PUBLICATIONS

PHARMACOVIGILANCE

1. WHAT IS PHARMACOVIGILANCE?

Pharmacovigilance is the science and activities relating to the knowledge, detection, assessment and prevention of adverse effects or any drug-related problem.

2. WHAT IS AN ADVERSE DRUG REACTION (ADR)?

The World Health Organization defines an adverse drug reaction (ADR) as a response to a medicine which is noxious (harmful) and unintended and which occurs at doses normally used in man for the prophylaxis (prevention), diagnosis or therapy (treatment) of diseases, or for the modification of physiological function.

The important point to note is that a patient experiences an unwanted and/or harmful reaction following drug therapy. 

3. WHAT IS THE DIFFERENCE BETWEEN AN ADR AND A SIDE EFFECT? 

A side effect can be defined as any unintended effect of a pharmaceutical product occurring at doses normally used in humans, which is related to the pharmacological properties of the drug. Such effects may or may not be beneficial. Side effects are related to the known properties of the drug and can often be predicted.

However, when a side effect occurs above the usual/expected level, it becomes an adverse drug reaction.

4. SHOULD I REPORT AN ADR AS WELL AS A SIDE EFFECT?

In Pharmacovigilance we are interested in all drug related reactions? These include side effects and suspected adverse drug reactions. Health professionals are therefore requested to report all suspected drug related problems to the National Pharmacovigilance Centre (NPC) in NAFDAC. 

5. WHO SHOULD REPORT ADVERSE DRUG REACTIONS?

All health care providers including doctors, dentists, pharmacists, nurses, traditional medicine practitioners and other health care providers are to report all suspected adverse reactions to medicines including orthodox medicines, vaccines, X-ray contrast media, medical devices, chemicals, cosmetics, traditional and herbal remedies.

6. HOW CAN I REPORT AN ADVERSE DRUG REACTION?

All drug related problems (suspected adverse drug reaction and side effect) should be reported using the ADR reporting form also known as the ‘Yellow form’. Reporters must at least provide the following information as requested on the form;

- Name or initials of the patient making sure to include the age and sex

- Description of the adverse reaction making sure to include the date the reaction started

- Brand or generic name of the suspected medicine including the date the medicine was started and stopped (if applicable)

- Name and address of the reporter including contact details for follow-up if necessary

7. WHERE DO I OBTAIN AN ADR REPORTING FORM AND OR SEND A COMPLETED FORM?

ADR reporting forms can be obtained and or completed ADR forms (individual case safety reports) sent by the following means;

- Any NAFDAC state office in all 36 states of Nigeria and the FCT

- The National Pharmacovigilance Centre (NPC), NAFDAC Headquarters, Wuse, Zone 7, Abuja

- Any of the Zonal Pharmacovigilance Centres (ABUTH, Zaria; FMC, Owerri; LUTH, Lagos; UBTH, Benin; UITH, Ilorin and UMTH, Maiduguri).

- By calling any of these numbers 08086899571, 09 2905110 or 07098211221

- Forms can also be downloaded from the NAFDAC website on www.nafdac.gov.ng

- Filled reports can be scanned and emailed to This email address is being protected from spambots. You need JavaScript enabled to view it.

You can also report ADRs through PRASCOR

8. WHAT IS PRASCOR?

PRASCOR – Pharmacovigilance Rapid Alert System for Consumer Reporting is a short code service for consumers to alert NAFDAC of safety and quality issues via SMS.

9. HOW DOES THE SHORTCODE SERVICE (PRASCOR) WORK?

The service works in three simple steps

Step 1:A consumer sends information with the name of the medicine or product and the suspected ADR by SMS to the number (short code) 20543 for free on MTN, Glo and Etisalat. For example: “I took paracetamol and cannot sleep”.

Step 2: An auto response acknowledging receipt of the alert and next steps is sent to the consumer (sender).

