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SUMMARY FOR ISSUANCE OF CRIA FOR FINISHED PHARMACEUTICAL PRODUCTS (FPP)

AS OF SEPTEMBER 12, 2020 BY NAFDAC

 

As per new directives which are being placed by NAFDAC as of September 12, 2020 are for continuing improving the CRIA issuance process we request Indian manufacturer / exporter requesting for CRIA for FPP on www.silislabs.com as below :

 

  1. FPP will be analyzed as per official Pharmacopeial Monograph only i.e. as per USP / BP / Ph. Eur. / International Pharmacopoeia and if the FPP is not official in any Pharmacopoeia then In-house Testing Method used must conform to test & parameters as available in any of the above Pharmacopeial Monographs, which would become the basis for the analysis.
  2. Manufacturer / exporter has to provide approximately 5 grams of the sample of API (in securely packed condition) of same batch which is used in the manufacturing of that particular FPP batch;
  3. If in case two or more batches of API has been used in the manufacturing of a particular batch of FPP than all batches of the sample of API used in the production are to be provided (in securely packed condition) for analysis;
  4. Products with multi ingredients – manufacturer / exporter has to provide the sample of one of the main API & two micro API’s for the analysis used (as per label claim)
  5. Mandatory documents to be submitted :
    1. Self-attested copy of valid NAFDAC issued Product Registration Certificate
    2. Self-attested copy of valid Electronic NAFDAC Certificate
    3. Self-attested copy of valid COPP
    4. Self-attested copy of FORM M
    5. Pack Size Extension in case there is change in packing style other than the one mentioned in the NAFDAC issued Product Registration Certificate
    6. Self-attested copy of Manufacturing License as issued by the State FDA.
    7. Copy of Airway Bill or Bill of Lading

 

(All these above documents would become part of the CRIA issued, therefore Final Original CRIA would be issued once Airway Bill or Bill of Lading is received by our (SILIS LABS Pvt. Ltd., Ahmedabad office)

 

  1. Product can be dispatched ONLY to the Nigerian Company holding the Product Marketing Authorization Holder as mentioned in the NAFDAC issued Product Registration Certificate or any deviation has to be supported by NAFDAC issued Letter.
  2. Product cannot be manufactured / exported with same NAFDAC Product Registration Number in different colored monocartons or two or more different colored FPP.
  3. FPP has to be manufactured at the same site which has been approved by NAFDAC & is indicated in the NAFDAC issued Product Registration Certificate

 

 

As a relief from NAFDAC – DO NOT TO PUT ANY SAMPLE OF API used in manufacturing of FPP in the consignment.

 

NOTE :  IF THE SAMPLE OF API FAILS IN ANALYSIS AND THE FPP PASSES THE ANALYSIS OR VICE VERSA THE SAMPLE / BATCH OF THE FPP WOULD BE CONSIDERERD FAILING ANALYSIS & THE LABORATORY DIRECTLY REPORTS THIS TO THE CRIA DESK.

 

In case of any clarification or doubts feel free to contact NAFDAC Officials at :

 

cria@nafdac.gov.ng                           ports@nafdac.gov.ng

 

CONSIGNMENT IS NOT TO BE DISPATCHED TILL ONE RECEIVES PROVISIONAL CRIA OVER MAIL OR OTHERWISE IT WOULD BE CONSIDERED VIOLATION BY NAFDAC

SUMMARY FOR ISSUANCE OF CRIA FOR BULK ACTIVE PHARMACEUTICAL INGREDIENTS (API)

AND

BULK PHARMACEUTICAL EXCIPIENTS AS OF SEPTEMBER 12, 2020 BY NAFDAC

 

As per new directives which are being placed by NAFDAC are for continuing improving the CRIA issuance process, we request Indian manufacturer / exporter requesting for CRIA for Bulk Active Pharmaceutical Ingredients (API) and Bulk Pharmaceutical Excipients as below :

 

  • Bulk Active Pharmaceutical Ingredients (API) and Bulk Pharmaceutical Excipients are now exempted from mandatory “Clean Report of Inspection & Analysis (CRIA)” Scheme, therefore these products can be exporter without any Inspection and CRIA.

 

  • API’s & Excipients used in Cosmetic and Food Products Manufacturing at Federal Republic of Nigeria still requires mandatory inspection & CRIA for exports from India.

 

  • The issue of “Drug Master File (DMF)” would be handled by related NAFDAC Office at Federal Republic of Nigeria while processing Permits to Import Bulk APIs and Bulk Pharmaceutical Excipients

 

 

In case of any clarification or doubts feel free to contact NAFDAC Officials at :

 

cria@nafdac.gov.ng                           ports@nafdac.gov.ng

As per related NAFDAC Officials, those who do not have electronic versions of their registration certificates do not have any excuse because they require it to process their Central Bank of Nigeria Forex Form M. Indian Manufacturer / Exporter has to inform his related Nigerian Importer to follow the instruction below to process the electronic version :

Nigerian Importer has to submit an application by following the manual at :

https://www.nafdac.gov.ng/our-services/product-registrationevaluation/

Under Registration & Regulation Section Click NAFDAC e-Certificate Enrollment Manual

Download the manual and use

Other resource :

https://www.nafdac.gov.ng/wp-content/uploads/Files/Resources/Guidelines/R_and_R_Guidelines/GENERAL/e-Certificate_User-Manual-for-Applicants.pdf

https://www.nafdac.gov.ng/public-announcement-nafdac-elicense-go-live-on-national-single-window-for-trade/

In case of any issues contact the NAFDAC Registration and Regulatory Affairs (R&R) Directorate, Nigeria in order to expedite the approval of the electronic document through the email below:

registration@nafdac.gov.ng


WELCOME TO SILIS LABS PVT. LTD.

NAFDAC, Federal Republic of Nigeria appointed "QUALITY CONTROL ANALYST" for approving Pharmaceutical Finished Products and API's holding valid Registration Certificate for Exports to Federal Republic of Nigeria from Republic of India.

Whether you require analytical testing of food and drink, dairy, water, or pharmaceuticals SILIS Labs group companies provide a comprehensive range of microbiological, physical and chemical testing services combined with industry leading technical expertise and customer service.

SILIS Labs has a strict Quality Assurance program, and most of the work is compliant with applicable GMP and GLP regulations. In addition the group laboratories are certified by a number of agencies and associations, the group laboratories participate in round-robin, performance evaluation studies.

The group laboratories are specialized in testing of products using ICPMS, ICPOES, GC, LC, IC, GCMS, LC-MS/MS, FTIR, NMR, XRF etc.

SILIS Labs Provides –

  • Fast, efficient turn around of results
  • Complete client confidentiality
  • Independent testing and advice
  • Fast and flexible response to your needs

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