LEGAL ISSUES

Important issues in the gummed paper tape industry

– New legislation for pharmaceuticals implies important role for gummed paper tape

Packaging and closing tapes play a dominant role in meeting two major legal provisions for the European pharmaceutical industry: The Falsified Medicines Directive (2011/62/EU) and its derived Commission Delegated Regulation (EU) 2016/161, published this February. Gummed paper tape is a major contributer to fulfill the requirements.

These legal provisions supply details on how the authenticity of medicines should be verified and by whom, as well as the characteristics of the safety features. The deadline for pharmaceutical packaging compliance with the Falsified Medicines Directive is 9 February 2019 in the majority of EU member states.

A major element includes that tamper-proof sealed packaging must be used to prevent falsified medicinal products entering the legal supply chain. An estimated 30 billion medicinal packs are sold and handled annually in Europe.

Anti-tampering device has to enable verification of package tampering. CEN standard EN 16679/2014: “Tamper verification features for medicinal product packaging”, serves to define the features used for tamper verification. These features should indicate that the outer packaging of a finished product has been opened or tampered with in order to prevent the unnoticed entry of falsified medicines into the legal supply chain.

The information provided by this standard primarily serves as guidance to pharmaceutical manufacturers and relevant approval and test institutes with respect to testing the suitability of seals, and lays down the following

requirements:

  • The tamper-proof seal must not impair the readability of the prescribed information
  • The prescribed packaging text must remain readable after the pack has been opened
  • The application of features to check tampering attempts may lead to an increase of the physical force required to open the packaging but must not substantially aggravate handling and opening the pack
  • The utilization of opening aids, such as special perforations or starter tabs, may be necessary.

In fact, the standard describes the scope of application, the requirements and features of tamper-proof pharmaceutical packaging, and provides specific recommendations for appropriate sealing. Gummed paper tape is the appropriate sealing method to support these requirements.

– Environment: Carbon Footprint
CO2 emissions caused by production of raw materials and recycling of gummed paper, have relatively low levels. Supported by the government, in the Netherlands research has been done on different packaging materials. The results:

Cimate: CO2-emissions (kgs) per tonne of packaging material

Wood                            < 0
Glass                            443
Paper and board          675
Steel                           1095
Plastics                        3453
Aluminium                   5570

(source: Dutch ministry of Environment, CE Delft)

– Standards. Fipago standards are critically reviewed on a continual basis. At the moment DIN standards (Germany) nrs. 55475 and 55477 are revised. As soon as this revision will be completed, they will be incorporated in the Fipago standards.

– Food Contact: The Industry Guideline considers the specific nature of food contact in case of paper and board. It is a self-regulating document, published in cooperation with a.o. the European association of paper and board converters (CITPA). Gummed papers are included in the document (watch the explanatory video).

TARGETS

Marketing And Technique
Members in countries worldwide are working together to satisfy the requirements in a sophisticated manner for needs posed by modern society. FIPAGO promotes and investigates every aspect of marketing and technical applications related to production and marketing needs, including recommending and providing suitable application equipment to its members.

Environmentally Friendly
FIPAGO through its members promotes environmentally friendly natural kraft plain and reinforced Gummed Paper Tapes. They are convinced that their competitors in the filmic tape market cannot match these products.

Economical And Efficient
With natural paper tapes, FIPAGO and its members provide economical and efficient sealing system that offers the customer substantial benefits. A modern system, based on broad experience in the past and steady improvement in the future.