The Directive 2001/83 having as main objective the protection of public health has set the conditions for the production, distribution or use of medicinal products. The main definitions for the packaging of medicines have been defined as follows:
- Immediate packaging: The container or other form of packaging immediately in contact with the medicinal product.
- Outer packaging: The packaging into which is placed the immediate packaging.
In the same directive are given the marking instructions of the immediate and outer packaging with the required information (in Braille language as well) but also with the mandatory references to the expiration date:
It is worth mentioning that the mock-ups of the outer and the immediate packaging of a medicinal product are submitted to the folder of the product in order to apply for the marketing authorization.
Directive 2011/62 amended the directive 2001/83 aiming to the prevention of entrance of falsified medicinal products for human use in the legal supply chain. The key points concerning the safety features applied on the packaging are the following:
- The safety features should allow verification of the authenticity and identification of individual packs, and provide evidence of tampering.
- The safety features should allow the verification of each supplied pack of the medicinal products, regardless of how they are supplied, including through sale at a distance.
- In order for the safety features to be effective, a manufacturing authorization holder who is not himself the original manufacturer of the medicinal product should only be permitted to remove, replace or cover those safety features under strict conditions. In particular, the safety features should be replaced in the case of repackaging by equivalent safety features.
- Falsified medicinal product :is defined as any medicinal product with a false representation of: its identity, including its packaging and labeling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients;
In the regulation 161/2016 are specified the necessary rules concerning the safety features appearing on the packaging of medicinal products for human use.
- It should be possible to identify and verify the authenticity of an individual pack of a medicinal product for the entire time the medicinal product stays on the market and the additional time necessary for returning and disposing of the pack after it has expired. For this reason, the character sequence resulting from the combination of the product code and the serial number sequence should be unique to a given pack of a medicinal product until at least one year after the expiry date of that pack or five years after the product has been released for sale or distribution in accordance with Article 51(3) of Directive 2001/83/EC, whichever is the longer period.
- The data elements of the unique identifier should be printed on the packaging in human-readable format so to allow the verification of the authenticity of the unique identifier and its decommissioning in case the two- dimensional barcode is unreadable.
- The presence of multiple two-dimensional barcodes on the packaging can engender confusion with regard to which barcode should be read for the purpose of verifying the authenticity of and identifying a medicinal product.
- The verification of the authenticity of the unique identifier aims at ensuring that the medicinal product originates from the legitimate manufacturer. The verification of the integrity of the anti- tampering device shows whether the packaging has been opened or altered since it left the manufacturer, thereby ensuring that the content of the packaging is authentic.
- The manufacturer shall place on the packaging of a medicinal product a unique identifier Manufacturers shall print the barcode on the packaging on a smooth, uniform, low-reflecting surface.
In this regulation are also provided new significant definitions:
- 'unique identifier' means the safety feature enabling the verification of the authenticity and the identification of an individual pack of a medicinal product;
- 'anti-tampering device' means the safety feature allowing the verification of whether the packaging of a medicinal product has been tampered with;
In order to fulfill the obligations emanating from the implementation of safety mechanisms (tampering) to protect against falsified medicinal products it is necessary to study the relevant European Standard of Control: BS ΕΝ 16679: (Packaging. Tamper verification features for medicinal product packaging). The latest edition of this European standard was published in December 2014.
The described mechanisms are divided into the following categories:
- Flaps of folding boxes closed with glue or closed with labels or tapes
- Specially constructed folding boxes
- Sealing labels and tapes
- Film wrappers
- Sleeves
- Breakable or tear-away closure
- Display blister pack
- Flexible packaging
- Blow-fill-and-seal-container (BFS)
The new approach of the European legislation enables packaging manufacturers to develop new structures and materials of higher added value ensuring that way consumers' protection against counterfeited medicinal products.
