FREQUENTLY ASKED QUESTIONS FOR EXPORTS TO THE FEDERAL REPUBLIC OF NIGERIA FROM INDIA

1. What are the regulations for the import of Foodstuffs (including drinks), pharmaceuticals (Allopathic, Ayurvedic, Siddha & Unani) and chemicals into Federal Republic of Nigeria ?

2. Can we export to The Federal Republic of Nigeria if we comply with the expiry dates and/or shelf life and specify active ingredients where applicable on their packaging for Foodstuffs (including drinks), pharmaceuticals and chemicals ?

3. What points are mandatory to be looked into for exporting Pharmaceuticals to The Federal Republic of Nigeria ?

4. Is Physical Inspection of the consignment is mandatory ?

5. When should we request SILIS Labs Pvt. Ltd. for inspection ?

6. What should we do for requesting for inspection with SILIS Labs Pvt. Ltd., Ahmedabad, Gujarat ?

7. What are the necessary documents, details to be sent via courier to the SILIS Labs Pvt. Ltd., Ahmedabad, Gujarat on requesting for inspection?

8. To which address we should send these necessary documents for the request of inspection made to SILIS Labs Pvt. Ltd. ?

9. What documents etc. are to kept as a Manufacturer / Exporter for the consignment requested for inspection ?

10. What documents are the documents / details to be kept ready during the visit of inspector from SILIS Labs Pvt. Ltd. ?

11. Documents as detailed in Point No. 9 is to be handed over to the inspector from SILIS Labs Pvt. Ltd. ?

12. What the inspector would inspect / do ?

13. Will the inspector inspect in case the consignment is FCL ?

14. What details are mandatory on primary and secondary packing material as per NAFDAC ?

15. How many samples will be withdrawn ?

16. Why these many samples and does it free us from retaining the samples at our premises ?

17. Do we have to replace these samples withdrawn ?

18. Can we do something to fasten the testing procedure for injectable products ?

19. How much we have to pay for the inspection ?

20. What would happen if we request for inspection and on arrival of inspector from SILIS Labs Pvt. Ltd. the consignment is not ready for inspection ?

21. Payments are to be made by Bank Cheque / Bank Draft and what should be indicated ?

22. When we can get the Clean Report Of Inspection And Analysis (CRIA) for the inspected goods with signed Invoice and Packing List from SILIS Labs Pvt. Ltd. ?

23. What happens in case the product fails in the analysis ?

24. Do we get back the testing amount in case the samples fail in analysis ?

25. How long the CRIA will be valid for the related Invoice, Packing List, Product inspected and sampled ?

26. Can we export goods without having the related signed Invoice, Packing List and Clean Report Of Inspection And Analysis (CRIA) from SILIS Labs Pvt. Ltd. ?

27. Are there chances of goods seizure in absence of CRIA and related Invoice and Packing List stamped and signed by SILIS Labs Pvt. Ltd. ?

28. What document does NAFDAC require to clear regulated Products at the Ports?

29. Can our importer be able to get information on the testing / release of the consignment intended to his company ?

30. We still have questions to be clarified, what do we do ?

1. What are the regulations for the import of Foodstuffs (including drinks), pharmaceuticals (Allopathic, Ayurvedic, Siddha & Unnani) and chemicals into Federal Republic of Nigeria ?

Foodstuffs (including drinks), pharmaceuticals and chemicals should carry batch no., expiry dates and/or shelf life and specify active ingredients where applicable on their packaging.

2. Can we export to The Federal Republic of Nigeria if we comply with the expiry dates and/or shelf life and specify active ingredients where applicable on their packaging for Foodstuffs (including drinks), pharmaceuticals, APIs, Excipients and chemicals ?

No, it is unlawful to import into The Federal Republic of Nigeria any regulated product not duly registered by The National Agency for Food, Drug Administration & Control (NAFDAC). Therefore the primary and secondary package should have this unique NAFDAC registration number printed on it. Agents of foreign manufacturers are to take the necessary steps to ensure that regulated products intended for the Nigerian market are registered before consignments of such products are imported into the country.

In the event of any violation in this regard, the consignment of the unregistered product would be cleared from the ports to a bonded warehouse at the expense of the importer. Thereafter the importer is prosecuted and the products forfeited to the Government together with any assets or property obtained or derived directly or indirectly from the commission of the offence.

