French Public Health Code
In forcePersons authorised to supply proprietary medicinal products for human use, proprietary veterinary medicinal products, investigational medicinal products for human use or auto-vaccines for veterinary use containing micro-organisms or toxins must transcribe all entries and withdrawals in a register or record them on a specific computer system meeting the following conditions:
1° It must not be possible to modify the data once it has been validated;
2° It must be possible to print out the information provided for in this article immediately at the request of any supervisory authority;
3° Each page published must include the name and address of the establishment.
The entry or recording of entries and withdrawals is made for each operation with a different serial number, specifying the date on which it was established.
The entry or recording of receipts includes the description and quantity of medicines received, expressed in units taken.
The record of withdrawals includes the name of the medicinal product, the quantities dispensed expressed in units of dosage, the name and address of the prescriber, the name and address of the patient or the name and address of the animal owner and, where applicable, the identification of the animal or batch of animals.
Renewals are subject to a new registration. When the renewal is made by the same dispensing agent, the registration may consist solely of the number relating to the previous issue.
A monthly balance of entries and withdrawals is entered in the register or printed out. These entries are made in ink, without blanks or overwriting.
Each year, an inventory is taken of the stock. Any discrepancies noted between the balance and the inventory are submitted to the supervisory authorities during the first visit following the establishment of the inventory. Any discrepancies found are noted on the inventory. This inventory is entered in the register in ink, without blank spaces or erasures or overwriting, or by electronic recording. It must not be possible to modify the data once it has been validated. The data must be recorded on a medium that guarantees its permanence and integrity. They must be duplicated on two separate media, the first used for normal consultation, the second kept in reserve. Archived data must be accessible, consultable and usable for as long as it is kept.
The register, the computer recordings and the editions of these recordings per maximum period of one month, as well as the documents attesting to their destruction, are kept for ten years from the date of their last mention, in order to be produced at the request of the supervisory authorities.
The pharmacist who transfers his pharmacy or the veterinary surgeon who transfers his professional place of practice shall, in the presence of the purchaser, draw up an inventory of proprietary medicinal products for human use, proprietary medicinal products for veterinary use or auto-vaccines for veterinary use containing micro-organisms or toxins. This inventory is recorded in the register or in the computer records and, in the latter case, appended to the editions of the records. This inventory is signed by the transferor and the purchaser and is kept by the latter for ten years.
The transferor shall hand over the register or recordings and the editions of the recordings, as well as the documents to be kept in accordance with articles R. 5139-29, R. 5139-30 and R. 5139-31, to the purchaser, who shall give him a discharge.
In the event of the permanent closure of the dispensary or the veterinarian's place of professional practice, this register or the records and editions of the records are deposited with the Agence nationale de sécurité du médicament et des produits de santé.
