For Non-Governmental Organizations (NGOs) & Individual/Corporate Donors :- Provisions Of The NAFDAC Guidelines For Donated Medical Products in Nigeria
The National Agency For Food and Drug Administration and Control (NAFDAC) guidelines on donated medical products in Nigeria are for the interest of the general public, donors and recipients of donor medical products.
It is necessary to emphasize that no donated medical product shall be imported into Nigeria unless it has undergone due processing with the NAFDAC in accordance with the regulations for drug donation.
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The recipient organization must demonstrate the capacity to handle the type and quantity of the drug product e.g. for cold chain products.
The recipient organization must also liaise with the NAFDAC State Co-ordinator in the location of project/program execution.
Products deleted from the application during assessment must not be imported and all approvals should be forwarded to the Heads of Ports of entry and respective state coordinators.
Heads of Ports of entry should under the NAFDAC Guidelines, get the contact of the focal person of the recipient organization for monitoring of program activities.
The recipient organization after obtaining approval and having successfully imported and cleared any donated drug, shall invite the NAFDAC state and or zonal offices in the area where the donated drugs are to be used to witness the event.
The NAFDAC state and/or zonal offices would periodically monitor and evaluate the level of compliance with the conditions of approval for each consignment of donated drugs.
A report should be generated regarding the donation exercise and the utilisation of the donated items and submitted to PVG/PMS state coordinators.
The Pharmacovigilance and Post Marketing Surveillance directorate of the agency shall also be involved in monitoring the public for any unexpected adverse drug reaction associated with the use of donated drugs.
The following important further provisions of the guidelines will thus be highlighted in detail.
Applications/Recipients/Donors
– An application for drug donation shall be made by the recipient organization in Nigeria to the Agency before the drug leaves the country of origin. The recipient organization must be an entity registered by the Corporate Affairs Commission(CAC).
– The application shall be in form of letter addressed to the Director General, NAFDAC, stating the type and quantities of the medical supplies or drug(s); including the generic name, strength, dosage form, manufacturing and expiry dates. The inventory list should be submitted in a soft editable copy (Ms Word/Excel).
– The identity and contact address of the donor and expected date of arrival at the port of entry shall be stated.
– The applicant should provide information on the port of arrival of the consignment before shipping.
– In addition, the following documents shall be attached:
i. Evidence of correspondence between the recipient and donor showing how the donation was initiated.
ii. Detail plan on how the program will be executed which must include: date, venue and details of its Nigerian contact/focal person must be included.
iii. Evidence that the donated drugs are relevant for the purpose and shall be of maximum benefit.
iv. Evidence of skilled professionals (Pharmacists) in the organization, be they volunteers or validly contracted by the organization (with evidence attached proving such engagement) who can handle the drugs safely.
v. The premises (warehouse) where the donated drugs will be kept pending usage must be licensed by the Pharmacist council of Nigeria (PCN) and evidence should be attached alongside the application form.
iv. The premises must not necessarily be owned by the recipient organization but could be owned by a third party which it has an understanding with a copy of an agreement to this effect attached.
Products
All donated drug products shall meet the following requirements:
-Be of good quality, safe and efficacious.
– The presentation, strength and formulation shall be as much as possible similar to those used in this country, unless specifically requested for by the recipient.
– Be labelled in English language and bear the generic name, batch number, dosage form, composition, strength, name of manufacturer, quantity in each container, storage condition and date markings.
– Shall be obtained from reliable sources and must comply with quality standards in Nigeria and donor country. (Evidence of complying with the quality standards of the Donor country should be attached).
Port Clearance Of Donated Drugs
– Upon arrival in the country, the following documents are required before clearance at the ports.
– A copy of the approval letter from the agency to import the donated drugs.
– A letter of undertaking as required by the port inspection Directorate attaching the following documents:
- A Single good declaration (SGD) form, if applicable.
- Certificate of analysis.
- Packing list.
- Clean report of inspection/evidence of destination inspection (if applicable).
- Narcotics permit to import and clear (if applicable).
- Bill of lading/Airway bill.
- Pre-Assessment Arrival Report (PAAR).
- Invoice or letter transferring the donated drug from the donor to the recipient containing the name and quantity of drugs.
Tariff
Donated drugs are exempted from all processing fees, however where the need for product laboratory analysis arises, the recipient may bear the cost.
Report
– On completion of the proposed program, the recipient organization is required within thirty (30) calendar days to provide feedback to the Agency’s Pharmacovigilance and Postmarketing Surveillance (Pv/PMS) Directorate and a copy to the Drug Registration and
Regulatory Affairs Directorate by forwarding a detailed report that must include:
- pictorials,
- detailed distribution record,
iii. stock utilization record of the donated drugs,
- any other pertinent details.
– Failure to do so may result in denial of future requests.
Conditions For Destruction
– Where drugs donated do not comply with requirements, or are expired upon arrival, the NAFDAC shall seize and destroy the drugs.
– The recipient shall bear the cost of destruction as stipulated in the appropriate guidelines with the Investigation & Enforcement Directorate.
Notes
– Donated medical product are drugs, drug products and medical devices sent by a Donor to a Recipient in Nigeria in the face of a disaster and suffering or on humanitarian basis which may or may not be on request.
– A copy of the approval letter issued by Drug Registration and Regulatory Affairs Directorate should always be forwarded to the Ports Inspection Directorate, the Directorate, Pharmacovigilance and Post marketing Surveillance and the Director-General’s Office.