Medicines: permissions and operating records · France / Switzerland
Pharmaceutical establishment: activity permission map
A pharmaceutical-establishment dossier starts with the actual activity and product category. Identify premises, responsible pharmaceutical roles, outsourced operations and the permission route before matching quality and inspection evidence to the requested scope. France and Switzerland have different establishment frameworks and exceptions. Track material changes separately. A medicine’s marketing authorisation does not itself establish permission for the operator’s manufacturing, import or distribution activities at particular premises.
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What establishment and premises fall within the application?
France: map each activity to actual premises and the establishment decision. Switzerland: reconcile sites and rooms with the AMBV application; permission for one location should not be assumed to cover every company warehouse.
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Which pharmaceutical activity and product category are proposed?
France: separate manufacturing, import and distribution operations before reading L5124-3. Switzerland: identify the activity and product category under HMG Articles 5, 18 and 28; a company registration proves neither operating permission nor scope.
CSP L5124-3 : L5124-3LPTh / HMG / LATer : 5, 18, 28OAMéd / AMBV / OAMed : 3, 11, 12, 16, 17
What establishment and premises fall within the application?
France: map each activity to actual premises and the establishment decision. Switzerland: reconcile sites and rooms with the AMBV application; permission for one location should not be assumed to cover every company warehouse.
CSP L5124-3 : L5124-3LPTh / HMG / LATer : 5, 18, 28OAMéd / AMBV / OAMed : 3, 11, 12, 16, 17
Pharmaceutical activity, premises and responsibility matrix
Synthetic example: fictional records. Pharmaceutical activity, premises and responsibility matrix.
Synthetic example: fictional records · Pharmaceutical activity, premises and responsibility matrix
- Jurisdiction
- France
- Activity and products
- Manufacturing or distribution A1, products P1
- Establishment and premises
- Site S1, plan L1
- Responsible role and quality
- Role R1, system Q1
- Permission and changes
- Decision D1, change M1
A medicine’s marketing authorisation does not itself establish permission for the operator’s manufacturing, import or distribution activities at particular premises.
Who holds the responsible technical and pharmaceutical functions?
France: retain appointments and evidence of the pharmaceutical roles relevant to the activity. Switzerland: document the fachtechnisch verantwortliche Person and applicable AMBV requirements; a generic quality-manager title does not establish the necessary qualification.
CSP L5124-3 : L5124-3LPTh / HMG / LATer : 5, 18, 28OAMéd / AMBV / OAMed : 3, 11, 12, 16, 17
Preparation reference: Pharmaceutical activity, premises and responsibility matrix
| Preparation question | Point to verify |
|---|---|
| Which pharmaceutical activity and product category are proposed? | France: separate manufacturing, import and distribution operations before reading L5124-3. Switzerland: identify the activity and product category under HMG Articles 5, 18 and 28; a company registration proves neither operating permission nor scope. |
| What establishment and premises fall within the application? | France: map each activity to actual premises and the establishment decision. Switzerland: reconcile sites and rooms with the AMBV application; permission for one location should not be assumed to cover every company warehouse. |
| Who holds the responsible technical and pharmaceutical functions? | France: retain appointments and evidence of the pharmaceutical roles relevant to the activity. Switzerland: document the fachtechnisch verantwortliche Person and applicable AMBV requirements; a generic quality-manager title does not establish the necessary qualification. |
| Which manufacturing, import or wholesale permission route applies? | France: compare the requested operation with ANSM permission and restrictions. Switzerland: identify the corresponding manufacturing, import or wholesale permission and any specifically justified exception; product authorisation does not settle the operator’s permission. |
CSP L5124-3 : L5124-3LPTh / HMG / LATer : 5, 18, 28OAMéd / AMBV / OAMed : 3, 11, 12, 16, 17
Which manufacturing, import or wholesale permission route applies?
France: compare the requested operation with ANSM permission and restrictions. Switzerland: identify the corresponding manufacturing, import or wholesale permission and any specifically justified exception; product authorisation does not settle the operator’s permission.
