Guidelines For The Importation And Release Of Investigational Medicinal Products, and Food and Drug Items by NGOs, in Nigeria

Regulatory Guidelines For The Importation & Release of Investigational Medicinal Products in Nigeria.

This article will be looking at the regulatory guidelines governing the Importation and release of investigational medicinal products, which are unregistered medicines, and which may only be brought into the country after a positive ethical opinion is obtained, the clinical trial application has been approved and a letter of authorization has been issued by NAFDAC (National Agency For Food and Drug Administration and Control).

The holder of the authorization must ensure that permit to import IMP has been issued by NAFDAC, prior to importation. The quantity(ies) of IMPs to be imported will be dependent on the sample size of the study, in accordance with the approved study protocol.

The National Regulatory Authority (NRA) of the producing country should be responsible for assurance of compliance with Good Manufacturing Practice (GMP) for the manufacture and lot release of clinical batches of the IMP.

The Agency should take all appropriate measures to ensure that the holder of the authorization has permanently and continuously at his disposal the services of at least one qualified person who is responsible for ensuring:

a). In the case of investigational medicinal products that each batch has been manufactured and checked in accordance with internationally accepted standards of good manufacturing practice for medicinal products for human use, the product specification file and the information submitted in the application for authorization;

b). in the case of an investigational medicinal product which is a comparator product from a third country, and which has a marketing authorization, where the documentation certifying that each production batch has been manufactured in conditions at least equivalent to the standards of good manufacturing practice referred to above cannot be obtained, that each production batch has undergone all relevant analyses, tests or checks necessary to confirm its quality in accordance with the information submitted in the application for authorization.

In as much as the provisions laid down in the guidelines are complied with, investigational medicinal products shall not have to undergo any further testing if they are imported into the country in which the clinical trial is to be conducted, together with batch release certification signed by the qualified person.

-In all cases, the qualified person must certify in a register or equivalent document that each production batch satisfies the provisions as stated above. The said register or equivalent document should be kept up to date as operations are carried out and shall remain at the disposal of the agents of the competent authority for a period of not less than five years.

What is the scope of the guidelines?

-This guideline applies to all investigational medicinal products, including vaccines, which do not have marketing authorization in the country of intended use.

-All procedures should apply to the placebo product, if applicable to the relevant clinical trial.

-During the period of validity of the trial authorization, any subsequent importations should be subject to the same procedures.

What are the responsibilities of the sponsor?

-The sponsor should not supply an investigational medicinal product until the sponsor obtains all required documentation (e.g. approval from the appropriate ethics committee and regulatory authority(ies)).

-The sponsor should ensure that the investigational product(s) (including active comparator(s) and placebo, if applicable) is characterized as appropriate to the stage of development of the product(s), is manufactured in accordance with applicable GMP, is coded and labeled in a manner that protects the blinding, if applicable.

-The sponsor should determine the investigational medicinal product(s) acceptable storage conditions (e.g. Temperature, protection from light, etc.), reconstitution fluids and procedures, and devices for product infusion, if any.

-The sponsor should:

a).Ensure timely delivery of investigational medicinal product(s) to the investigator(s);

b). Maintain records that document shipment, receipt, disposition, return and destruction of the investigational product(s);

c).Maintain a system for retrieving investigational medicinal product(s) and documenting this retrieval (e.g. for deficient product recall, reclaim after trial completion, expired product reclaim);

d). Maintain a system for the disposition of unused investigational medicinal product(s) and for the documentation of this disposition.

e).Take steps to ensure that the investigational medicinal product(s) are stable over the period of use; this data should be available on request and for inspection purposes (where applicable). If non-compliance with the specifications becomes evident in the stability studies during the period of use in the clinical trial, the sponsor should notify the investigators and arrange to take appropriate steps;

f). Maintain sufficient quantities of the investigational medicinal product(s) used in the trial to reconfirm specifications, should this become necessary, and maintain records of batch sample analyses and characteristics. To the extent stability permits, samples should be retained either until the analyses of the trial data are complete or as required by the applicable NAFDAC requirement(s), whichever represents the longer retention period.

What are the provisions of the guidelines regarding labeling and packaging?

-The labeling of investigational medicinal products should comply with the relevant NAFDAC requirements.

-The particulars should appear in English and any other language on the outer packaging or, where there is no outer packaging, on the immediate packaging.

-The particulars should include at least the following information:

a).State clearly that it is a clinical trial material.

b).The product name or unique code.

c). Storage temperature and conditions.

d) . Expiry date.

e). Sponsor contact details.

