GMP Verification – Abridged Guide for PIC/S Member Certified Sites

The Maldives Food and Drug Authority (MFDA) operates under the Ministry of Health and plays a crucial role in ensuring that pharmaceutical, nutraceutical, and healthcare products imported or manufactured for the Maldivian market adhere to international Good Manufacturing Practices (GMP) standards. When the manufacturing site is certified by a PIC/S member NRA (National Regulatory Authority), it simplifies and strengthens the regulatory submission process for GMP verification under MFDA guidelines.

This comprehensive guide provides detailed insights into the essential dossier components and documentation required for successful MFDA GMP verification and product registration — particularly for sites already approved under PIC/S-compliant NRAs.


Evidence of PIC/S-GMP Compliance for the Site

Manufacturing sites that hold a valid GMP certificate issued by a PIC/S member NRA must provide clear, verifiable evidence of compliance. This evidence typically includes:

  • Copy of the GMP Certificate issued by the relevant authority.
  • Inspection Report Summary indicating compliance with current PIC/S GMP Guidelines.
  • Manufacturing License with clear indication of dosage forms and manufacturing activities authorized.
  • Site Master File (SMF) confirming layout, utilities, equipment, quality systems, and validation status.

The MFDA uses this documentation to confirm that the site meets global manufacturing quality benchmarks and operates under recognized regulatory oversight.


Evidence of Approval by the NRA of the Country

To establish credibility and traceability, applicants must attach official evidence of site approval by the country’s own National Regulatory Authority (NRA).
The submission should include:

  • Approval or License Renewal Letters from the NRA.
  • Official communication or notifications confirming GMP status.
  • NRA contact details and website link for verification.

This document reinforces regulatory transparency and assures MFDA that the site remains under continuous NRA supervision.


Product Label and Package Insert Requirements

A Product Label and Package Insert (or Leaflet) must comply with MFDA guidelines and international labeling standards. Key requirements include:

  • Generic and Brand Name clearly displayed.
  • Strength, Dosage Form, Batch Number, and Manufacturing/Expiry Dates.
  • Storage Conditions, Shelf-life, and Directions for Use.
  • Manufacturer’s Name, Address, and Country of Origin.
  • Warning/Caution Statements in compliance with WHO and MFDA labeling norms.

For combination products or injectables, the insert should contain pharmacological data, mechanism of action, contraindications, and adverse effects, ensuring healthcare professionals and patients receive accurate and complete information.


Stability Summary and Conclusions

A detailed Stability Study Summary must be provided, outlining:

  • Testing Parameters: Physical, chemical, and microbiological stability.
  • Conditions Tested: Accelerated and real-time studies.
  • Storage Statement: As per ICH Q1A(R2) climatic zone IVB (hot and humid conditions).
  • Shelf-life Justification: Supported by analytical trend data.

The summary should conclude with a recommended shelf life and storage condition based on real-time stability findings.


Real-Time Stability Data

Real-time stability data is mandatory for the proposed shelf life of the product. The data should include:

  • Time Points: 0, 3, 6, 9, 12, 18, and 24 months (as applicable).
  • Testing Parameters: Assay, dissolution, degradation products, appearance, pH, moisture content.
  • Conditions: 30°C ± 2°C / 75% ± 5% RH for Zone IVB.

All results must be compiled in tabulated form, signed, and verified by the Quality Control Head of the manufacturer.


Pharmaceutical Product Checklist (Excel Form)

The Pharmaceutical Product Checklist (Annexure-A1) is an essential part of the MFDA submission dossier. It ensures completeness of the regulatory file.
Typical fields include:

  • Product name, dosage form, and strength.
  • Manufacturer and country of origin.
  • Pharmacopoeial standards (BP/USP/EP).
  • Regulatory approvals and reference NRAs.
  • Batch release certificate and CoA availability.

The checklist must be filled in Excel format and signed by the Authorized Regulatory Representative.


Stability Data Statement

A concise Stability Data Statement must accompany the stability data set. It summarizes:

  • Conditions Tested, Duration, and Key Findings.
  • Proposed Storage Temperature and Shelf-life.
  • Statement of Compliance with ICH or WHO Guidelines.

