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LMHRA Boss Attends WA-MRH Steering Committee Meeting

(Monrovia-April 28, 2022): Liberia’s Medicines and Health Products Regulatory Authority (LMHRA) Managing Director, Pharmacist Keturah C. Smith-Chineh (Mrs.), has departed Liberia for Abidjan, the Ivory Coast, to attend the 11th West Africa Medicines Regulatory Harmonization (WA-MRH) Steering Committee Meeting.

The Liberia Medicines & Health Products Regulatory Authority (LMHRA) is the statutory arm of the Government of Liberia with the responsibility to ensure that all medicines and health products circulating the borders of Liberia are safe and efficacious.

The WA-MRH Steering Committee meeting was formulated to appraise the West Africa Medicines Regulatory Harmonization (WA-MRH)-related activities in the region and provide the necessary guidance for more efficiency.

The 11th West Africa Medicines Regulatory Harmonization Steering Committee Meeting is slated from April 28th to May 1st, 2022.

The African Medicines Regulatory Harmonization (AMRH) Initiative is an attempt by the African Union to strengthen regulatory capacity, encourage harmonization of regulatory requirements, and expedite access to good quality, safe, and effective medicines.

The initiative is implemented as part of the African Union’s Pharmaceutical Manufacturing Plan for Africa (PMPA); a policy framework to provide an enabling regulatory environment for local production and contribute to the Universal Health Care (UHC), AU Agenda 2063, and the Sustainable Development Goals (SDGs).

The AMRH initiative is as well implemented in the Economic Community of West African States (ECOWAS), Inter-governmental Authority on Development (IGAD), and Economic Community of Central African States (ECCAS). It covers more than 85% of the Sub-Saharan African countries which are at different levels of its implementation. To address the problem of non-coherent medicines laws in African countries, the AMRH Initiative developed a Model Law on medical product regulations to ensure effective regulation and promotion of harmonization.

The model law which among other things promotes the establishment of autonomous agencies; was adopted by the AU Assembly in January 2016 and has been domesticated by more than 12 of the AU Member States. Since 2014, eleven regional centers of regulatory excellence have been designated 2014 to provide coordinated and structured regulatory science training programs using the existing academic institutions in partnership with regulatory agencies.

While Managing Director Smith-Chineh will be away, the Technical Director, Dr. G. Flomoku Miller, will steer the affairs of operation at the authority pending her return.

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LMHRA, Stakeholders Conclude Five-Year Strategic Plan

For Effective Medicines Regulation:

 Participants at the Stakeholders Meeting & Blueprint of the Strategic Plan (2021-2025

(Monrovia, April 22, 200): The Liberia Medicines and Health Products Regulatory Authority (LMHRA), in collaboration with stakeholders, has concluded a five-year strategic plan (2021-2025) for the effective governance and implementation of medicines regulation in Liberia; and to further ensure that safe, effective, and quality medications are provided to the population.

Making a formal presentation of the strategic plan to a cross-section of stakeholders and donor partners, at a day-long introductory meeting of stakeholders,  held at the Cape Hotel in Monrovia, the Managing Director of the LMHRA, Pharmacist Keturah Smith-Chineh, noted that without a guiding tool for medicines regulations, the country will not have the quality of health services desired, therefore, it is high time the narrative is changed by supporting the regulatory authority as it should be because it is the genesis of quality healthcare.

“So in the next five years, the LMHRA wishes to change the narrative of how regulations are implemented not only in Liberia but the sub-region. Because if there is a poor system in place, the population might not have the quality of healthcare desired by all,” the LMHRA Managing Director emphasized.

She added: “As we go through these plans, we pray that our partners take note and begin to support wherever area they can as envisaged by the LMHRA in the next five years.”

Providing the overview of the LMHRA, Dr. Flomoku Miller, Technical Advisor to the LMHRA Managing Director, noted that to ensure that the national medicine supply system, is safe, effective, and good quality medicines reach the Liberian public, the LMHRA continues to audit pharmaceutical manufacturers for Good Manufacturing Practices; conducts an assessment of medicines dossiers through CTD evaluation; issue Marketing Authorization and Conduct quality control and quality assurance activities and as well monitor the safety of medicines.

According to him, to protect the Liberian public from the harmful effects of substandard and counterfeit medicines and health products, the LMHRA conducts container inspections, Premise inspections Post Market Surveillance, Combats drug peddling through confiscation, community & school awareness, radio talk shows, billboard installations, publishing of awareness messages on LMHRA’s website notices, supervise product recalls, incineration of expiries and confiscated medicines and health products from peddlers.

