Production of medicinal products
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
- Status and registration Authorisation for manufacturing medicinal products Certificate of good manufacturing practice Manufacture of medicinal products compliant with the Compilation of Community Procedures Obligations of a manufacturer of medicinal products relating to medicinal products Pharmacovigilance system Responsible person for pharmacovigilance system Regular certification of metering devices
- Medicinal Products Act
- Rules on conditions for completing activities of making medicinals and determining of conditions and procedure of publishing or revocation of execution good production practices
- Rules on clinical testing of medicinal products
- Rules on radiopharmacological products
- Rules on pharmacovigilance of medicinal products for human use
- Rules on the pharmacovigilance of veterinary medicinal products
- Rules on the charges in the field of medicines
- Metrology Act
- Rules on the labelling and instructions for medicinal products for human use
- Rules on the identification and use instructions of veterinary medicinal products