Libya regulatory pharmaceuticals medical devices registerations, Drug registeration libya

Drug Registration Requirements and Procedures

Libyan (MOH)

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Libya Pharmaceuticals Regulatory MOH registerations

Libya registration, Libya regulatory of drugs, pharmaceuticals, medicines Libya ministry of health

Herein we will outline the Libyan Ministry of Health (LMOH) drug registration requirements with a background on the (LMOH) drug approval process. We aim to cover the high-level points to help draw the big picture of the drug submission requirements and procedures

Introduction

The Libyan Ministry of Health (LMOH), and The Libyan Food and Drug Control Center (FDCC) both both work together and regulate drug products in Libya and enforce the drug registration requirements, and These requirements had evolved significantly during the past decade with the adoption of the ICH guidelines. the submission file format requirements to the (LMOH) are both CTD (Original Hard copies), and eCTD (through transmission media), Currently )Flash Drive, CD-ROM, CD-R, DVD-R) are considered acceptable media standards.

(LMOH) Drug Registration Requirements

Please note that their are no exact confined registration requirements checklist since every required document has its compliance measures. Let alone the needed comprehensive due diligence that goes further off the drug file.

Therefore, the information provided herein is the general requirements of procedures, detailed as follows:

(LMOH) Guidelines
Drug dossier
Drug application & fees
CTD, and eCTD Submissions

Drug Registration Guideline

According to the drug type, included below are the related (LMOH) drug registration guidelines.

Note: It is not mandatory but recommended to perform a product classification to determine your type of product before initiating your compliance checks, especially if your product is known to be a borderline as product classified as a cosmetic product in its country of origin might be classified as a medical device, similar cases with food supplements which might be classified as a drug in Libya,

Human Drug Registration Guidelines

Data Requirements for Human Drugs Submission List
(FDCC) Stability Guidelines
(LMOH) Drug Master File (DMF) guidelines
(FDCC) SPC, PIL, and Labeling requirements
The naming of Medicinal Products
(FDCC) Tamper- Evident Packaging guidelines
Graphic Design of Medication Packaging
Registration According to Verification and Abridged
Module 1 Specifications Guidelines for Bioequivalence
(LMOH) Biosimilars Guidelines
Investigational New Drugs (IND) Requirements
Pharmaceutical Reference Standard
(LMOH) Biowaiver Guidelines
Production and Quality Control of Vaccines

Herbal Drug Registration Guidelines

Data Requirements for Herbal & Health Products Submission (Food Supplements)
Guidance for Presenting PIL and Labeling Information of Herbal and Health Products
General Rules For Products Containing Vitamins And Minerals

Veterinary Drug Registration Guidelines

SFDA VNeeS specifications for the veterinary medicinal product
Data Requirements for Veterinary Medicinal Products
SFDA SPC, Leaflet, and Labeling for Veterinary Products

(LMOH) Drug Dossier Requirements

Dossier Files

Requirements of (LMOH) (DMF) Registration Files List, Including:
New drug & Generics Application forms:
- Form LY/MOH/001/012 - General Information
- Form LY/MOH/002/012 - Specific Information/ Personnel
- Form LY/MOH/003/012 - Specific Information/ Production and premises
- Form LY/MOH/004/012 - Specific Information/ Quality Control
- Form LY/MOH/005/012 - Specific Information/ Production Documentation

Dossier Format

Human drug: CTD (Original Hard Copies), and eCTD (transmission media)
Herbal and health products: CTD
Veterinary drug: CTD.

(Transmission Media); (Must be free of potential Viruses and Malwares scanned with up to date available software)

Currently USB Drive, CD-ROM, CD-R, DVD-R are considered acceptable media standards. (USB Drive is preferred)

If submitted on CD Applicants should provide the electronic information on the smallest number of discs possible, taking into consideration the size of the submission. If an individual eCTD submission is of such a size as to span several CDs, the provision of a DVD is recommended. However, if CD-R must be used, when large applications are submitted it is inevitable that the application will necessarily span multiple CDs. Where possible, individual modules should not be split over multiple CDs (e.g. if possible, a single CD should contain Module 1, Module 2, if too large to fit on the same CD should then go onto the next CD even if this requires CD 1 not to be filled to capacity and so on). If, in the case of larger modules, where a split over multiple CDs is inevitably necessary, subfolders should be distributed in sequence, and these subfolders should not be split between CDs, even if this requires a CD to be sent not full to capacity.

Application Procedures

(LMOH) drug registration application is to be filled out CTD, eCTD and submitted through the (Local Assigned Agent) for the (LMOH) registration in the following steps by order:

Submit dossier Applications, with supporting documents from the requirements guide list for validation.
Submit (Finished product samples) (2 samples each)
Pay (LMOH) Application fee
Pay the fee for each new drug submitted for registration (Applicable by end of year 2022)
Pay the fee for each Additional dosage form, strength, pack type or pack size.
Receive and respond to assessment inquiries RFI.
Receive the application review decision
Arrange for (LMOH) Inspection team visit to the Manufacturing Site in the country of origin. (Usually 4-5 persons). The duration of the inspection depends on the production lines and sites to be visited (usually 2 days for each production line)
Registration certificate is provided (in the Name of the Manufacturer) for the Duration of 5 years, renewable.
Manage the drug file life cycle (variations & renewals).