Step 3: The information is forwarded to NAFDAC by secure email to be accessed only by NAFDAC staff at the National Pharmacovigilance Centre; the received message will help NAFDAC to contact you for more information that will be used to fill an ADR reporting form if needed or to guide the consumer on what next to do.

10. WHAT IS DONE WITH THE INFORMATION ON THE COMPLETED ADR FORM?

The information obtained from the Individual Case Safety Report (ICSR) is entered into the national adverse drug reaction database and analysed by expert reviewers. A well-completed ICSR submitted to the NPC could result in any of the following:

-          Additional investigations into the use of the medication in Nigeria.

-          Educational initiatives to improve the safe use of the medicines.

-          Institution of appropriate risk minimization measures such as labeling changes to include the potential for the reaction reported by Nigerian health care providers.

-          Changes in the scheduling or manufacture of the medicine to make the medicine safer.

-          Other regulatory and health promotion interventions as the situation may warrant including change in supply status or withdrawal 

-         

11. WHAT ARE THE BENEFITS OF ADR REPORTING TO HEALTHCARE PROVIDERS AND PATIENTS?

Reporting of adverse drug reactions benefits the health care provider and patient in several ways such as

  1. Making the use of medicines safer
  1. Improving Quality of patient Care
  2. Enhancing Patient – healthcare relationship
  3. Increasing patient’s confidence in healthcare services
  4. Contributing to Global Knowledge on Drug Safety.

12. ARE THERE ANY NEGATIVE CONSEQUENCES ON THE HEALTHCARE PROVIDER OR THE PATIENT FOR REPORTING AN ADR?

There are no negative consequences for reporting an adverse drug reaction. The adverse drug reaction report does not constitute an admission that a healthcare provider or the drug contributed to or caused the event in any way.

The details of an ADR report are stored in a confidential database in Nigeria and the analyzed report sent to the Uppsala Monitoring Center (UMC). The names of the reporter or any other healthcare provider on a report and the patient are removed before any detail about a specific adverse drug reaction are used or communicated to others.

The information obtained from an ADR report will not be used for commercial or litigation (court case) purposes. The information is only meant to improve understanding and use of the medicines in Nigeria.

ADR reports cannot be used in a court of law under any circumstance

The National Pharmacovigilance Center NPC, National Agency for Food and Drug Administration and Control (NAFDAC) Plot 2032 Olusegun Obasanjo Way, Wuse Zone 7, Abuja, PMB 5032 Wuse Abuja

NAFDAC offices Nationwide.

NAFDAC Drug Safety Advisory Committee members in the zones.

 end faq

NARCORTICS

How long does it take to process a chemical import permit?

It takes two (2) weeks from the date of submission for renewal and additional applications without any compliance directive. For fresh applications, it takes about one(1) week from the date of inspection of the office and warehouse if there is no compliance directive.

How much does it costs to process a chemical import permit?

For fresh application, it costs twenty-two thousand five hundred and fifty Naira (N22, 550.00), for the first twenty-five (25) items and eight thousand five hundred Naira (N8, 500.00) for subsequent twenty-five (25) items. For renewal of chemical import permit, it costs ten thousand five hundred Naira (N10, 500.00), for the first twenty-five (25) items and eight thousand five hundred (N8, 500.00), for subsequent twenty-five (25) items. For additional chemical import permit, it is fifteen thousand seven hundred and fifty Naira (N15, 750.00), for the first twenty-five (25) items and eight thousand five hundred Naira (N8, 500.00), for subsequent twenty-five (25) items.

What are the ranges of items that Chemical Import Control Unit issues permit for?

General chemicals (non-controlled chemicals), car care products, lubricants/ additives, fire extinguishers, sealants, etc.

What are NAFDAC requirements for storage of chemicals or chemical products?

