NAFDAC (Vaccine and Other Biological Products (Lot Release) Regulations Statutory Instrument no. 50 of 2024

Extraordinary Federal Republic of Nigeria Official Gazette No. 255 Lagos - 6th November, 2024 Government Notice No. 55 The following is published as supplement to this Gazette: S. I. No. Short Title 50 NAFDAC (Vaccine and Other Biological Products (Lot Release) Regulations. 2024 Printed and Pub I ished by The Federal Government Printer. Lagos. Nigeria r-GP 81/112024/150 Vol.111 Page B 1021-1028 Annual Subscription from I st January. 2024 is Local : NI 00.000.00 Overseas : N 130,000.00 [Surface Mail] N 150.000.00 I Second Class Air Mail]. Present issue N3.500 per copy. Subscribers who wish to obtain Ga::elle afler I st January should apply to the Federal Government Printer. Lagos for amended Subscriptions. NAFDAC (VACCINE AND OTHER BlOLOGICAL PRODUCTS (LOT RELEASE)) REGULATIONS, 2024 ARRANGEMENT or R1 GULAI ION~ Regulation : PARl I - OBJECTIVE A'sl) APPi ICMION 1. Objective 2. Application PART II - Rrn1sTRA110N. LABELLING, Docu~1.NIATI0N AND LoT RELEASES 01 VAcc1Nrs, AND OnlDER B1010G1CAL PRODUCTS 3. Registration of vaccine and other biological products 4. Labelling infonnation 5. Submission of application for Lot release of Vaccine and other biological products 6. Documentation 7. Proofof cold chain integrity 8. Procedure for Lot release vaccines and other biological products 9. Issuance of Lot Release Certificate 10. Issuance of Lot Rejection Certificate 11. Expedited Lot Release 12. Further Lot Release 13. Vaccine Vial Monitor 14. Lot Release Timelines 15. Regulatory Reliance 16. Prohibition PART 111 -OFFrNCES AND PrNAI TIES 17. Offences and penalties 18. Forfeiture after conviction PART IV - M1sn1.1ANrous 19. Enforcement of these Regulations 20. Interpretation 21. Citation B 1021 B 1023 S. I. No. 50 of 2024 NAFDAC (VACCINE AND OTHER BIOLOGICAL PRODUCTS (LOT RELEASE)) REGULATIONS, 2024 [ 16th Day of October, 2024] Commence- ment In exercise of the powers conferred on the Governing Council of the National Agency for Food and Drug Administration and Control ("the Governing Council") by section 30 of the National Agency for Food and Drug Administration and Control Act, Cap. N 1, LFN, 2004 and section 12 of the Food, Drugs and Related Products (Registration, Etc.) Act, Cap. F33. LFN, 2004 and all other powers enabling it in that behalf, the Governing Council, with the approval of the Minister, makes the following Regulations - PART I - OBJECTIVF AND APPLICATI01\ 1. The objective of these Regulations is to ensure that vaccines and Objective other biological products imported, exported, distributed, advertised, sold, displayed for sale or used in Nigeria are safe and comply with the provisions ofthese Regulations. 2. These Regulations shall apply to the lot release of vaccines and other Application biological products manufactured, imported, exported, advertised, sold, displayed for sale distributed or used in Nigeria. PART II - REGISTRATION, LABELLING, DOCUMl:NTATI0N AND LOT RELEASES OF VACCINES, AND OTHER BIOLOGICAL PRODUCTS 3. The registration of vaccines and other biological products shall be in accordance with the provisions of the Agency's Regulations on Drug and Related Products Registration and other relevant Guide I ines. 4. Vaccines and other biological products shall be labelled in accordance with the provisions of the Agency's Regulations on Drug and Related Products Labelling and other relevant Guidelines. 5. An applicant for a Certificate of Registration shall - (a) fill out an application form as prescribed by the Agency for the lot release of the vaccines and other biological products; (b) submit the application and pay the prescribed fee to the Agency; and (c) submit any other document as may be requested by the Agency. 6.--{ I) An applicant for a Certificate of Registration shall submit to the Agency the following documents with each batch subjected to independent lot release - Registration of,accincs and other biological products Labelling information Submission of application for lot release of vaccines and other biological products Doo..m1entation B 1024 Proof of cold chain int.:grit) (a) notification of product release from Ports Inspection Directorate (PIO), where applicable; (b) summary lot protocol; (c) National Regulatory Authority (NRA) lot release certificate from country of origin, where applicable; (d) Plasma Pool Certificate, for plasma derived medicinal products; (e) certificate of analysis of finished product; (f) certificate of analysis of solvent, where applicable: (g) proofofcold chain integrity: and (h) any other document as be requested by the Agency. (2) In the case of products using albumin as stab ii izer, an applicant or a holder of certificate of registration shall submit- (a) batch release certificate for albumin batch used from country of origin; and (b) declaration on link between albumin batch used in the production and the batch of finished product. (3) Documents to be submitted annually or when required by the Agency are - (a) annual product quality report; (h) Good Manufacturing Prartice (GMP) certificate; and (c) any other document as may be requested by the Agency. 