PV/PMS FAQs

Consumer Complaints

How Do I Report a Consumer Complaint?

Consumer complaints can be reported to the NAFDAC offices in the 36 states of Nigeria, and via PRASCOR.

What Should be Reported?

All issues involving the quality and safety of regulated products.

What is Required to Make a Valid Complaint?

The product details such as production date, expiry date/best before, batch/lot number and address of purchase preferably with receipt of purchase, an uncompromised complaint product (if available).

How Will I Know if My Complaint Has Been Investigated?

When investigations are concluded, the complainant is given feedback by the Director (PV/PMS).

NAFDAC Consumer Safety Club (NCSC)

What is NCSC?

NCSC is a public enlightenment and sensitization platform of NAFDAC in its campaign to eradicate fake/substandard regulated products and enthrone quality culture amongst secondary school students.

Who can be a member?

Membership of NCSC is drawn from secondary schools in all the 36 states of the Federation and Abuja. Members must therefore be bonafide students of the schools, of good character and high academic standing.

How do Schools Become Members of NCSC?

Schools interested in becoming members of the NCSC can apply in writing to the office of the Director-General (NAFDAC). If approved, the schools will then be registered to participate in the club’s activities.

What are the activities of NCSC?

  • Circulation of the NAFDAC Consumer Safety Publication (NCSP) to all member schools
  • Coordination of club activities at school level
  • Workshops on public health issues
  • Lectures on NAFDAC regulatory issues
  • Members/NAFDAC interaction on dedicated website – ncsc-nafdac.org
  • Annual competitions at state, zonal and national levels

Award of prizes to students, school coordinators and member schools at state and national levels

What does membership of NCSC entail?

Annual NCSC competitions are organized for member schoolsat the state, zonal and national levels in both junior secondary and senior secondary categories, and winners are awarded prizes.

State level examinations are conducted to identify both state level and zonal level winners. First place winners from the zonal examinations in both categories are invited to the headquarters (Abuja) to participate in a grand finale which is in the form of a quiz competition. The grand winners are recognized and honored at a National Award Ceremony.

Pharmacovigilance

What is Pharmacovigilance?

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

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.

What is the Difference Between an ADR And A Side Effect?

A side effect can be defined as an 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 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.

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. Therefore, we expect that all reactions be reported.

Who Should Report Adverse Drug Reactions?

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

How can I report an ADR?

All drug related problems (suspected ADRs and side effects) should be reported using the ADR reporting 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)

Who do I report an ADR to?

ADRs should be reported to healthcare providers or NAFDAC offices in 36 states and FCT.

How do I report an ADR?

Reports can be made by:

  • Going to the Healthcare Provider (HCP)
  • Filling an ADR/Yellow Form. (*forms can be downloaded from the NAFDAC website at nafdac.gov.ng)