or assignor;
When the granting or registration was done against the patent law and its requirements.

Trademark registrations can be revoked by a non-use cancellation or nullity action file at the Panamanian Court.

5. Are foreign patents and trademarks recognized and under what circumstances?

Yes, foreign patents and trademarks are recognized in accordance with the Paris Convention and the Patent Cooperation Treaty which Panama is a member of but, these treaties are only for defending in process or claiming priority. The principle of territoriality applies for trademarks and patents. Therefore, it is mandatory to obtain registration in Panama in order to be able to claim exclusive use.

6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?

No, to the best of our knowledge but, it is necessary to declare the distributor at the time to request sanitary registration to marketing the product. There is no patent linkage in Panama.

7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?

Please see Question 3.

8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?

No, in Panama, is not mandatory to submit the registration or the government approval of the license agreement.

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6. Traditional Medicines and OTC Products: Panama

A brief overview of the situation regarding traditional medicines and OTC products 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 99.

1. What are the regulatory requirements for traditional, herbal, complementary, or alternative
medicines and devices?

The requirements for traditional, herbal, complementary, or alternative medicines and devices that have therapeutically property are the same as for drugs. Please see Question 1 of Chapter 3: Marketing, Manufacturing, Packaging and Labeling Advertising.

Only Traditional, herbal, complementary, or alternative “indigenous medi-cines and devices products” are ruled through special Law No. 17 of June 27, 2016.

If the products don’t have therapeutic properties will be considered food with different regulatory requirements and different Government Offices.

Good manufacturing practices for natural medic products for human use was approved by Resolution No. 58 of September 9, 2020.

2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?

The advertisement for these products requires previous approval by the Publicity and Propaganda Commission of The Ministry of Health.

3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?

There are no specific required claims for traditional, herbal, complementary, or alternative products. However, it is forbidden to advertise properties or characteristics that are not object of the market authorization for the product. All claims must be proven with documental evidence.

4. What are the regulatory requirements for over-the-counter (non-prescription) medications?

To be classified as OTC over-the-counter (non-prescription) medications, the product must meet the following characteristics:

Preferably constitute by one active principle or by a long recognized therapeutically effect.
Possess a wide therapeutic range, proven effectiveness and minimal adverse effects or small clinical urgency.
Dosage range must be effective, safe and adaptable regarding patient age and weight.
Must have indication of a medical diagnosis not required and be known for not least of five years.
Must be aimed to treat symptoms and signs as: mild, common, short duration, widely known and easily identifiable.
Must be oral administration or topical administration through the skin or mucus membranes, in which the absorption must be minimal. It is not allowed for products to be administered for any parenteral way.
Must comply with a minimal, effective and safe concentration, without requiring any medical supervision.
It must not develop tachyphylaxis, dependency or hide more serious diseases.
The high accidental or intentional dosages must not represent a high or imminent danger for the patient health.
That the active ingredient or associations have been in the national or international market and preferably be considered as common sold without medical prescription in other countries, with a proven safety for more than five (5) years.
Must not have the caption “sold under medical prescription” or any other similar phrase.

5. Are there any limitations on locations or channels through which OTC products may be sold?

OTC medicines can be sold at any authorized pharmaceutical and non-pharmaceutical establishment. OTC products must be presented in one-dose containers that have written all the information required for these products or sell the complete container in integral form (not for individual sale).

6. What health, advertising, and marketing claims may be made for OTC products?

OTC products must have the following claims:

If you are pregnant or in breastfeeding period, please consult with your doctor before consuming the product.
If an overdose occurs, please immediately contact a doctor.
Not for use of children under____.
If the symptoms persist with the use, reappear or get worse please stop the use and contact a doctor.
Do not exceed the recommended dosage.
The Ministry of Health can recommend more claims according to the product.
Usage and dosage instructions must be clear, specific and in an understandable language for the public.
The maximum dose administered in 24 hours and the time period for treatment.
Warnings, contraindications, adverse reactions and interactions. If the product is for pediatric use, it must include: “this medication produces temporary relief. If there is no improvement in 48 hours, please contact a doctor”.
Storage conditions.
Other texts that the Pharmaceutical and Drug Department considers applicable.

7. Can OTC products be marketed or advertised directly to the public?

Yes, previous approval from the Advertising Commission from the Ministry of Health.

8. What is the mechanism by which a prescription-only product can be converted to an OTC product?

Filing before the Drug and Pharmaceutical Department a petition for modification of the condition of the sanitary registration.

9. What are the requirements for the importation of either traditional medicines or OTC products?

Please see Question 3 of Chapter 1.

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7. Marketing, Manufacturing, Packaging & Labeling, Advertising: Panama

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 99.

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

Before the application for registration, a quotation for the product analysis must be obtained before the Specialized Analysis Institute.
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.
Once admitted, the application passes to be technically evaluated by the authority to verify the compliance with the sanitary standards.
Once evaluated, the authority proceeds to issue a payment order for the government fees and post-registration analysis.
After the settlement of the payment, the authority grants the product the sanitary registration and issues the corresponding certificate.

