Swissmedic Guidelines: Formal Requirements & GMP Compliance for Foreign Manufacturers
- Sharan Murugan
- May 3
- 3 min read
When navigating Switzerland's regulatory landscape for medicinal products, two key guidance documents from Swissmedic stand out for their practical importance: the “Guidance on Formal Requirements” and the “Guidance on GMP Compliance by Foreign Manufacturers.” Together, these documents form the backbone of a compliant and efficient application process for both local and foreign pharmaceutical companies aiming to market products in Switzerland.
The “Formal Requirements” guidance outlines the essential structural and administrative components required for submitting applications related to marketing authorisation, renewals, variations, and notifications. Swissmedic mandates that all applications be submitted electronically using the eCTD (electronic Common Technical Document) format. This format ensures standardization and traceability across submissions. Documents must be submitted as searchable PDFs, adhering strictly to defined naming conventions to avoid processing delays.
The content of the application must be thorough and include several critical elements such as a cover letter, completed application form, summaries and reports from qualified experts, product information (including SmPC, package leaflet, and labelling), and comprehensive quality documentation.
Additionally, legal authorization demonstrating the applicant’s capacity to act on behalf of the marketing authorization holder must be provided. Language plays a pivotal role as well—Swissmedic accepts German, French, Italian, or English for the application file, but patient-facing documents must be translated into the three national languages of Switzerland.
The guidance also stresses the importance of clarity when referencing previous submissions. For example, when filing a variation or renewal that builds on earlier data, applicants must use “related sequence” fields to explicitly refer to the original documentation. Administrative diligence is also critical. Proof of fee payment, accurate applicant contact details, and valid digital signatures are mandatory components that Swissmedic verifies before processing any dossier.
This guidance ensures that all foreign manufacturing sites supplying medicines to Switzerland meet Good Manufacturing Practice (GMP) standards, safeguarding product quality and patient safety.
Swissmedic places a high priority on product safety and quality, especially for products imported from outside Switzerland. To ensure that these products meet Swiss standards, foreign manufacturers must provide a valid GMP certificate issued by a recognized health authority. Ideally, this certificate should be no more than three years old. If such documentation is unavailable or outdated, Swissmedic reserves the right to perform its inspections or delegate the task to another qualified body.
Responsibility for maintaining GMP compliance does not fall on the foreign manufacturer alone. Instead, it is the Swiss marketing authorization holder who is ultimately accountable for ensuring that all outsourced manufacturing sites comply with Swissmedic’s GMP expectations. This responsibility includes promptly notifying Swissmedic of any changes to manufacturing sites, production processes, or GMP status. To support transparency and regulatory confidence, the authorization holder must also submit written confirmations or translations where necessary, especially if documents are in languages other than German, French, Italian, or English.
Swissmedic exercises a risk-based approach when deciding whether to rely on existing certifications or conduct its inspections. If a GMP certificate is not recent or concerns arise about a manufacturing facility’s compliance history, Swissmedic may opt for a direct inspection, adding another layer of scrutiny to protect patient safety.
You can access the official documents on the Swissmedic website using the following links:
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