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France / Switzerland

Medicines: permissions and operating records

Product approval, establishment permission and trial submissions concern different responsibilities. Select the actual medicine dossier before comparing actors, procedures and document versions. The English pages keep France and Switzerland separate, retaining unknown decisions and treating stock reconciliation as evidence rather than a supply forecast.

Choose the page matching your document and the decision you need to prepare.

By the AlphaDeep legal editorial team

Sources checked on

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.

Julie by AlphaDeep

Illustrative conversation
Example question

Product approval, establishment permission or clinical trial?

Julie Illustration

Product approval follows the medicine, establishment permission follows operations, and a trial dossier follows sponsor and protocol. One submission does not establish every other permission.

Read the references

Your records concern “Medicines: permissions and operating records”. Which document should we examine, and does it concern France or Switzerland?

French law

3 free questions at signup. Avoid names and sensitive information.

Next steps

Which medicine dossier matches the documents?

Frequent questions

What other questions arise in this file?

Product approval, establishment permission or clinical trial?

Product approval follows the medicine, establishment permission follows operations, and a trial dossier follows sponsor and protocol. One submission does not establish every other permission.

Which stock figures help with an announced shortage?

Use the same presentation, unit and period with dated movements. A discrepancy establishes neither future availability nor exceptional import permission for the product.

Which framework applies to “Medicines: permissions and operating records”?

The English pages separate France and Switzerland. Select the country, authority and relevant period; a Swiss cantonal example does not establish a French requirement or one rule for every canton.

How can Julie continue “Medicines: permissions and operating records”?

Choose the page matching the document, then retain facts, versions and the question in the preparation. Julie can help research references and prepare the next document; the record itself grants no permission.

Sources

Which official references should you consult?

  1. Code de la santé publique : L5121-8www.legifrance.gouv.fr
  2. ANSM soumission AMMansm.sante.fr
  3. LPTh / HMG / LATer : 9, 10, 11www.fedlex.admin.ch
  4. OMéd / VAM / OM : 8, 28www.fedlex.admin.ch
  5. Swissmedic forms updatewww.swissmedic.ch
  6. Commission européenne : essais cliniques et CTIShealth.ec.europa.eu
  7. ANSM essai cliniqueansm.sante.fr
  8. OClin / KlinV / OSRUm : 2, 19, 23, 24, 25, 30, 31, 34www.fedlex.admin.ch
  9. LRH / HFG / LRUm : 45, 19, 20www.fedlex.admin.ch
  10. Swissmedic clinical-trial applicationswww.swissmedic.ch
  11. CSP L5124-3 : L5124-3www.legifrance.gouv.fr
  12. OAMéd / AMBV / OAMed : 3, 11, 12, 16, 17www.fedlex.admin.ch
  13. ANSM effet indésirableansm.sante.fr
  14. ANSM visas GP/PMansm.sante.fr
  15. OPuM / AWV / OPuM : 2, 5, 23www.fedlex.admin.ch
  16. ANSM MITM shortageansm.sante.fr
  17. OFAE notification bureauwww.bwl.admin.ch
  18. CSP L5121-1 : L5121-1www.legifrance.gouv.fr
  19. French customs personally carried medicineswww.douane.gouv.fr
  20. CNOP non-EU prescriptionwww.ordre.pharmacien.fr
  21. CNOP EU prescriptionwww.ordre.pharmacien.fr
  22. DGCCRF internet medicineswww.economie.gouv.fr

Texts cited last checked: 3 November 2026

Next steps

Which neighbouring situations should remain separate?