Medicines: permissions and operating records · France / Switzerland
Magistral preparation: category and traceability dossier
A magistral-preparation dossier establishes the category, prescription and intended recipient before linking the pharmacy, materials and documented operations. France’s preparation framework differs from Switzerland’s formula categories and permission conditions. Assemble quality controls, batches, outsourced work and dispensing references. Do not extend a restriction for one preparation category to every other category. The output organises regulatory evidence without selecting a treatment, formula or dose.
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- Jurisdiction
- Category and prescription
- Recipient and pharmacy
- Materials and preparation
- Controls and dispensing
- Official texts cited
- Sources checked on
- Drafted with AI assistance, our method
General legal information with official references and dated checks. It is not personalised advice: for a decision that commits you, have your situation checked by a qualified professional.
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What distinguishes it from a medicine requiring ordinary marketing authorisation?
France: retain the facts justifying magistral status rather than assuming small manufacture is exempt. Switzerland: document the specific HMG exception; formula manufacture is not an unrestricted substitute for ordinary product authorisation.
Read the referencesYour file concerns “Magistral preparation: category and traceability dossier”. Does it concern France or Switzerland? Share the document for category and prescription and the decision you need to prepare.
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Which preparation category and prescription basis are invoked?
France: connect the prescription and particular patient with the current L5121-1 definition, including suitable or available specialties. Switzerland: HMG Article 9(2)(a) sets its own prescription, recipient and pharmacy conditions; the definitions are not interchangeable.
CSP L5121-1 : L5121-1Code de la santé publique : L5121-5LPTh / HMG / LATer : 9OAMéd / AMBV / OAMed : 8OMéd / VAM / OM : 35, 36, 37, 39
What distinguishes it from a medicine requiring ordinary marketing authorisation?
France: retain the facts justifying magistral status rather than assuming small manufacture is exempt. Switzerland: document the specific HMG exception; formula manufacture is not an unrestricted substitute for ordinary product authorisation.
CSP L5121-1 : L5121-1Code de la santé publique : L5121-5LPTh / HMG / LATer : 9OAMéd / AMBV / OAMed : 8OMéd / VAM / OM : 35, 36, 37, 39
Which person or pharmacy may carry out the activity?
France: identify pharmacy, responsible person and actual operations. Switzerland: check the competent manufacturing permission and AMBV Article 8 risk route; product-authorisation exemption does not establish unrestricted manufacturing rights.
CSP L5121-1 : L5121-1Code de la santé publique : L5121-5LPTh / HMG / LATer : 9OAMéd / AMBV / OAMed : 8OMéd / VAM / OM : 35, 36, 37, 39
Prescription-to-preparation and dispensing evidence chain
Synthetic example: fictional records. Prescription-to-preparation and dispensing evidence chain.
Synthetic example: fictional records · Prescription-to-preparation and dispensing evidence chain
- Jurisdiction
- France
- Category and prescription
- Preparation C1, prescription P1
- Recipient and pharmacy
- Person A1, pharmacy F1
- Materials and preparation
- Batches L1, order O1
- Controls and dispensing
- Checks Q1, dispensing D1
The output organises regulatory evidence without selecting a treatment, formula or dose.
What connects prescription, recipient and preparation order?
France: link prescription, recipient, formula and preparation order through references. Switzerland: preserve the equivalent prescription and intended-recipient chain; avoid unnecessary identifiable patient records in the general preparation tool.
CSP L5121-1 : L5121-1Code de la santé publique : L5121-5LPTh / HMG / LATer : 9OAMéd / AMBV / OAMed : 8OMéd / VAM / OM : 35, 36, 37, 39
Preparation reference: Prescription-to-preparation and dispensing evidence chain
| Preparation question | Point to verify |
|---|---|
| Which preparation category and prescription basis are invoked? | France: connect the prescription and particular patient with the current L5121-1 definition, including suitable or available specialties. Switzerland: HMG Article 9(2)(a) sets its own prescription, recipient and pharmacy conditions; the definitions are not interchangeable. |
| What distinguishes it from a medicine requiring ordinary marketing authorisation? | France: retain the facts justifying magistral status rather than assuming small manufacture is exempt. Switzerland: document the specific HMG exception; formula manufacture is not an unrestricted substitute for ordinary product authorisation. |
| Which person or pharmacy may carry out the activity? | France: identify pharmacy, responsible person and actual operations. Switzerland: check the competent manufacturing permission and AMBV Article 8 risk route; product-authorisation exemption does not establish unrestricted manufacturing rights. |
| What connects prescription, recipient and preparation order? | France: link prescription, recipient, formula and preparation order through references. Switzerland: preserve the equivalent prescription and intended-recipient chain; avoid unnecessary identifiable patient records in the general preparation tool. |
CSP L5121-1 : L5121-1Code de la santé publique : L5121-5LPTh / HMG / LATer : 9OAMéd / AMBV / OAMed : 8OMéd / VAM / OM : 35, 36, 37, 39
Which quality and preparation controls are documented?
France: L5121-5 provides the good-practice and traceability foundation, with detailed standards to check. Switzerland: retain documented risk assessment and applicable controls; a preparation register alone does not validate pharmaceutical quality.
CSP L5121-1 : L5121-1Code de la santé publique : L5121-5LPTh / HMG / LATer : 9OAMéd / AMBV / OAMed : 8OMéd / VAM / OM : 35, 36, 37, 39
Which official provision helps explain this situation?
