Packaging of medicines by pharmaceutical manufacturers fully comply with the standards of Good Manufacturing Practice (GMP). Pharmaceutical Law provides a high level of health protection through stringent provisions which guarantee the quality, safety and efficacy of medicines traded on the EU market. However, the scale of counterfeiting of medicinal products from year to year is rising.
8th of June 2011 the European Parliament and the Council adopted Directive 2011/62/EU1 amending Directive 2001/83/EC2 on the Community Code relating to medicinal products for human use, which improves the protection of public health by tools against counterfeiting of drugs. The Directive requires from all 28 Member States the number of new requirements, i.e.: a unique packaging serialization of medicinal products, security system against forgery and verifying the authenticity of the product before releasing to patients. All these actions are designed to detect counterfeit drugs.
Since 2019, planned for implementation in the European Union, the requirement for drug packaging serialization, confronts pharmaceutical manufacturers and manufacturer of packaging materials to a serious challenges.
In the near future serializing and coding system will be implemented using a matrix of 2D Data Matrix, which allows assigning a unique number to each packaging and will contain other information contained in the requirements of the Directive. The serialization services will be implemented and will obtain it’s full functionality by the time designated in the FMD Directive. Serialization will cover all services not only in subject of printing and verifying the unique identifiers on each and every single unit box but also will, according to the FMD requirement, will extort the application of tamper evident labels. In scope of sterilization Prespack will provide the software managing of all manufacturing operations strictly connected to the communication of the data to and form the central repository of serialization data – EUHUB. This unique software, among many functions, will be created to meet the expectations, of not only marketing authorization holders of the medicinal product, but also marketing authorization holders with the parallel import and distribution activity.