Swissmedic Updates Technical Interpretation on Market Release and Pre-Wholesaler Distribution

Swissmedic has updated its technical interpretation “Market release and distribution in cooperation with a pre-wholesaler” to version 6.0.

The document is valid from 7 September 2026 and replaces version I-SMI.TI.06_05, dated 9 August 2022.

Purpose and Scope

The document addresses situations where a Marketing Authorisation Holder, or MAH, fully or partially contracts out storage facilities and related physical operations to another company.

These outsourced operations may include storage, retention sample storage and delivery. The document highlights requirements linked to batch release for the Swiss market and GDP-compliant distribution after market release.

Legal and Regulatory Basis

Swissmedic identifies several legal and regulatory references as the basis for the interpretation.

These include Articles 13, 15 paragraph 2 and 18 paragraph 2 of the Medicinal Products Licensing Ordinance, MPLO, Chapter 7 and Annex 16 of the Guide to Good Manufacturing Practice, EU GDP guidance for human medicinal products, EU GDP rules for veterinary medicinal products and Article 59 of the Therapeutic Products Act, TPA.

Key Definitions

The document defines a pre-wholesaler as an authorised wholesaler to whom an MAH that does not maintain its own storage facilities has contracted out the physical operations of market release and distribution.

Examples include receipt, visual checks of received goods, storage and delivery.

It also defines the Responsible Person, or RP, designated by the MAH, as the person who should carry out duties to ensure company compliance with GDP, GMP and legal requirements.

General Remarks on Market Release

Swissmedic explains that, with market release, the MAH assumes responsibility for the released medicinal product.

The MAH confirms that the batch complies with the marketing authorisation regarding composition, manufacturing process, specifications, quality requirements, container type and package presentation, and that it was manufactured according to GMP.

The market release decision must be based on complete knowledge and unambiguous documentation of the full supply chain of the batch through all manufacturing stages, including transport to the stock where the batch is stored.

Distribution After Market Release

For distribution after market release, the MAH must ensure that clear documentation is available for the purchase and sale of distributed medicinal products.

This documentation must be easily accessible and must allow fast and complete notification of recipients in case of product recalls. The MAH must also define how the legitimacy of customers is checked and must ensure that medicinal products are stored and delivered under the necessary conditions.

Cooperation With a Pre-Wholesaler

Swissmedic states that the MAH may contract out physical operations related to market release and distribution to a pre-wholesaler, provided specific conditions are met.

These include that the MAH holds an establishment licence including market release, all market release requirements under the MPLO are fulfilled, the pre-wholesaler holds the required establishment licence for the activities performed, and post-release distribution is performed in compliance with applicable GDP requirements.

Quality Agreement and Oversight

The document emphasizes the need for a Quality Agreement between the MAH and the pre-wholesaler.

The agreement must be established and continuously updated, assign clear responsibilities and define which procedures or conditions are applied by the pre-wholesaler on behalf of the MAH.

Swissmedic also states that the MAH must ensure full oversight and accountability for compliance, traceability and product integrity across all outsourced activities. Delegated activities must be assessed regularly by the MAH on a risk-based basis and whenever outsourced activities change.

Audits and Contract Acceptor Qualification

The document clarifies that while general legal compliance may rely on establishment licences, certificates or inspections by competent authorities, concrete compliance with the contract must be assessed through regular audits.

The MAH should have a documented risk-based programme for qualification and periodic assessment of contract acceptors. This programme should define assessment methods, scope, depth and frequency, with documented justification for the selected approach.

Final Market Release Decision

Swissmedic emphasizes that the MAH must clearly communicate the final decision on market release or rejection of a batch to the wholesaler.

Final responsibility for the released batch, including any batch recall decision, remains with the MAH and cannot be delegated or outsourced. The Responsible Person of the MAH must have the necessary education and experience under Article 18 paragraph 2 MPLO.

Documentation and Retention Samples

The MAH is required to keep on its premises all documents on which market release was based.

In exceptional cases, some relevant documentation for market release and distribution, as well as retention samples, may be stored at the contract acceptor, provided that documents or copies, retention samples or justified alternatives can be accessed by the MAH at short notice, meaning within several hours, and this arrangement is agreed with the relevant competent inspectorate.

Market Surveillance and Pharmacovigilance

The MAH’s overall responsibility for marketed medicinal products includes establishing and maintaining a market surveillance system, including pharmacovigilance.

The MAH must also report conclusions from market surveillance to the competent authority, including decisions on batch recalls.

Changes Introduced in Version 6.0

The change history states that version 6.0 adds a reference to Annex 16 of the GMP Guide and rephrases the definition of the Responsible Person.

It also clarifies that the release decision should be based, among other elements, on documented delivery and reception information for the released batch.

For cooperation with pre-wholesalers, the updated version adds several precisions, including the requirement for the MAH to hold an establishment licence including market release, GDP compliance for post-release distribution, full MAH oversight of outsourced activities, Responsible Person education and experience, and conditions for storage of retention samples and relevant documentation at the contract acceptor.

Impact on Marketing Authorisation Holders

For Marketing Authorisation Holders working with pre-wholesalers in Switzerland, the updated technical interpretation is relevant because it clarifies that outsourcing physical operations does not transfer final responsibility for market release, batch recall decisions, product integrity or compliance oversight.

MAHs should pay particular attention to:

• establishment licence scope including market release;

• pre-wholesaler licence scope;

• GDP-compliant distribution after market release;

• full supply chain documentation before batch release;

• delivery and reception documentation;

• Quality Agreement content and maintenance;

• risk-based qualification and periodic assessment of contract acceptors;

• audit rights and audit frequency;

• prohibition on further subcontracting without prior evaluation and approval;

• communication of final release or rejection decisions;

• Responsible Person qualification requirements;

• short-notice access to retained documentation and retention samples;

• market surveillance and pharmacovigilance responsibilities.

For companies using pre-wholesalers in Switzerland, the key message is that outsourced physical operations must remain under strong MAH governance, with clear contractual controls, documented oversight and rapid traceability across the batch lifecycle.