The Guidelines of the National Agency For Food and Drug Administration and Control (NAFDAC) for the clearing of Imported Donated Items at Ports of Entry in Nigeria (forming the focus of this article) are for the interest of the general public and in particular importers of donated products into Nigeria.

It is necessary to emphasize that, no regulated product shall be manufactured, imported,advertised, offered for sale, 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.

The notable provisions of these guidelines are as follows:

Documentation For Clearance

– Applicants intending to clear donated items should submit an application letter on the company’s letter head addressed to the Director-General, NAFDAC.

– The following information should be attached to the application letter;

1. A Single Goods Declaration (SGD) Form

2. A Commercial invoice

3. PAAR (Pre-Arrival Assessment Report)

4. A Form M

5. A Bill of Lading/Airway Bill

6. Packing List

8. Letter of Undertaking stating that the product(s) will not be sold used until satisfactory laboratory report is out. The letter should also state that in event of the product(s) being  substandard or illegally imported, or unfit for human consumption, the product(s) will be forfeited to the Federal Government for destruction.
9. Evidence of approval from Director General, NAFDAC to import donation items.

9. Photocopy of payment advice.

10.Photocopy of NAFDAC Receipt of payment.

Physical Examination

– Physical examination of the consignment should be conducted by NAFDAC with other relevant goovernment agencies at the port of Entry or Importer’s premises warehouse where applicable.

– Samples of the imported product shall be drawn during physical examination by NAFDAC inspectorsand forwarded to the relevant NAFDAC laboratory for analysis.

Release Of The Consignment From The Port of Entry

– The finished pharmaceutical product should be granted second endorsement for release to the importer’s warehouse within 24 hours of sample collection.

– The Finished Pharmaceutical Product can only be marketed and used after a satisfactory laboratory evaluation.

Tariff

As advised by NAFDAC.

Notes

– The importation of unapproved donated items should be regarded as a violation.

– Imported donated items must be limited to the number and quantity of the product approved.

– Approval for importation can be obtained through a written application submitted to the Director-General,NAFDAC on the donor’s letter head paper, stating the following:

1. The profile of the donor

2. The purpose of the donation

3. The target population

5. The list of regulated products indicating the batch numbers, appropriate date markings and quantity
6. No donated item must be sold or distributed for sale to the public

6. The following conditions must be met for issuance of approval :

• Regulated products shall have a minimum of 6 months shelf life on arrival at any of the designated ports.
• Regulated products on Federal Government Import Prohibition List as published by the Nigerian Customs Service.
• Permits shall be obtained for restricted and controlled regulated products from the relevant directorates.

Timelines

– The timeline for cost assessment and issuance of payment advice is Ten (10) minutes.

– The timeline for issuance of 1st Endorsement is Thirty (30) minutes.

– The timeline for Physical inspection as determined by the Joint Task Force is Two (2) hours.

– The timeline for issuance of 2nd Endorsement is Fifteen (15) minutes.

News broke out earlier this week that one of the branches of arguably the largest church in Nigeria collapsed killing the resident pastor of the church and other worshippers sustaining grave injury in Makurdi, Benue state. 

When it has to do with religious settings like this the first person to accuse is the devil. The default response will be some religious mantra like, “It is the work of the devil but the devil has failed the battle”. Expectedly, this was the response of the pastors of the church and other members. 

Honestly, I am not oblivion of the forces of dark supernatural powers and their activities, I have seen it at work on numerous occasions and religiously and spiritually speaking the collapse of a large church building like that and the occurrence of other despicable evils could be the work of the devil but after cussing out the devil and all the accusations we will have to go back to the drawing board and analyze facts and logic on why a large church building like that collapsed. 

Building collapsing is becoming the order of the day in Nigeria; residential buildings and commercial complexes are always caving in, especially in big cities like Lagos and Abuja but a church building with thousands of active daily worshippers who could have been the victims collapsing is highly nerve-racking. Just imagine if the building had collapsed on a Sunday or during a weekly church service, hundreds of people could have died and the survivors could have blamed the devil and prayed that affliction should not rise again the second time. 

