The Pharma Legal Handbook: Nicaragua

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

Prepared in association with Bendaña & Bendaña, a leading Nicaraguan law firm, it should answer any questions linked to regulation, pricing, clinical and preclinical trials, marketing, manufacturing, trademarks and patents.

If legal handbook content is updated, you will receive a free updated PDF for up to one year after purchase.

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March 2019

1. Regulatory Reforms: Nicaragua

The ins and outs of regulatory reforms in Nicaragua. Prepared in association with Bendaña & Bendaña, a leading Nicaraguan law firm, this is an extract from The Pharma Legal Handbook: Nicaragua, available to purchase here for GBP 75.

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

2. When are they likely to come into force?

N/A

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2. Patents and Trademarks: Nicaragua

The legal framework for patents and trademarks in Nicaragua. Prepared in association with Bendaña & Bendaña, a leading Nicaraguan law firm, this is an extract from The Pharma Legal Handbook: Nicaragua, available to purchase here for GBP 75.

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

Power of Attorney, duly legalized by Apostille
For patents, all data related to the priority or PCT application, as well as a copy of the specification and claims in Spanish
For trademarks, a listing of goods and/or services, separated by classes in accordance with the international classification

2. What agencies or bodies regulate patents and trademarks?

Intellectual Property Registry (trademarks, patents and copyrights), Ministry of Development, Industry and Commerce (MIFIC). The IP Registry is a department of the Ministry of Development.

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

Trademarks: Any products or substances, as long as they are legal and not interfere with public order.

Patents: Patents can be obtained for products, processes or use.

Excluded from patentability are:

Simple discoveries;
Matters or energies as found in nature;
Biological procedures as they occur in nature and that do not involve human intervention to produce plants and animals, except microbiological procedures;
Scientific theories and mathematical methods;
Purely aesthetic creations, literary and artistic works;
Plans, principles, rules or economic, advertising or business methods, and those related to purely mental or intellectual activities or game matter;
Computer programs as such;
Animal breeds;
Therapeutic, surgical or diagnostic methods applicable to humans or animals;
Inventions whose commercial exploitation must be prevented to protect public order or morality;
Inventions whose commercial exploitation must be prevented to protect human, animal or plant health, or life or to preserve the environment.

4. How can patents and trademarks be revoked?

Patents: Through civil proceedings, by showing that the invention was not novel or lacked an inventive step at the time the application was filed.

Trademarks: Through civil proceedings, on the basis of absolute or relative grounds. In order to bring court proceedings, the plaintiff must show that he did not oppose the application.

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

The registration of patents and trademarks is territorial.

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

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

Patents: No (other than matter excluded from patentability as shown in number 3 above).

Trademark: No (other than goods/services deemed to be ilegal or contrary to public order).

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

No, but it is advisable in order to give public notice to third parties.

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3. Product Liability: Nicaragua

All legal aspects surrounding product liability in Nicaragua. Prepared in association with Bendaña & Bendaña, a leading Nicaraguan law firm, this is an extract from The Pharma Legal Handbook: Nicaragua, available to purchase here for GBP 75.

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

Civil Liability
Criminal liability

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

It must be shown that human health has been affected as a consequence of the medicines or devices. As of today, these types of actions are extremely uncommon in Nicaragua.

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

The responsibility belongs to the manufacturer only. The legal representative is notified by the Ministry of Health to respond on behalf of the manufacturer. Corporate executives, employees and representatives of the manufacturer are not responsible in their personal character.

4. How can a liability claim be brought?

It must be filed before a civil court. This type of trial can take from 2 to 5 years in the first instance.

5. What defenses are available?

Submission of tests on the safety of the medicine or device.
Documentation issued by the authorities of the country of origin.
Laboratory tests by the manufacturer.
Any foreign ruling dismissing a liability action.

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4. Traditional Medicines and OTC Products: Nicaragua

An insight into traditional medicines and OTC products in Nicaragua. Prepared in association with Bendaña & Bendaña, a leading Nicaraguan law firm, this is an extract from The Pharma Legal Handbook: Nicaragua, available to purchase here for GBP 75.

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

Find attach a document with drugs Requirements.
Find attachment document with Device Requirements.

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

Traditional, herbal, complementary, or alternative products can be sold directly to the public or through pharmacies or grocery stores.

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

According to the LAW OF DEFENSE OF CONSUMERS. LAW No. 182, consumers are protected in the following articles:

Article 12.– Consumers have the right to:

Protection of their health and safety in the consumption of goods and services;
Education for consumption;
A truthful, timely, clear and adequate information on the goods and services available in the market;
Equitable and non-abusive treatment by the suppliers of goods and services;
A comprehensive, timely and adequate compensation for the damages suffered and which are the responsibility of the supplier;
Require compliance with promotions and offers when the provider does not comply;
Associate and form consumer groups;
Access the corresponding administrative or judicial bodies for the protection of their rights and legitimate interests;
The preservation of an adequate environment that guarantees the conservation and development of natural resources;
Claiming to the institutions of the State about negligence for the public services provided and that have caused direct harm to the consumer;
Be protected in relation to their life, safety and property, when they make use of land, water and air transport services, all in charge of the providers of these services, who must compensate them when they are affected.

Chapter IV. Information and Publicity – Article 13.– Every supplier of goods will provide the consumer with clear, truthful and sufficient information at least on the following characteristics:

Composition, purpose and additives used;
Quantity of products;
Date of production and expiration of the product;
Instructions and indication for its use;
Warning, risks and incompatibilities with other products.

