Licensing And Enforcement

OUR

Licensing and Enforcement

General

The Department of Licensing and Enforcement is mandated to strengthen the Inspection and Licensing of Premises and Import/Export Controls and ensure general enforcement of the MRSA and regulations. 

The Department is also responsible for the testing and analysis of samples through the laboratory services function.

The function contributes to BoMRA’s 3rd Strategic Goal of Establishing a Fully Functional Regulatory System by the year 2023.

List of Gazetted Inspectors

Dr Seima Dijeng

Acting CEO

Dr. Ndindonga Mosimane

Regulatory Officer

Ms. Tshegofatso Chilume

Manager Inspection and Licensing

Mr. Patrick Mokula Kgori

Regulatory Officer

Ms. Matshediso Ramotshabi

Regulatory Officer

Ms. Tebogo Mokotedi

Clinical Trials Manager

Mr. Lebogang Koitsiwe

Pharmacovigilance Manager

Ms. Kago Ntsetselele

Dossier Specialist

Ms. Ethel Sebua

Dossier Assessment Specialist

Mr. Nonofo Thipe

Legal and Corporate Secretary

Mr. Richard Leepo

Manager, Law Enforcement

Mr. Bashi Ntshonono

Enforcement Officer

Mr Amantle Diare

Enforcement Officer

The Role and Functions of each Unit

Inspections and Licensing-IL Unit:

Imports & Exports Control – IMPEX Unit

Enforcement Unit

Laboratory Services

Inspection of Pharmaceutical Operations

The Inspectorate is mandated by the MRSA to conduct inspections to assess compliance with the minimum requirements for operating a pharmaceutical business according to set standards.

The following inspection types shall be undertaken:

Spot-inspection

Routine inspection

Investigative inspection

Pre-licensing inspection

Licensing of Premises

The licensing function is tasked with the role of issuing the following types of licenses.

Manufacturers

Three types of manufacturers are licensed (issued in compliance with the applicable current Good Manufacturing Practices (cGMP).

  1. Human medicines
  2. Veterinary
  3. Medical devices

Wholesalers: Inspection conducted on facilities for Good Storage and Distribution Practices.

Retailers

Enforcement

Import/Export Control

BoMRA Inspectorate performs the following import/export control activities.

Issuance of permits: Issues import, export and transit authorization for both human and veterinary medicines and medical devices.

PoE Verification: To ensure all regulated products that are imported and exported comply with the set standards.

COLLABORATING PARTNERS

BOTSWANA UNIFIED REVENUE SERVICES (BURS)

PORT HEALTH

BOTSWANA BUREAU OF STANDARDS (BOBS)

DEPARTMENT OF VETERINARY SERVICES DVS

LOCAL AUTHORITIES

LICENSING COMMITTEE