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 USD 99.
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.
- Precautions and warnings.
- 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.