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

Same requirements detailed in the Central American Technical Regulations.

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

No, these can be sold in authorized pharmacies, grocery stores.

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

According to the LAW OF DEFENSE OF CONSUMERS. LAW No. 182, consumers are protected in the following articles:

Article 12.– Consumers have the right to:

Protection of their health and safety in the consumption of goods and services;
Education for consumption;
A truthful, timely, clear and adequate information on the goods and services available in the market;
Equitable and non-abusive treatment by the suppliers of goods and services;
A comprehensive, timely and adequate compensation for the damages suffered and which are the responsibility of the supplier;
Require compliance with promotions and offers when the provider does not comply;
Associate and form consumer groups;
Access the corresponding administrative or judicial bodies for the protection of their rights and legitimate interests;
The preservation of an adequate environment that guarantees the conservation and development of natural resources;
Claiming to the institutions of the State about negligence for the public services provided and that have caused direct harm to the consumer;
Be protected in relation to their life, safety and property, when they make use of land, water and air transport services, all in charge of the providers of these services, who must compensate them when they are affected.

Composition, purpose and additives used;
Quantity of products;
Date of production and expiration of the product;
Instructions and indication for its use;
Warning, risks and incompatibilities with other products.

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

OTC products can be sold directly to the public or through pharmacies or grocery stores.

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

Does not exist

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

The product must have the health registration number.

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5. Marketing, Manufacturing, Packaging & Labeling Advertising: Nicaragua

The key facts about marketing, manufacturing, packaging & labeling, advertising in Nicaragua. Prepared in association with Bendaña & Bendaña, a leading Nicaraguan law firm, this is an extract from The Pharma Legal Handbook: Nicaragua, 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?

Have a distributor authorized by the Ministry of Health that has a valid health license.
Grant power to a legal representative and pharmacist to perform these procedures.
Comply with all the requirements established in the Central American Technical Regulations.
Successfully pass the analysis of each product when applicable.

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

Have a distributor authorized by the Ministry of Health that has a valid health license.
Grant power to a legal representative and pharmacist to perform these procedures.
Comply with all the requirements established in the Central American Technical Regulations.
Successfully pass the analysis of each product when applicable.

3. What are the typical fees for marketing approval?

Health Records of Medications:
Official expenses – US $ 485.10 – These costs are increased at the time of performing the analysis for each product, depending on the batch number to be imported.
Miscellaneous expenses – US $ 50.00
Fees and taxes – US $ 300.00

Biological products:
Official expenses – US $ 485.10 – These costs are increased at the time of performing the analysis for each product, depending on the batch number to be imported.
Miscellaneous expenses – US $ 50.00
Fees and taxes – US $ 300.00

Medical Devices:
Official Expenses – US $ 300.00
Variable expenses – US $ 100.00
Fees – US $ 500.00

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

For registration it is from 8 to 12 months.
For renewals it is approximately 8 months.

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

We attach Normative Norm 063 “NORMA Y GUÍA PARA LA NOTIFICACIÓN
COMPULSORY ADVERSE REACTIONS ASSOCIATED TO MEDICAL SUPPLIES (Norma document and-Guide-Notification for FV)

6. Are foreign marketing authorizations recognized

In this case, a recognition procedure is carried out, only for the countries of Central America. The following requirements must be met:

Power duly legalized that proves the legal representation
Have a distributor authorized by the Ministry of Health that has a valid health license.
Original Pharmaceutical Product Certificate, issued by the country of origin, duly legalized or apostilled, which includes the qualitative-quantitative formula, the shelf life, the approved storage conditions, the approved sale method of the product and compliance of the Good Manufacturing Practices of the manufacturing laboratory. When two or more laboratories are involved in the manufacturing process, their identification and compliance with Good Manufacturing Practices must be included as an annex.
File a copy of the complete file together with an affidavit indicating that it is a true copy of the one filed in the country where the registration was made, in order to have the necessary information to carry out the health surveillance after the Recognition. The declaration must be duly legalized by apostille.

7. Are parallel imports of medicines or devices allowed?

It is not possible, since they must have the approval of the Ministry of Health taking out the health registration number.

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 Law 292, Law on Drugs and Pharmacies, details the following:

Article 79. Active promotion within the country must be limited to legally obtainable medicines, with all the propaganda that contains affirmations related to medicines, which must be reliable, accurate, true, informative, balanced, updated, and susceptible to verification and of good presentation.
Article 81.– The text and illustrations of advertising or literature, intended for physicians and health professionals, must be entirely compatible with the technical sheet of the sanitary registry authorized by the corresponding instance of the Ministry of Health.
Article 82.– The packaging, labeling and prospectus of the specialties that do not require a medical prescription, shall be adjusted to the standards established by the Ministry of Health.
Article 83.– Advertising on medicines in the mass media, such as television, radio, press, public places, etc., is limited to over-the-counter or popular medicines.
Article 84.– Advertising of ethical medicines through any means of mass communication is totally prohibited.
Article 85.– The promotion to the general public of psychotropic and narcotic drugs is prohibited; only scientific information will be allowed to prescribers through literature through the medical visit.
Article 86.– Advertising of non-medicated cosmetics and personal hygiene products shall not be subject to the regulations of this Chapter.
Article 88.– The obligations of the Medical Promoter are:

Promote only medical samples with health records;
The information and promotion to be transmitted must be in accordance with the data contained in the sanitary registry and must be well-founded and objective and not misleading, in accordance with the technical specifications;
The means of information and promotion used, will be basically scientific, will be directed and distributed exclusively to health professionals;
Keep a record of promotion of medical samples.