3. What points are mandatory to be looked into for exporting Pharmaceuticals to The Federal Republic of Nigeria ?

When a foreign regulated product is duly registered by NAFDAC, it can be lawfully imported, distributed and sold in Nigeria. The procedures for the exportation of such regulated products are as follows:

• The Manufacturer / Exporter of the goods (i.e. the party with whom the Nigerian importer has a contractual relationship) shall be required to arrange for the physical inspection of goods with the NAFDAC appointed inspection company i.e. SILIS Labs Pvt. Ltd., Ahmedabad, Gujarat in the country of supply i.e. India.
• The Manufacturer / Exporter shall make the necessary arrangements for handling and presentation, of the goods for the purpose of inspection and any expenses incurred therefore shall be for his account. In the event that the Manufacturer / Exporter has called in the Company without having prepared the goods for inspection, or in the event that the goods have been inspected and are found not to be up to requirements or specifications, the expenses of any additional intervention by the Company shall be borne by the Manufacturer / Exporter.
• The Manufacturer / Exporter shall provide the appointed inspection agent i.e. SILIS Labs Pvt. Ltd., Ahmedabad, Gujarat with a copy of the packing list, final invoice and any other document as would be requested by the inspection agent i.e. SILIS Labs Pvt. Ltd., Ahmedabad, Gujarat.

4. Is Physical Inspection of the consignment is mandatory ?

YES

5. When should we request SILIS Labs Pvt. Ltd. for inspection ?

The request has to be made only after the consignment is manufactured in totality, analyzed and entirely packed as if ready for the shipment.

6. What should we do for requesting for inspection with SILIS Labs Pvt. Ltd., Ahmedabad, Gujarat ? For what time period the inspection would be valid ?

First the account is to be created on silis website by visiting www.silislabs.com Details as requested are to be filled by creating an account on by all Manufacturer / Exporter, who intend to export the goods (pharmaceuticals) to the importer at The Federal Republic of Nigeria. These details are to created for one time only.

Further request for inspection has to requested online through logging on to www.silislabs.com a unique ID would be generated for the said Invoice, Packing List and goods intended for inspection and this has to be quoted at all times during any correspondence.

The inspection request has to be made keeping a lead time of minimum 7 (seven) working days and therefore accordingly “from” and “to” dates for inspection are necessary to mention while making the inspection request.

The inspection related to any related Invoice and Packing List would be valid for a period of 60 (Sixty) days only from the date of withdrawing of samples against the said Invoice and Packing List.

7. What are the necessary documents, details to be sent via courier to the SILIS Labs Pvt. Ltd., Ahmedabad, Gujarat on requesting for inspection?

• Detailed Packing List – two copies for endorsement
• Copy of Export Invoice in Two identical original for endorsement.
• Certificate of Analysis (COA) in Original of each batch & for each product to be exported,
• Active Raw Material Reference standard with it’s Certificate of Analysis (COA) and Method of Analysis ( MOA),
• Method of Analysis (MOA) if the product is patent and proprietary medicine.
• Copy of valid Drug Manufacturing License as issued by related Indian State Drug Authority,
• Copy of valid product manufacturing license (product permission) as issued by related Indian State Drug Authority,
• Copy of valid COPP and WHO GMP Certificate
• Product Registration Certificate as issued by NAFDAC, Nigeria for the product in question for inspection,
• In case of absence of Product Registration Certificate as issued by NAFDAC, Nigeria copy of “Payment Advice for Registration Certificate” and “Treasury Receipt for Registration Certificate” to be enclosed,

All copies should be attested by authorized signatory as appointed by the exporting organization.

8. To which address we should send these necessary documents for the request of inspection made to SILIS Labs Pvt. Ltd. ?

SILIS Labs Pvt. Ltd.
505, Safal Prelude
Opp Prahladnagar AUDA Garden,
Off. 100 ft. Satellite Road,
Satellite Ahmedabad – 380015,
Gujarat, India.
Phone : (079) 29096952 / 29096953
Fax : (079) 26840049 / 46
e-mail : support@silislabs.com
Web : www.silislabs.com

9. What documents etc. are to kept as a Manufacturer / Exporter for the consignment requested for inspection ?

• BMR of each product & each Batch to be kept in safe custody with the manufacturer / exporter.
• Sufficient sample of product of the same batch (as withdrawn by the inspector) to be kept safely with the manufacturer for a period shelf life plus six months

All copies should be attested by authorized signatory as appointed by the exporting organization and the box would be sealed by the inspector of SILIS Labs Pvt. Ltd.

10. What documents are the documents / details to be kept ready during the visit of inspector from SILIS Labs Pvt. Ltd. ?

• Detailed packing list – one copies
• Certificate of Analysis in Original of each batch & for each product to be exported,
• Active Raw Material Reference standard and COA with MOA,
• Method of analysis if the product is patent and proprietary medicine.
• Product Registration Certificate as issued by NAFDAC, Nigeria for the verification of NAFDAC No. of the product in question for inspection or copy of “Payment Advice for Registration Certificate” and “Treasury Receipt for Registration Certificate”

All copies should be attested by authorized signatory as appointed by the exporting organization.

