Informative Notice
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Non-clinical pharmacological/toxicological testing of medicinal products
Before a medicinal product is placed on the market, it must be analysed, non-clinically pharmacologically and toxicologically and clinically tested in order to assess its quality, safety and effectiveness. A medicinal product is also tested analytically, non-clinically pharmacologically and toxicologically and clinically when it has already obtained a permit for placement on the market or when it is already placed on the market if the test is in order to acquire additional data about the product or because of quality control of the product.
Non-clinical pharmacological and toxicological testing of a medicinal product is a procedure that establishes the safety of the product in accordance with the principles and guidelines of good laboratory practice.
Non-clinical pharmacological and toxicological testing determines the pharmacodynamic, pharmacokinetic and toxicological features of a medicinal product which were established on laboratory animals, isolated organs and tissues and other pharmacological models, and projects the possible effects on humans or targeted animal species.
For products used in veterinary medicine, non-clinical pharmacological and toxicological testing provides, in addition to the data referred to in the previous paragraph, data on pharmacokinetics, especially metabolism and the excretion of residues of medicinal products and data on the routine analytical method which can be used to determine residues of medicinal products.
Non-clinical pharmacological and toxicological testing of a medicinal product is performed by business entities which meet the conditions regarding staff, premises, equipment and the keeping of documentation in accordance with the principles good laboratory practice.
The manner and procedure of analytical and pharmacological and toxicological testing of medicinal products for human use and the content of documentation on the quality, safety and effectiveness of a medicinal product are determined in the Annex to Commission Directive 2003/63/EC of 25 June 2003 amending directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (L No 159 of 27 June 2003, page 46) and in the Annex to Directive 2009/120/EC.
Detailed guidelines and the content of the documentation referred to in the previous paragraph are published in the guidelines adopted by the European Commission: The Rules Governing Medicinal Products in the European Union, Volume 3 – Medicinal Products for Human Use: Guidelines.
Applies for SKD:
- Technical testing and analysis M71.200
Conditions
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Applicants who wish to pursue this activity must register the business activity, and have the appropriate legal status.
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The business entity ensures that premises and production equipment are planned, manufactured, installed, adjusted and maintained so that they comply with the anticipated procedures.
Premises and production equipment must be planned, arranged and managed in a way that reduces the risk of errors to the minimum and to enable effective cleaning and maintenance in order to avoid pollution, cross-contamination and any other factors which may have a negative impact on the quality of the product.
The premises and equipment to be used in production procedures which have a decisive impact on the quality of products must be defined and validated accordingly.
Legal basis
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The business entity establishes, keeps and updates the system of documentation, which is based on specifications, product tallies, instructions for production and packaging, procedures and reports, which include all production procedures. Documents must be clear, without errors and updated. Procedures for production procedures determined in advance and for conditions, together with special documents for the production of each series, are available. The set of documents enables the traceability of production of each series and the traceability of changes introduced during the development of the medicinal product being tested.
In all cases, and particularly when the medicinal products are being placed on the market, a qualified person must confirm in the register or in an equivalent document prescribed for this purpose that every individual production series meets the provisions under this article; the register or an equivalent document must be updated by entering new data relating to the work performed, and the authorised persons of the agency must be enabled access to the relevant document.
In the case of medicinal products, the documentation on each series is stored for at least one year after the expiry date of the relevant series or at least five years after the issue of the certificate under the preceding paragraph depending on which period is longer.
In the case of medicinal products being tested, the documentation on each series is stored for at least five years after the completion or official suspension of the last clinical trial in which the series was used. The sponsor or the marketing authorisation holder if these are two different persons must ensure that records which could be used for further marketing authorisations are stored as determined for marketing authorisations.
When electronic, photographic or other data processing systems are used instead of written documents, the business entity first validates these systems in a way that assures that the data on the aforementioned data carriers will be stored accordingly during the anticipated period.
Data stored in the above systems must be legible and accessible to authorised persons of the agency.
Electronically stored data are protected against loss or damage to data by means of a duplicate or a backup copy and transferred to other storage systems.
Legal basis