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

If the product is manufactured in Nicaragua, a Sanitary License must be requested at the f governmental instances:

Ministry of Health
Directorate of Sanitary Regulation (medical devices)

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?

They are not compatible, however, they are accepted to these institutions.

11. What is the inspection regime for manufacturing facilities?

See ANNEX TO RESOLUTION No. 339-2014 (COMIECO-LXVII). VERIFICATION GUIDE OF THE CENTRAL AMERICAN TECHNICAL REGULATION RTCA 11.03.42: 07 TECHNICAL REGULATION ON GOOD MANUFACTURING PRACTICES FOR THE PHARMACEUTICAL INDUSTRY. PHARMACEUTICAL PRODUCTS AND MEDICINAL PRODUCTS FOR HUMAN USE.

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

Factory facilities are available as long as the inspection is carried out by the Ministry of Health, which regulates this area. If inspectors authorized by the FDA / EMA are present, they must go to the Ministry of Health so they can take them to inspect the factories.

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

According to RTCA 11.01.04:10. PHARMACEUTICAL PRODUCTS. STUDIES OF STABILITY OF MEDICINES FOR HUMAN USE:

For products that do not require refrigeration or freezing:

Storage conditions of 40°C ± 2°C with 75% ± 5% relative humidity for solid dosage forms.
Storage conditions of 40°C ± 2°C for liquid and semi-solid pharmaceutical forms

For products that require refrigeration:

Storage conditions of 25°C ± 2°C with 60% + 5% relative humidity.
Store in a cool, dry place.

The labeling must not disappear under normal handling conditions, be easily legible to the naked eye and be written in Spanish. The labels may be of paper or any other material that may be attached to the containers or packaging or of permanent printing on them; as long as this printing process does not alter the integrity of the container or packaging on which said printing is made.

Storage areas must have sufficient capacity to allow orderly storage of various categories of materials and products: raw materials, packaging and packaging materials, intermediate products, bulk, finished, quarantined products, approved, rejected, returned or withdrawn.

Storage areas should be designed or adapted to ensure good storage conditions. They must be kept clean, orderly, at temperature and humidity according to the specifications of the materials and products.
In cases where special conditions of temperature and humidity are required, they must be established, controlled and monitored.

Primary containers and closures must be designed with a material that is not reactive, additive or absorbent and thus avoid alterations in the security, identity, potency or purity of the product at all times. The primary packaging requirements and closures must be supported by formulation studies, stability tests and supplier approval.

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

We attach the labeling regulation “RTCA 11.01.02: 04, Annex of Resolution No. 143-2005 (COMIECO-XXXII)”

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

Go to the Labeling Regulation. We attach the labeling regulation “RTCA 11.01.02: 04, Annex of Resolution No. 143-2005 (COMIECO-XXXII)”

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

They must adhere to the Labeling Regulation. We attach the labeling regulation “RTCA 11.01.02: 04, Annex of Resolution No. 143-2005 (COMIECO-XXXII)”

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

They must adhere and comply with the RTCA.

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

Medicines and medical devices must be delivered to a distributor authorized by the Ministry of Health that has a valid health license. These products must be sent through an agency of your choice, either air or land.

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

They must adhere and comply with the RTCA.

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

Everything is done through the authorized distributor or authorized pharmacies.

21. How is compliance monitored?

The monitoring is done by the Ministry of Health, this institution frequently performs the inspections personally in the market so that the laboratories comply with established.

22. What are the potential penalties for noncompliance?

They discard all the product of the laboratory that is in the market with noncompliance. Fines and the complete closure of the commercialization of the product or the products manufactured by that laboratory.

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6. Preclinical & Clinical Trial Requirements: Nicaragua

A brief overview of the situation regarding preclinical & clinical trial requirements in Nicaragua. Prepared in association with Bendaña & Bendaña, a leading Nicaraguan law firm, this is an extract from The Pharma Legal Handbook: Nicaragua, available to purchase here for GBP 75.

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

It is not a requirement that they be done locally.

2. How are clinical trials funded?

The Manufacturer Laboratory is responsible for financing all these costs. Once the documents are submitted to the Ministry of Health, clinical studies should be included.

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

The manufacturing laboratory performs these studies. Once submitted to the Ministry of Health in Nicaragua, they must comply with RTCA 11.03.59: 11 (APPENDIX 1 OF RESOLUTION No. 333-2013 (COMIECO-LXVI), Section 7.11 (Attached document).

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

See RTCA 11.03.59: 11 (APPENDIX 1 OF RESOLUTION No. 333-2013 (COMIECO-LXVI), Section 7.11 (Attached document).

5. May participants in clinical trials be compensated?

This depends on the agreement between the laboratory that performs the trial and the participants.

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

This depends on the agreement between the laboratory that performs the trial and the participants.

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7. Regulatory, Pricing and Reimbursement: Nicaragua

All you need to know about regulation, pricing and reimbursement in Nicaraguan pharma. Prepared in association with Bendaña & Bendaña, a leading Nicaraguan law firm, this is an extract from The Pharma Legal Handbook: Nicaragua, available to purchase here for GBP 75.

