Suspension or Cancellation of Registration

Suspension or Cancellation of Certificate of Registration

• The Agency may suspend or cancel the registration of a processed food, drug, drug product, cosmetic, or medical device if:
  • The grounds for registration were later found to be false or incomplete
  • The circumstances under which the product was registered no longer exist
  • Any conditions under which the product was registered have been contravened
  • The standard of quality, safety, or efficacy is not being complied with
  • The premises where the product is manufactured, assembled, or stored are unsuitable

Offences

• A person who contravenes a provision of this Act or a regulation made under it is guilty of an offence and liable on conviction:
  • In the case of an individual, to a fine not exceeding N50,000 or to imprisonment for a term not exceeding two years or to both
  • In the case of a body corporate, to a fine not exceeding N100,000

Dangerous Drug Act

• The Dangerous Drugs Act regulates and controls the production, distribution, and use of certain drugs
• The specifics of the Act can vary from country to country and even change over time

Pharmacy Law and Ethics

• Definitions:
  • LAW: a system of rules created and enforced through social or governmental institutions to regulate behavior
  • ACT: a document that records a fact that has been said, done, or agreed upon
  • DECREE: an official order given by a person with power or government
  • AGENCY: an organization providing a particular service on behalf of another person or group
  • PARASTATAL: institutions which are wholly or partially owned and managed by the government

Code of Ethics for Pharmacists

• A code of professional conduct is a means by which a profession regulates itself and states the principles by which members interact with clients, other professionals, and the general public
• The code of ethics for pharmacists applies to all registered pharmacists holding licenses, certificates, or permits under the PCN decree No. 91 of 1992, the Poisons and Pharmacy Act, Cap 535 of 1990, and any other relevant legislation

Pharmacy Council of Nigeria (PCN)

• The PCN is a Federal Government Agency of Nigeria, established by decree 91 of 1992 (now Act 91 of 1992) to regulate and control the practice of pharmacy in Nigeria

Essential Medicine List (EML)

• Definition by WHO: Essential medicines list is a comprehensive list containing essential medicines
• Essential medicines are the medicines that "satisfy the priority health care needs of the population"
• These medicines should be accessible at all times in sufficient amounts and at affordable prices

National Drug Policy (NDP)

• Introduction: The NDP was adopted and launched in 1990 against the background of inadequacies in drug availability, supply, and distribution
• Reasons for NDP:
  • Ineffective system of drug administration and control
  • Inadequate funding of drug supply and drug control activities
  • High dependence on foreign sources for finished drug products, pharmaceutical raw materials, reagents, and equipment
  • Inadequate facilities for storage, transportation, and distribution of drugs
  • Poor selection and procurement practices
  • The involvement of unqualified persons in procurement, distribution, and sale of drugs
  • Poor performance of drug suppliers to public health care institutions
  • Lack of political will to provide safe, efficacious, and good quality drugs to meet the health needs of Nigerians

Terms and Terminologies

• Law: a system of rules created and enforced through social or governmental institutions to regulate behavior
• Act: a document that records a fact that has been said, done or agreed upon
• Decree: an official order given by a person with power or government
• Agency: an organization providing a particular service on behalf of another person or group
• Parastatal: institutions which are wholly or partially owned and managed by the government

Definition of Code of Ethics

• A code of professional conduct is a means by which a profession regulates itself and states the principles by which members interact with clients, other professionals, and the general public
• Code of ethics for pharmacists applies to all registered pharmacists holding licenses, certificates, or permits under the PCN decree No. 91 of 1992, the Poisons and Pharmacy act, Cap 535 of 1990, and any other relevant legislation regulating the handling of drugs and poisons in Nigeria

Functions of Pharmacist Council of Nigeria (PCN)

• Determine the standards of knowledge and skill to be attained by persons seeking to become registered members of the Pharmacy profession
• Review those standards from time to time as circumstances may require
• Secure the establishment and maintenance of registers of persons entitled to practice as members of the profession
• Publish lists of registered persons from time to time
• Review and prepare a statement as to the code of conduct for the practice of the Pharmacy profession
• Regulate and control the practice of the profession in all its aspects and ramifications

Register of Pharmacists

• The register shall consist of four parts, with three parts enumerated: associate members, members, and premises of members
• The register shall be under the custody of the Registrar
• The register shall contain the profile of all registered members and premises

Amendment of the PCN Act

• Extension of the chairman's tenure from 3 years to 4 years
• The new law includes all stakeholders: pharmacists, pharmacy technicians, and patent medicine vendors in the pharmacy distribution chain
• The new law confers power to the new Registrar to suspend, revoke, withdraw, or cancel licenses
• The new law provides fines for offenses ranging from 250,000 to 2,000,000 naira, as opposed to the previous fines ranging from 250 to 1,000 naira