A magistral-preparation dossier establishes the category, prescription and intended recipient before linking the pharmacy, materials and documented operations. France’s preparation framework differs from Switzerland’s formula categories and permission conditions. Assemble quality controls, batches, outsourced work and dispensing references. Do not extend a restriction for one preparation category to every other category. The output organises regulatory evidence without selecting a treatment, formula or dose.
How are materials, batches and document versions traced?
France: connect material references, batches and document versions. Switzerland: likewise link the actual preparation to ingredients and records; invoices or a generic recipe do not prove every component’s origin and release status.
CSP L5121-1 : L5121-1Code de la santé publique : L5121-5LPTh / HMG / LATer : 9OAMéd / AMBV / OAMed : 8OMéd / VAM / OM : 35, 36, 37, 39
Which outsourcing or quantity conditions need examination?
France: verify the specific quantity and outsourcing conditions rather than inventing a universal ceiling. Switzerland: VAM Article 35 customer limits concern Article 9(2)(b–cbis), while magistralis has its own conditions; Article 36 quantity branches remain distinct.
CSP L5121-1 : L5121-1Code de la santé publique : L5121-5LPTh / HMG / LATer : 9OAMéd / AMBV / OAMed : 8OMéd / VAM / OM : 35, 36, 37, 39
What evidence links dispensing to the preparation concerned?
France: connect release and dispensing records to the intended preparation. Switzerland: retain formula-category labelling and dispensing evidence separately; an entry stating that a batch was made does not demonstrate its actual supply to the intended recipient.
CSP L5121-1 : L5121-1Code de la santé publique : L5121-5LPTh / HMG / LATer : 9OAMéd / AMBV / OAMed : 8OMéd / VAM / OM : 35, 36, 37, 39
Which preparation steps come first?
Editorial preparation order, not a popularity or success-probability ranking. Establish category and prescription first, then responsibility, traceability and dispensing evidence.
Establish the category
The claimed formula route determines which preparation conditions must be examined.
CSP L5121-1 : L5121-1Code de la santé publique : L5121-5LPTh / HMG / LATer : 9OAMéd / AMBV / OAMed : 8OMéd / VAM / OM : 35, 36, 37, 39
Connect the prescription
Prescription, recipient and formula must align before assessing the manufacture.
CSP L5121-1 : L5121-1Code de la santé publique : L5121-5LPTh / HMG / LATer : 9OAMéd / AMBV / OAMed : 8OMéd / VAM / OM : 35, 36, 37, 39
Identify responsible actors
Each operation needs a documented pharmacy, permission and responsible role.
CSP L5121-1 : L5121-1Code de la santé publique : L5121-5LPTh / HMG / LATer : 9OAMéd / AMBV / OAMed : 8OMéd / VAM / OM : 35, 36, 37, 39
Trace manufacture
Materials, batches and controls make the prepared product identifiable in the evidence.
CSP L5121-1 : L5121-1Code de la santé publique : L5121-5LPTh / HMG / LATer : 9OAMéd / AMBV / OAMed : 8OMéd / VAM / OM : 35, 36, 37, 39
Document dispensing
Release and actual supply complete the chain to the intended recipient.
CSP L5121-1 : L5121-1Code de la santé publique : L5121-5LPTh / HMG / LATer : 9OAMéd / AMBV / OAMed : 8OMéd / VAM / OM : 35, 36, 37, 39
Which official references should you consult?
- CSP L5121-1 : L5121-1www.legifrance.gouv.fr
- Code de la santé publique : L5121-5www.legifrance.gouv.fr
- LPTh / HMG / LATer : 9www.fedlex.admin.ch
- OAMéd / AMBV / OAMed : 8www.fedlex.admin.ch
- OMéd / VAM / OM : 35, 36, 37, 39www.fedlex.admin.ch
Texts cited last checked: 3 November 2026
What other questions arise in this file?
What distinguishes it from a medicine requiring ordinary marketing authorisation?
France: retain the facts justifying magistral status rather than assuming small manufacture is exempt. Switzerland: document the specific HMG exception; formula manufacture is not an unrestricted substitute for ordinary product authorisation.
CSP L5121-1 : L5121-1Code de la santé publique : L5121-5LPTh / HMG / LATer : 9OAMéd / AMBV / OAMed : 8OMéd / VAM / OM : 35, 36, 37, 39
What connects prescription, recipient and preparation order?
France: link prescription, recipient, formula and preparation order through references. Switzerland: preserve the equivalent prescription and intended-recipient chain; avoid unnecessary identifiable patient records in the general preparation tool.
CSP L5121-1 : L5121-1Code de la santé publique : L5121-5LPTh / HMG / LATer : 9OAMéd / AMBV / OAMed : 8OMéd / VAM / OM : 35, 36, 37, 39
How are materials, batches and document versions traced?
France: connect material references, batches and document versions. Switzerland: likewise link the actual preparation to ingredients and records; invoices or a generic recipe do not prove every component’s origin and release status.
CSP L5121-1 : L5121-1Code de la santé publique : L5121-5LPTh / HMG / LATer : 9OAMéd / AMBV / OAMed : 8OMéd / VAM / OM : 35, 36, 37, 39
What evidence links dispensing to the preparation concerned?
France: connect release and dispensing records to the intended preparation. Switzerland: retain formula-category labelling and dispensing evidence separately; an entry stating that a batch was made does not demonstrate its actual supply to the intended recipient.
CSP L5121-1 : L5121-1Code de la santé publique : L5121-5LPTh / HMG / LATer : 9OAMéd / AMBV / OAMed : 8OMéd / VAM / OM : 35, 36, 37, 39