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

The National Health Regulation Authority (ANRS) has been created, which is the competent body of the Ministry of Health, which will aim to facilitate, regulate, implement, develop and coordinate policies, laws, regulations and standards related to health authorizations, in the following departments:

Pharmacy Management
National Laboratory
Directorate of Sanitary Regulation (medical devices) – Exhibit 1

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

Central American Technical Regulations
Law on Drugs and Pharmacies, Law No. 292.
Regulation of Law No.292, Law on Drugs and Pharmacies
Standard for the Registry of Medical Devices, Regulations – 064

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

We enclose the steps to follow (Document “PHARMACEUTICAL PRODUCTS REGISTRATION PROCEDURE”) – Exhibit 2 / Requirements – Exhibit 3

4. What are the approximate fees for each authorization?

Health Records of Medications:

Official expenses – US $ 485.10 – These costs are increased at the time of performing the analysis for each product, depending on the batch number to be imported.
Miscellaneous expenses – US $ 50.00
Fees and taxes – US $ 300.00

Biological products:

Official expenses – US $ 485.10 – These costs are increased at the time of performing the analysis for each product, depending on the batch number to be imported.
Miscellaneous expenses – US $ 50.00
Fees and taxes – US $ 300.00

Medical Devices Products:

Official Expenses – US $ 300.00
Variable expenses – US $ 100.00
Fees – US $ 500.00

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

It has a validity of 5 years.

Renewal process: renewal is carried out 3 months before its expiration.
Attachment document (General Procedure for Renewal of Pharmaceutical Products) – Exhibit 4

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 is the same for branded and generic products.

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

In Nicaragua, this class of compounds is not regulated, only drugs + drugs, but drug + biological, drug + device, biological + device, drug + biological + device does not regulate this class of combinations.

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?

It is regulated by the Central American Technical Regulation that is used at the Central American level. It is not equal to the regulatory regime of the US Food and Drug Administration. UU., Nor is it equal to the expectations and requirements of the European Medicines Agency.

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

According to Law 292, Law on medicines and pharmacies, declares in the following articles:

Article 96.– Any natural or juridical person that infringes this Law and its complementary regulations will be sanctioned administratively by the authorities of the Ministry of Health, without prejudice to the criminal and civil responsibility of which it could be object.

Article 97.– For the purposes of this Law, infractions shall be classified as minor, serious and very serious according to the criteria of health risks, amount of the eventual benefit obtained, degree of intentionality, severity of the sanitary and social alteration produced, generalization of the infraction and recidivism.

Article 98.– Minor infractions are the following conducts:

The modification by any of the conditions on the basis of which the authorization of the establishment was granted when there is no risk to the health of the population;
Failure to comply with the reports addressed to the Ministry of Health;
The lack of pharmacopoeias and basic lists in establishments;
Difficulty the work of pharmaceutical inspectors;
Dispense medications when the expiration date of the prescription has expired;
Not to mention the substitutions in the prescription dispensed when the case occurs;
Not to make the pharmaceutical substitutions when it is requested and it can be done;
Modify the labels without having the required authorization;
The offer of perks for the consumption of pharmaceutical products;
Prescribe non-registered medicines or products not recognized as medicines;
Commercialize medical samples;
Carry out the promotion, information or advertising of medicines in an unauthorized manner.

Article 99.– Serious infractions:

The preparation, import, export, distribution, promotion, dispensation, possession and marketing of medicines by people who do not have the respective authorization;
Failure to comply with quality controls;
The operation without regent of a pharmaceutical establishment;
Prevent the performance of duly accredited pharmacy inspectors;
Not having reported the adverse effects of the medications at the time of registration;
Manufacturing, importing, exporting, distributing, marketing, promoting and dispensing products that are not legally recognized as medicines;
Sell to unauthorized establishments such as pharmacies by drug laboratories or distributors;
Buy non-registered medicines from establishments not authorized by the Ministry of Health;
Sell to the public without recipes, medicines that contain controlled substances;
The import, distribution, commercialization, use and supply of medicines that are in the experimentation phase;
The preparation of magisterial and officinal formulas without the authorization of the Ministry of Health or not complying with the requirements of the law;
Conduct clinical trials without the prior authorization of the Ministry of Health;
Carry out the promotion or advertising of non-registered medicines, in the experimentation phase or of products not recognized as medicines;
The recidivism of a minor offense in a period not exceeding two years.

Article 100.– Very serious infractions:

The elaboration, import, distribution and commercialization of products without sanitary registration;
Prepare, import, distribute, market, promote, dispense and hold altered, deteriorated, adulterated and forged medicines;
The preparation of secret remedies;
Not having the consent of the people when conducting clinical trials;
The import and export of blood, fluids, glands and human tissues and their derived components, without prior authorization;
Failure to comply with the precautionary and definitive measures on medicines that the health authorities agree on for serious public health reasons;
Perform clinical trials without adjusting to the content of the protocols on the basis of which the authorization has been granted;
The recidivism in the commission of serious misconduct in a period not greater than two years;

Article 101.– The following sanctions are established:

Written warning;
Public warning;
Fines;
Confiscation;
Suspension or cancellation of the sanitary registration;
Final closure of the establishment.

Article 102.– The amounts of fines shall be applied in accordance with the regulatory and administrative provisions issued by the Ministry of Health for that purpose.

Article 104.– Inspectors are authorized to confiscate the following in pharmaceutical establishments:

Medical samples sold to the public;
Raw materials, altered, adulterated, falsified or expired pharmaceutical products and those acquired illegally;
Other supplies that do not comply with health requirements.

Article 105.– Confiscation shall be carried out when the health authority proves that the handling, use and consumption of certain raw materials and pharmaceutical products do not meet the conditions of sanitary quality and that they may cause damage or imply a risk to the health of the population.

