Article 9 Information to be provided by manufacturers

Article 9

Information to be provided by manufacturers

1.   ►M2  Without prejudice to Article 45 of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures ( 24 ), manufacturers placing on the market the substances and/or mixtures covered by this Regulation shall hold at the disposal of the competent authorities of the Member States: ◄

2.  Whenever substances and/or ►M2  mixtures ◄ covered by this Regulation are placed on the market, the manufacturer shall be responsible for the correct performance of the relevant tests mentioned above. He shall also have available documentation on the testing carried out to demonstrate compliance with this Regulation, and to show that he is allowed to benefit from the property rights concerning the test results, other than for those test results already in the public domain.

3.  Manufacturers placing on the market the ►M2  mixtures ◄ covered by this Regulation shall, upon request, make available without delay and free of charge, to any medical personnel, an ingredient datasheet as stipulated in Annex VII C.

This is without prejudice to the right of a Member State to request that such a datasheet be made available to a specific public body to which the Member State has assigned the task of providing this information to medical personnel.

The information contained in the datasheet shall be kept confidential by the specific public body and by the medical personnel, and shall be used only for medical purposes.