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Drug Registration in Liberia

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Drug Registration in Liberia

Comprehensive Guide to Drug Registration in Liberia - Liberia Medicines and Health Products Regulatory Authority (LMHRA)

Regulatory Authority

Liberia Medicines and Health Products Regulatory Authority (LMHRA)

Link for Regulatory Authority 

https://www.lmhra.gov.lr/new/index.php

Local Authorized 

Yes

Registration Timeline

6-12 months

Registration Fee 

$500-1000 USD per product

License Validity

5 Years 

New Drug Registration

Application Submission

The applicant, whether for a locally manufactured or imported drug, must submit a written application using the specified Application Form.

Completion of Application Form

The Application Form must be completed following the sequence of appendices and should include the date, signature, and stamp of the applicant/license holder.

Local Responsible Person

Non-resident applicants must appoint a local responsible person residing in Liberia and authorized by the Liberia Medicines and Health Products Regulatory Authority (LMHRA). This person is required to facilitate communication and assume legal responsibilities for the product’s safety, efficacy, and quality in the Liberian market.

Documentation for Local Representative

Evidence of the appointment of the local responsible person is submitted through a power of attorney complying with Liberian laws. A duly signed agreement between the local representative and the manufacturers, along with a list of products covered by the agreement, should be appended.

Accompanying Documents

The application must be accompanied by:

  1. a) A duly signed covering letter.
  2. b) Two completed application forms.
  3. c) Samples of the product in the final package as specified in the Samples Schedule.
  4. d) Reference or working standard for Active Pharmaceutical Ingredient and related impurities where necessary.
  5. e) All supporting documents specified on the application form.
  6. f) Clinical trial and/or bioequivalence trial certificate where applicable.
  7. g) Non-refundable application fee as specified in the Fee Schedule.

Approval Process

The LMHRA must approve the application before any importation of the product (other than samples for the application) can occur in the country.

Registration Variation

The process for registering a variation of a product prior to its re-registration becoming due in Liberia involves the following steps and requirements:

1. Application Submission

Applicants must submit an application for the variation of the product’s registration to the Liberia Medicines and Health Products Regulatory Authority (LMHRA).

2. Accompanying Documents

The application must include:

  1. a) A duly signed covering letter.
  2. b) Documentation supporting the variation.
  3. c) Samples reflecting the variation as specified in the Samples Schedule.
  4. d) A non-refundable variation fee as specified in the Fee Schedule.

Approval Process

The LMHRA reviews the application and approves the variation before any importation of the varied product (other than samples for the application) can occur in the country.

Re-Registration

Timely Application

An application for the re-registration of a drug should be submitted three (3) months before the expiration of the last registration.

Application Submission

The applicant must submit an application for re-registration to the Liberia Medicines and Health Products Regulatory Authority (LMHRA).

Accompanying Documents

The application should include:

  1. a) A covering letters.
  2. b) Supporting documentation for any variations that occurred since the product was last registered.
  3. c) Samples of the product in the final package as specified in the Samples Schedule.
  4. d) A non-refundable application fee as specified in the Fee Schedule.

Approval Process

The LMHRA reviews the re-registration application and approves it before any importation of the product (other than samples for the application) can occur in the country.

General Requirements for Drug Registration in Liberia

Samples

  • Product names and packaging must be unique and not resemble existing registered products.
  • Oral liquids must include a graduated measuring device in the final packaging.
  • All samples must adhere to Liberian labeling regulations.
  • Brand names cannot replicate an International Non-proprietary Name (INN).

General Labeling

  • Each product requires proper labeling, including package inserts and container labels.
  • All information must be in English.
  • Labels must be accurate, clear, and easily readable.
  • Information should not be misleading or deceptive.
  • Required information includes:
    • Product name
    • Dosage form
    • Indications and recommended dosage
    • Administration method
    • Duration of use
    • Major side effects
    • Overdose symptoms and management
    • Contraindications, warnings, precautions, and major drug interactions
    • Use during pregnancy and breastfeeding
    • Expiration date
    • Batch number
    • Shelf life and storage conditions
    • Manufacturer name and address

New Chemical Entities or Innovator Products

Registration of pharmaceutical products in Liberia for new chemical entities or innovator drugs is typically not permitted within the initial two years of the drug’s first registration on the international market. 

To facilitate the evaluation process, the applicant must provide verifiable information regarding the patent’s expiry date. While clinical trial data from studies conducted in other countries will be considered, the Liberia Medicines and Health Products Regulatory Authority retains the right to request local clinical evaluation, in accordance with existing guidelines for clinical trials if deemed necessary. The associated costs for such trials will be the responsibility of the applicant.

