detecting and removing poor quality medicines that harm the most vulnerable patients and damage public health

Definitions

Falsification of medical products (Medical crime or Medicrime) is a multibillion-dollar global business that poses a threat to both patients and the brands of legitimate pharmaceutical companies. Falsification/counterfeiting of medical products is instituted and perpetuated by criminals and opportunists for purely selfish gains with a total disregard for the end user. This results in a plethora of detrimental effects and consequences.

A medicinal product is any product or combination of products having properties for treating or preventing disease. Medicinal products are administered with the aim of restoring, correcting, or modifying physiological functions by exerting a pharmacological, immunological, or metabolic action, or with the aim of making a medical diagnosis. 

A medical device is any instrument, apparatus, appliance, software, material, or other article, whether used alone or in combination, designed by its manufacturer to be used specifically for diagnostic or therapeutic purposes. Medical devices do not achieve their principal intended action in or on the human body by pharmacological, immunological, or metabolic means. Instead, they are designed for:

  • Diagnosis, prevention, monitoring, treatment, or alleviation of disease
  • Diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or handicap
  • Investigation, replacement, or modification of the anatomy or of a physiological process
  • Control of contraception

What is a Falsified Medicine?

Any medicinal product with a false representation of:

  • It’s identity, including its packaging or labelling, its name or its composition;
  • It’s source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or
  • It’s history, including the records and documents relating to the distribution channels used.

A ‘falsified medicinal product’ should be clearly distinguished from other illegal medicinal products, as well as from products infringing intellectual property rights. Furthermore, medicinal products with unintentional quality defects resulting from manufacturing or distribution errors should not be confused with falsified medicinal products. 

Quality Risk Management

A systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product life cycle.

Quality System

The sum of all aspects of a system that implements quality policy and ensures that quality objectives are met.

Supplying

All activities of providing, selling, donating medicinal products to wholesalers, pharmacists, or persons authorised or entitled to supply medicinal products to the public.

Good Distribution Practice (GDP)

GDP is that part of quality assurance which ensures that the quality of medicinal products is maintained throughout all stages of the supply chain from the site of manufacturer to the pharmacy or person authorised or entitled to supply medicinal products to the public.

Holding

Storing medicinal products

Transport

Moving medicinal products between two locations without storing them for unjustified periods of time

Procuring

Obtaining, acquiring, purchasing or buying medicinal products from manufacturers, importers or other wholesale distributors

Validation

Action of proving that any procedure, process, equipment, material, activity or system actually leads to the expected results. The word validation is sometimes widened to incorporate the concept of qualification.

Qualification

Action of proving that any equipment works correctly and actually leads to the expected results.