expiry date
The expiration date (also: expiration date ) describes in medicines and medical products specified on the packaging date by which the product is to be used ( run time by the manufacturer). It requires proper storage that does not change the properties of the product in terms of quality and effectiveness.
In addition to the expiry date, finished medicinal products in packaging for multiple withdrawals often also contain information on the shelf life after the container has been opened for the first time ( usable after opening , e.g. for eye drops ) or after making it ready for use (usable after preparation , e.g. production of a dry juice by adding from water to dry matter). Similarly, in the case of medical devices that are to be reprocessed in a sterile manner prior to the date printed by the manufacturer, the date indicated by the reprocessor up to which sterile use is possible ( sterile goods storage period ) must be observed .
The legal basis is:
- Germany: Medical Devices Act , Medicines Act and subordinate legal provisions
- Austria: Medical Devices Act, Medicines Act and subordinate legal provisions
Medicinal products and medical devices that have passed their expiry date may no longer be placed on the market, with the exception of use in a military context if necessary. According to investigations by the American FDA and the US Department of Defense as part of the Shelf Life Extension Program , many drugs can often be used safely and effectively years after the expiry date if they are continuously monitored and properly stored.
The indication of the expiry date or the use-by date (including the necessary storage conditions) on the packaging is required by law for finished medicinal products. It is to be stated unencrypted, at least in the year and month, whereby the words “Usable until” or “Us. until “are to be placed in front. The abbreviation EXP (for 'expiry date') is also possible for small packaging and blisters . In the case of prescription drugs, the period of use is with the note "use by" stating the day, month and year and, if necessary, the shelf life after opening the container or after production of the ready-to-use preparation on the containers and, if used, the outer ones To attach wrappings.
See also
- Best before date
- Period of use or period after opening for cosmetics
- Shelf Life Test (Medicines)
Individual evidence
- ↑ § 4 (3) Austrian Medicines Act / Art. 1 § 6 Austrian Medical Devices Act / § 8 (2), German Medicines Act / § 4 German Medical Devices Act
- ↑ z. B. § 4 (4) Austrian Medicines Act / § 4 Para. 1 German Medical Devices Act
- ↑ Extending the Shelf life of Critical Chemical Biological, Nuclear and Radiological (CBRN) Medical Material using the FDA / DOD Shelf life Extension Program ( Memento of the original of July 22, 2011 in the Internet Archive ) Info: The archive link was automatically inserted and not yet checked. Please check the original and archive link according to the instructions and then remove this notice. , US Department of Defense
- ↑ The DoD / FDA Shelf Life Extension Program ( Memento of the original from July 22, 2011 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. , Defense Medical Materiel Program Office
- ^ Many Medicines Are Potent Years Past Expiration Dates , Laurie P. Cohen, Wall Street Journal, March 28, 2000.
- ↑ a b § 10 (1), dArzneimittelgesetz / § 15 ö Labeling Ordinance 2008.
- ↑ Switzerland: Art. 12, Paragraph 1, Medicinal Products Licensing Ordinance (AMZV; PDF; 280 kB).
- ↑ Appendix IV - Terms and abbreviations for batch number and expiry date to be used on the labeling of human medicinal products , July 1, 2008.
- ↑ § 14 Paragraph (1), Pharmacy Operation Regulations (ApoBetrO).