Article 106.– The confiscated goods, if they are suitable for consumption, will be destined to the uses or purposes that the Ministry of Health disposes.

Article 107.– The registration of a product shall be suspended, when it does not conform or does not meet the specifications or requirements established by this Law, the technical standards and other applicable provisions.

Article 108.– The registration will be canceled when the situations referred to in the previous article are maintained, even after the competent authority has instructed them to correct themselves.

Article 109.– The temporary or definitive closure of a pharmaceutical establishment shall be carried out in the following cases:

Not having a pharmaceutical manager;
Failure to comply with health regulations and regulations;
When it does not have a license for its operation;
When there are no adequate pharmaceutical storage conditions;
Failure to comply with the rules governing psychotropic or narcotic substances;
Being fraudulently selling drugs;
Temporary, unjustified or total absences of the pharmacist regent;
In all cases in which it is necessary to impose this measure to protect the health of the population.

Article 110.– When the temporary closure is warranted, the license extended to the owner of the establishment will be suspended for the same period.

Article 111.– In the most serious case, the definitive closure shall be resorted to, with the authorizations granted to the establishment without effect.

Article 112.– Taking into account the particularities of the different security measures and sanctions, these will be applied by the inspectors or other competent authorities, according to the regulations that apply in this regard.

Article 113.– The sale of authorized pharmaceutical specialties as medical samples, the sale to the public of those destined for the Ministry of Health and their commercialization in public roads and squares is prohibited.

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

Yes, there is a national healthcare system. The government of Nicaragua administers and funds the national healthcare system through the Ministry of Health as well as related institutions.

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

There are public and private hospitals and both serve insured persons, all under the government regime.

Members of the public who are not insured through the Nicaraguan Social Security Institute and cannot afford private treatment have access to health care through public hospitals.

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

Yes, they are regulated by the Ministry of Industry and Trade Promotion “MIFIC”, through the Office of Regulation of Drug Prices.

The Distributor must be registered as a Distributor and Importer of Medicines before said office.
The Distributor carries a list of products with suggested prices to MIFIC and they evaluate the costs and decide if they approve the price list or not.

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

Within the public health system, some medications and low-cost medical devices are paid by the government through funds paid into Social Security, other medications and devices are sold to patients. Within the private health system, each patient pays the full cost of the medication and treatment.

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

There are distributors and these take these products to different private pharmacies and hospital pharmacies and then sell them to patients.

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?

According to Law 292, Law on Drugs and Pharmacies, the following must be met:

Article 60.– The owners of pharmaceutical establishments (laboratories, distributors and pharmacies) shall have the following obligations:

Request the authorization of operation and register before the corresponding instance of the Ministry of Health;
Request and process the sanitary registry of medicines, medical devices that import, distribute, elaborate or commercialize;
Have a pharmaceutical professional who will act as Regent during the operating hours;
Allow the immediate entrance of the inspectors and pharmaceutical supervisors of the Ministry of Health duly identified;
Comply with the recommendations issued by the pharmaceutical inspectors and supervisors;
Declare to the health authority all known characteristics of pharmaceutical products.

Article 61.– Pharmaceutical laboratories and distributors or importers shall have the following obligations:

Comply with the standards, procedures and processes established in the good manufacturing practices described in the corresponding regulations;
Request from the Ministry of Health, authorization to import controlled substances (narcotic, psychotropic);
Sell your production or the products that you distribute only to the pharmacies authorized by the Ministry of Health. In the event that these products are part of the over-the-counter listing, they may be sold to drug sales stalls;
Produce, store and transport pharmaceutical products under the necessary technical conditions for their conservation.

They will only be able to import and export raw materials to elaborate pharmaceutical products, laboratories and distributors of raw materials legally registered in the Ministry of Health.

Article 63.– Pharmacies will have the following obligations:

Request the authorization for changes of location to the corresponding instance;
Request authorization from non-professional personnel who will work in the pharmacy;
Declare the hours of operation that cannot be less than eight hours;
Comply with the shifts indicated to them;
Buy only medicines with sanitary registration to distributors or laboratories authorized by the Ministry of Health, which must be supported with the appropriate invoice;
Dispatch only those prescriptions of physicians that appear in the list that for this purpose the Ministry of Health will provide to all authorized pharmacies in which the code number, specialty and signature of the same will be included.

Article 66.– Pharmacies are obliged to provide the shifts that the Ministry of Health indicates for that purpose. The Regent must provide technical support and attention during the shifts.

Article 67.– Every pharmaceutical establishment must have the professional services of a pharmaceutical regent for the duration of its technical operations and the attention to the public according to its nature.

Article 68.– The owner and the pharmaceutical regent shall assume the civil and criminal responsibilities during the operating hours of the pharmaceutical establishment.

Article 73.– Responsibilities of the Laboratory Regent:

Supervise that the acquired raw materials comply with the quality specifications established in the pharmacopoeias;
Carry out the necessary steps to verify the quality of the raw materials;
Check that the storage conditions are as specified, depending on the product;
Supervise that the environmental conditions are considered to the type of activity to be developed;
Control compliance with good manufacturing practices;
Prepare product records;
Process the sanitary registry of each one of the pharmaceutical products that are elaborated;
Advise the general management in the technical aspects;
Supervise and control that the medicines produced comply with the guarantees of efficacy, purity and stability, identification, composition, information and prevention of accidents.