7.-( I) A holder of Certificate of Registration shal I submit to the Agency a Vaccine Arrival Report (VAR) for each lot to be released. (2) Where a lot is imported in multiple shipments, each shipments' documentation shall be clearly distinguished. (3) The VAR shall include - (a) the product name and lot number clearly indicated on al I documents; (h) the date, time and location of dispatch and receipt of shipment; (c) copy of the air waybill; (cf) the quantity per shipment; (e) packing list indicating the number of containers and shipment, and the number of doses per container and shipment: (f) detailed temperature monitor check sheet: (g) the vaccine lot number and the number of the container, and shipment clearly indicated on the document displaying the temperature monitor data; (h) supporting documentation which shall be attached showing the serial numbers of electronic monitors used in each container of the shipment; (i) raw data from electronic temperature monitoring devices; and (i) any other document related to VAR as may be prescribed by the Agency. 8. Vaccines and other biological products shall be subject of­ (a) inspection on arrival and sample collection at relevant point; (b) review of relevant documents; (c) laboratory testing; and (d) any other requirement as may be prescribed by the Agency. 9. Where the Agency is satisfied that there is the need to release the lot of any vaccine and other biological products, it shat I do so and issue to the applicant a Lot Release Certificate signed by the Director, Vaccines, Biological and Medical Device Laboratory Services Directorate (YBM-LSD) or the designate, subject to such conditions as it may deem fit. l 0.-( 1) Where the Agency is unsatisfied with the outcome of the review of application for lot release of any vaccine and other biological products, it shall issue to the applicant a Lot Rejection Certificate signed by the Director, Vaccines, Biological and Medical Device Laboratory Services Directorate (VBM-LSD) or the designate. (2) The vaccines and other biological products referred to in subregulation ( 1) of this regulation shall be disposed in accordance with the Agency's Regulations on Recall, Handling and Disposal of Substandard and Falsified Medicinal Products and other relevant Guidelines as may be prescribed by the Agency. B 1025 Procedure for lot release of vaccines and other biological products Issuance of Lot Release Certificate Issuance of Lot Rejection Certificate 11.-( I) Upon appropriate justification, the Agency may grant expedited Expedited lot release of vaccine and other biological products in exceptional cases, lot release including- (a) product shortage in Nigeria; (b) public health emergency; (c) biological products donated from international organisations; (d) urgent need as may be determined by the Agency; and (e) any other case as may be determined by the Agency. (2) Vaccines for expedited lot release shall be accompanied by - (a) Lot Release Certificate issued by the responsible NRA or National Control LaboratOI)' (NCL); and (b) application for expedited lot release submitted to the Agency accompanied with the prescribed fees, where applicable. 12.-( I) Consignments with identical final labelled primary container Further lot lot, including identical expiration dates, imported after the release of the first release consignments, shall be regarded as a further lot release. (2) The importer shall submit VAR, proofof secondary packaging and a copy of the lot summary protocol to the Agency. B 1026 Vaccine Vial Monitor Lot release timelines Regulator) reliance Prohibition (3) The importer shall, inform the Agency in writing that the shipment is a further lot release and provide evidence of first lot release certificate. (4) The Agency may release the lot after evaluation of relevant documents. 13. Vaccines manufactured, imported, exported, advertised, sold. distributed, or used in Nigeria shall be accompanied with the Vaccine Vial Monitor (VVM) for the period of its use. 14. The timeline for each activity in the lot release process shall be as may be prescribed by the Agency. 