This declaration validates the reliability and robustness of the stability study conducted.


Letter of Appointment (Annexure-I)

A formal Letter of Appointment (LoA) designates the Local Agent or Marketing Authorization Holder (MAH) responsible for product representation in the Maldives.
The letter must:

  • Be on company letterhead.
  • Clearly state the scope of authorization (registration, submission, correspondence).
  • Include contact details of the representative.
  • Be signed and stamped by the manufacturer’s authorized signatory.

Letter from Manufacturer to MFDA

The Manufacturer’s Letter to MFDA must officially confirm the manufacturer’s intent to register the product and authorize the local partner or agent to communicate on their behalf.
The letter typically includes:

  • Product name and dosage form.
  • Manufacturing site address.
  • Confirmation of GMP compliance under PIC/S member authority.
  • Statement of authenticity of all submitted data.

Applicant Business Registration/Licence Information

Applicants must provide certified copies of:

  • Business Registration Certificate.
  • Pharmacy or Wholesale License.
  • Tax Registration Number (if applicable).

This verifies the applicant’s legal status in the Maldives for pharmaceutical import and distribution.


Product Information Sheet (According to the Guideline)

The Product Information Sheet (PIS) must be structured as per MFDA’s prescribed format, covering:

  • Pharmaceutical Form, Strength, and Composition.
  • Therapeutic Indications.
  • Dosage and Administration.
  • Contraindications, Warnings, and Adverse Reactions.
  • Pharmacodynamic and Pharmacokinetic properties.

This document ensures uniform presentation of essential product information.


Cost and Retail Price

A complete pricing breakdown must be submitted, indicating:

  • Ex-factory cost, wholesale margin, and retail price.
  • Currency and applicable taxes.
  • Justification for pricing based on comparable markets or reference NRAs.

Verifiable Declaration of Approval by at Least Three NRAs

MFDA mandates proof that the product is approved in at least three other countries regulated by recognized NRAs. Documentation includes:

  • Certificates of Pharmaceutical Product (CPPs) issued by WHO-authorized NRAs.
  • Marketing Authorization Letters from reference markets.
  • Online verification links or copies of public NRA listings.

This supports regulatory reliance and accelerates MFDA review.


Product Information for Reliance (Annex III)

Products seeking reliance-based approval must include detailed information as per Annex III, such as:

  • Reference NRA dossier summary.
  • Assessment report or approval letter.
  • Comparative product data.

Reliance procedures enable faster registration when equivalent products have been approved by stringent regulatory agencies.


Real-Time and Accelerated Stability Data

Both real-time and accelerated stability data must be submitted, consistent with ICH guidelines.
Accelerated testing (40°C ± 2°C / 75% ± 5% RH for 6 months) provides early assurance of stability and supports interim shelf-life assignment.


Product Information for Healthcare Professionals (SmPC)

The Summary of Product Characteristics (SmPC) is mandatory and must follow the European Medicines Agency (EMA) format. It includes:

  • Therapeutic Indications, Posology, and Method of Administration.
  • Pharmacological Properties.
  • Contraindications and Adverse Events.

Declaration of Sameness and Description of Finished Product

Applicants must declare that the formulation, strength, and specifications of the product are identical to those approved by the reference NRA.
Additionally, a visual and physical description of the finished product must be attached (e.g., color, shape, texture, odor, and coating type).


Product Information for Patients

The Patient Information Leaflet (PIL) should be designed for readability and compliance with WHO standards. It should explain in simple language:

  • How to take the medicine.
  • Possible side effects.
  • Storage instructions.
  • Contact information for reporting adverse events.

By following these comprehensive guidelines, manufacturers and applicants can ensure seamless MFDA GMP verification and product registration, especially when leveraging PIC/S-recognized approvals for reliance-based regulatory review.

