Today (01 May 2024) Switzerland's Swissmedic released updated guidance on "Import of a Human Medicinal Product according to Art. 14 para. 2 and 3 TPA (Parallel Import)".
Any medicinal product that is imported from a country with comparable medicinal product control and has been authorised by Swissmedic in response to an application under Article 14 para. 2 and 3 TPA is termed a parallel imported medicinal product.
This guidance document describes the documentation requirements for submitting and obtaining authorisation of parallel imported human medicinal products: It is intended primarily for administrative bodies.
For applicants, the document is intended to elucidate the specific requirements that must be fulfilled to ensure that applications for the authorisation of and variations to parallel imported human medicinal products under Art. 14 para. 2 and 3 TPA are processed as quickly and efficiently as possible.
If a parallel imported human medicine product is imported from a country with comparable medicinal product control, it can only be authorised.
Parallel imported human medicines must comply with the same requirements as their original Swiss approvals, particularly with regard to their labeling and medicinal product information in accordance with Section 4 TPLRO and Art. 26ff.TPO
The importer must satisfy the same safety and quality requirements with respect to the parallel imported medicinal product as the marketing authorisation holder with respect to the original medicinal product.
If variations are made to the original medicinal product that also affect the parallel imported medicinal product, the variations should also be applied to the parallel imported medicinal product. There must be a note indicating the medicinal product pack size that is being imported if all pharmaceutical forms, dosage strengths, or pack sizes are not being imported or if the package size is not authorized in Switzerland for the original medicinal product.
Check out this guidance for more details on the formal requirements and the associated documents required for this submission.
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