P-42, r. 10 - Regulation respecting medicinal premixes and medicinal foods for animals

Section 8 Disposition versions

2023-01-01

8. The holder of a permit shall use equipment providing homogeneous distribution in a medicinal premix or in a medicinal food of substances having a content of less than 5% by weight of the medicinal premix or 2% by weight of the medicinal food.

The distribution of substances is homogeneous when the coefficient of variation of the concentration of any of the substances in several parts of the medicinal premix or the medicinal food is less than 5% in the case of a medicinal premix and 10% in the case of a medicinal food.

The coefficient of variation is calculated using the results of an analysis of 9 samples taken from the medicinal premix or the medicinal food by a member of a professional order defined in section 1 of the Professional Code (chapter C-26) practising in an area related to the production of medicinal premixes or medicinal foods or to inspection of equipment covered by this Division, using one of the methods provided for in section 28, 29 or 30, as the case may be. The samples must be sent for analysis in accordance with section 30.1.

The coefficient of variation is calculated using the results of an analysis of 9 samples taken from the medicinal premix or the medicinal food by a member of a professional order defined in section 1 of the Professional Code practising in a field of practice connected to the production of medicinal premixes or medicinal foods or the verification of equipment referred to in this Division, using one of the methods provided for in section 28, 29 or 30, as the case may be. The samples must be sent for analysis in accordance with the provisions of sections 30.1 and 30.2.

The mixing equipment used for the preparation of a medicinal premix or medicinal food must be inspected annually to ensure the homogeneity of the medicines it contains. The compliance of such equipment is verified through a chemical analysis of the medicine contained in the medicinal premix or medicinal food.

O.C. 728-87, s. 8; O.C. 1443-2022, s. 8.

2012-09-01

8. The holder of a permit shall use equipment providing homogeneous distribution in a medicinal premix or in a medicinal food of substances having a content of less than 5% by weight of the medicinal premix or 2% by weight of the medicinal food.

The distribution of substances is homogeneous when the coefficient of variation of the concentration of any of the substances in several parts of the medicinal premix or the medicinal food is less than 5% in the case of a medicinal premix and 10% in the case of a medicinal food.

The coefficient of variation shall be determined according to the method described in Division III.

O.C. 728-87, s. 8.