Liberia - Registration of Medical Device and In-Vitro Devices (IVDs)

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Procedure

How to apply:

1. Applicant should visit Liberia Medicines and Health Products Regulatory Authority (LMHRA) with all the require documents
2. Request for the application form which should be completed in accordance with the sequence of appendices and shall be dated, signed and stamped by the applicant/license holder.
3. Applicant who are not resident in Liberia shall appoint a local responsible person who must be a person residing or a company incorporated in Liberia and authorized by LMHRA to deal in medicine and Health Products.
4. The application will be investigated, verified and processed if all the information are in order. The IVDs will be registered, gazetted and you will be issued with a certificate of registration

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Required Documents

• A duly signed covering letter
• Two (2) completed application forms
• Samples of the product in the final package as specified in Samples Schedule
• Reference or working standard for Active Pharmaceutical Ingredient and related impurities where necessary.
• All supporting documents as specified on the application form
• Clinical trial and/or bioequivalence trial certificate where applicable
• non-refundable application fee (bank slip or bank draft)

Office Locations & Contacts

Liberia Medicines and Health Products Regulatory Authority (LMHRA):
PO BOX 1994 VP Road
Old Road, Sinkor; Monrovia, Liberia
Telephone + (231) (0)886562019
Email [email protected]:
[email protected]
Website: LMHRA

Eligibility

• Manufacturing, export, import companies in Liberia and abroad

Fees

• Application fee of $3,000 USD (non-refundable)
  
• fast track the application review process, the fee is $6,000 USD (non-refundable)
  

The Liberia Medicines and Health Products Regulatory Authority (LMHRA)
Account Name: The Liberia Medicines and Health Products Regulatory
Authority General Account
Account No. 0011134721054401
Currency: United States Dollars
Swift Code: ECOCLRLM
Name of bank: ECOBANK Liberia Ltd.
11th Street, Tubman Boulevard, Sinlor
P. O. Box 71625 Monrovia, Liberia

The Liberia Medicines and Health Products Regulatory Authority (LMHRA):
Account Name: LMHRA Project
Account No.: 207700196210
Name of Bank: Guaranty Trust Bank (Lib) Limited
Currency: United States Dollars
Swift Code: GTBILRLM
13th Street Sinkor, Tubman Boulevard Monrovia, Liberia

Validity

• Registration certificates shall be valid for five (5) years except when the Authority suspended or revoked or terminated the certificates

Documents to Use

(Application form ANNEX11)

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

• within 6 month (fast track) or 9 months (regular)

Related Videos

Videos explaining the procedure or to fill the applications. 
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites. 	
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver, 
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

All applications and supporting documents for registration shall be done in English and must be legibly printed but not handwritten. Applications submitted in languages other than English will automatically be rejected.

• When all accompanying documents of an IVD are not originally in English, a copy of the original language should be submitted along with a copy of the full translation into English. The applicant is accountable for the accuracy of the translation.
• The local responsible person shall be responsible for facilitating communication with the applicant and when the product is registered he shall assume all legal responsibilities regarding the product safety, efficacy and quality follow-up on the Liberian market.

Required Information

• Details of the applicant
• Detail of the manufacturing site
• Details of the local agent
• Details of the In vitro devices (IVDs)
• Applicant declaration

Need for the Document

The objective of registration of medical product /device by the Liberia Medicines and Health Products Regulatory Authority (LMHRA) is to protect patients and the general public by ensuring that all medicinal products circulating in the country are

• Safe
• Efficacious
• Of good quality
• Suitable/appropriate to the local market
• Therapeutically relevant to the health needs of the population (for community health diseases)

Information which might help

Appeal:
Any applicant that is aggrieved due to a decision made by the LMHRA regarding any IVD application for registration may make formal representations in writing to the LMHRA. Said representation/appeal should be made to the following address:
The Managing Director Liberia Medicines and Health Products Regulatory Authority (LMHRA)
P. O. Box 1994, VP Road, Old Road,
Oldest Congo Town, Monrovia, Liberia

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

Liberia medicine and health
Liberia guide lines
Health products regulatory authority

Others

More information which might help people.