11. Documents as detailed in Point No. 9 are to be handed over to the inspector from SILIS Labs Pvt. Ltd. ?

YES

12. What the inspector would inspect / do ?

The inspector would verify all the details as detailed in the Packing List with special emphasis on :

• Correctness and legibility of NAFDAC Registration no. on Primary & Secondary packing Material with reference to the provided NAFDAC Registration Certificate / Treasury Receipt for the said product offered for inspection
• Full Name of the Manufacturer on Primary and Secondary Packing material.
• Full location address of the manufacturer
• Name of the Product (brand and generic names where applicable)
• Date of Manufacture
• Expiry Date or Best Before Date
• Batch Number
• Manufacturing License No.
• Direction for storage and use.
• Correctness and legibility of Shipping Marks
• Leaf insert with all relevant details with name of manufacturer

The inspector has full authority to reject the consignment and call for re-inspection if any of the details are not met with in the first instance.

A document provided by the inspector has to be signed, stamped and provided to the inspector for such non-compliance by manufacturer / exporter legal representative.

13. Will the inspector inspect in case the consignment is FCL ?

Yes, the inspector will inspect the FCL consignment at designated site and will affix Container Seal with unique no.

14. What details are mandatory on primary and secondary packing material as per NAFDAC ?

For Solid Dosage Form packaged in blisters / Alu-Alu, Strip etc., the following are mandatory :

• Brand name
• Generic name
• Strength of the active ingredients
• Name of the manufacturer
• Address of the manufacturer if blisters are big enough
• NAFDAC registration number, mandatory for multiple blisters in a package
• Batch number
• Expiration date
• Indian FDA provided Manufacturing License No.
• Manufacturing date is optional for small blisters (<5cm)

For Liquid Orals & Dry Syrup in bottles, the Label & Monocarton of the bottle should contain :

• Brand name
• Generic name
• Strength of the active ingredients
• Name of the manufacturer
• Address of the manufacturer if the labels are big enough
• NAFDAC registration number
• Batch number
• Expiration date
• Indian FDA provided Manufacturing License No.
• Net content
• Caution for children
• Storage condition

For Injectable (LVP & SVP) / Eye Drops / Ear Drops :

• Brand name
• Generic name
• Strength of the active ingredients
• Name of the manufacturer
• Address of the manufacturer if the labels are big enough
• NAFDAC registration number
• Batch number
• Expiration date
• Indian FDA provided Manufacturing License No.
• Net content
• Storage condition
• Manufacturing date is optional for small labels

For tubes of ointments, creams :

• Brand name
• Generic name
• Strength of the active ingredients
• Name of the manufacturer
• Address of the manufacturer if the labels/tubes are big enough
• NAFDAC registration number,
• Batch number
• Expiration date
• Indian FDA provided Manufacturing License No.
• Net content
• Caution for children
• Storage condition
• Manufacturing date

For sachets / powders in pouches :

• Brand name
• Generic name
• Strength of the active ingredients
• Name of the manufacturer
• Address of the manufacturer if the sachets / pouches are big enough
• NAFDAC registration number, mandatory for multiple sachets / pouches in a package
• Batch number
• Expiration date
• Indian FDA provided Manufacturing License No.
• Net content
• Caution for children
• Storage condition
• Manufacturing date

15. How many sample will be withdrawn by the inspector ?

Dosage Form Quantity of Samples Required (Nos.) per batch subjected to inspection Tablets / Capsules / Solid Orals 100 Liquid Injections 60 Powder Injections 60 Small Volume Parenterals 60 Eye / Ear Drops 60 Liquid Orals / Syrup / Dry Syrup / Lotions etc. 30 Ointments / Creams 30 Sprays / Metered Dosage 40 Sachets 70

A document provided by the inspector has to be signed, stamped and provided to the inspector for confirming the quantity of sample withdrawn per product and as indicated in the Invoice & Packing List.

16. Why these many samples and does it free us from retaining the samples at our premises ?

One lot would be subjected to analysis other lot would be kept for re-analysis in case of failure or request for re-testing by any relevant authorities.

This sample withdrawal and storage has no relation to the “Retain Sample” regulations as laid down by Indian Drug authorities or as per Indian Drugs & Cosmetic Act 1940 Indian Drugs & Cosmetic Rules 1945 (latest amendments incorporated as of date). The manufacturer has to abide in totality with reference to the same as per Indian Laws and Regulations.

17. Do we have to replace these samples withdrawn ?

YES, samples are to be replaced with the same batch no., manufacturing date, expiry date etc. so that the consignment is exactly as per the Packing List & Invoice submitted earlier to SILIS Labs Pvt. Ltd. for endorsement.

18. Can we do something to fasten the testing procedure for injectable products ?

Yes, if your organization is so very confident that the injectable product manufactured / exported are going to pass the sterility test than the entire consignment should be packed as if ready to be exported.

