LMHRA Promulgates Seven New Regulations

The Liberia Medicines & Health Products Regulations Authority (LMHRA) in collaboration with the United States Pharmacopeia, through the Promoting of Quality Medicines Plus (USP PQM+), has promulgated seven new regulations that seek to guide the pharmaceutical sector of Liberia.

The promulgation of these regulations by the LMHRA is in fulfillment of Part 5 Section 7 of the Liberia Medicines & Health Products Regulations Authority Act of 2010; which confers upon the authority, the responsibility of regulating medicines and health products within the country. Hence, LMHRA management, with approval of the Board of Directors, on January 6, 2022, approved seven new regulations that will guide how medicines and health products are regulated in Liberia.

The seven regulations promulgated by the authority are Advertisement on Medicines & Health Products; Regulations on Donations of Medicines & Health Products; Regulations on Withdrawal, Recall, and Confiscation and Regulations on Treatment and Disposal of Medicines & Health Products.

Other regulations also promulgated by the LMHRA include Regulations on Registration of Medicines & Health Products; Regulations on Labelling of Medicines & Health Products and Regulations on Importation & Exportation of Medicines & Health Products.

On the 25th and 26th of May 2022, the LMHRA held a Presentation and Dissemination Meeting at USP PQM+-Liberia offices, with Importers (Commercial), County Pharmacists, Superintendent Pharmacists, Pharmacists of medical institutions, Non-Governmental Organizations (NGOs Importers), USAID, PQM+ and the Ministry of Health, as well as institutional bodies like Medicine San Frontier, Samaritan Purse, Partners in Health and Last Mile Health among others.

The meeting was held to circulate to stakeholders in the sector, the seven new regulations promulgated by the regulatory authority.

The purpose of the regulations on advertisement is a legal framework for the effective and efficient regulation of advertisement of Over the Counter (OTC) medicines and health products. The guiding principle for the advertisement of OTC medicines and health products is to ensure the health and safety of all people within Liberia.

While the purpose of the regulation on registration is to provide a legal framework to ensure effective and efficient regulation of the registration of all medicines and health products; and to provide an open, transparent and non-discriminatory process for the registration of all medicines and health products coming into the country.

At the same time, the regulations on donations seek to ensure that all donated medical products meet the current World Health Organization (WHO) Guidelines as well as the 2014 guidelines for the donation of medicines and medical supplies to Liberia and the National Standard Treatment Guidelines of Liberia.

Accordingly, the regulation on importation and exportation is to provide a regulatory framework for the effective and efficient importation and exportation of medicines and health products.

Also, the regulation on labeling provides legal frameworks for the effective regulations of the label(s) that is or are printed/affixed to packaging material, including leaflet, which provides the necessary information about the medicine and ensures misleading information is not disseminated to the public.

And, the regulation of treatment and disposal of unfit medicines and health products provides a legal framework for the effective and efficient handling, treating, and disposing of unfit medicines and health products and also provides a transparent and non-discriminatory process for the treatment and disposal of unfit medicines and health products to protect human health and the environment from potential health hazards.

Several Technical Staff of the LMHRA’s Inspectorate, Registration & Evaluation, and Pharmacovigilance departments made separate presentations during the two-day event.

Other regulations governing the pharmaceutical sector are being drafted and would also subsequently be adopted and approved by the Board of Directors of the LMHRA.

The Liberia Medicines & Health Products Regulatory Authority 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 of good quality.