Medicines: permissions and operating records · France / Switzerland
Medicine marketing authorisation: dossier map
A medicine marketing-authorisation dossier depends on the product, applicant and selected procedure. Identify presentation, intended use and territories before linking quality, safety and efficacy evidence to the application. France’s national and European routes must be distinguished from Swissmedic’s Swiss framework. The preparation maps documents and versions; it does not infer permission from a commercial registration, foreign approval or isolated study, and it remains separate from establishment authorisation.
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Who submits the dossier and holds the prospective authorisation?
France: distinguish applicant, manufacturer and proposed holder; L5121-8 requires EU or EEA establishment. Switzerland: identify the applicant and the relevant establishment permission under HMG Article 10 rather than importing the French establishment rule.
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Which product and presentation define the application?
France: identify substance, strength, dosage form and intended indication before applying L5121-8. Switzerland: record the same product facts for the HMG Article 9 assessment; a trade name establishes neither classification nor approval.
Code de la santé publique : L5121-8ANSM soumission AMMLPTh / HMG / LATer : 9, 10, 11OMéd / VAM / OM : 8, 28Swissmedic forms update
Who submits the dossier and holds the prospective authorisation?
France: distinguish applicant, manufacturer and proposed holder; L5121-8 requires EU or EEA establishment. Switzerland: identify the applicant and the relevant establishment permission under HMG Article 10 rather than importing the French establishment rule.
Code de la santé publique : L5121-8ANSM soumission AMMLPTh / HMG / LATer : 9, 10, 11OMéd / VAM / OM : 8, 28Swissmedic forms update
Which French, European or Swiss route applies?
France: document the proposed national or European procedure and its submission channel. Switzerland: identify the Swissmedic route separately; an EU approval or submission receipt does not itself demonstrate a Swiss authorisation.
Code de la santé publique : L5121-8ANSM soumission AMMLPTh / HMG / LATer : 9, 10, 11OMéd / VAM / OM : 8, 28Swissmedic forms update
Product, procedure and authorisation evidence map
Synthetic example: fictional records. Product, procedure and authorisation evidence map.
Synthetic example: fictional records · Product, procedure and authorisation evidence map
- Jurisdiction
- France
- Product and presentation
- Product P1, form F1
- Applicant and territory
- Holder A1, territory T1
- Regulatory route
- Procedure R1 to confirm
- Dossier and decision
- Modules D1, decision M1
The preparation maps documents and versions; it does not infer permission from a commercial registration, foreign approval or isolated study, and it remains separate from establishment authorisation.
What quality, safety and efficacy evidence supports that route?
France: link quality, safety and efficacy evidence to the applicable dossier requirements, which need category-specific checking. Switzerland: HMG Article 11 provides the dossier foundation; the preparation index does not certify completeness of every annex.
Code de la santé publique : L5121-8ANSM soumission AMMLPTh / HMG / LATer : 9, 10, 11OMéd / VAM / OM : 8, 28Swissmedic forms update
Which data and product-document versions must agree?
France: reconcile product information, study references and manufacturing versions. Switzerland: also connect the Swiss product information and submission version; record discrepancies explicitly instead of assuming that documents with similar filenames are identical.
Code de la santé publique : L5121-8ANSM soumission AMMLPTh / HMG / LATer : 9, 10, 11OMéd / VAM / OM : 8, 28Swissmedic forms update
Preparation reference: Product, procedure and authorisation evidence map
| Preparation question | Point to verify |
|---|---|
| Which product and presentation define the application? | France: identify substance, strength, dosage form and intended indication before applying L5121-8. Switzerland: record the same product facts for the HMG Article 9 assessment; a trade name establishes neither classification nor approval. |
| Who submits the dossier and holds the prospective authorisation? | France: distinguish applicant, manufacturer and proposed holder; L5121-8 requires EU or EEA establishment. Switzerland: identify the applicant and the relevant establishment permission under HMG Article 10 rather than importing the French establishment rule. |
| Which French, European or Swiss route applies? | France: document the proposed national or European procedure and its submission channel. Switzerland: identify the Swissmedic route separately; an EU approval or submission receipt does not itself demonstrate a Swiss authorisation. |
| What quality, safety and efficacy evidence supports that route? | France: link quality, safety and efficacy evidence to the applicable dossier requirements, which need category-specific checking. Switzerland: HMG Article 11 provides the dossier foundation; the preparation index does not certify completeness of every annex. |
Code de la santé publique : L5121-8ANSM soumission AMMLPTh / HMG / LATer : 9, 10, 11OMéd / VAM / OM : 8, 28Swissmedic forms update
What exemption or special procedure is actually invoked?