B. Over-the-counter medications:

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.
Once admitted, the application passes to be technically evaluated by the authority to verify the compliance with the sanitary standards.
Once evaluated, the authority proceeds to issue a payment order for the government fees and post-registration analysis.
After the settlement of the payment, the authority grants the product the sanitary registration and issues the corresponding certificate.

C. Medical devices:

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.
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:

Good storage practices
Organizational manual
Personal Training
Care for design, internal and external environments
Humidity and temperature controls
Receipt and dispatch conditions
Waste handling care
Compliance with transport requirements
Queries and complaints systems
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.

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8. Preclinical & Clinical Trial Requirements: Panama

Preclinical and clinical trial requirements in Panamanian Pharma – an overview. 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 99.

Preclinical & Clinical Trial in Panama are regulated on Law 1 January 10, 2001; Law 78 November 20, 2003; Law 84 of May 14, 2019; Executive Decree 1110 June 6, 2012; Resolution No. 512 of June 28, 2019; Executive Decree 1843 December 16, 2014.

1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?

No, it is not a requirement to conduct the clinical trials for products locally. Moreover, clinical trials are only required when the product is an innovative product and new indications not contemplated in the accepted references for the Ministry of Health.

2. How are clinical trials funded?

If clinical trials are conducted by a public entity, the trial is funded by the government, included in the annual state budget.

In a private entity, the clinical trials are funded by sponsorships or donations. The amount is not regulated but it is verified by the Committee.

In all cases it is mandatory “informed consent” duly signed by participant.

3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?

The requirements for pre-clinical and clinical trial protocols are going to depend on the type of product/device or subject on trial.

4. What are the requirements for consent by participants in clinical trials?

The consent must be obtained through an informed consent form in Spanish accompanied with a description of the process used for obtaining and documenting the informed consent.

5. May participants in clinical trials be compensated?

Compensation is not forbidden.

6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?

Participants are covered by the required insurance to the clinical trial. If any harm arise that it is not covered by the insurance clause and was not consent, participants have the right to initiate any civil and criminal legal action.

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9. Product Liability: Panama

The legal framework for product liability 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 99.

1. What types of liability are recognized in your jurisdiction?

Contractual and extracontractual responsibility. These can be administrative, civil, or criminal sanctions.

2. How do these types of liabilities apply to the manufacturers of medicines and devices?

In general terms, manufacturers, promoters, sellers, and all persons who have participated in one way or another up to the commercialization of the products are liable. Therefore, administrative, civil, or criminal sanctions may be applied.

3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?

Will depend on the type of liability claimed. The executives, employees, and representatives can be liable due contractual or extracontractual responsibility.

4. How can a liability claim be brought?

Claims before the Panamanian Civil and Criminal Courts of Justice by government, individuals, or competitor.

5. What defenses are available?

Depending on the type of infringement or the claim (i.e., bad use, bad storage, breach of the provisions of the law, the agreement signed, consent).

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10. Regulatory, Pricing and Reimbursement: Panama

An intro to the legal situation for regulatory, pricing and reimbursement in Panamanian Pharma. 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 99.

1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?

The Authority that regulates drugs, biologicals and medical devices in Panama is the Ministry of Health through the following authorities:

Pharmaceutical and Drug Department
Medical Devices National Department
Bioethical National Committee.

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

2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?

DRUGS AND BIOLOGICALS

Law No. 66 of November 10, 1947: Sanitary Code.
Law No. 1 of January 10, 2001 which regulates Drugs and other Human Health related products.
Executive Decree No. 95 of May 14, 2019 whereby the Law No. 1 of January 10, 2001 is regulated.
Executive Decree No. 36 of January 17, 2020 whereby the Law No. 1 is regulated and other dispositions are implemented.
Resolution N°774 of October 7, 2019establishes the legal requirements regarding the price of drugs basic basket.

MEDICAL DEVICES

Law No. 90 of December 26, 2017 which regulates Medical Devices and related products.
Law No. 92 of September 2, 2019, whereby Law No. 90 is modified.
Executive Decree No. 490 of October 4, 2019 whereby Law No. 90 is regulated as modified by Law No. 92
Executive Decree No. 468 of November 7, 2007 whereby is regulated the issuance, renewal and suspension of the Technical Criteria of Medical Devices Certificates.
Resolution No. 600 of April 23, 2018 whereby is regulated the License and Technical Verification Certificate for Medical Devices and related products.
Resolution No. 7 of May 10, 2021 whereby the Guidelines for the storage and distribution of medical devices and related products and adopts the Form called Guide to Good Practices for the Storage and Distribution of Medical Devices and Related Products are adopted.

3. What are the steps to obtain authorization to develop, test, and market a product?

DRUGS AND BIOLOGICALS

It is mandatory to obtain previous authorization to import, develop, test and market a drug product by the manufacturer, distributor, and importer (License); to market a product, it must obtain the sanitary registration and obtain a pharmaceutical or non-pharmaceutical License; for testing, all trials must be approved by the Bioethical National Committee.