The LMHRA Technical Advisor further intimated that since the ascendency of the current management team, there has been the establishment of new departments,    new units, sub-offices, regional offices, recruitment of staff, capacity-building of staff, procurement of vehicles and other logistical material, erection of structures, drafting of new guidelines and regulations as well as the drafting of the new strategic plan.

Despite these achievements outlined, Dr. Miller decried challenges confronting the LMHRA as the full decentralization of the entity, the understaffing of departments, with technical personnel, limited logistics especially vehicles, workspace, software for the various technical departments, completion of the Quality Control Laboratory infrastructure, as well as functioning equipment, and certified Quality Control Laboratory and more capacity building. 

Upon the setting up of the Authority in 2010, the first strategic plan was drawn up for 2011-2013 to give direction for the first five years of the existence of the LMHRA

Highlighting the five-year Strategic Plan 2021-2025, United States Pharmacopeia PQM+ Consultant, Benjamin Kwame Botwe, said the five years plan was developed based on the mandate given by the Act establishing the LMHRA as well as experiences and lessons learned over the last ten years of the existence of the authority, international best practices and results of some internal and environmental assessments undertaken so far.

According to him, the purpose of this strategic plan is to: design strategies for achieving the vision, mission, and objectives of the authority; provide a long-term perspective of what the authority would look like in the future; develop performance indicators for monitoring and evaluation; development of an operational plan and budget as a basis to seek for both technical and financial assistance to facilitate the achievement of these set objectives.

The USP PQM+ Consultant further mentioned that the process of developing the strategic plan involved an assessment of the state of implementation of the first strategic plan; the self-assessment of the LMHRA on its regulatory functions using the World Health Organization (WHO) Global Benchmarking Tools; further assessment on Quality Management Systems situation by the West African Health Organization (WAHO);  all levels of management, staff and various stakeholders and professional groups were engaged for their inputs and buy-in.   He said upon performing a SWOT and PESTEL analysis, the vision and mission statements were developed and the strategic goals were identified to be able to achieve the mission of the authority. 

Some of the thematic areas captured in the plan include regulatory system strengthening, legislation and regulations, evaluation and registration, inspections, import and export control, post-market surveillance, Pharmacovigilance and clinical trials, quality control, quality management system, human resource development, harmonization, collaboration and decentralization, financial sustainability communication and information technology.

Mr. Botwe also highlighted that the plan also encapsulates the establishment of an effective and efficient medicines and related products regulatory system;   setting up of a quality management system and undertaking operational research activities to support regulatory functions; development and implementation of an effective information management system; promotion of partnership, cooperation, collaboration and decentralization; recruitment, development, and maintenance of adequate human resource capacity and the mobilization of technical and financial resources for the implementation of regulatory functions.

In conclusion, Mr. Botwe emphasized that medicines and health products regulation is meant to ensure safety, efficacy, and quality. Hence, the activities of marketing authorization, post-market surveillance, inspections, and quality control laboratory requires a state-of-the-art infrastructure, well-trained and skilled human resources as well as technical and financial assistance. According to him, the strategic and accompanying operation plan is costed to give opportunity for investment in particular areas and where necessary provide the technical assistance to achieve the objectives because experience shows that government budgetary allocation alone is not enough to ensure full implementation of the plan.

Also speaking, the Director of USP-Ghana and PQM+ West Africa, Mr. Kwasi Poku Boateng, highlighted that USP PQM+ support to the LMHRA includes the establishment of the LMHRA, the implementation of an aspect of the first strategic plan, providing the technical assistance funding from USP, the development of the current strategic plan, support to key regulatory functions, support to products evaluation and registration, training for PMS staff, compliance training for anti-malaria, support to the quality control lab and capacity building of the Inspectorate Department.

PQM+ is working with LMHRA to build its capacity to carry out regulatory functions. PQM+ also supported LMHRA to develop its current five-year Strategic Plan (2021-2025) to strengthen the governance of the medical product quality assurance system.

In addition, the program is helping to draft regulations that seek to strengthen LMHRA’s enforcement actions and the registration and importation of medicines, as well as improve the national quality control laboratory’s ability to undertake post-marketing surveillance to monitor the quality of medical products in circulation and boost its revenue stream.

