The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU) in charge of scientific evaluation, regulation, and quality control of medicines in the EU.
Before approving medicinal products for distribution in the 27 EU member states along with Norway, Lichtenstein, and Iceland, the EMA makes sure that they meet safety, efficiency, and quality standards.
In relation to the labelling and packaging of medicinal products, there are certain requirements to be met before the EMA can finish its scientific evaluation. If these standards are not met, the product will not be distributed in the EU and can cause delays in your product reaching patients.
Labelling and Packaging Regulations
Title V of EU Directive 2001/83/EC sets out the labelling requirements for medicinal products in the EU. The following shows a non-exhaustive selection of some of the key considerations outlined in this directive:
Article 54 outlines the considerations for the outer packaging of the product. It must show the full title of the medicinal product, as well as its strength, contents, pharmaceutical form, route of administration, and it should state, if appropriate, whether it is suitable for adults or children. Further information such as any special warnings, storage precautions, and expiry date/batch number should also be shown, as well as the message to store the product out of the reach and sight of children. Importantly, information regarding the Marketing Authorization Holder’s (MAH) address and details, or its appointed representative, must be shown clearly on the packaging along with the Marketing Authorization number. Any change of address in the MAH or equivalent must therefore take the packaging requirements into consideration and reflect accordingly.
In accordance with Article 56a, the product’s name, strength, and form must be written in Braille on the outer packaging.
There are also specific requirements in relation to excipients and their reference on labels, especially when excipients that have a recognized action or effect are used. In the case of injectable, topical, or eye preparations all excipients must be listed.
Regarding the design of the product, the use of colours, pictograms, and logos (for non-promotional purposes) are permitted but care must be taken to ensure that mandatory information on the packaging is not obstructed and the design does not distract from any information. Where colour is used on the outer pack, it is recommended that it is carried onto primary packaging to aid identification of the medicine. When choosing a colour, it is advised that if your product has different strength levels, it should be displayed using different colours. It is recommended that the colour scheme, layout, logo, and format is consistent on all products or any variations of the product that may exist in the market, however, article 82(3) of regulation 726/2004 states that: “Without prejudice to the unique, Community nature of the content of the documents referred to in Article 9(4)(a), (b), (c) and (d) and in Article 34(4)(a) to (e), this regulation shall not prohibit the use of two or more commercial designs for a given medicinal product covered by a single marketing authorization”.
With the implementation of the Falsified Medicines Directive, tamper-evident packaging is now a requirement to show where packages have been interfered with and to help reduce the introduction of falsified goods into the supply chain. Furthermore, serialization is another key component of your packaging design as a unique identifying 2D barcode is required to ascertain the authenticity and traceability of the product.
The official language of the Member State where the product is to be placed on the market must be on the pack, however, there are exceptions to this outlined in article 63(1) and 63(3) for certain orphan drugs and products that are not intended to go directly to a patient e.g., specialist use only. In this instance, it can be agreed with the EMA/competent authority that only one of the official languages of the community will be placed on the pack.
With 24 official languages designated in the EU, often companies have multilingual packaging. In fact, this is referenced in Article 63(1) which states that several languages are permitted provided that they have the same information in each language and the readability of the pack is not compromised i.e., by placing a sufficient amount of white space around each section to clearly distinguish different languages. The process of grouping different stock-keeping units (SKU’s) is commonly referred to as regionalization and involves the clustering of certain jurisdictions/countries on a single SKU. When carrying out this activity, considerations such as launch timelines, geographic location, and forecasted sales/distribution are important to ensure that SKUs are not constrained and left in storage for extended periods of time.
Country-specific Information (“Blue Box”)
Certain Member States, in accordance with Article 57, may require additional information to be contained on the label. This includes pricing, reimbursement, the legal status of supply, authenticating characteristics, etc. This information is in a single boxed area which is commonly referred to as a “blue box”. The blue box is presented in the official language of the member state and highlights country-specific information required by the local competent authority. An example of country-specific information being contained on a pack is the “Bollino” label that is added to products in Italy as an anti-counterfeiting safeguard.
The information presented within this blog is for illustration purposes only and is not to be considered as professional advice. Any information related to health contained within this article is not a substitute for appropriate medical advice from licensed healthcare professionals.
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