Production of medicinal products

A medicinal product is any substance or combination of substances which has therapeutic properties for humans or animals.

Also considered as a medicinal product is any substance or a combination of substances which can be used on humans or animals or which is given to humans or animals for the purpose of re-establishing, improving or changing physiological functions by means of pharmacological, immunological or metabolic action or in order to determine a diagnosis of illness.

The substances referred to in the first and second paragraph can be:

  • of human,
  • animal plant,
  • microbiological or chemical origin,
  • a chemical product,
  • produced by a chemical change or synthesis or
  • produced with biotechnological procedures.


A business entity can produce medicinal products only on the basis and in accordance with the authorisation for manufacturing medicinal products.

The activity of the production of medicinal products and pharmaceutical forms is determined in the Compilation of Community Procedures on Inspection and Exchange of Information, which is published on the website of the European Commission.

 


Conditions and evidence

Last updated: 18. 12. 2015