Periodic safety update reporting should therefore be linked to the risk management system for newly authorised medicinal products and routine reporting should be required for generic, well-established use, informed consent, homeopathic, or traditional use registered herbal medicinal products.

Periodic safety update reporting should therefore be linked to the risk management system for newly authorised medicinal products and routine reporting should not be necessary for generic, well-established use, informed consent, homeopathic, or traditional use registered herbal medicinal products.

Different periods of time may be necessary for establishing well-established use of different substances.

Periodic safety update reporting should therefore be linked to the risk management system for newly authorised medicinal products and routine reporting should not be necessary for generic, well-established use, informed consent, homeopathic, or traditional use registered herbal medicinal products.

Jurisprudence of the European Court of Justice in the area of dual-use goods has established that the rules restricting the exports of these goods to third countries fall within the scope of the common commercial policy, as set out in Article 133 of the EC Treaty.

1. By way of derogation from point (j) of the first subparagraph of Article 12(3), and without prejudice to the law on the protection of industrial and commercial property, the applicant shall not be required to provide the results of safety and residue tests or of pre-clinical tests or clinical trials if he can demonstrate that the active substances of the veterinary medicinal product have been in well-established veterinary use within the Community for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex I. In that event, the applicant shall provide appropriate scie ...[+++]ntific literature.