For their part, representatives of the World Health Organization (WHO), Global Fund, UNICEF, the United Nations Development Program (UNDP), USAID, and other partners commended the management of LMHRA and USP PQM+ for the establishment of the regulatory authority’s five years strategic plan; promising to collaborate with the LMHRA for the authority to achieve its desired objectives and targets.

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APPROVED PHARMACEUTICAL MANUFACTURERS MARCH 2022

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LMHRA Inspectorate Department Conducts Rigorous Inspection of Pharmacies & Medicines Stores Across Montserrado

To Rid Counters & Warehouses Of Substandard & Falsified Medicines:

As part of its mandate area to rid the society of Substandard, Falsified and Counterfeit Medicines and Health Products, the Inspectorate Department under the auspices of the Post Market Surveillance Unit of the Liberia Medicines and Health Products Regulatory Authority (LMHRA), is conducting an Intensive and Rigorous 10-days unannounced inspection of all Pharmacies and Medicine Stores across Montserrado County.

The inspection is geared towards ensuring that medicines on various counters and warehouses of pharmacies and medicine stores are compliant with the LMHRA standards and regulations.

Also, the process is further geared towards ensuring that medicines sold to the public/citizens or inhabitants of Liberia by these pharmaceutical outlets are registered with the LMHRA and also meets all requirements and policies as set out by the Act establishing the LMHRA.

The Inspectorate team is also ensuring that these pharmacies and medicines stores are legally registered with the LMHRA and as well compliant with the Pharmacy Board of Liberia.

LMHRA has a mandate to “protect the public from the harmful effects of Substandard and Falsified (SF) Medicines and Health Products” coupled with “ensuring that, in the national medicine supply system, only safe, effective, and good quality medicines reach the Liberian public, promulgate regulations to fight illegal trade in medicines, including counterfeit and adulterated medicines and health products and fair trade practices.” Hence, the LMHRA remained unwavering in enforcing established guidelines and regulations to attain its goals and objectives.

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Public Awareness Against Street Peddling

To curb or alleviate the proliferation of street peddling of the sales, usage, and danger of Sub-standard & Falsified (SF) Medicines in the Liberian society, the Liberia Medicines and Health Products Regulatory Authority (LMHRA), on February 1, 2022, commenced a 16-day Public Awareness to various high schools and universities across Montserrado County.

The LMHRA is the statutory arm of the Government of Liberia with the responsibility to ensure that all medicines and health products circulating the borders of Liberia are safe and effective. The LMHRA was established based on provisions of the National Drug Policy for the establishment of a Medicines Regulatory Authority to enact and update medicines regulations to regulate the Pharmaceutical Sector and the establishment of a national quality control laboratory under the Authority. The Authority was officially established on 29 September 2010.

Our role is to protect and enhance public health. We do this by assessing the safety, quality, and effectiveness of medicines and health products on behalf of the public to ensure the benefits they provide outweigh any potential risks. Our core regulatory functions and our aims and objectives are expressed in our mission, vision, and values.

As part of the LMHRA Communications Unit’s mandate to educate and sensitize the public on the sales, usage, and danger of Sub-standard & Falsified (SF) Medicines in the Liberian society, the Unit, hired the services of two top Liberian Comedians, to help propagate the danger street peddling, sales, and usage sub-standard & falsified (SF) medicines poses to the health outcome of the citizenry.

In view thereof, the Communications and Program Units are conducting awareness at various private & public high schools and universities across Montserrado County.

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BID FOR RENDERING OF PERSONNEL NON-INSURANCE COVERAGE

IFB.No.LMRHA/SBA/NCB/004/2022

The Government of the Republic of Liberia through the Liberia Medicines and Health Products Regulatory Authority intends to apply part of its budgetary allocations from its GOL Budget and  Internal revenue generation Budgets for fiscal year 2022 for the procurement of PERSONNEL NON-LIFE INSURANCE COVERAGE

The LMRHA now invites sealed bids from eligible registered bidders for the supply of Personnel Non-life Insurance Coverage for FY2022.

Bidding will be conducted through the Restricted Bidding process, a procedure specified in the PPCA and approved by the PPCC and is now open to all bidders.