CSP L5124-3 : L5124-3LPTh / HMG / LATer : 5, 18, 28OAMéd / AMBV / OAMed : 3, 11, 12, 16, 17
What quality-system and inspection evidence supports the scope?
France: connect inspections, quality procedures and corrective responses to site and activity. Switzerland: do the same for the AMBV scope; an inspection report from another location or period does not demonstrate current coverage.
CSP L5124-3 : L5124-3LPTh / HMG / LATer : 5, 18, 28OAMéd / AMBV / OAMed : 3, 11, 12, 16, 17
Which official provision helps explain this situation?
A pharmaceutical-establishment dossier starts with the actual activity and product category. Identify premises, responsible pharmaceutical roles, outsourced operations and the permission route before matching quality and inspection evidence to the requested scope. France and Switzerland have different establishment frameworks and exceptions. Track material changes separately. A medicine’s marketing authorisation does not itself establish permission for the operator’s manufacturing, import or distribution activities at particular premises.
Which outsourced activities need separate documentation?
France: record outsourced activities and the actual quality agreement. Switzerland: reconcile contractor, tasks, sites and interfaces under the relevant AMBV framework; an invoice alone does not allocate every regulatory responsibility.
CSP L5124-3 : L5124-3LPTh / HMG / LATer : 5, 18, 28OAMéd / AMBV / OAMed : 3, 11, 12, 16, 17
What material activity or organisational change requires examination?
France: L5124-3 addresses substantial changes to authorisation conditions; compare the approved and proposed scope. Switzerland: establish the applicable change or notification route separately; the French rule cannot be treated as the Swiss procedure.
CSP L5124-3 : L5124-3LPTh / HMG / LATer : 5, 18, 28OAMéd / AMBV / OAMed : 3, 11, 12, 16, 17
Why does product authorisation not establish permission for the premises?
France: medicine marketing approval and establishment permission concern different objects. Switzerland: likewise keep product and operating decisions separate; a valid medicine authorisation does not prove permission for all manufacturing, import or wholesale sites.
CSP L5124-3 : L5124-3LPTh / HMG / LATer : 5, 18, 28OAMéd / AMBV / OAMed : 3, 11, 12, 16, 17
What other questions arise in this file?
What establishment and premises fall within the application?
France: map each activity to actual premises and the establishment decision. Switzerland: reconcile sites and rooms with the AMBV application; permission for one location should not be assumed to cover every company warehouse.
CSP L5124-3 : L5124-3LPTh / HMG / LATer : 5, 18, 28OAMéd / AMBV / OAMed : 3, 11, 12, 16, 17
Which manufacturing, import or wholesale permission route applies?
France: compare the requested operation with ANSM permission and restrictions. Switzerland: identify the corresponding manufacturing, import or wholesale permission and any specifically justified exception; product authorisation does not settle the operator’s permission.
CSP L5124-3 : L5124-3LPTh / HMG / LATer : 5, 18, 28OAMéd / AMBV / OAMed : 3, 11, 12, 16, 17
Which outsourced activities need separate documentation?
France: record outsourced activities and the actual quality agreement. Switzerland: reconcile contractor, tasks, sites and interfaces under the relevant AMBV framework; an invoice alone does not allocate every regulatory responsibility.
CSP L5124-3 : L5124-3LPTh / HMG / LATer : 5, 18, 28OAMéd / AMBV / OAMed : 3, 11, 12, 16, 17
Why does product authorisation not establish permission for the premises?
France: medicine marketing approval and establishment permission concern different objects. Switzerland: likewise keep product and operating decisions separate; a valid medicine authorisation does not prove permission for all manufacturing, import or wholesale sites.
CSP L5124-3 : L5124-3LPTh / HMG / LATer : 5, 18, 28OAMéd / AMBV / OAMed : 3, 11, 12, 16, 17
Which official references should you consult?
- CSP L5124-3 : L5124-3www.legifrance.gouv.fr
- LPTh / HMG / LATer : 5, 18, 28www.fedlex.admin.ch
- OAMéd / AMBV / OAMed : 3, 11, 12, 16, 17www.fedlex.admin.ch
Texts cited last checked: 3 November 2026