15.-{ I) The requirement for routine independent lot release testing sh al I be based on a risk assessment or application reliance. (2) The Agency shall consider the risk assessment of post-marketing experience related to the quality. safety and efficacy of the product. (3) The Agency may consider reliance on some tests or reduced independent testing, subject to the availability of a Lot Release Certificate issued by a releasing NCL that is a full member of the World Health Organisation National Control Laboratory Network for Biologicals (WHO­ NNB) or as detailed in the Agency·s Regulatory Directives. 16. A person shall not manufacture, import. export, distribute, advertise, sale, display for sale or use any vaccine or other biological products except the lot release of such vaccine or other biological products is in accordance with the provisions of these Regulations. PART Ill - OIFLNCTS /\NO PEJ\i\LTIES Ofli!nccs and 17 .-{I) A person who contravenes any of the provisions of these penalties Regulations commits an offence and is liable on conviction, in the case of- (a) an individual, to imprisonment for a term not exceeding one year or to a fine not exceeding N800,000 or both; and (b) a body corporate, to a fine not exceeding NS,000,000. (2) Where an offence under these Regulations is committed by a body corporate, firm or any other association of individuals, every- (a) director, manager, secretal) or other similar officer of the body corporate; (b) partner or officer of the firm; (c) trustee of the body concerned: (cl) person concerned in the management of the affairs of the association; or (e) person who purports to act in a capacity referred to in paragraphs (a) to (cl) of this regulation, is liable to be proceeded against and punished for the offence the same manner as if the person committed the offence, unless the person proves that the act or omission constituting the offence took place without his knowledge, consent or connivance. 18.-( I) A person convicted of an offence under these Regulations shall forfeit to the Federal Government- (a) asset or property constituting proceeds derived from or obtained, directly or indirectly, as a result of the offence: and (b) any of the person's property or instrument used in any manner to commit or facilitate the commission of the offence. (2) In this regulation, "proceeds" means any property derived or obtained, directly or indirectly, through the commission of the offence. PART IV -MISCELLANEOUS 19. The Agency shall be responsible for the enforcement of these Regulations. 20. In these Regulations - "Agency" means National Agency for Food and Drug Administration and Control; "Annual Product Quality Report (APQR)" means a report submitted annually by manufacturers to the NRA or NCL containing production information on both bulk and final lots, including test methods and results, reasons for any recalls and corrective action taken, as well as other pertinent post-market information; "Lot" means a defined quantity of starting material, packaging material, or product processed in a single series of processes so that it is expected to be homogeneous; "Lot release" means the process of NRA or NCL evaluation of an individual lot of a licensed vaccine before giving approval for its release into the market; "Lot release certificate" means an official document that authorizes the manufacturer to release the specific lot into the market; "Lot Summary Protocol" means a document summarizing all manufacturing steps and test results for each producing lot which is certified and released by the responsible person of the manufacturing company and the test results shall include the test specification and date of test conducted; "Minister" means the Coordinating MinisterofHealth and Social Welfare; "C!ther Biological Products" means biologicals products except human vaccines; B 1027 Forfeiture after conviction Enforcement of these Regulations Interpretations B 1028 Citation "Plasma Derived Medicinal Products (PDMPs)" means products prepared industrially from human plasma by pharmaceutical companies; and "Vaccine" means suspension of weakened, killed, or fragmented microorganisms or toxins or other biological preparation, such as those consisting of antibodies, lymphocytes, or messenger RNA (mRNA), that is administered primarily to prevent disease. 21. This Regulations may be cited as the Vaccines and Other Biological Products (Lot Release) Regulations, 2024. MADE at Abuja this 16th day of October, 2024. MUHAMMAD Au PATE, CON Coordinating Minister of Health and Social Welfare