  • The storage facilities/warehouses should be located in an industrial area.
  • The Warehouse should not be located in an office complex, market or residential building.
  • For rented warehouse, photocopy of evidence of payment of rent or certificate of ownership for Company using its own warehouse must be submitted.
  • The following safety aids must be available in the warehouse, i.e. fire extinguishers, nose masks, hand gloves, eye goggles, overalls, safety boots, first aid box, pallets and source running water.
  • Standard ndard Operating Procedure (SOP) for storage and handling of chemicals must be pasted at strategic locations in the warehouse.
  • Chemicals in the warehouse must be properly labeled and stored on pallets

What are the reasons why some material safety data sheets (MSDS) are rejected?

  • If the MSDS does not have the name and address of the manufacturer
  • If the MSDS does not contain the specific chemical composition of the item
  • If the MSDS is suspected and confirmed to be fake.

Who is qualified to be a Company’s technical officer?

The technical officer should have at least an OND in any of the science related disciplines.

Who can collect the Company’s permit?

  • A Company’s staff with valid I.D. card or
  • Director of the Company whose name is listed in the Company’s Particulars of Directors (FORM CO7), with evidence of identification like valid Driver’s License or International Passport.

Who is qualified to submit fresh application for a Company?

It should be the Company’s technical officer or any management staff of the Company.

Who is expected to be in the warehouse during inspection?

At least the technical officer should be available.

Why is inspection of Company’s office/warehouse carried out for fresh applicants before issuance of chemical import permit?

  • To ascertain the suitability of the warehouse for storage of items being applied for
  • To ensure that the Company’s technical person is knowledgeable in storage and handling of chemicals or items being applied for.
  • To ensure that the safety aids are provided in the warehouse.
  • Office inspection is carried out to ensure that the Company exists.

How are NAFDAC fees paid?

NAFDAC fees are paid with Bank draft addressed to NAFDAC in full. Payment in cash is not acceptable.

What is the purpose of the inspection conducted by Chemical Monitoring unit?

The Chemical Monitoring unit inspects to assess the location, storage, capacity, handling, usage, technical Personnel and disposal of chemicals on routine basis. The unit also inspects the Warehouses and offices of Companies that apply for listing certificates to ensure they meet the expected requirements for Chemical handling, storage and marketing.

Why should a Chemical marketing Company obtain the Listing Certificate after collecting chemical import permit from NAFDAC?

The Listing certificates are issued to marketers be they importers or local marketers after they have met the requirements for listing and it authorizes them to market and sell chemicals in Nigeria whilst the Import permit is an importation document that enables an importer, marketer or end user to import Chemicals into Nigeria.

Company Officials often ask inspectors on routine inspections why they were not notified before the inspection?

As a rule, routine inspection is supposed to be unscheduled. The objective is to see how Company Officials normally handle Chemicals in the absence of inspectors

Why do some regulated products do not have NAFDAC numbers?

Any regulated product without a NAFDAC Number is deemed fake by NAFDAC ?

What is the difference between Drug Abuse and Drug Misuse?

Drug Misuse is the use of drugs without following the doctors prescription, this includes, over dosage and under dosage.

Drug Abuse is the indiscriminate use of drugs for non-medical purposes such that the emotional, mental and psychological state of the user is affected.

How can we identify fake drugs?

Any drug without the following information:

  • list of active ingredients
  • No full name and address of manufacturer
  • No expiry date/ batch number and manufacturing date.
  • No NAFDAC Registration number
  • No English translation on the label and label sound- alike with a registered brand
  • Storage conditions not written on the label
  • Directions for use not on the label

Why Is Federal Ministry Of Health The Sole Importer Of finished Narcotic Drugs?

It is an administrative arrangement for the control of Narcotic drugs and to ensure sure that these drugs are only available for medical and scientific purposes only.

What are Controlled Chemicals?

Controlled chemicals are chemicals, which can be used illicitly to manufacture Narcotic drugs and psychotropic substances. The importation and exportation of these chemicals are controlled internationally by the International Narcotics Control Board (INCB). Examples are Hydrochloric acid, Potassium Permanganate, Toluene, Acetone, Sulphuric acid e.t.c.

Why Are Some Drugs Banned?

A drug is banned when it is found to be injurious, poisonous or have serious adverse effects on man.

