Swissmedic has issued detailed guidance on (01 August, 2024) on the "Packaging for Human Medicinal Products" to ensure their safety, efficacy, and quality. This guidance explains how primary and secondary packaging (packages) for human medicinal products must be labelled and how it may be designed.
The guidance is intended to clarify the specific requirements that must be fulfilled so that corresponding applications can be processed as quickly and efficiently as possible. This guidance is valid for the labelling and design of packaging for human medicinal products.
Generally, according to Article 1, approval will not be granted for packaging that compromises drug safety, misleads patients, leads to an inappropriate or excessive use of the medicinal product, or distorts information about the product.
In general, packaging should only contain information that is useful, necessary, clear, and not misleading (Art. 12 para. 1 TPLRO).
Additional languages (such as EU languages, Arabic, etc.) can also be included by the marketing authorisation holder, provided that all mandatory information is clearly legible in the required languages and meets the font size requirements. Swissmedic approves packaging texts in the correspondence language; it is the responsibility of the marketing authorisation holder to ensure that the information is correct in other languages.
There are several ways to specify the composition of a medicinal product, including the official Swiss languages and internationally recognized short forms (International Nonproprietary Name (INN) of the World Health Organization, or Latin (Art. 26 para. 3 TPO). Packaging texts for medicinal products intended exclusively for hospital use can only be written in one official Swiss language or in English (Art. 26 para. 4TPO).
The authorisation holder shall ensure that any additional information can be provided in the official language required by the users. The dispensing category must be stated on the folding carton using the Swissmedic pictogram (licence symbol). Although the font size is not specified, the dispensing category must be clearly legible.
By following Swissmedic’s guidance, pharmaceutical companies can ensure that their products are packaged to the highest standards, thereby protecting consumer health and maintaining the integrity of the medicinal product throughout its lifecycle. For more detailed information, refer to the full Swiss Medical Guidance Document on Packaging for Human Medicinal Products.
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