Taj Pharma Ltd. has an extensive range of registered pharmaceutical and healthcare products approved by the Maldives Food and Drug Authority (MFDA). The portfolio covers major therapeutic segments including antibiotics, antivirals, antihistamines, analgesics, antacids, antifungals, antiseptics, nasal decongestants, and dermatological preparations.

Key registered products include Amoxicillin, Azithromycin, Cefixime, and Amoxicillin with Clavulanate in the antibiotic category; Aceclofenac and Diclofenac formulations as analgesic/anti-inflammatory agents; Aciclovir Cream as an antiviral; Fexofenadine, Loratadine, and Montelukast with Levocetirizine as antiallergic and antihistamine medications.

Topical preparations like Calamine Lotion, Silver Sulfadiazine Burn Cream, and Terbinafine Cream are approved for skin care and infection management. Taj Pharma’s Povidone Iodine formulations (mouthwash, ointment, solution) serve as trusted antiseptics, while Oxymetazoline and Xylometazoline sprays cater to nasal decongestion.

Other notable registrations include Pantoprazole Tablets (Proton Pump Inhibitor), Tadalafil Tablets (Erectile Dysfunction), Minoxidil Solution (Hair Growth), Oral Rehydration Salts, and Disodium Hydrogen Citrate Syrup.

Through this comprehensive and diverse product line, Taj Pharma continues to strengthen its footprint in the Maldivian healthcare market, ensuring high-quality, affordable, and globally compliant medicines across therapeutic categories.

Generic NameGeneric BrandStrengthDosage FormTherapeutic Category
Aceclofenac Combination Gel——GelAnalgesic / Anti-inflammatory
Aceclofenac Combination Spray——SprayAnalgesic / Anti-inflammatory
Aciclovir—5%CreamAntiviral
Amoxicillin—125mg/5mlSyrupAntibiotic
Amoxicillin with Clavulanate—625mgTabletAntibiotic
Antacid Syrup (Pink Colour)——SyrupAntacid
Azithromycin—500mgTabletAntibiotic
Burn Cream (Silver Sulfadiazine)——CreamAntibacterial / Burn Treatment
Calamine Lotion—100mlLotionSkin Protectant
Calamine Lotion—50mlLotionSkin Protectant
Carboxymethyl Cellulose——Eye Drops 10mlLubricant / Artificial Tears
Cefixime—200mgTabletAntibiotic
Cetirizine—10mgTabletAntihistamine
Diclofenac Combination Gel——GelAnalgesic / Anti-inflammatory
Diclofenac Combination Spray——SprayAnalgesic / Anti-inflammatory
Disodium Hydrogen Citrate——SyrupUrinary Alkalizer
Fexofenadine—120mgTabletAntihistamine
Fexofenadine—180mgTabletAntihistamine
Fexofenadine——SyrupAntihistamine
Loratadine——SyrupAntihistamine
Loratadine——TabletAntihistamine
Minoxidil—5%Topical SolutionHair Growth Stimulant
Montelukast with Levocetirizine—10mg + 5mgTabletAntiallergic
Ondansetron—4mgTabletAntiemetic
Oral Mouth Ulcer Gel——GelOral Care
Oral Rehydration Salts——SachetElectrolyte Replacement
Oxymetazoline——Nasal Drops/Spray (Adult)Nasal Decongestant
Oxymetazoline——Nasal Drops/Spray (Pediatric)Nasal Decongestant
Pantoprazole—40mgTabletProton Pump Inhibitor
Povidone Iodine—2% w/vMouthwashAntiseptic
Povidone Iodine—5%OintmentAntiseptic
Povidone Iodine—5% w/vSolutionAntiseptic
Saline Nasal Drops/Spray——Nasal Drops/SprayNasal Moisturizer
Tadalafil—10mgTabletErectile Dysfunction
Tadalafil—20mgTabletErectile Dysfunction
Terbinafine Hydrochloride—1%CreamAntifungal
Terbinafine—250mgTabletAntifungal
Xylometazoline Hydrochloride——Nasal Drops/Spray (Adult)Nasal Decongestant
Xylometazoline Hydrochloride——Nasal Drops/Spray (Pediatric)Nasal Decongestant