You need to register your products so that the Pharmacy Board will ensure that medicines and other related products that are manufactured imported exported distributed and/or utilized in Sierra Leone are of good quality fit for human consumption and are of the optimum safety.
These products must be registered:
Three months if all requirements of a compliant application are met.
You begin with an application letter addressed to the Registrar of the Pharmacy Board of Sierra Leone Central Medical Stores New England Ville. You purchase relevant registration/application forms from the Pharmacy Board of Sierra Leone’s office at New England and then pick up the applicable guidelines.
Head Quarters-Central Medical Stores New England Ville Freetown Sierra Leone. Regional Offices- Bo Kenema Makeni and Kono.
Product registration takes a maximum of three months after the date of submission of a complete application.
No test marketing of products is not permitted.
You can get the list from the Pharmacy Board Office.
The flowchart is shown below.
Adverse Drug Reaction Reporting - Frequently Asked Questions (FAQs)
A response to a medicinal product that is noxious and unintended and which occurs at doses normally used in man for the prophylaxis diagnosis or therapy of disease or the restoration correction or modification of physiological function.
A serious ADR is:
· Causes hospitalization or prolongs hospitalization
· Causes a congenital abnormality
· Causes disability or incapacity
The Pharmacy Board of Sierra Leone encourages reporting of all suspected ADRs including product quality defects treatment failure medication errors drug resistance drug abuse drug-drug or drug-food interaction effects and any other medicine-related problems
The patients and the general public medical doctors and pharmacists. Nurses pharmacy technicians laboratory scientists community health officers and other healthcare professionals are all requested to report suspected adverse drug reactions (ADRs).
· Tests in the laboratory and animals are insufficiently predictive of human safety;
· In clinical trials patients are selected and limited in number the conditions of use differ from those in clinical practice and the duration of trials is limited;
· Information about rare but serious adverse drug reactions (ADRs) chronic toxicity use in special groups or drug interactions is often incomplete or unavailable.
Patients may tell healthcare professionals (HCPs) about symptoms they have experienced since taking a medicine. However some ADRs may not be apparent to the patient. HCPs need to be alert to the possibility of suspected ADRs and link signs or symptoms to current or previous drug therapy. In addition HCPs should be alert for abnormal clinical measurements and laboratory results or when new drug therapy is initiated to treat the symptoms of an ADR.
No the reporter need only suspect that the medicinal product may have caused the adverse reaction experienced by the patient. If in doubt please report.
8. From where can I get the reporting form?
To report a side effect or other drug-related problems complete an ADR reporting form available at all tertiary secondary and primary healthcare facilities pharmacies and drug stores nationwide. Reporting forms can also be obtained from the central and regional offices of the Pharmacy Board of Sierra Leone in Freetown Kenema Bo Makeni and Kono.
You can also download the adverse drug reaction form from our website www.pharmacyboard.gov.sl or report online by clicking the Report an adverse drug reaction on the PBSL website and submit your report (Click or go to this link for online reporting-
In addition the National Pharmacovigilance Centre can be contacted on mobile: at 099117117 or
9. Where can further information about the safety of medicines be found?
Should you require further information you are kindly asked to contact the Pharmacy Board of Sierra Leone the contact details of which are supplied below.
PBSL HEAD OFFICE
Pharmacy Board of Sierra Leone
Central Medical Stores New England Ville Freetown PMB 322
Tel :(0023222) 025-282826 Email: registrar@pharmacyboard gov.sl or email@example.com Website:pharmacyboard.gov.sl
Kono Regional Office
57 Masinqbi road
Freetown International Airport
Bo Regional Office
Kenema Regional office
9 Humonya Avenue
Makeni Regional Office
87 Aluzin highway