Pharmaceutical Product Registration in Lesotho

Transfer of Certificate of Registration

The certificate of registration is transferable. If a certificate holder wishes to transfer it, an application must be submitted to the Board for approval to transfer it to another person eligible for the registration of a medicine or medical device. The application must be submitted in a form determined by the Minister, accompanied by a copy of the certificate to be transferred, and a transfer fee determined by the Minister.

Cancellation or Amendment of Registration

The Board has the authority to cancel or amend the registration of a medicine or medical device under various circumstances, including when it is not in the public interest, the retention fee is unpaid, the holder fails to comply with set conditions, the product no longer meets requirements, false advertisements, or non-compliance of manufacturing premises with set standards.

• Before cancellation or amendment, the Board must:
  • Provide notice to the holder about the intention to cancel or amend.
  • Give the holder an opportunity to appear before the Board and present their case.
  • Specify the grounds for the proposed cancellation or amendment.
  • Allow the holder to provide reasons why the registration should not be cancelled or amended.
  • Direct the Chief Executive Officer to make necessary entries in the register if cancellation or amendment is deemed necessary.

Notification of Registration, Cancellation, or Amendment

The Minister is mandated to inform the public through Gazette notices about the registration, cancellation, or amendment of medicines or medical devices. For registered items, the notice details include the name, active components, applicant and manufacturer names, registration number, and any associated conditions. In cases of cancellation or variation, the notice includes the registered name, applicant name, and registration number.

Medicines Register

The register contains comprehensive information on various entities related to medicines and medical devices, such as registered medicines, complimentary medicines, medical devices, cosmetics, licensed individuals dealing with these products, licensed premises, nutraceuticals, and related substances. The Chief Executive Officer manages this register in electronic form.

Amendment and Cancellation of Entries

Any person can request changes or cancellations for a medicine entry in the register by submitting an application in a prescribed form along with a fee. The Chief Executive Officer forwards these applications to the Board for consideration. If approved, the Chief Executive Officer updates the register accordingly.

Retention Fee

Certificate holders are required to pay an annual retention fee for each registered medicine or medical device. The Minister determines the form and manner of payment, setting an annual fee applicable to all registered medicines or medical devices.

Purchase and Sale by Wholesalers

Wholesalers can only purchase medicines or medical devices from manufacturers or primary importers. They are authorized to sell these products to the retail sector or other wholesalers based on the authorized category of Schedules determined by the Board. If a product lacks safety, quality, or efficacy, the importer or wholesaler can return it to the manufacturer for a refund. Violation of this process is considered an offense.

Return of Undesirable Medicine and Medical Device

If the Board deems a medicine or medical device against public interest, it can direct individuals possessing such items to return them to the manufacturer or importer or deliver them to a designated person. Failure to comply with this directive is an offense, punishable by a fine, imprisonment, or both.

Licensing of Persons Handling Medicines or Medical Devices

No individual shall engage in manufacturing, dispensing, selling, distributing, or importing medicines or medical devices unless granted a license by the Board. Furthermore, the premises where these activities occur must meet the standards set by the Board. Licensing eligibility depends on qualifications and adherence to prescribed terms and conditions. Failure to comply constitutes an offense punishable by fines, imprisonment, or both.

Application for a License

Individuals seeking to manufacture, dispense, sell, distribute, or import medicines or medical devices must submit a written application to the Board. The Board may request additional information if necessary. Upon satisfaction of prescribed requirements and payment of fees, the Board issues a license within thirty days of receiving the application. 

For applications from registered companies, a shareholder and director must be a pharmacist and a citizen of Lesotho. The Board may refuse licenses that do not meet requirements, informing applicants in writing with reasons for refusal. Licenses are valid for one year and subject to renewal under previous terms and conditions.

Cancellation, Suspension, or Amendment of a License

Licenses may be cancelled, suspended, or amended if holders fail to comply with prescribed terms or if the Board deems it in the public interest. Holders dissatisfied with such decisions may appeal to the Appeals Committee against cancelation, suspension, or amendments, as well as conditions and requirements of issuance.

Importation and Exportation of Medicines or Medical Devices

Importing or exporting medicines or medical devices requires licensing under the Act or authorization by the Board for unregistered items. The container or package must bear labels in Sesotho or English, and the products must comply with quality, efficacy, and safety standards set by the Board. A certificate issued by the Board, upon payment of fees, is necessary for such importation or exportation. Failure to comply constitutes an offense punishable by fines, imprisonment, or both.