I still cannot forget about a building that collapsed close to my area here in Abuja earlier this year when I witnessed many dead people being excavated from the debris of the collapsed building. Some of us wrote petitions to the Federal Capital Territory Development Agency (FCDA) and even to the FCT minister himself asking him to launch an active investigation on the cause of that collapse but we are yet to hear of what has been done about that especially if the developers and the contractors have been made to face the music of the law and steps that has been taken to ensure that incidents like that do not occur regularly hence why anytime I see or hear from the news that a building collapsed it is always traumatizing for me because most of the reason why some of these buildings do collapse is just sheer carelessness and negligence of the builders, the contractors and the development agencies contrary to the accusation that it is devil’s handwork.

We may continuously accuse the devil but the devil did not actually or directly cause them. Someone somewhere approved a building without doing a proper inspection; some developer somewhere did bribe a development control agent so as to overlook some irregularities; someone somewhere used substandard materials for the building, someone somewhere failed to properly supervise the ongoing building process, someone somewhere wanted to cut cost and used a bag of cement to get tonnes of bricks more than it was due. These were not the devil, these are human beings; believe me, the devil did not do it. 

Building control agencies really need to step up their games. It is now a national crisis that the federal government will have to take charge and declare a state of emergency on building collapses and set up active task forces to monitor buildings; vet and approve new buildings, insist on standards and quality control and demolish old buildings that pose risks. 

Builders also need to stop using cheap or substandard materials or trying so much to cut costs or to get more for less. These are human lives that we are using to gamble like this. If your budget as a builder is two million naira, please build a house that is worth two million naira. Trying to build a house that is worth ten million naira on a two-million naira budget is dangerous. You cannot use one bag of cement to get a hundred or even more bricks of blocks. It may save immediate cost for you but the future threat could be devastating and when it happens, everyone will blame the devil. 

Service drugs are medicines that are not readily available in the Nigerian market but are needed to meet varying unique individual health needs of patients and clients within the community while orphan drugs are medicines that are developed specifically to treat rare medical conditions in fewer than 200,000 persons within the country.

This article looks into the notable provisions of the National Agency For Food and Drug Administration and Control NAFDAC Guidelines on The Operation Of Service Drugs and Orphan Drug Schemes in Nigeria.

Application

– Applications shall be open to all community pharmacies (valid licenced premises by Pharmacist Council Nigeria (PCN) owned and operated by Pharmacists with valid and current license which must be issued by the PCN).

– The Applicant should show evidence of membership with the Association of Community Pharmacists of Nigeria (ACPN).

– For multinational concerns, requests for service drugs for specific products, application can be processed under this scheme in special circumstances.

– Products that qualify to be treated under the Service Drug scheme are those which are needed for the treatment of critical health conditions for which there are no local capacity to meet those needs.

– Products that qualify should be sourced from any of the following manufacturing facilities:

i.Facilities situated in countries within the Stringent Regulatory Authority (SRA) Region.

ii.Facilities situated in countries that are among the Pharmaceutical Inspection Convention Scheme (PIC/S) member countries.

– Products should be labelled in English language.

– Pharmacies are to maintain a register for the disposal of the service/orphan drugs for ease of verification.

– Orphan drug request should be submitted with a prescription from a recognised hospital with clear indication on the name of the prescriber, signature of the prescriber and duration of the medication.

– Only generics and brands not already registered shall be allowed. However,any company wishing to import small quantities of an already registered brand or generic must bring a “no objection letter” from the party that registered it and this letter shall be verified by NAFDAC.

– The following products are not qualified under the Service Drug and Orphan Drug Scheme and should be excluded from the Scheme:

i.Products for which there is local capacity.

ii.Products for which there are safety concerns.

iii.Product on the NAFDAC Ceiling list.

iv.Products on the Federal Government Import Prohibition.

-The number of products per application should not be more than 2000 items.

– The quantity to be imported shall not exceed 500unit packs per product perannum and the importation may be in parts.

– The following information: Brand name, Active ingredient(s) and strength, pack size, quantity, and manufacturer name and country of origin should be provided in soft copies (Ms word/Excel).

– Where there are Narcotics, Psychotropic substances, and any controlled drugs,an authorization to import and clear such drugs must be obtained from the Narcotics & Controlled Directorate of NAFDAC.

Tariffs

The processing fee for Service drugs and Orphan drugs are as follows:

–Over The Counter (OTC)

N 30,000.00 per product

– Prescription only medicines (POM)

N 25,000.00 per product

–Orphan Drugs: Payment is not required.

Notes

– It should be noted that :-

• A permit for Service and Orphan drugs is valid for one (1) year from the date of issue.

• All approved application should be immediately enrolled on the single window for trade to enable importation.
• Products under this scheme are prohibited from Advertisement.