Medicines: permissions and operating records · France / Switzerland
Medicine advertising: audience and claim comparison
A medicine communication must be assessed by its content, audience and medium. Compare proposed claims with authorised product information before determining the relevant control route. France’s visa framework and Switzerland’s advertising rules require separate analysis; prior control must not be assumed for every Swiss message. Preserve approval scope, validity and amendments. A permission for one campaign version does not establish permission for every medium or revised claim.
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Advertising audience, claim and approval matrix
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What medicine and authorised indications support its claims?
France: compare claims with the authorised medicine and product-information version. Switzerland: AWV Article 5 ties professional advertising to approved information and substantiation; an attached study does not itself broaden the approved indication.
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Which public or professional audience receives the communication?
France: identify the actual audience and access restrictions before distinguishing public and professional advertising. Switzerland: likewise separate Fachwerbung and Publikumswerbung; a claimed professional purpose does not establish who can actually see the material.
ANSM visas GP/PMCode de la santé publique : L5122-9LPTh / HMG / LATer : 31, 32OPuM / AWV / OPuM : 2, 5, 23
What medicine and authorised indications support its claims?
France: compare claims with the authorised medicine and product-information version. Switzerland: AWV Article 5 ties professional advertising to approved information and substantiation; an attached study does not itself broaden the approved indication.
ANSM visas GP/PMCode de la santé publique : L5122-9LPTh / HMG / LATer : 31, 32OPuM / AWV / OPuM : 2, 5, 23
Preparation reference: Advertising audience, claim and approval matrix
| Preparation question | Point to verify |
|---|---|
| Which public or professional audience receives the communication? | France: identify the actual audience and access restrictions before distinguishing public and professional advertising. Switzerland: likewise separate Fachwerbung and Publikumswerbung; a claimed professional purpose does not establish who can actually see the material. |
| What medicine and authorised indications support its claims? | France: compare claims with the authorised medicine and product-information version. Switzerland: AWV Article 5 ties professional advertising to approved information and substantiation; an attached study does not itself broaden the approved indication. |
| What distinguishes promotion from other information? | France: retain content, context and promotional purpose for classification. Switzerland: AWV Article 2 addresses promotion of prescribing, dispensing, sale or use; calling a communication educational does not alone remove its advertising character. |
| Which media and versions form the actual campaign? | France: retain each distributed text, image, channel and date. Switzerland: preserve equivalent versions and audience records; approval or review of an earlier draft does not establish review of every later campaign variation. |
ANSM visas GP/PMCode de la santé publique : L5122-9LPTh / HMG / LATer : 31, 32OPuM / AWV / OPuM : 2, 5, 23
What distinguishes promotion from other information?
France: retain content, context and promotional purpose for classification. Switzerland: AWV Article 2 addresses promotion of prescribing, dispensing, sale or use; calling a communication educational does not alone remove its advertising character.
ANSM visas GP/PMCode de la santé publique : L5122-9LPTh / HMG / LATer : 31, 32OPuM / AWV / OPuM : 2, 5, 23
Advertising audience, claim and approval matrix
Synthetic example: fictional records. Advertising audience, claim and approval matrix.
Synthetic example: fictional records · Advertising audience, claim and approval matrix
- Jurisdiction
- France
- Product and information
- Medicine P1, information V1
- Audience and media
- Recipients A1, media S1
- Proposed claims
- Messages M1, references R1
- Control and versions
- Review C1, campaign V2
A permission for one campaign version does not establish permission for every medium or revised claim.
Which media and versions form the actual campaign?
France: retain each distributed text, image, channel and date. Switzerland: preserve equivalent versions and audience records; approval or review of an earlier draft does not establish review of every later campaign variation.
ANSM visas GP/PMCode de la santé publique : L5122-9LPTh / HMG / LATer : 31, 32OPuM / AWV / OPuM : 2, 5, 23
Which official provision helps explain this situation?