Please note:

The (Local Assigned Agent) must be a registered company who is pre-registered, verified and approved by the (LMOH).

Application Types

For the moment their is only one general application and no sub categories for drug registration which includes the followings:

Human Medicinal Product
Veterinary Product

Application Fees

Please contact us to receive all fee amounts, structure and details for registration

Validation

(LMOH) Technical Validation

The (LMOH) receives the submitted dossier and performs a validation on the compiled CTD, and eCTD according to the (LMOH) Validation Criteria. Also worth mentioning that (LMOH) only recognizes certifications from the the following regulating bodies, the (FDA), (EMEA), and (MHRA).

(LMOH) Business Validation

This is a manual primary business validation process performed on the file. It is a step before the initiation of the actual evaluation. It aims to reduce the number of obvious file deficiencies that are usually discovered during the evaluation process.

The (LMOH) will validate (not evaluate) the presentation and main compliance issues.

Akeel Health will assist in validating your documents with the (LMOH), before the actual submission, and before moving forward to the (required authentication and legalization of licenses and certificates) by the Libyan embassy or the Libyan representative office in the country of origin.

Approval Timelines

Previously Registered in Libya: 280 working days.
New registration: 405 working days

Review and Approval Process

After knowing how to submit LMOH drug registration application, we find it essential for you to understand the internal details of the LMOH approval process. Hence, the scientific assessment and the application journey through the departments. This is important so we put the registration requirements into context and help you later when you are determining your application progress.

The approval process consists of evaluation stages that take place in a parallel way within the drug sector. This allows multiple departments to assess the application simultaneously. Let us go through each stage in more detail:

Evaluation Department

Quality

Active Pharmaceutical Ingredient (API)
Finished Pharmaceutical Products (FPP)

Benefit & Risk Evaluation

Clinical evaluation
Bioequivalence (BE)
Reference Safety Information (RSI)
- Summary of Products Characteristics (SPC)
- Patient Information Leaflet (PIL)

Inspection

This department is responsible for the evaluation and LMOH GMP certification of drug manufacturers. Applicant should expect a mandatory manufacturer GMP licensing by LMOH for all drug, health products. It will include a site inspection by LMOH & FDCC inspectors and payment of inspection fees.

Testing

During the SFDA drug registration, you should expect a request for analysis samples from the SFDA lab. Sometimes, you may be able to waive this request to a later stage, so the analysis is to be performed on the first batch arriving at the Saudi market.

Lab analysis
Revision of related analysis documents
Request drug samples and reference standards
Testing commercial batches

Pricing

The pricing evaluation is the last SFDA drug registration stage. This department performs a pharmacoeconomic study on the drug and generates a report for the SFDA pricing committee. The committee will recommend a price that will make the final approval from the main registration committee before communicating to the company for acceptance or appeal if applicable.

Registration Committee

The SFDA main registration committee is responsible for reviewing the final comprehensive evaluation report from all departments. They make the final decision to approve or reject the application.

Registration Certificate

Approved drug applications will receive a registration certificate that entitles the company to market in Saudi Arabia. The expiry date of this document is 5 years.

Conclusion of Drug Review

After we understand that the drug application will go through an extensive assessment by SFDA experts, the applicant should expect multiple waves of inquiries (RFI) during the process, especially on the API sections and their related pharmacopoeias. In addition to safety inquiries (leaflets & SPC), pharmacovigilance system notes, and the presence of a Saudi QPPV.

SFDA Accelerated Drug Approval

There are two accelerated registration routes in the SFDA; the first one is the drug priority review based on the added value of the drug, which results in a 40% reduction of the normal approval timelines. While the other is the verification and abridged registration, which is only applicable on FDA or EMA approved drugs and provides the greatest reduction in timelines.

Life Cycle Management LCM

Changes in the Registered Information

After you receive your drug approval, the maintenance process usually starts immediately, where you will have in your schedule one or more changes to the registered information that you have to update at the SFDA. Those are known as variation applications, and they have their own complex procedures and requirements. Be it administrative or technical information changes, they all have to be approved by SFDA in a variation dossier. Read more here: SFDA Variation Guidelines Overview.

Drug License Renewal

On the other hand, companies must maintain their registration license validity by submitting a renewal application before the SFDA certificate expires. This is possible 6 months before the certificate expiry date. Note that renewal is required even if the drug is not marketed as long as it has a registration in the SFDA.

Akeel representative can assist you by providing the exact information you need to make an informed decision. Please Contact Us today