-The Investigational medicinal products should be packaged to prevent contamination and unacceptable deterioration during transport and storage.

– The investigational medicinal product(s) should be stored as specified by the sponsor, and in line with NAFDAC Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP guidelines ), and other NAFDAC regulations and conditions (if applicable).

-In blinded trials the coding system for the investigational medicinal product(s) should include a mechanism that permits rapid identification of the product(s) in case of a medical emergency but does not permit undetectable breaks of the blinding.

What are the provisions of the guidelines on importation and release?

-Shipping of investigational medicinal products should be conducted according to instructions given by or on behalf of the sponsor in the shipping order. 

-A pre-clearance inspection should be carried out at the port of entry by the Agency. This should include the shipping documentation and overall physical condition of the consignment.

-If specific storage conditions are essential to ensure the quality of the product, e.g. maintenance of cold chain in the case of vaccines, a device that will confirm that storage temperatures were not exceeded during transport should be included with the shipment.

Documentation

-Documentation that should accompany each consignment of IMP should enable NAFDAC at the port of entry to release the product to the investigator(s) responsible for conducting the clinical trial in the country.

-This documentation should include at least:

1. A valid Import Permit stating the quantity(ies) of IMPs to be imported.

2. The CoA of each batch of the investigational medicinal product(s) as well as comparator(s), if relevant.

3. A copy of NAFDAC letter of authorization of clinical trial.

4. A copy of a valid Certificate of Manufacture issued by the competent Regulatory Authority in the country of origin.

5. A copy of a valid WHO certificate of a pharmaceutical product issued by the competent Regulatory Authority in the country of origin.

6. The Cover Sheet should be completed by the sponsor and should accompany each consignment of investigational medicinal products.

7. The Checklist may be used by the sponsor to ensure that the required documents are attached and correct, but a blank document should be submitted with the Cover Sheet for use by the Agency staff responsible for authorizing the importation of the IMP.

Guidelines For The Importation of Food and Drug Items by NGOs in Nigeria

The National Agency For Food and Drug Administration and Control (NAFDAC) guidelines for the approval of food and drug importation for the interest of the general public and in particular, various Non-Governmental Organizations (NGOs) that wish to import NAFDAC regulated items in pursuit of their humanitarian objectives. 

This article will be focused on highlighting the requirements needed by NGOs to procure food and drug importation permits in Nigeria.

What is the implication of the NAFDAC guidelines?

Under the guidelines,no food, drug, cosmetics, packaged water, detergent, medical device shall be manufactured, imported, exported, advertised, sold, distributed or used in Nigeria unless it has been registered in accordance with the provisions of NAFDAC Act CAP N1 (LFN) 2004, other related Legislations and the accompanying Guidelines 

– For Pharmaceutical product(s), approval of Letter of No Objection can only be granted for applications made in favor of a duly registered Pharmaceutical company.

What are the regulatory steps involved in applying for an importation approval under the guidelines?

Step I

Application

-The following documents should be uploaded online in addition to an application (handled by legal counsel):

-A duly signed application letter titled Approval to Import Donated items by Non-Governmental Organizations addressed to the Director, Ports Inspection.

Step II

Review of application

-The application and accompanying documents are subsequently reviewed.

Step III

Payment

The applicant is required to visit www.remita.net to generate a Remita invoice from any nearest commercial bank for payment.

Step V

Issuance of Authorization

-Upon satisfactory review of the documents, an electronic copy of the Approval to Import Donated items by Non-Governmental Organizations is issued which the applicant can access through their TIN (Tax Identification Number) on the trade portal

What are the cautionary notices stipulated by the guidelines?

-NAFDAC does not take responsibility for any risk associated with the mode of transportation of the products being exported.

-The timelines for the Issuance of Approval to Import Donated items by NonGovernmental Organizations is seventy-two (72) hours from time of submission. The timeline for processing is suspended when there is a compliance directive and resumes when applicant complies and communicates compliance to the Agency.

-The Approval to Import Donated items by Non-Governmental Organizations expires 31st December every year.

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What are the definitions and abbreviations of various terms under the guidelines?

• CoA: Certificate of Analysis
• GMP: Good Manufacturing 
• Practices IMP: Investigational Medicinal Product
• It is a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorization but used or assembled (formulated or packaged) in a way different from the authorized form, or when used for an unauthorized indication, or when used to gain further information about the authorized form.
• NRA: National Regulatory Authority
• NAFDAC: National Agency for Food and Drug Administration and Control.
• Sponsor: An individual, company, institution or organization which takesresponsibility for the initiation, management and/or financing of a clinical trial.