Article 74.– The Regents of Distributors are responsible for:

Keep the inventory of the controlled products;
Keep the inventory of due dates;
Prepare the report of movements of psychotropic products;
Supervise that storage conditions are appropriate for the products;
Prepare and endorse applications for authorization of pharmaceutical establishments and health registration of each of the products of the laboratories they represent;
Monitor, inform and communicate to the respective authorities the destruction of products in poor condition or expired;
Guarantee that the pharmaceutical products they distribute have a quality certificate of pharmaceutical product from the country of origin.

Article 75.– Responsibilities of the Regent of Pharmacy:

Carry out the attention to the public through the dispensing of the recipes and necessary information for the use of the medication, which includes indications, contraindications, side effects and drug interactions;
The acquisition, possession, custody and sale of registered drugs, including narcotic drugs, psychotropic drugs and other subjects subject to special legal controls;
Prepare the elaboration of magisterial and officinal recipes;
Maintain a storage system for medicines that ensure their preservation, stability and quality;
Train auxiliary personnel and supervise the correct performance of their duties;
Withdraw the medications from circulation at the expiration date;
Keep the narcotics and psychotropic records up-to-date;
Guarantee that the operation and activities are developed in the pharmacy within the current legal framework;
Inform the health authority of the date on which it assumes and leaves the regency of a pharmacy;
Ensure that pharmacies do not sell medicines without sanitary registration, expired, altered, adulterated, fraudulent or forged.

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Also from this Legal Handbook

8. Procedure for Renewal of Pharmaceutical Products in Nicaragua

Procedure for renewal of pharmaceutical products in Nicaragua – an overview. Prepared in association with Bendaña & Bendaña, a leading Nicaraguan law firm, this is an extract from The Pharma Legal Handbook: Nicaragua, available to purchase here for GBP 75

RENEWALS OF PRODUCTS THAT HAVE NOT BEEN MARKETED IN NICARAGUA

Bill Authorization for sending a sample to file the application.
The reference standard can be sent together with the sample to file the application or send it together with the first import of the product.
Filing of the renewal application.
Pre-evaluation.
Evaluation.
Acceptance Certificate.
Issuance of Certificate.
Approval of invoice to import the product. This procedure is carried out by the distributor before the Minister of Health.
Importation of the product in Nicaragua.
Deposit of the product in the warehouse of the distributor.
Request for Analysis. The cost of the analysis depends on the number of batches that have been imported from the product.
Obtaining samples for the National Laboratory of Quality Control, delivered by the distributor to the Head of the Registry.
Approval of Analysis. This result will be delivered by the Ministry of Health to the Registrar.
Marketing of the product.

RENEWAL OF PRODUCTS THAT ARE ALREADY TRADED IN NICARAGUA

The distributor must deliver a sample to the person responsible for the registration, to file the application.
El estándar de referencia puede ser enviando junto con los documentos.
Filing of the renewal application.
Pre-evaluation.
Evaluation.
Request for Analysis.
Obtaining samples for the National Quality Control Laboratory, delivered by the distributor to the Director of the Registry.
Approval of Analysis. This result will be delivered by the Ministry of Health to the Registrar.
Acceptance Certificate.
Issuance of Certificate.
Marketing of the product.

Also from this Legal Handbook

9. Requirements for Pharmaceutical Regulatory Affairs in Nicaragua

All of the requirements for Pharmaceutical Regulatory Affairs in Nicaragua. Prepared in association with Bendaña & Bendaña, a leading Nicaraguan law firm, this is an extract from The Pharma Legal Handbook: Nicaragua, available to purchase here for GBP 75.

According to the RTCA, subsection 7.

The requirements for sanitary registration are the following:

1. Power of attorney to the legal representative duly legalized or apostilled. We attach format.

2. Copy of the acknowledgment of receipt of the distribution power or contract in the name of the Distributor in Nicaragua.

3. WHO-type pharmaceutical product certificate, which must be filed in original, duly legalized.

4. Certificate of Good Manufacturing Practices (GMP) of each of the establishments involved in the manufacture of the product, for the pharmaceutical form and specific type of product to be registered, issued by the Regulatory Authority of the country or countries where the product is carried out, manufacturing process, legalized original.

5. Manufacturing contract or the extract relating to the parts of the manufacturing contract, when applicable, in an original that contains at least the following information:

Signed by the owner and the manufacturer jointly or separately.
Commitment to comply with Good Manufacturing Practices.
Establish production conditions, analysis when applicable, or any other technical management related to them.
It must describe the handling of raw materials, conditioning material, bulk material and finished product and in the event that they are rejected.
Allow the contracting party to enter the premises of the contractor (contracted) for audits.
Allow the contractor (contracted) to enter the contractor’s premises.
List each of the analysis products or services that are the subject of the contract.

6. Complete quantitative and qualitative formula of the product per dose unit. It must be submitted in original signed and stamped by the professional responsible for the manufacturing laboratory or the product owner.

Also it must be declared the following:

6.1. All the components of the medicine must be described with their common denomination or generic internationally accepted and they should not be presented with acronyms or abbreviations, the units must be given according to the International System (SI). In case of active principles in the form of salts, esters or others, the equivalent amount of the molecule to which the therapeutic dose refers must be declared.

6.2. Composition of the release system for modified release products.

6.3. Qualitative composition of empty capsules.

6.4. Qualitative composition of printing inks in capsules, coated tablets and tablets

6.5. Qualitative declaration of organic solvents class 2 or 3, used in the manufacturing process.

The registration of medications using Class 1 organic solvents will not be allowed.

