Swiss GMP — Medicinal Products Licensing Ordinance
The Ordinance on Establishment Licences (Arzneimittel-Bewilligungsverordnung, AMBV / Medicinal Products Licensing Ordinance, SR 812.212.1) is the Swiss instrument that sets GMP for medicines. Issued under the Therapeutic Products Act (TPA, SR 812.21), it makes the manufacture and wholesale of medicinal products conditional on a Swissmedic establishment licence, and its annexes point to the internationally recognised GMP rules — the PIC/S GMP Guide and the EU GMP Guide — as the applicable standard.
What this does not cover
stated in the document's own scope- Sets the licensing and GMP framework; the detailed technical requirements are the PIC/S and EU GMP guides it references, not a separate Swiss GMP code.
- Governs manufacturing, import, and wholesale licensing, not the marketing-authorisation pathway, which the Therapeutic Products Act and its other ordinances handle.
- Applies to medicinal products for the Swiss market; medical devices and other therapeutic products are covered by their own instruments.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
The Ordinance on Establishment Licences (Arzneimittel-Bewilligungsverordnung, AMBV; in English the Medicinal Products Licensing Ordinance, SR 812.212.1) is the Swiss instrument that sets Good Manufacturing Practice for medicines. It makes the manufacture, import, and wholesale of medicinal products conditional on an establishment licence issued by Swissmedic, the Swiss Agency for Therapeutic Products, and it requires that manufacturing be carried out in accordance with the recognised rules of GMP. Rather than restate a full GMP code, the ordinance incorporates the internationally recognised technical rules by reference — the PIC/S GMP Guide and the EU GMP Guide — so a Swiss site works to the same text used across the EEA and the PIC/S membership.
Scope & applicability
Manufacturers, importers, and wholesalers supplying the Swiss market. The AMBV sets the licensing and GMP framework; the recognised GMP technical rules are the PIC/S and EU GMP guides it references.
Legal basis & how it acquires force
The AMBV is a Federal Council ordinance made under the Therapeutic Products Act (Heilmittelgesetz, HMG / TPA, SR 812.21), Switzerland’s primary medicines and medical-devices statute. As an ordinance it carries the force of law for the Swiss market: a site must hold a Swissmedic establishment licence, and the licence is conditional on demonstrated GMP compliance and on a designated technically responsible person. Because the recognised GMP rules are incorporated by reference, the binding technical standard is the current PIC/S and EU GMP text, applied and enforced domestically by Swissmedic.
Document structure
| Part | Covers |
|---|---|
| Establishment licences | Conditions for the manufacturing, import, and wholesale licences Swissmedic issues |
| Recognised GMP rules | Incorporation of the PIC/S GMP Guide and EU GMP Guide as the applicable technical standard |
| Technically responsible person | The role, qualifications, and duties of the fachtechnisch verantwortliche Person |
| Import and wholesale distribution | Requirements for importers and for good distribution practice |
| Annexes and references | The recognised GMP and GDP rules incorporated by reference into the ordinance |
Key requirements
- Hold a Swissmedic establishment licence to manufacture or distribute medicinal products.
- Manufacture in accordance with the recognised GMP rules (PIC/S GMP Guide and EU GMP Guide) referenced by the ordinance.
- Maintain the qualification, validation, and quality-system documentation the recognised rules require.
Implementation tips
- Work from the recognised PIC/S/EU GMP text — Switzerland does not maintain a separate national GMP code.
Revision notes
The revised AMBV (SR 812.212.1) entered into force on 1 January 2019 alongside the revised Therapeutic Products Act.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
Switzerland was among the founding members of the Pharmaceutical Inspection Convention in 1970 and remains a PIC/S participating authority, so its recognised GMP rules are the PIC/S Guide, which is kept harmonised with EU GMP. Switzerland and the European Union also operate a Mutual Recognition Agreement covering GMP inspection of medicinal products, under which each side can rely on the other’s inspection outcomes for many product types — the practical reason Swiss GMP certificates are accepted in the EU and vice versa.
AMBV (SR 812.212.1): frequently asked questions
Quick answers to common questions about AMBV (SR 812.212.1).
Does Switzerland have its own GMP code?
No. The AMBV (SR 812.212.1) requires manufacturing to the recognised rules of GMP and incorporates the PIC/S GMP Guide and the EU GMP Guide by reference, so Swiss sites work to the same text used across the EEA rather than a separate national code.
Is Switzerland a PIC/S member?
Yes. Switzerland was among the founding members of the 1970 Pharmaceutical Inspection Convention and remains a PIC/S participating authority, which is why its recognised GMP rules are the PIC/S Guide.
Are Swiss GMP inspections recognised in the EU?
Largely, yes. Switzerland and the EU operate a Mutual Recognition Agreement covering GMP inspection of medicinal products, so each side can rely on the other’s inspection outcomes for many product types.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.