A medicine communication must be assessed by its content, audience and medium. Compare proposed claims with authorised product information before determining the relevant control route. France’s visa framework and Switzerland’s advertising rules require separate analysis; prior control must not be assumed for every Swiss message. Preserve approval scope, validity and amendments. A permission for one campaign version does not establish permission for every medium or revised claim.
What prior visa or control route applies to this case?
France: L5122-9 requires prior ANSM approval for professional advertising. Switzerland: AWV Article 23 covers specified public-advertising media and medicine groups where product information mentions abuse or dependence, plus certain authority orders; it is not a universal GP/PM visa system.
ANSM visas GP/PMCode de la santé publique : L5122-9LPTh / HMG / LATer : 31, 32OPuM / AWV / OPuM : 2, 5, 23
Which statements exceed or contradict authorised product information?
France: identify unsupported or broader benefit and comparison claims against authorised information. Switzerland: apply the relevant HMG advertising restrictions and approved-information boundary; selective evidence does not validate the complete message.
ANSM visas GP/PMCode de la santé publique : L5122-9LPTh / HMG / LATer : 31, 32OPuM / AWV / OPuM : 2, 5, 23
How are scope, validity and amendments recorded?
France: connect the visa decision, support version and any stated conditions or validity limits. Switzerland: retain the applicable review or authority order and changes; neither country’s process supplies a universal validity period for all campaigns.
ANSM visas GP/PMCode de la santé publique : L5122-9LPTh / HMG / LATer : 31, 32OPuM / AWV / OPuM : 2, 5, 23
What separate checks concern a sales website or distribution intermediary?
France: an advertising visa does not authorise pharmacy sales online. Switzerland: advertising review similarly does not establish pharmacy or mail-order permission; record operator, distributor and selling permissions as separate questions.
ANSM visas GP/PMCode de la santé publique : L5122-9LPTh / HMG / LATer : 31, 32OPuM / AWV / OPuM : 2, 5, 23
What other questions arise in this file?
What medicine and authorised indications support its claims?
France: compare claims with the authorised medicine and product-information version. Switzerland: AWV Article 5 ties professional advertising to approved information and substantiation; an attached study does not itself broaden the approved indication.
ANSM visas GP/PMCode de la santé publique : L5122-9LPTh / HMG / LATer : 31, 32OPuM / AWV / OPuM : 2, 5, 23
Which media and versions form the actual campaign?
France: retain each distributed text, image, channel and date. Switzerland: preserve equivalent versions and audience records; approval or review of an earlier draft does not establish review of every later campaign variation.
ANSM visas GP/PMCode de la santé publique : L5122-9LPTh / HMG / LATer : 31, 32OPuM / AWV / OPuM : 2, 5, 23
Which statements exceed or contradict authorised product information?
France: identify unsupported or broader benefit and comparison claims against authorised information. Switzerland: apply the relevant HMG advertising restrictions and approved-information boundary; selective evidence does not validate the complete message.
ANSM visas GP/PMCode de la santé publique : L5122-9LPTh / HMG / LATer : 31, 32OPuM / AWV / OPuM : 2, 5, 23
What separate checks concern a sales website or distribution intermediary?
France: an advertising visa does not authorise pharmacy sales online. Switzerland: advertising review similarly does not establish pharmacy or mail-order permission; record operator, distributor and selling permissions as separate questions.
ANSM visas GP/PMCode de la santé publique : L5122-9LPTh / HMG / LATer : 31, 32OPuM / AWV / OPuM : 2, 5, 23
Which official references should you consult?
- ANSM visas GP/PMansm.sante.fr
- Code de la santé publique : L5122-9www.legifrance.gouv.fr
- LPTh / HMG / LATer : 31, 32www.fedlex.admin.ch
- OPuM / AWV / OPuM : 2, 5, 23www.fedlex.admin.ch
Texts cited last checked: 3 November 2026