NOTE: The organic solvents mentioned in the previous paragraph are those established in USP as of issue 31.

6.6. The excesses of active ingredients used in manufacturing.

6.7. In the case of creams and ointments, the concentration should be expressed for each gram, 100g or as a percentage. Lotions, eye drops, topical and parenteral infusions must express their concentration per mL, 100 mL or as a percentage.

7. Monograph of the product.

The information included in the bibliography must be based on the official books. In case of divergences with such books or if the medicine is not described in them, the scientific information that supports it, must be filed, which will be evaluated by the Regulatory Authority.

All bibliography must correspond to the pharmaceutical form of the medication to be registered, however, it may include other presentations or concentrations as long as the one being registered is included. Bibliography must contain the following information:

Common or generic name internationally accepted and drug concentration.
Pharmaceutical form.
Structure, chemical name of the active principle or if not, attach the technical sheet that declares this information.
Clinical pharmacology.
Indications.
Contraindications.
Precautions and warnings.
Interactions.
Adverse effects.
Dosage and administration.
Recommendation in case of over dosage according to the toxicological profile.
Abuse and addiction.
Date of review of the bibliography.
List of complete bibliographic references.
Therapeutic category according to Anatomical Therapeutic Classification (ATC), in the pharmacological subgroup, updated version.

NOTE: When the requested information is not applicable to the characteristics of the product it can be ignored in the monograph.

8. Methods of analysis validated according to the Central American Technical Regulation of Validation of Analytical Methods for the evaluation of the quality of current medicines, attaching the corresponding validation study report.

9. Organoleptic, physical, chemical, biological and microbiological specifications of the finished product that comply with the provisions of the Central American Technical Quality Verification Regulation in force. Medications with concentrations greater than 30% alcohol; as well as those that by their nature are antiseptic, are exempt from presenting microbiological specifications.

10. Three Labels of the container / primary packaging, secondary packaging and insert in original or three sets of your projects (primary packaging, secondary and insert) in original with signature and seal of the responsible, according to the Central American Technical Labeling of Pharmaceutical Products for current human use.

11. Stability Study Report in accordance with the Central American Technical Regulation for Stability Studies of Drugs for current human use.

12. Studies of safety and efficacy. All reports of the clinical studies must have been prepared in a period not greater than 10 years or file their due justification if it were greater than this period. The reports should refer to the same medicine that is filed for health registration.

12.1. For drugs that contain active ingredients previously registered but that have one or more of the following characteristics:

New fixed combinations of active principles.
New pharmaceutical form with a route of administration already registered.
New pharmaceutical form with a new route of administration.
New pharmaceutical form with a new release form.
New concentrations of active ingredients previously registered.
New potencies or concentrations of active principles registered with the same route of administration, pharmaceutical form and posology.
New release form with the same route of administration of a previously registered medication.
New routes of administration with a pharmaceutical form already registered.

The conclusive reports of the clinical studies must be filed to prove the objective or objectives set according to the variations mentioned above for the product under evaluation and to demonstrate to the Authority its quality, safety and efficacy.

13. Primary standards or standardized raw materials, 1g, of the raw material of each active ingredient, with its respective Certificate of analysis.

14. Samples of finished product, according to the Central American Technical Regulation in force for the Verification of the Quality of Medicines. In this case, the analysis of each product will be made with samples taken from the first import done by the laboratory. This is the first time the laboratory can import it until the product is registered with its respective registration number.

15. A sample of the finished product along with the file, you must submit a sample of the product to be registered with 1 year of validity or more. Said sample must equal as it is going to be commercialized in Nicaragua.

16. Certificate of Analysis of finished product, in original with signature and stamp of the person responsible for the batch sent in the first import.

The time for the issuance of the registration certificate for a pharmaceutical drug product is approximately 8 to 12 months, for smooth registration.

Also from this Legal Handbook

10. Pharmaceutical Registrations in Nicaragua

All about pharmaceutical registrations in Nicaragua. Prepared in association with Bendaña & Bendaña, a leading Nicaraguan law firm, this is an extract from The Pharma Legal Handbook: Nicaragua, available to purchase here for GBP 75.

REGISTRATION OF NEW PRODUCTS

Bill Authorization for sending a sample to file the file
The reference standard can be sent together with the sample to file the file or send it together with the first importation of the product.
Filing of the application of sanitary registration
Pre-evaluation
Evaluation
Acceptance Certificate
Issuance of Certificate
Approval of invoice to import the product and / or first marketing. This procedure is carried out by the distributor before the Minister of Health.
Importation of the product to Nicaragua with the registration number assigned by the Ministry of Health
Deposit of the product in the warehouse of the distributor
Request for Analysis. The cost of the analysis depends on the number of batches that have been imported of the product.
Obtaining samples for the National Laboratory of Quality Control, delivered by the distributor to the Head of the Registry.
Approval of Analysis. This result will be delivered by the Ministry of Health to the Registrar.
Marketing of the product. The product will be marketed until its analysis is approved; while it is not approved, it cannot be commercialized.

Also from this Legal Handbook

11. Requirements for the Sanitary Registration of Medical Devices in Nicaragua

All of the Requirements for the Sanitary Registration of Medical Devices in Nicaragua. Prepared in association with Bendaña & Bendaña, a leading Nicaraguan law firm, this is an extract from The Pharma Legal Handbook: Nicaragua, available to purchase here for GBP 75.