LMHRA Regulations and Processes for Generics

Naming Convention

Generic drugs shall not be marketed with a name similar in pronunciation or form to the innovator product.

Bio-equivalence Study

A bio-equivalence study report shall be submitted in accordance with existing guidelines, particularly WHO Guidelines.

Local Clinical Evaluation

Although bio-equivalence data from studies in other countries will be considered, the Authority reserves the right to request local clinical evaluation based on existing WHO guidelines for bio-equivalence studies, where necessary. The cost of this trial shall be borne by the applicant.

Additional Requirements for Solid Oral Dosage Forms

  • For all solid oral dosage forms, reports of dissolution studies are required. If the official compendia monograph doesn’t require dissolution, the dissolution requirement in the USP shall apply.
  • If the product is manufactured on a contract basis, evidence of the contract shall be submitted. This information must be clearly stated on the product label and package insert.
  • For both locally manufactured and imported drugs, the original certificate of analysis for the drug, issued by a recognized public analyst, shall be submitted.
  • For imported drugs, a Certificate of Pharmaceutical Product (CPP) issued by the statutory national drug regulatory authority, following the World Health Organization (WHO) Certification Scheme for Pharmaceutical Products Moving in International Commerce, shall be submitted along with the certificate of analysis.

Product Differences and Justification

If the product is not identical to that in the issuing country, the applicants must list any differences in the application form and justify them. The Authority will decide whether the differences are minor and have been adequately justified, determining the relevance of the certificate for the intended purposes.

Manufacturing in Different Countries

  • Where different phases of manufacturing are conducted in different countries, the CPP must be issued by the competent authorities in the country that directly exports the product to Liberia.
  • If the product is fully manufactured in different countries, and the applicant wishes to obtain approval to use both sites of manufacture, the certificate should be submitted from both countries.
  • The certificate should be officially stamped and dated, together with all copies of product information submitted in support of an application for registration.
  • The applicant is responsible for providing a notarized translation of the certificate’s contents in English if the certifying Authority issued the certificate in any other language.
  • The certificate should be an original and/or a notarized or certified copy and current.

Additional Submission Requirements

  • A Drug Master File and process validation protocols shall be submitted for all applications.

Stability study reports conducted for three (3) trial batches of the product, and suited to the conditions specified below, shall be submitted: –

 

  1. a) WHO Zone IV climatic conditions

Condition

Accelerated Real Time Storage

Shelf-Life Transfer

Temperature

40°C ± 2°C

30°C

Relative Humidity

75% ± 5%

70% ± 5%

Duration

6 months

Until end of shelf life

  1. b) The stability study shall be conducted in the container closure system in which the product will be marketed in Liberia.

Stability Study

  • The stability study must be conducted in the container closure system intended for marketing in Liberia.
  • If the product is to be registered in multiple container closure systems, stability data must be provided for each presentation. Real-time stability data is required for all biologicals.
  • Stability test results should be presented in both tabular and graphical forms, and the proposed shelf-life and storage conditions should be determined based on these results.

Authority’s Consideration of Applications

  1. a) The Authority shall ensure the necessity of registering the drug in Liberia.
  2. b) The applicant will be requested to submit a manufacturer’s authorization for registering the drug.
  3. c) The Authority may consult with other bodies and experts with knowledge of the drug.
  4. d) All applications must be accompanied by a Site Master File for verification of compliance with current Good Manufacturing Practice (cGMP).
  5. e) The Authority reserves the right to conduct a Good Manufacturing Practice (GMP) audit inspection on the manufacturing facility for the product, at a fee prescribed by the Authority. f) The Authority may ask the applicant to provide any other information necessary for reaching a decision on the application.
  6. g) Receipt of all applications will be acknowledged upon submission and payment of fees, with processing typically completed within three months. If additional information is required, this period may be extended.
  7. h) Failure to submit written responses to queries within 6 months from the date of issuance will be considered withdrawal of the application. If queries are reissued for a second time and unsatisfactory responses are provided, the product will be disqualified, and the application rejected. The applicant will be required to reapply.
  8. i) If no response is received within six months of the request, the application will be discontinued.
  9. j) Decisions on registration will be based on the dossier evaluation report, quality control report, and inspection report on compliance with cGMP where necessary.

Appeal Process

An appeal for the review of an application can be submitted in writing to the Chairman of the LMHRA within thirty (30) days of receiving the rejection notice.