MEDICAL DEVICES

For Importation, Exportation, marketing and use of a medical device on a public or private level can be authorized once the applicant demonstrates with documental evidence that the medical device complies with all the security, efficiency and quality defined by international regulations. Also, the manufacturer and distributor need the authorization (License) to import and market medical devices.

Requirements and procedures depend on each product. Please refer to Chapter 3, Question 1 regarding authorization process.

4. What are the approximate fees for each authorization?

The approximate government and analysis fees vary from between USD 800 and USD 3,500 per product.

5. For how long are marketing authorizations/registrations valid? How are marketing Authorizations/registrations renewed?

Marketing authorizations are valid for a period of one (1) year and the renewal must be done one (1) month before the renewal date.

Sanitary registrations for drugs, biological and medical devices products are valid for a period of five (5) years. The renewal for sanitary registration must be requested one (1) month before the renewal date.

6. How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?

The authorization process does not differ between brand-name products and generic product.

7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?

In general terms, the mentioned combination products are regulated under (i) Law No. 1 of January 10, 2001; (ii) the Sanitary Code and (iii) Executive Decree No. 95 of May 14, 2019 as phytopharmaceuticals, biological and biotechnological products, magistral preparations, radiopharmaceuticals, homeopathic medicines.

8. How is compliance with regulation monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?

The compliance of regulations is monitored and evaluated by the National System of Pharmacovigilance (NSP) which is integrated by the following:

Ministry of Health
Public and Private Health Facilities
Pharmaceutical and Drug Department
National Centre of Pharmacovigilance
Regional, Institutional centres and Hospital or Committees Pharma-covigilance units
Public and Private Pharmaceutical Establishments
National and foreign pharmaceutical industry and Distribution agencies of the country
Health Care Providers and Patients
Universities
Health Research Scientific Organisms

The NSP uses the International Harmonization Guide and the European Medicine Agency and as a principal source for data (according to Executive Decree No.40) from the following:

1. Health Care Providers:

Ministry of Health
Social Security Fund
Trusts
Patronage
Hospitals, Clinics and Private Pharmaceutical Establishments

2. National and foreign Pharmaceutical Manufacturer Laboratories

3. Distribution agencies for pharmaceutical products

4. Universities

Recognized International Organisms

5. Patients

6. Health Research Scientific Organisms

7. Pharmacovigilance Technologic Platforms

9. What is the potential range of penalties for noncompliance?

The potential penalties for noncompliance of Drugs Regulation ranged between USD 500 to 25,000 including the suspension of sanitary registration, suspension, and cancellation of License for pharmaceutical establishments and temporary or permanent closure of establishments.

10. Is there a national healthcare system? If so, how is it administered and funded?

Yes, in Panama, the National Healthcare System is the Social Security Fund (CSS).

CSS is administered by a Managing Board which include the Ministers from The Ministry of Health, The Ministry of Economy and Finance and several representatives from workers, doctors, retirees. CSS is funded by the contribution of private (affiliations) and public (subsidies).

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

11. How does the government (or public) healthcare system function with private sector healthcare?

The public healthcare system it is not linked nor functions with the private sector healthcare.

Executive Decree No. 95 of May 14, 2019 contemplates a special process for public acquisitions of drugs from private sector through the National Offerors Committee, which is in charge of creating the National Offerors Registry of all those contractors that are interested in participating in drugs public tenders.

12. Are prices of drugs and devices regulated and, if so, how?

In general terms, there is no price control fixed regarding drugs and medical devices.

Nevertheless, according to Law No. 1 January 10, 2001 and Resolution No. 367 September 4, 2013 the Ministry of Health, CSS, ACODECO, Gorgas Hospital has the authority to determine the price cap for some products through an executive decree.

13. How are drugs and devices used by patients paid for? What roles do public and private payers play?

PUBLIC SECTOR:

CSS provides drugs and medical devices to patients at no cost when they are affiliated and/or beneficiary.

The Ministry of Health through the clinics named MinsaCapsi, provide available drugs at a low cost to patients without limitations or restrictions.

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

PRIVATE SECTOR:

The patients are in charge to afford their own drugs and devices in pharmaceuticals establishments, which can be also done through private medical insurance.

14. Who dispenses drugs and devices to patients and how are those dispensers compensated?

Each one of the healthcare providers have a special method to directly dispense the drugs and devices, on public sector there is no cost.

15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?

All medical professionals that assume the technical direction or pharmaceutical regency of any pharmaceutical establishment, has the legal and moral responsibility of all technical operations. It is in charge to ensure that all pharmaceutical products that are sold and dispensed preserve the characteristics stated by the manufacturer, in connection with the stability, handling and storage of products. It will also be responsible for repackaging and preparations done at the pharmaceutical establishment. The responsibility of the medical professional does not exclude from liability to the owner of the pharmaceutical establishment.

The healthcare providers are obligated to have a License and/or authorization for the activity they do issued by the Ministry of Health and are obligated to provide patient care, information and safety as well as they must comply with special regulations to reception, storage, distributions and marketing products.

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