Production of active ingredients
An active ingredient is any substance or a mixture of substances intended for use in the production of medicinal products which becomes in the production procedure an active ingredient in the product whose purpose is a pharmacological, immunological or metabolic effect in order to re-establish, improve or change physiological functions or to determine a diagnosis.
A producer of active ingredients must fulfil the following conditions:
- employ an adequate number of experts with adequate education, considering the scope and complexity of the production of active ingredients;
- have adequate premises, devices and equipment for the production, control, storage and transport of active ingredients in accordance with the guidelines and principles of good production practice for active ingredients;
- perform the activity in accordance with the guidelines and principles of good production practice for active ingredients.
A producer of active ingredients must be entered in the registry of producers of active ingredients, which is kept by the competent authority.
Conditions and evidence
- Status and registration Entry in the register of manufacturers of active substances Certificate of good manufacturing practice Notification of changes of conditions Informing about counterfeits or suspected counterfeiting of substances Annual reporting on changes of conditions