Description and Quantity of PERSONNEL NON-INSURANCE COVERAGE to be supplied:

         Description                                                                            Quantity

  1. Personnel Medical Insurance Coverage———————- Assorted

Qualification requirements include:

  • Valid tax clearance
  • Valid Business registration certificate
  • Past performance records including the names and contact numbers of at least three (3) clients
  • Article of Incorporation
  •  Evidence of PPCC Vendor registration
  • Bid Securing Declaration

A complete set of bidding documents in English may be purchased by interested Bidders from the Procurement Unit of LMHRA

  1. upon a payment of a nonrefundable fee of US$50
  2. For each set from February 21, 2022, from 9:00am to 4:00pm, Monday to Friday.

All bids must be accompanied by a bid securing Declaration.

Sealed bids must be delivered to the Procurement Unit of the LMRHA no later than 12:00pm on March 22, 2022. Bids shall be valid for a period of 90 days after the deadline for submission of bids. Electronic bidding will not be permitted. Late bids will be rejected and returned unopened.

Bids will be opened in the presence of bidders or their representatives who choose to attend in the Conference Room of LMHRA on March 23, 2022 at 12:30 pm.

The address of the Procurement Unit is:

Sekou Toure Avenue Mamba Point

Contact: 0777430122/0880742702

Signed: ____________________________

Mrs. Hawa T. Tambah

Procurement Director LMHRA

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BID FOR SUPPLY OF CLEANING MATERIALS

IFB.No.LMRHA/SBA/RB/001/2022

The Government of the Republic of Liberia through the Liberia Medicines and Health Products Regulatory Authority (LMHRA) intends to apply part of its budgetary allocations from its GOL Budget and Internal revenue generation Budgets for the fiscal year 2022 for the procurement of CLEANING MATERIALS.

The LMRHA now invites sealed bids from eligible registered bidders for the supply of CLEANING MATERIALS for FY 2022.

Bidding will be conducted through the Restricted Bidding process, a procedure specified in the PPCA and approved by the PPCC and is now open to all bidders.

Description and Quantity of Laboratory Equipment to be supplied:

         Description                                                                          Quantity

  1.  Cleaning Materials————————————————— Assorted

Qualification requirements include:

  • Valid tax clearance
  • Valid Business registration certificate
  • Past performance records including the names and contact numbers of at least three (3) clients
  • Article of Incorporation
  •  Evidence of PPCC Vendor registration
  • Bid Securing Declaration

A complete set of bidding documents in English may be purchased by interested Bidders from the Procurement Unit

  1. upon payment of a non-refundable fee of US$50
  2. For each set from February 22, 2022, from 9:00 am to 4:00 pm, Monday to Friday.

All bids must be accompanied by a bid securing Declaration.

Sealed bids must be delivered to the Procurement Unit of the LMRHA no later than 12:00 pm on March 23, 2022. Bids shall be valid for a period of 30 days after the deadline for submission of bids. Electronic bidding will not be permitted. Late bids will be rejected and returned unopened.

Bids will be opened in the presence of bidders or their representatives who choose to attend in the Conference Room on March 24, 2022, at 12:00 pm.

The Address of the Procurement Unit is:

Sekou Toure Avenue Mamba Point

Contact: 0777564585/0888888125

Signed: ____________________________

Mrs. Hawa T. Tambah

Procurement Director LMHRA

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BID FOR SECURITY GUARD AND SERVICES

IFB.No.LMRHA/SBA/NCB/SBA/003/2022

The Government of the Republic of Liberia through the Liberia Medicines and Health Products Regulatory Authority (LMHRA) intends to apply part of its budgetary allocations from its GOL Budget and Internal revenue generation Budgets for fiscal year 2022 for the procurement of SECURITY GUARD SERVICES.

The LMRHA now invites sealed bids from eligible registered bidders for rendering of Security Guard Services for FY 2022.

Bidding will be conducted through the National Competitive Bidding process, a procedure specified in the PPCA and approved by the PPCC and is now open to all bidders.

Description and Quantity of Security Guard Services to be rendered:

         Description                                                                   Quantity

  1. Security services—————————–For all LMHRA facilities

Qualification requirements include:

  • Valid tax clearance
  • Valid Business registration certificate
  • Past performance records including the names and contact numbers of at least three (3) clients
  • Article of Incorporation (for corporations)
  •  Evidence of PPCC Vendor registration
  • Bid Securing Declaration

A complete set of bidding documents in English may be purchased by interested Bidders from the Procurement Unit

  1. of LMHRA for a nonrefundable fee of US$50.00
  2. For each set from February 21, 2022, from 9:00am to 4:00pm, Monday to Friday.

All bids must be accompanied by a bid securing Declaration.