CLASS I. LOW RISK:

Sanitary license of the establishment, issued by the Directorate of Registration of Medical Devices of the Ministry of Health.
Free sale certificate that demonstrates its use in the country of origin.
Certificate of Good Manufacturing Practices (GMP).
Labels and packaging.
Medical devices must comply with one of the international certificates (FDA, CE, TUV) or its fully demonstrable equivalent among others.
The devices must comply with international standards of quality management applicability and current designation (ISO).
Power of legal representation from the manufacturer to the establishment for Registration purposes.
Power of the legal representative.
Responsible Healthcare Professional.
Technical and medical specifications, if applicable

For refurbished products, the declaration issued by the establishment that rebuilt it will be requested to guarantee its quality, safety and efficiency, in addition to the necessary spare parts for its maintenance.

CLASS II. MODERATE RISK:

Attach necessary scientific information that supports the safety of the product and an analysis of the risk of the medical device according to the indications, list of specific norms to be applied totally and partially, if applicable, and a description of solutions adopted to comply with the essential requirements of safety and operation, sterilization method if applicable.

Sanitary license of the establishment, issued by the Directorate of Registration of Medical Devices of the Ministry of Health.
Free sale certificate that demonstrates its use in the country of origin.
Certificate of Good Manufacturing Practices (GMP)
Sanitary registry of the country of origin.
Labels and packaging.
Medical devices must comply with one of the international certificates (FDA, CE, TUV) or its fully demonstrable equivalent among others.
The devices must comply with international standards of quality management applicability and current designation (ISO).
According to the type of the medical device, it must comply with one of the international safety standards for patients and operators with current designation according to regulations (UL, IEC, CSA) or its fully demonstrable equivalent.
Power of the legal representative.
Responsible Healthcare Professional
Technical and Medical specifications if applicable (In Spanish language).
Power of legal representation of the manufacturer to the establishment for purposes of Registration.
Standards of accuracy, precision and technical specifications in correlation for In-Vitro tests.
Samples in case of In-Vitro tests and periodic replacement material.
Catalog book updated where the product is shown.
Monitoring program provided by the manufacturer of medical devices for high-tech equipment.
Prior declaration of sterilization method (if reusable) for Medical Devices, if applicable.

For refurbished products, the declaration issued by the establishment that rebuilt it will be requested to guarantee its quality, safety and efficiency, in addition to the spare parts necessary for its maintenance.

CLASS III. HIGH RISK:

I – Clinical studies of third level on the use to demonstrate the safety and effectiveness.

II – In addition to what is established in the Class II requirements, submit the originals of the following information:

Description of the Medical Device, classification and the materials used in its manufacture (applicable to the level of risk).
List of countries where the Medical Device has been sold and a summary of any problems reported after entering the market, if any in those countries (applicable to the level of risk).
Medical device for In-Vitro diagnosis should be demonstrated that the experimental tests were performed in population and environments similar to those of the people to whom they are directed.
Clinical trials In-Vitro or in vivo for Medical Device Class III and IV, with the exception of Medical Devices from Australia, Canada, United States, European Union and Japan.
Presentation of a program to report therapeutic failures and adverse incidents for Medical Devices issued by the manufacturer. They should carry clinical studies of phase II and III, on the use to demonstrate safety and effectiveness.

CLASS IV. VERY HIGH RISK:

Clinical studies of phase III, on the use to demonstrate the safety and effectiveness.

In addition to what is established in the requirements of Class II and III, filing of originals of the following information:

Analysis and evaluation of risks and the measures to be adopted to reduce them, which satisfy the safety and efficacy requirements, prepared by the manufacturer.
Bibliography of published reports related to the use, safety and efficacy of the Medical Device.
In the case of the Medical Device for In-Vitro Diagnostics that use or have been manufactured from tissues or their derivatives of humans or animals, file objective evidence of the biological safety of these.

Requirements for Laboratory Reagent Supplies:

In addition to the established in the previous requirements, the literature of the input that should contain:

Biochemical principle of the test.
Presentation of the reagent.
Catalog number.
Lot Number
Description of the technique and the reagents used.
Due date of the product (for all DM sterilization quality or shelf life)
Test for which it is used.
Methods and procedures of the test
Storage conditions
Conditions for handling (Biosecurity Technical Sheet) when applying to the medical device
Symbology of the type of risk (Explosive, very toxic, corrosive, highly flammable, etc).
Method of disposal or final disposal of the product (when applicable).

Requirements for medical devices (Biomedical Equipment) used or refurbished:

In addition to what is established in the above requirements, a certificate issued by an internationally accredited entity that guarantees that the Medical Device complies with the requirements of safety, quality and efficacy.
The importation, acquisition or donation of used biomedical equipment of class I and II, which are considered as general and special control technology respectively, is authorized. For these devices, prior to their importation, they must be certified by the manufacturer or their representative in the country of origin or importer, stating that the equipment is not more than five years old and that it is in an optimum state of operation and functioning.
It is allowed to enter the country biomedical equipment replenished class III and IV provided they are accompanied by the certification of proper operation issued by the manufacturer or its legal representative in the country, in the same way as stated in the previous paragraph. If refurbished, in any way may alter the initial design of the equipment and the manufacturer or its official representative or the refactor authorized by the manufacturer shall ensure that the biomedical equipment has the same characteristics and effectiveness when the equipment was new.
The Ministry of Health is authorized to review at any time the records of Medical Devices issued, in order to verify whether they have modified the specifications thereof to the technical or scientific advances, so they may request validity documentation of the sanitary registration of a corresponding medical device.