Why Are Some Chemicals Banned?

Chemicals are banned when they are found to be poisonous to man or hazardous to the environment.

When was NAFDAC established?

NAFDAC was established by decree 15 of 1993 now NAFDAC Act Cap N1Laws of the Federation of Nigeria 2004.

What is the effect of Kola Nut and Coffee abuse?

Kola nut and Coffee contains caffeine which is a stimulant and it usually keeps users awake .It also stimulates the secretion of gastric acid from the stomach thus resulting in ulcer, constant headache e.t.c.

Is it necessary to go to the clinic even when you have a simple headache?

Yes, because headache could be an underlying symptom of a disease in the body e.g. Malaria, High Blood Pressure e.t.c...

How can you help someone who is a drug addict?

Drug Addicts are usually taken care of at Rehabilitation Centers/ Psychiatric hospitals. Counseling is also effective.

Does Paracetamol and Panadol Extra contain cocaine?

Cocaine is not present in these drugs. However, Panadol Extra contains caffeine and paracetamol.

How can you identify a drug addict?

The signs of drug addiction includes,

  • Possession of drug paraphernalia e.g. lighter
  • Change in mood
  • Sudden decline in school performance.
  • Stealing at home and at work place.
  • Criminal Behaviors/Tendencies

Can we divide antibiotics capsules /tablets for childrens use?

No, children should be given the syrup of the corresponding antibiotic when prescribed by the doctor

Can we divide antibiotics capsules /tablets for childrens use?

No, children should be given the syrup of the corresponding antibiotic when prescribed by the doctor.

Is it advisable to share drugs with others for the fact that similar symptoms are being treated?

Drugs should not be shared as people presenting with similar symptoms may have different underlying conditions. Thus, people should consult their doctor. Even when the same ailment is being treated because dosage, body weight, side effects/allergies, and tolerance differ.

end faq

 

 

REGISTRATION OF PRODUCTS

How long is the Process?

Three months if all requirements are met as and when due

How do i begin the process of Registration?

You begin with the purchase of the relevant registration application form from the NAFDAC office closest to you and pick up the applicable guidelines.

Where is Nafdac Registration Office?

In Lagos, with the following addresses.

  1. (a) NAFDAC Central Laboratory Complex

3/4 Oshodi ? Apapa Expressway, Oshodi ? Lagos.

(for Registration and Regulatory Affairs Directorate, Legal Unit, Establishment Inspection Directorate, Food Laboratory, Narcotics and Controlled Substances Directorate).

  1. (b) NAFDAC Central Drug and Vaccines Laboratory (CDVL)

Edmund Crescent, Yaba ? Lagos (for Drug Laboratory and Ports Inspection Directorate).

  1. (c) NAFDAC Enforcement Directorate.

Ahmadu Bello Way (Behind Nigerian Air Force Camp by Legico B/stop), Victoria Island - Lagos

Whom do I call to report a complaint?

Call the Director (Registration and Regulatory Affairs) on 01-4748627, 01- 4772452 

What is NAFDAC?s website and e-mail address?

Website:www.nafdac.gov.ng

E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

end FAQ 

ONLINE PORTALS

napams

Contact Us from Mon - Friday: 08:00-16:00 GMT+1

Write Us:

NAFDAC Corporate Headquarters,

Plot 2032, Olusegun, Obasanjo Way,

Zone 7, Wuse, Abuja, Nigeria

 

Lagos Operation Office:

Plot 1, Industrial Estate, Lagos- Oshodi Apapa Express Way, Isolo, Lagos, Nigeria

 

 

 

 

 

 

For Enquiries:

Call: +234(0)-1-4609750

Email:nafdac@nafdac.gov.ng

 

 

 

 

 

 

 

 

 

 

 

For Complaints:

Call: +234(0)909-763-0506

         +234(0)909-763-0507

Email:reforms@nafdac.gov.ng

Or Send Us a Complaint

 

 

 

 

 

 

 

 

 

Contact Other NAFDAC Offices Nationwide