Two important 2018’s provisions, the Falsified Medicines Directive (2011/62/EU) and its derived Commission Delegated Regulation (EU) 2016/161, published February-18, provide fundamental specifications on how and by whom the authenticity of the medicines must be verified, as well as the safety requirements. The gummed paper tape contributes in a special way to fulfillment of the conditions that these regulations require.
The main of these obligations refers to requirement to use tamper-proof sealed containers and packaging to prevent them from entering in the legal supply chain counterfeit medicines. An estimated 30 billion medicinal packs are sold and handled annually in Europe.
Anti-tampering device and seal has to enable verification of package tampering. CEN standard EN 16679/2014: “Tamper verification features for medicinal product packaging”, serves to define the mandatory requirements to verify handling: the packaging sealing system must show sings if the finished product’s packaging has been opened or manipulated, to avoid the inadvertent entry of falsified medicines into the legal supply chain.
The information provided by this standard mainly serves as a guide for pharmaceutical manufacturers and relevant approval and test institutes, respect to testing of the suitability of sealing systems and it's based on the following requirements:
- The tamped-proof seal must not prejudice the readability of the prescribed information.
- The packaging text must remain readable after the pack has been opened.
- The application of systems to control tampering and handling attempts may lead to an increase in the physical force required to open the packaging, but should not substantially aggravate the handling and opening of the package.
- The use of opening or easy aids, such as special perforations or starter tabs, may be necessary.
Due to its carbon footprint specifications, the exhaustive and continuous revision of its standards, its efficiency and economy, its sustainability and respect for the environment, gummed paper tape is the appropriate sealing method to support all the above requirements.
➪ https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0074:0087:EN:PDF
➪ https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R0161&from=ES
