The printed materials used in the packaging and labelling of medicines include the outer and inner packaging of the medicinal product as well as the printed package leaflet and, depending on the type of medicinal product, further instructions for healthcare professionals or patients. They correspond to the product information approved by the competent authorities.
The printed packaging components are highly important within the marketing process of any medicinal product. Packaging materials provide patients/users with the relevant information required for the safe and effective use of medicinal products. The design and layout can help medicinal products to be clearly recognised, to avoid medication errors and allow critical information to be easily identified.
The packaging materials shall reflect the product Information wording in national language as agreed with the relevant competent authority. Additionally, national requirements need to be considered, as detailed per Member State in the guideline documents ‘Blue-box requirements’ published by the CMDh for products authorised via a national, mutual recognition or decentralised procedure, or as per the ‘Guideline on the packaging information of medicinal products for human use authorised by the union’ for products authorised via the centralised procedure. For medicinal products approved via the centralised procedure this additional information required nationally is provided in the so called ‘blue box’ on the outer carton.
Two-dimensional copies of the packaging material artwork (mock-ups) are normally submitted as part of a marketing authorisation application. Depending on the procedure type and country, requirements can vary and there can be a local agency review of the mock-ups.
Multilingual packaging refers to the use of two or more languages on the packaging materials. The information must be the same in all languages. For medicinal products approved via the centralised procedure country-specific-information is presented in the blue box. Launching medicinal products with multilingual packaging is an important mechanism for maintaining medicinal products in EU markets, especially in so called “small markets” or for medicinal products approved for rare diseases (orphan drugs).
The review process for artworks/mock-ups performed by the marketing authorisation holder (MAH) includes checking the correct and complete implementation of the wording agreed with the competent authority including Braille and serialisation information as well as all local and blue box information (e.g. pictograms, warnings, national codes, reimbursement or prescribing status). Where mock-ups have been agreed with a competent authority these need to be adhered to. Additional considerations may be required by some local authorities such as how and where to include information on the outer and inner packaging.
The artwork review of package leaflets, cartons and labels may be assisted by validation software to ensure complete accuracy is achieved, but this cannot replace a review by an experienced person. Some countries also require a responsible person for scientific information to be involved in the approval process.
It is essential to plan the preparation and review of packaging artworks early enough as the process can take some time considering that, as applicable, different functions/parties are involved (e. g. artwork/graphic studio, manufacturing site for technical review, Regulatory Affairs, Scientific Service, Responsible Person, Legal Department).
Non-compliant artworks may result in serious issues, may put patient safety at risk and cause immense costs to companies, whereas ensuring proper artwork implementation in a timely manner ensures that the product can be launched without regulatory delays and safety information can be communicated appropriately.
During the lifecycle of a medicinal product any changes to the product information or local requirements need to be considered for their impact on the packaging materials and artworks need to be revised accordingly.