Section 10: Special provisions.

The application for authorisation to import a proprietary veterinary medicinal product in parallel is accompanied by a dossier comprising : 1° For each presentation, a sample of the proprietary medicinal product which has obtained marketing authorisation in France and a sample of the proprietary medicinal product marketed in the country of origin, which is intended to be imported into France; 2° Draft packaging and package leaflet for the medicinal product…

When the parallel import application concerns a proprietary veterinary medicinal product which has already been the subject of a parallel import authorisation, and the proprietary veterinary medicinal product which is the subject of the application comes from the same Member State as that which has already obtained the authorisation, the applicant is exempt from providing the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail with the…

The Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail shall notify the interested party of his decision with regard to the proven or potential risk to human or animal health within sixty days from the date of receipt of the complete application referred to in Article R. 5141-123-9 . The period mentioned in the previous paragraph is reduced to thirty days for…

The parallel import authorisation is issued for a period of five years. It specifies the differences mentioned in article R. 5141-123-8 with the speciality that has obtained marketing authorisation in France. An extract of the authorisation is published on the website of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail. By way of derogation from the provisions of the first paragraph, the duration of the…

I.- In the event of repackaging, the holder of a parallel import authorisation for a proprietary veterinary medicinal product shall notify the holder of the marketing authorisation for the proprietary medicinal product in the Member State from which the product originates of the fact that the product will be placed on the market in France when it is marketed. Upon request, it will provide the marketing authorisation holder with a…

The application for renewal of a parallel import authorisation must be accompanied, where appropriate, by a list of changes that have occurred since the initial authorisation or the last renewal was issued. Where the initial authorisation was granted for a period of five years in accordance with article R. 5141-123-12 of the Public Health Code, the application for renewal must be submitted no later than three months before the expiry…

After it has been issued, the parallel import authorisation is suspended or withdrawn by the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail if the speciality no longer satisfies the conditions of the authorisation. Except in urgent cases, these decisions to suspend or withdraw authorisation are taken only after the authorisation holder has been given the opportunity to present its observations. These…

When the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail notifies the holder of the parallel import authorisation for a proprietary veterinary medicinal product of a change to the marketing authorisation for the proprietary veterinary medicinal product authorised in France, this change is reproduced by the holder of the parallel import authorisation in the summary of product characteristics, the package leaflet and…

The holder of the parallel import authorisation is responsible for placing the product on the market and, in this capacity, ensures that the provisions of this Title are complied with, in particular those relating to possession and supply referred to in Article R. 5141-112, labelling referred to in Articles R. 5141-73 to R. 5141-75, and the package leaflet referred to in Articles R. 5141-76 to R. 5141-78 and, with regard…

The holder of a parallel import authorisation for a proprietary veterinary medicinal product shall immediately inform the marketing authorisation holder in the country of origin of any serious adverse reaction, within the meaning of Article R. 5141-92, concerning the imported proprietary medicinal product, as soon as he is aware of it.