France: state the specific exception or special route and supporting facts. Switzerland: identify the precise HMG Article 9 branch; a magistral preparation or trial product does not establish a general exemption for marketed medicines.
Code de la santé publique : L5121-8ANSM soumission AMMLPTh / HMG / LATer : 9, 10, 11OMéd / VAM / OM : 8, 28Swissmedic forms update
Which official provision helps explain this situation?
A medicine marketing-authorisation dossier depends on the product, applicant and selected procedure. Identify presentation, intended use and territories before linking quality, safety and efficacy evidence to the application. France’s national and European routes must be distinguished from Swissmedic’s Swiss framework. The preparation maps documents and versions; it does not infer permission from a commercial registration, foreign approval or isolated study, and it remains separate from establishment authorisation.
What variations or renewals require follow-up?
France: retain requests, responses and proposed variations with dates, without inventing a filing category. Switzerland: connect changes to the applicable VAM route and authority correspondence; this register determines neither renewal dates nor approval of modifications.
Code de la santé publique : L5121-8ANSM soumission AMMLPTh / HMG / LATer : 9, 10, 11OMéd / VAM / OM : 8, 28Swissmedic forms update
Why is product authorisation distinct from permission for the establishment?
France: product approval and establishment permissions have different scopes. Switzerland: likewise reconcile Swissmedic product authorisation with the operator’s actual activities and sites; permission for a medicine does not authorise every manufacturing or distribution operation.
Code de la santé publique : L5121-8ANSM soumission AMMLPTh / HMG / LATer : 9, 10, 11OMéd / VAM / OM : 8, 28Swissmedic forms update
Which official references should you consult?
- Code de la santé publique : L5121-8www.legifrance.gouv.fr
- ANSM soumission AMMansm.sante.fr
- LPTh / HMG / LATer : 9, 10, 11www.fedlex.admin.ch
- OMéd / VAM / OM : 8, 28www.fedlex.admin.ch
- Swissmedic forms updatewww.swissmedic.ch
Texts cited last checked: 3 November 2026
What other questions arise in this file?
Who submits the dossier and holds the prospective authorisation?
France: distinguish applicant, manufacturer and proposed holder; L5121-8 requires EU or EEA establishment. Switzerland: identify the applicant and the relevant establishment permission under HMG Article 10 rather than importing the French establishment rule.
Code de la santé publique : L5121-8ANSM soumission AMMLPTh / HMG / LATer : 9, 10, 11OMéd / VAM / OM : 8, 28Swissmedic forms update
What quality, safety and efficacy evidence supports that route?
France: link quality, safety and efficacy evidence to the applicable dossier requirements, which need category-specific checking. Switzerland: HMG Article 11 provides the dossier foundation; the preparation index does not certify completeness of every annex.
Code de la santé publique : L5121-8ANSM soumission AMMLPTh / HMG / LATer : 9, 10, 11OMéd / VAM / OM : 8, 28Swissmedic forms update
What exemption or special procedure is actually invoked?
France: state the specific exception or special route and supporting facts. Switzerland: identify the precise HMG Article 9 branch; a magistral preparation or trial product does not establish a general exemption for marketed medicines.
Code de la santé publique : L5121-8ANSM soumission AMMLPTh / HMG / LATer : 9, 10, 11OMéd / VAM / OM : 8, 28Swissmedic forms update
Why is product authorisation distinct from permission for the establishment?
France: product approval and establishment permissions have different scopes. Switzerland: likewise reconcile Swissmedic product authorisation with the operator’s actual activities and sites; permission for a medicine does not authorise every manufacturing or distribution operation.
Code de la santé publique : L5121-8ANSM soumission AMMLPTh / HMG / LATer : 9, 10, 11OMéd / VAM / OM : 8, 28Swissmedic forms update