NAFDAC Controlled Medicine Regulations 2019
Regulation · Health
Policy date: 2019-01-01
Regulations govern the manufacture, importation, distribution, prescription, and dispensing of controlled medicines in Nigeria by establishing record-keeping, reporting, and security requirements. They target pharmaceutical manufacturers, hospitals, pharmacies, prescribing healthcare professionals, and enforcement officers. This ensures controlled medicines are available for legitimate medical use while preventing diversion and abuse.
NAFDAC Controlled Medicine Regulations 2019
What Is This Policy?
Regulations governing the manufacture, importation, distribution, prescription, and dispensing of controlled medicines in Nigeria, establishing record-keeping, reporting, and security requirements to prevent diversion and abuse.
Who Does It Target?
Pharmaceutical manufacturers handling controlled substances Hospitals and pharmacies dispensing controlled medicines Prescribing healthcare professionals NAFDAC and NDLEA enforcement officers
What Does It Aim to Achieve?
Ensure that controlled medicines are available for legitimate medical purposes while preventing diversion, abuse, and trafficking through strict regulatory controls.
Key Features
Licensing: Special permits required for manufacturing, importing, and distributing controlled medicines Record-Keeping: Detailed transaction records that must be maintained and available for inspection Security: Physical security requirements for storing controlled substances Reporting: Mandatory reporting to NAFDAC on quantities received, dispensed, and remaining in stock Disposal: Approved methods for disposing of expired or unwanted controlled medicines
Current Status
Rollout Stage: Active Coverage: All entities handling controlled medicines Lead Agency: NAFDAC in coordination with NDLEA Enforcement: Inspections, audits, and sanctions for non-compliance
How to Access
Facilities must obtain special authorization from NAFDAC. Apply for controlled substance handling permits Implement required security and record-keeping systems Submit periodic reports on controlled medicine transactions
Official Resources
Website: nafdac.gov.ng Contact: NAFDAC, Abuja
Legal Framework
The NAFDAC Controlled Medicine Regulations 2019 are issued under the NAFDAC Act and operate alongside the Dangerous Drugs Act, the National Drug Policy, and the Pharmacy Council of Nigeria Act. They align with the UN Convention on Psychotropic Substances (1971), the UN Single Convention on Narcotic Drugs (1961), and the International Narcotics Control Board (INCB) guidelines on controlled substance licensing and record-keeping.