Translation of "Registre d'administration des médicaments " (French → English) :

A new subsection was added requiring that where the original test did not apply, a second person had to address the patent if a drug was being made with the same medicine in the same route of administration and with a comparable strength and dosage form as the drug for which a patent was listed on the patent register.

The Act provided for: a prohibition against importing or exporting drugs at a port not designated for that purpose by federal authorities; the issue of permits for the import, export, manufacture, sale and distribution of drugs; the imposition of criteria regarding packaging and labelling of packages containing such substances; an obligation for businesses to keep a record of their drug importing, exporting, manufacturing, sale and distribution activities duly authorized by federal authorities; an obligation for physicians to provide the information requested by federal authorities concerning the purchase, manufacture or prescription of medications containing drugs; an obligation for pharmacists to keep a record of their purchases and ...[+++]sales of drugs, the preparation of their own medications containing such substances and renewals of prescriptions signed by a physician; [58] and the authorization to sell medications (such as ointments and liniments) containing very small quantifies of scheduled drugs without a permit, provided they were not administered to children under two years of age and met certain labelling criteria.

The drug concerned shall be entered in the Community Register of Orphan Medicinal Products where it will remain until the end of the period of market exclusivity, unless the developing company requests its removal at an earlier stage or if it is established that the criteria laid down for the designation of orphan drugs are no longer met

(f)the veterinarian shall be required to keep detailed records of the animals treated, the diagnosis, the veterinary medicinal products administered, the dosage administered, the duration of treatment and the withdrawal period applied.

(f) the veterinarian shall be required to keep detailed records of the animals treated, the diagnosis, the veterinary medicinal products administered, the dosage administered, the duration of treatment and the withdrawal period applied.

When a veterinarian has recourse to the provisions of Article 10, he shall keep adequate records of the date of examination of the animals, details of the owner, the number of animals treated, the diagnosis, the medicinal products prescribed, the dosages administered, the duration of treatment and the withdrawal periods recommended, and make these records available for inspection by the competent authorities for a period of at least three years.