Knowledgeable person (Drugs Act)
The Qualified Person (Engl. Qualified Person ) is a term from the European pharmaceutical legislation . She is responsible for compliance with the relevant pharmaceutical regulations on manufacture, testing and approval before a pharmaceutical is placed on the market . The competent person is also responsible for the complete documentation of compliance with legal regulations.
Germany
In Germany, writes Drugs Act before the required qualification for the Qualified Person in § 15: in addition to a license to practice as a pharmacist or Certificate of one by a university degree of Pharmacy , the chemistry , the biology , the human medicine or veterinary medicine passed examination must Knowledgeable Person can prove at least two years of practical experience in drug testing. If you do not have a license to practice as a pharmacist, you must also demonstrate knowledge of the subjects of experimental physics , general and inorganic chemistry, organic chemistry , analytical chemistry , pharmaceutical chemistry , biochemistry , physiology , microbiology , pharmacology , pharmaceutical technology , toxicology and pharmaceutical biology . For the production and testing of blood products , sera , vaccines , allergens , test sera, test antigens, gene transfer drugs , drugs for in vivo diagnostics using marker genes , transplants , radioactive drugs and active ingredients , different regulations apply to the two-year practical activity.
With the 14th amendment to the Medicines Act, the competent person replaced the head of production and control in their legal responsibility and personal liability, but both remain indispensable functions in a pharmaceutical manufacturing company. Whereas in the past the responsibilities for manufacturing and testing were strictly separated by two independently acting managers, the competent person is responsible for a medicinal product from its manufacture through testing to release immediately before it is placed on the market.
In Germany, the qualified person for pharmacovigilance corresponds to the phased plan officer in the phased plan procedure .
Switzerland
The relevant function in Swiss therapeutic products law is performed by the technically responsible person (FvP).