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DIRECTORATE OF REGISTRATION AND REGULATORY AFFAIRS
GUIDELINES FOR DONATION OF VACCINES IN NIGERIA
NAFDAC/RR/021/00

A. GENERAL

1. All donations should be based on an expressed need and be relevant to the disease pattern in the recipient country. Vaccines should not be sent without the prior consent of the recipient.

2. All donated vaccines should be approved for use in the recipient country.

3. The presentation, strength and formulation of donated vaccines should, as much as possible, be similar to those commonly used in the recipient country.

4. All donated vaccines should be obtained from a reliable source and comply with quality standards in both donor recipient country and the WHO Certification Scheme.

5. No vaccines should be donated that have been issued to patients and then returned to a pharmacy or elsewhere, or were given to health professionals as free samples.

6. All donated vaccines should have a shelf life of at least six months upon arrival in the recipient country. An exception may be made for direct donations. In all cases it is important that the date of arrival and the expiry dates of the vaccines be communicated to the recipient well in advance.

7. All vaccines should be labeled in English language; the label on each individual container should at least contain the international Non-proprietary Name (INN, or generic name,) batch number, dosage form, strength, name of manufacturer, quantity in the container, storage conditions and expiry date.

8. All vaccine donations should be packed in accordance with international shipping regulations, and be accompanied by a detailed packing list. The weight per carton should not exceed 50 kilograms. Vaccines should not be mixed with other supplies in the same carton.

9. Recipients should be informed of all vaccine donations that are being considered, prepared or actually underway.

10. Costs of international and local transport, warehousing, port clearance and appropriate storage and handling should be paid by the donor agency, unless otherwise agreed with the recipient in advance.

11. All vaccines donated shall meet relevant regulatory requirements before acceptance in Nigeria.

12. The presentation, formulation and strength of a donated vaccine shall be in compliance with approved requirements of such dosage forms in Nigeria.

13. Donated vaccines shall be accompanied by summary Lot protocol, certificate of release from country of origin and Certificate of Analysis of the batches.

14. Donated vaccines shall conform to good handling practice and consignment shall be monitored by the inspectorate Establishment Directorate of NAFDAC to ensure compliance with good storage practice.

15. Donated vaccines shall be subject to laboratory evaluation before being accepted.

B. APPLICATION
1. Application shall be made for donation evidencing need and relevance to recipient and addressed to:

The Director General, National Agency for Food and Drug Administration and Control (NAFDAC), 2032 Olusegun Obasanjo Way, Wuse
Zone 7, Abuja,

2. Documents to be attached are;
i) Summary lot protocol
ii) Lot release certificate
iii) Certificate of Analysis
iv) Evidence Cold chain maintenance.

C. TARIFF
No applicable fee

All correspondences in respect of donated vaccines should be addressed to:
The Director General
National Agency for Food and Drug Administration and Control (NAFDAC)
2032 Olusegun Obasanjo Way
Wuze Zone 7
Abuja.

OR

The Director
Registration and Regulatory Affairs Directorate
NAFDAC
Central Laboratory Complex, 3/4 Oshodi-Apapa Express Way, Oshodi, Lagos.
NAFDAC website: www.nafdac.gov.ng
e-mail: registration@nafdac.gov.ng
tel no.: +234-1-4772452

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