Swissmedic, the Swiss Agency for Therapeutic Products, has recently updated its guidance documents for "Parallel Import" and "Description of Document Protection". These updates aim to streamline the approval and management processes while ensuring compliance with regulatory frameworks.
Guidance: Import of a human medicinal product according to Art. 14 para. 2 and 3 TPA (Parallel Import)
Parallel Imported Medicinal Products, are products authorized abroad and imported under Art. 14 para. 2 and 3 TPA. Swissmedic’s guidance document on Parallel Import addresses the procedures for the importation and marketing of human medicinal products from countries with comparable medicinal product controls.
Parallel import offers a simplified route to market for products that are already authorized in other jurisdictions, under certain conditions.
The key topics covered in this guidance are around
Products must meet the same quality, safety, and labeling standards as the original Swiss product.
Any variations in packaging, formulation, or labeling must be justified and approved.
Primary packaging is accepted as per the country of origin but must be supplemented with Swiss-specific information where necessary.
Secondary packaging must meet Swiss requirements, including dual-language labeling. Importers are responsible for pharmacovigilance and implementing any safety measures directed by Swissmedic.
Variations in the original product must be mirrored in the parallel-imported version.
For more details, refer to the full guidance document here.
This guidance outlines the rights and procedures for protecting proprietary data submitted during the authorization of medicinal products. Document protection ensures that innovative data, such as clinical trial results, cannot be used by third parties for a specified period.
Scope of Protection:
Data related to new active substances (NAS), paediatric indications, and orphan drugs are eligible for protection.
Protection can extend to new indications, dosage forms, or administration routes.
Protection Periods:
10 Years: For new active substances or medicinal products for paediatric use.
15 Years: For orphan drugs or those targeting rare diseases.
3 Years: For new indications or dosage forms for known active substances.
Extension of Protection:
Applications for extended protection must demonstrate significant clinical benefit or innovation.
The protection period begins from the date of authorization or approval of a new indication.
Implementation:
Document protection applies even after the authorization is transferred or discontinued.
Swissmedic maintains a public record of protected medicinal products.
For more information, consult the detailed guidance document here.
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