Your office can request for inspection and our inspector would withdrawn random samples from the consignment ready for shipment.

Your office should provide Certificate of Analysis (COA) with Sterility Test showing – “UNDER TEST”.

Our test results would be also informed more or less at the same time while your sterility test is over and your office has to provide us an updated COA which mentions the exact result of sterility test performed by your organization.

Note : Samples would be withdrawn only from “ready to ship and packed” shipper boxes.

19. How much we have to pay for the inspection ?

Once the request for inspection is solicited online over www.silislabs.com you would be able to see the amount to be paid for inspection on your screen, provided your office has indicated all the parameters requested online for the inspection. The charges depend on the Product type, No. of batches to be withdrawn, place of inspection etc.

20. What would happen if we request for inspection and on arrival of inspector from SILIS Labs Pvt. Ltd. the consignment is not ready for inspection ?

In the event that the goods have been inspected and are found not to be up to requirements or specifications, the expenses of any additional intervention by the Company shall be borne by the Manufacturer / Exporter requesting inspection.

The inspector is not authorized to wait at the inspection premises over an hour upon his/her arrival and reporting time in case the consignment is not ready and is not being offered to the inspector for inspection.

21. Payments are to be made by Bank cheque / Bank draft and what should be indicated ?

Yes, the payment can be made by either Bank cheque or Bank draft and these should be payable at Ahmedbad, Gujarat. It is mandatory to write overleaf of Bank cheque or Bank draft the Unique ID generated once you apply for the request for inspection.

22. When we can get the Clean Report of Inspection and Analysis (CRIA) for the inspected goods with signed Invoice and Packing List from SILIS Labs Pvt. Ltd. ?

This would be available as a hard copy only once the payment for inspection is realized by SILIS Labs Pvt. Ltd.

23. What happens in case the product fails in the analysis ?

Re-testing would be initiated once more and in case the sample fails the test again than the consignment is rejected and details are informed to relevant Indian Drug Authorities and to the NAFDAC with a copy marked to the Manufacture / exporter. The Clean Report of Inspection and Analysis (CRIA) is not provided in such cases.

24. Do we get back the testing amount in case the samples fail in analysis ?

NO

25. How long the CRIA will be valid for the related Invoice, Packing List, Product inspected and sampled ?

The CRIA will be valid for a period of 90 (ninety) days from the date of issue only and therefore the shipment of the said consignment has to be performed during this validity period.

26. Can we export goods without having the related signed Invoice, Packing List and Clean Report Of Inspection And Analysis (CRIA) from SILIS Labs Pvt. Ltd. ?

NO, as these documents are necessary for the release of goods for exports through any Zonal Offices of Drugs Controller General of India across India and Assistant Drug Controllers (ADC) at various ports & airports of India. They will be verifying the CRIA issued and related Invoice and Packing List stamped and signed by SILIS Labs Pvt. Ltd. for release of consignment for exports.

27. Are there chances of goods seizure in absence of CRIA and related Invoice and Packing List stamped and signed by SILIS Labs Pvt. Ltd. ?

Yes, these can be seized by ADC’s / Indian Customs and moreover the consignment could also be taken into custody on arrival at the port of import i.e. at Federal Republic of Nigeria by the relevant authorities if they lack proper stamps on the consignment shippers supposed to be inspected and the CRIA issued and related Invoice and Packing List stamped and signed by SILIS Labs Pvt. Ltd. for release of consignment for exports.

28. What document does NAFDAC require to clear regulated Products at the Ports?

Documents required depend on the type of products imported and the country of origin. The under listed is only a generalization. The Importer’s representative shall submit to NAFDAC office at the port the following documents:

• Physical Inspection Report - Clean Report of Inspection and Analysis (CRIA),
• Face of Entry (SGD) carrying the NAFDAC first stamp
• NAFDAC receipt of payment
• Risk Assessment Report
• Certificate of Analysis of product
• Packing list of product
• Invoice
• Bill of Lading
• Import Permit
• Chemical Permit (where applicable)
• Permit to clear in the case of controlled chemicals / pharmaceutical product
• Certificate of product registration in the case of finished product.

29. Can our importer be able to get information on the testing / release of the consignment intended to his company ?

As a manufacturer / exporter your organization has to provide password to your respective importer by filling information online over www.silislabs.com the importer can see only few data of the data, which can be observed by the manufacturer / exporter who creates an account for his respective importer.

SILIS Labs Pvt. Ltd. will not provide any information of any kind to any importer.

30. We still have questions to be clarified, what do we do ?

Please feel free to write an e-mail at : support@silislabs.com or fax at : (079) 26840049 / 46 or send feedback online on web page www.silislabs.com