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To,
All Indian Manufacturers / Exporters
Republic of India

 

Subject : Information on Product Package Design and Drug Formulation for Prescription Only Medicines (POM)

 

Compliments of the Day !!

 

This has reference to the above subject and it has been categorically informed by NAFDAC, Federal Republic if Nigeria Authority(ies) with regards to Product Package Design and Drug Formulation for Prescription Only Medicines (POM), which may kindly be noted.

 

It has been observed by NAFDAC Officials that several prescription medicines manufactured in India and registered in Nigeria are being exported with outrageous unapproved pictorial representation and change in product formulations. The manufacturers and exporters alter the registered approved product formulation, colour and package design in order to improve the pictorial appeal of prescription medicines to patients which encourages self-medication thereby promotes drug abuse, public health risk and Nigerian National Security challenges.

 

It is therefore strictly advised by NAFDAC Officials as detailed below that :

  1. As an Indian Manufacturer and exporter you have to ensure strict compliance to NAFDAC registration guidelines, labelling and Good Manufacturing Practice Regulations as the products were registered with the Registration Authority of Nigeria. These guidelines and Regulations are easily accessible on NAFDAC website https://www.nafdac.gov.ng
  2. All Prescription only Medicines (POM) and other categories of pharmaceutical products must strictly follow NAFDAC approved formulations and package designs.
  3. A moratorium of six (6) months only has been approved by NAFDAC as of date for manufacturers to clear every consignment that violates the approved formulations and package designs.
    Note : The clearance of such products is contingent upon processing and issuance of Clean Report of Inspection and Analysis (CRIA) issued by NAFDAC Approved CRIA Agents. This moratorium commences from 1st May 2022 and ends on 30th October 2022.
  4. Any violative product that is boarded on airlines or shipping vessels from 1st November, 2022 will be confiscated upon arrival in Nigeria and any erring importer and manufacturer/exporter will be subjected to strict penalties, sanctions, product deregistration and consequent blacklisting.
  5. All manufacturers / exporters who are in doubt of the approved formulation and package design presented to them by respective Nigeria Importers can contact NAFDAC Registration Authority via drugregistration@nafdac.gov.ng at the very earliest for clarification(s).

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

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.

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