Sealed bids must be delivered to the Procurement Unit of the LMRHA no later than 12:00 pm on March 22, 2022. Bids shall be valid for a period of 30 days after the deadline for submission of bids. Electronic bidding will not be permitted. Late bids will be rejected and returned unopened.

Bids will be opened in the presence of bidders or their representatives who choose to attend in the Conference Room of LMHRA on March 24, 2022 at 12:00 pm.

The address of the Procurement Unit is:

Sekou Toure Avenue Mamba Point

Contact: 0777430122/0880742702

Signed: ____________________________

Mrs. Hawa T. Tambah

Procurement Director LMHRA

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BID FOR RENDERING ELECTRONIC MATERIALS

IFB.No.LMRHA/SBA/NCB/002/2022

The Government of the Republic of Liberia through the Liberia Medicines and Health Products Regulatory Authority (LMHRA) intends to apply part of its budgetary allocations from its GOL Budget and Internal revenue generation Budgets for fiscal year 2021/2022 for the procurement of ELECTRONIC MATERIALS.

The LMRHA now invites sealed bids from eligible registered bidders for the supply of Electronic Materials for FY 2022

Bidding will be conducted through the National Competitive Bidding process, a procedure specified in the PPCA and approved by the PPCC and is now open to all bidders.

Description and Quantity of Electronic Materials to be supplied:

  1. Electronic Materials———————————————————————— Assorted

Qualification requirements include:

  • Valid tax clearance
  • Valid Business registration certificate
  • Past performance records including the names and contact numbers of at least three (3) clients
  • Article of Incorporation
  • Evidence of PPCC Vendor registration
  • Bid Securing Declaration

A complete set of bidding documents in English may be purchased by interested Bidders from the Procurement Unit

  1. upon a payment of a nonrefundable fee of US$50
  2. For each set from February 22, from 9:00am to 4:00pm, Monday to Friday.

All bids must be accompanied by a bid securing Declaration.

Sealed bids must be delivered to the Procurement Unit of the LMRHA no later than 12:00 pm on March 23, 2022. Bids shall be valid for a period of 30 days after the deadline for submission of bids. Electronic bidding will not be permitted. Late bids will be rejected and returned unopened.

Bids will be opened in the presence of bidders or their representatives who choose to attend in the Conference Room on March 24, 2022 at 12:30pm.

The Address of the Procurement Unit is:

Sekou Toure Avenue Mamba Point

Contact: 0777564585/0888888125

Signed: ____________________________

Mrs. Hawa T. Tambah

Procurement Director LMRHA

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SUPPLY OF PRINTING & BINDING SERVICES

IFB.No.LMRHA/SBA/NCB/001/2022

The Government of the Republic of Liberia through the Liberia Medicines and Health Products Regulatory Authority intends to apply part of its budgetary allocations from its GOL Budget and  Internal revenue generation Budgets for the fiscal year 2022 for the Procurement of PRINTING AND BINDING SERVICES.

The LMRHA now invites sealed bids from eligible registered bidders for the provision of BILLBOARDS for FY2022

Bidding will be conducted through the Restricted Bidding process, a procedure specified in the PPCA and approved by the PPCC and is now open to all bidders.

Description and Quantity of Billboards to be provided:

  1. Billboards ————————————————————–Assorted
  2. Booklets, letterheads, stickers—————————————-Assorted

Qualification requirements include:

  • Valid tax clearance
  • Valid Business registration certificate
  • Past performance records including the names and contact numbers of at least three (3) clients
  • Article of Incorporation (if possible)
  •  Evidence of PPCC Vendor registration
  • Bid Securing Declaration

A complete set of bidding documents in English may be purchased by interested Bidders from the Procurement Unit

  1. upon payment of a non-refundable fee of US$50
  2. For each set from February 21, 2022, 9:00 am to 4:00 pm, Monday to Friday.

All bids must be accompanied by a bid securing Declaration.

Sealed bids must be delivered to the Procurement Unit of the LMRHA no later than 12:00 pm on March 22, 2022. Bids shall be valid for a period of 30 days after the deadline for submission of bids. Electronic bidding will not be permitted. Late bids will be rejected.

Sealed bids will be opened in the presence of bidders or their representatives who choose to attend in the Conference Room on March 22, 2022, at 1:00 pm.

The address of the Procurement Unit is:

Sekou Toure Avenue Mamba Point

Contact: 0777564585/0888888125

Signed: ____________________________

Mrs. Hawa T. Tambah

Procurement Director LMHRA