Certificate of Registration

If the Authority is satisfied with the necessity to register a medicinal product and all registration requirements have been met, it will issue a certificate of registration to the applicant. This certificate is subject to conditions prescribed by the Authority.

Validity and Renewal

The registration of a drug under these regulations, unless revoked, is valid for a period of three (3) years and may be renewed.

Publication of Registration

The Authority will periodically publish a notice in the Gazette announcing the registration of a drug under these regulations.

Confidentiality of Information

No information provided in the application will be disclosed by the LMHRA to a third party, except:

  1. a) With the written consent of the license holder.
  2. b) In accordance with the directive of the Board of Directors of LMHRA.
  3. c) For the purpose of a legal process under the LMHRA Act of 2010.

Grounds for Cancellation, Suspension, or Withdrawal 

The Authority shall cancel, suspend, or withdraw the registration of a drug if:

  1. a) The grounds on which the drug was registered are later found to be false.
  2. b) The circumstances under which the drug was registered no longer exist.
  3. c) Any of the provisions under which the drug was registered has been contravened.
  4. d) The standard of quality, safety, and efficacy, as prescribed in the documentation for registration, is not being complied with.
  5. e) The premises, in which the drug or part thereof is manufactured, packaged, or stored by or on behalf of the holder of the certificate of registration, is unsuitable for the manufacture, packaging, or storage of the drug.

Generic Drugs

For generic drugs in Liberia, certain regulations are in place to ensure differentiation from innovator products and uphold safety standards. Generic drugs should not be marketed with a name similar in pronunciation or form to the corresponding innovator product. Additionally, applicants must submit a bio-equivalence study report following existing guidelines, particularly WHO Guidelines. 

While bio-equivalence data from studies in other countries will be considered, the regulatory authority reserves the right to request local clinical evaluation based on WHO guidelines for bio-equivalence studies if deemed necessary. Similar to new chemical entities, the expenses associated with these trials will be borne by the applicant. 

The process for drug registration in Liberia involves several key requirements and steps to ensure the safety, efficacy, and quality of pharmaceutical products. Here is a summary of the key points outlined in the provided text:

Submission Requirements

  • For all solid oral dosage forms, dissolution studies are required, following the USP dissolution requirement if not specified in the official compendia monograph.
  • Evidence of contracts for contract-manufactured products must be submitted and clearly stated on the product label and package insert.
  • Original certificates of analysis issued by recognized public analysts are required for both locally manufactured and imported drugs.
  • For imported drugs, a Certificate of Pharmaceutical Product (CPP) issued by the national drug regulatory authority, in line with WHO Certification Scheme, must be submitted along with the certificate of analysis.

Manufacturing and Stability Requirements

  • A Drug Master File and process validation protocols must be submitted for all applications.
  • Stability study reports for three trial batches of the product, conducted under specified conditions, must be submitted.

Application Evaluation

  • The Liberia Medicines and Health Products Regulatory Authority evaluates the application and may request additional information, including a manufacturer’s authorization and compliance with cGMP.
  • An application is processed within three months but may be extended if additional information is required.
  • Failure to respond to queries within six months may result in withdrawal of the application.

Decision and Appeals

  • Decisions on registration are based on dossier evaluation, quality control, and inspection reports.
  • An appeal for application review can be made within thirty days of rejection.
  • If registration requirements are satisfied, the Authority issues a certificate of registration, valid for three years and renewable.

Confidentiality and Cancellation

  • Information provided in the application is kept confidential unless consented or required by law.
  • The Authority may cancel, suspend, or withdraw registration if certain grounds are met, ensuring ongoing compliance and safety.

REGISTRATION VARIATION 

An application for a variation of a product’s registration, prior to its re-registration becoming due, can be submitted to the Authority. The application must include the following documents:

  1. a) A duly signed covering letter
  2. b) Documentation supporting the variation
  3. c) Samples reflecting the variation as specified in the Samples Schedule
  4. d) A non-refundable variation fee as specified in the Fee Schedule

The Authority must approve this variation before any importation of the varied product, except for those used as samples for the application’s purpose, can occur in the country.

RE-REGISTRATION

An application for the re-registration of a drug should be submitted three (3) months before the expiration of the last registration. The application must include the following:

  1. a) A covering letters
  2. b) Supporting documentation for any variations since the product was last registered
  3. c) Samples of the product in the final package as specified in the Samples Schedule
  4. d) A non-refundable application fee as specified in the Fee Schedule

The re-registration must be approved by the Authority before any importation of the product, except for those used as samples for the application’s purpose, can be made into the country. 

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