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:
- Medicinal products and Medical devices
- Chemical substances and Cosmetics
- Herbal/complementary products
- Food/dietary supplements Ebikes Store
- Nutritional agents including energy drinks beverages and packed and bottled water.
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)
1. What is an Adverse Drug Reaction (ADR)/ Side effects?
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.
2. What is a serious ADR?
A serious ADR
is:
· Fatal
· Life-threatening
· Causes hospitalization or
prolongs hospitalization
· Causes a congenital abnormality
· Causes disability or incapacity
3. Which ADRs should be reported by health professionals or consumers?
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
4. Who should submit suspected ADR reports?
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).
5. Why should ADRs be reported?
·
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.
6. How can healthcare professionals identify ADRs?
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.
7. Do I need to be sure the drug caused the reaction?
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-
https://primaryreporting.who-umc.org/SL
In addition the National Pharmacovigilance Centre can be contacted on mobile: at
099117117 or
by e-mail: at drugsafety@pharmacyboard.gov.sl. Or info@pharmacyboard.gov.sl
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
Postal address
The
Registrar
Pharmacy Board of Sierra
Leone
Central
Medical Stores New England Ville Freetown PMB 322
Tel :(0023222) 025-282826 Email: registrar@pharmacyboard gov.sl or info@pharmacyboard.gov.sl Website:pharmacyboard.gov.sl
Kono Regional Office
57 Masinqbi
road
Koidu city
Email:
konooffice@pharmacyboard.gov.sl
Tel: 025-388748
Lungi Office
Freetown
International Airport
Lungi
Email:
pbsllungi@gmail.com
Tel: 077-527220
Bo Regional Office
Bo-Kenema
Highway
Nyagolihun
junction
Email: booffice@pharmacyboard.gov.sl
Tel: +232-76466786
Kenema Regional office
9 Humonya Avenue
Tel: 025582886
Email: registrar@pharmacyboard.gov.sl
Makeni Regional Office
87 Aluzin highway
Makeni
Tel: +2327885547