Legal & Regulatory > Nicaragua > Regulatory, Pricing and Reimbursement

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:

1. 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;
2. Failure to comply with the reports addressed to the Ministry of Health;
3. The lack of pharmacopoeias and basic lists in establishments;
4. Difficulty the work of pharmaceutical inspectors;
5. Dispense medications when the expiration date of the prescription has expired;
6. Not to mention the substitutions in the prescription dispensed when the case occurs;
7. Not to make the pharmaceutical substitutions when it is requested and it can be done;
8. Modify the labels without having the required authorization;
9. The offer of perks for the consumption of pharmaceutical products;
10. Prescribe non-registered medicines or products not recognized as medicines;
11. Commercialize medical samples;
12. Carry out the promotion, information or advertising of medicines in an unauthorized manner.

Article 99.– Serious infractions:

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

Article 100.– Very serious infractions:

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

Article 101.– The following sanctions are established:

1. Written warning;
2. Public warning;
3. Fines;
4. Confiscation;
5. Suspension or cancellation of the sanitary registration;
6. 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:

1. Medical samples sold to the public;
2. Raw materials, altered, adulterated, falsified or expired pharmaceutical products and those acquired illegally;
3. 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:

1. Not having a pharmaceutical manager;
2. Failure to comply with health regulations and regulations;
3. When it does not have a license for its operation;
4. When there are no adequate pharmaceutical storage conditions;
5. Failure to comply with the rules governing psychotropic or narcotic substances;
6. Being fraudulently selling drugs;
7. Temporary, unjustified or total absences of the pharmacist regent;
8. 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:

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

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

1. Comply with the standards, procedures and processes established in the good manufacturing practices described in the corresponding regulations;
2. Request from the Ministry of Health, authorization to import controlled substances (narcotic, psychotropic);
3. 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;
4. 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:

1. Request the authorization for changes of location to the corresponding instance;
2. Request authorization from non-professional personnel who will work in the pharmacy;
3. Declare the hours of operation that cannot be less than eight hours;
4. Comply with the shifts indicated to them;
5. Buy only medicines with sanitary registration to distributors or laboratories authorized by the Ministry of Health, which must be supported with the appropriate invoice;
6. 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:

1. Supervise that the acquired raw materials comply with the quality specifications established in the pharmacopoeias;
2. Carry out the necessary steps to verify the quality of the raw materials;
3. Check that the storage conditions are as specified, depending on the product;
4. Supervise that the environmental conditions are considered to the type of activity to be developed;
5. Control compliance with good manufacturing practices;
6. Prepare product records;
7. Process the sanitary registry of each one of the pharmaceutical products that are elaborated;
8. Advise the general management in the technical aspects;
9. 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:

1. Keep the inventory of the controlled products;
2. Keep the inventory of due dates;
3. Prepare the report of movements of psychotropic products;
4. Supervise that storage conditions are appropriate for the products;
5. Prepare and endorse applications for authorization of pharmaceutical establishments and health registration of each of the products of the laboratories they represent;
6. Monitor, inform and communicate to the respective authorities the destruction of products in poor condition or expired;
7. 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:

1. 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;
2. The acquisition, possession, custody and sale of registered drugs, including narcotic drugs, psychotropic drugs and other subjects subject to special legal controls;
3. Prepare the elaboration of magisterial and officinal recipes;
4. Maintain a storage system for medicines that ensure their preservation, stability and quality;
5. Train auxiliary personnel and supervise the correct performance of their duties;
6. Withdraw the medications from circulation at the expiration date;
7. Keep the narcotics and psychotropic records up-to-date;
8. Guarantee that the operation and activities are developed in the pharmacy within the current legal framework;
9. Inform the health authority of the date on which it assumes and leaves the regency of a pharmacy;
10. Ensure that pharmacies do not sell medicines without sanitary registration, expired, altered, adulterated, fraudulent or forged.