Individual distinguishing features and safety precautions on the packaging of medicinal products


On 29 September 2017, the Federal Council approved the proposal to approve and implement the Medicrime Convention. The newly drafted Article 17a of the revised Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA, SR 812.21) creates the legal basis for the inclusion of distinguishing features, in the form of two-dimensional barcodes (data matrix), also on medicines intended for the Swiss market.

Affixing a data matrix on the packaging elements is already currently permitted (see guidance document Information on packaging). Even after Art. 17a of the revised TPA enters into force, the marketing authorisation holder will still be responsible for affixing a data matrix. The data matrix will still not be checked by Swissmedic and can continue to be affixed by the authorisation holder without the involvement of Swissmedic. The requirements of the Ordinance of the Swiss Agency for Therapeutic Products of 9 November 2001 on the Licensing Requirements for Therapeutic Products (TPLRO, SR 812.212.22) must all be fulfilled in a format readable by humans (e.g. the open expiry date must still be printed on the pack and may not be replaced by the data matrix).

Queries on the actual implementation of Article 17a of the revised TPA should be addressed to the responsible authority, i.e. the Federal Office of Public Health (FOPH). Specific statements on substantive questions of implementation, particularly on the content of the “Ordinance on the individual distinguishing features and safety precautions on the packaging of medicinal products”, can be issued only when the legislative process is concluded.