Biochemicals :- Important Provisions Of The NAFDAC Regulations on the Registration of Bio-similars in Nigeria

Rendered effective from 13/12/2021, the National Agency For Food and Drug Administration and Control (NAFDAC) guidelines forming the focus of this article are aimed at the general public and Nigerian pharmaceutical industries in particular.

As with other NAFDAC regulations, it is important to state that no medicinal product shall be manufactured,imported, exported advertised, sold or distributed in Nigeria without necessary registration in compliance with laid-down NAFDAC regulations.

We will then be looking at the notable provisions of these guidelines.

Definition of Terms

– Reference Biotechnology Product (RBP) :- A product used as the comparator for head-to-head comparability studies with a Bio-similar in order to show similarity in terms of quality, safety and efficacy which must be licensed in Nigeria with some exceptions.

– Bio-similar – A product is said to be a biosimilar if it demonstrates similarity in terms of quality, safety and efficacy to a named reference bio-therapeutic product licensed in Nigeria and/or by s stringent regulatory authority. 

Applications

– The manufacturer shall be represented by an applicant – a duly registered pharmaceutical company – who must be in possession of a notarized power of attorney from the manufacturer authorizing him to speak for the principal on all matters relating to the product.

– The manufacturer must have:-

1. A manufacturer’s license/certificate :- This is the documentary evidence issued by a competent health authority of the country of manufacture that the company is licensed to manufacture biotechnological products which may be used in the country of origin/exported.

2. A product license/Certificate of registration.

3. A Certificate of Pharmaceutical Product(COPP) in conformity with WHO formats :- This is the documentary evidence by the competent health authority that the sale of the product does not constitute a contravention of the drug laws of the country of manufacture.

4. A valid World Health Organization (WHO) Certificate.

Product

– There must be evidence to demonstrate similarity to a named reference biotechnological product of assured quality, safety and efficacy in respect to the indication(s), note of administration and dosage forms that has been licensed based on a full registration dossier in Nigeria and or by w stringent regulatory authority.

– Failure to comply with this requirement will bar a product from registration.

Labelling Requirements

– The minimum labelling requirements on the primary and secondary package labels are :-

1. Name of product :- INN/Scientific name and brand name where applicable, which must be written directly under the brand name and in same character.

2. Manufacturer’s name and factory location address.

3. Provision for NAFDAC registration number.

5. Batch/Lot number.
6. Manufacturing and expiry dates.

6. Quantitative listing of all the active ingredients per unit dose.

7. Precisely defined storage conditions.

Documentation

– Applicants shall be required to submit the following documents (originals and 2 copies) along with the duly completed application forms to NAFDAC:-

1. Power of attorney or a contract manufacturing agreement.

2. Manufacturer’s license/Certificate indicating:-

– The name of products to be registered.

– The name and address of the manufacturer.

3. A certificate of pharmaceutical products (COPP- WHO format).

4. A valid WHO Good Manufacturing Practice (GMP) Certificate.

5. Evidence of trademark approval.

6. A comprehensive certificate of analysis, issued by the manufacturer indicating the name, designation and signature of the analyst.

7. Evidence of membership or approved sectoral group.

Validity period of Bio-similar Approval

– 5 years.

Fee Schedule

– Total regulatory payment for Bio-similar registration is 350 Thousand Naira plus 5% VAT( This is minus legal costs). 

Issuance of Certificate of Registration

– The applicant upon registration shall be issued a notification of product registration with the registration number which shall be subsequently used to obtain a registration certificate.

The National Agency For Food and Drug Administration and Control (NAFDAC) introduced the warehouse inspection guidelines for the public and in particular, persons intending for warehouse inspection.

These guidelines prescribe the minimum safety standard for chemical handling, documentation, personnel requirements, facilities and timeline for warehouse inspection.

It should be noted that warehouse inspection is a prerequisite to issuance of chemical Importation permits of listing certificates which are authorizations to market chemicals.

The procedures involved in NAFDAC warehouse inspection are what will form the focus of this article.

Step 1 – Application

– An application letter on the applicant company’s letterhead paper addressed to NAFDAC which should include names of the chemicals, the quantities required and uses for which the chemicals are intended. The application must be signed by the Managing Director/Chief Executive Officer (CEO) or Technical Officer of the company.

– The following documents should be attached to the application :-

1. Evidence of business incorporation

2. Copies of the company’s Memorandum and Articles of Association (MEMART)

3. Evidence of Particulars of Directors

4. 2 passport photos of technical officer with name and company written on the back of the passport

5. Evidence of the appointment letter, acceptance letter and credentials of the technical officer

6. Standard Operating Procedure (SOP) for storage/handling of chemicals duly signed by the MD/CEO or Technical Officer with name and designation

7. Evidence of payment for warehouse inspection

8. Evidence of payment of rent for a minimum of 1(One) year

9. Medical fitness certificate for the technical officers which should be presented biannually

Step 2 – Submission of Application

– The application letter and accompanying documents should be submitted at the liaison office of the Director, Chemical Evaluation and Research (CER) , NAFDAC.

Step 3- Review of Company documents followed by scheduling an inspection of the warehouse.

Step 4- Inspection of the warehouse as scheduled.

Step 5- Processing of Permit

– Upon satisfactory inspection of warehouse the permit applied for is processed. For unsatisfactory inspections, a compliance directive is issued within 2 work days.

Step 6 – Payment of Applicable Tariffs

It should be noted that:-

– A processing period of 16 work days should be allowed from the time of submission of a complete application.

– The timeline for processing is suspended when there is a compliance directive and resumes when the applicant compiles and communicates compliance to the agency.

– Warehouse Inspection is conducted annually for importers and marketers of restricted & agro chemicals. It is conducted every 2 years for importers and marketers of industrial and laboratory chemicals.

Requirements For Warehouse

Personnel

– The company representative responsible for interfacing with NAFDAC should be a technical officer with scientific background (a minimum of an Ordinary National Diploma/OND) or its equivalence is required.

– The technical officer must be present during inspection of facilities and must be the officer whose passport photograph was submitted.

Facility Location

– Storage and handling of chemicals in residential building and/or area is prohibited.

– The applicant shall have a warehouse that will be inspected for adequacy and appropriateness for the storage of chemicals.

– The facility provided will depend on the nature of the chemicals stored.

Storage

– The facilities provided will depend on the nature of the chemicals in the warehouse. Some chemicals are required to be stored under controlled (below ambient) temperature to maintain their potency for the validity period.

– Flammable chemicals should not be stored close to sources of ignition or sparks.

Labeling Information on the Chemicals

– All chemicals should be properly labeled according to the globally harmonized system (GHS) of labeling & classification of chemicals.

Safety Requirements

– Personnel are to be provided with masks, hand gloves, eye goggles, overalls and safety boots.

– Appropriate water supply, first aid boxes and fire extinguishers at strategic locations should be in place.

Documentation

– Companies should keep proper records of chemicals imported, sold and/or purchased locally (disposal/utilization records).