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

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chapter P-42, r. 10

Regulation respecting medicinal premixes and medicinal foods for animals

ANIMAL HEALTH PROTECTION — MEDICINAL FOODS

Animal Health Protection Act

(chapter P-42, s. 55.9).

P-42

04April 011 2016

The fees prescribed in the Regulation have been indexed as of 1 April 2019 pursuant to the notice published in Part 1 (French) of the Gazette officielle du Québec of 16 March 2019, page 256. (s. 2)

DIVISION I

CONDITIONS FOR THE ISSUE AND RENEWAL OF PERMITS

O.C. 728-87, Div. I; O.C. 1633-92, s. 1.

1. A person required to hold a permit for one of the activities referred to in section 55.2 of the Animal Health Protection Act (chapter P-42) shall submit to the Minister of Agriculture, Fisheries and Food an application for a permit for each place where he intends to operate under his permit.

The application for a permit shall be accompanied by a postal money order or a cheque covering the permit fee made out to the Minister of Finance.

O.C. 728-87, s. 1; O.C. 1633-92, s. 2; O.C. 248-96, s. 1.

2. The fees for permits for the activities referred to in section 55.2 of the Act are:

(1) $80 for a permit to sell or supply a medicinal premix or a medicinal food;

(2) $32,25 for a permit to prepare a medicinal food for the permit holder’s own animals or animals in his custody;

(3) $40 for a permit to prepare a medicinal food or a medicinal premix for the permit holder’s own animals or animals in his custody;

(4) $119 for a permit to sell, supply or prepare a medicinal premix or a medicinal food.

O.C. 728-87, s. 2; O.C. 1633-92, s. 2; O.C. 248-96, s. 2; 1443-2022O.C. 1443-2022, s. 111.

3. The permit fees provided for in section 2 shall be increased on 1 April of each year on the basis of the rate of increase in the general Consumer Price Index for Canada for the period ending on 30 September of the preceding year, as determined by Statistics Canada.

The indexed fees shall be rounded off as follows:

(1) where a fee is less than or equal to $35, it shall be increased or reduced to the nearest multiple of $0.25;

(2) where a fee is greater than $35, it shall be increased or reduced to the nearest dollar.

The Minister of Agriculture, Fisheries and Food shall inform the public, through Part 1 of the Gazette officielle du Québec or by such other means as the Minister considers appropriate, of the indexing calculated under this section.

O.C. 728-87, s. 3; O.C. 1633-92, s. 2; O.C. 248-96, s. 3.

4. The holder of a permit shall not be reimbursed for the fee for the issue or renewal of the permit, or for a part thereof.

O.C. 728-87, s. 4; O.C. 1633-92, s. 2.

4.1. To obtain a permit, the applicant must have premises and containers that prevent all chemical, biological or physical contamination of medicines, medicinal premixes and medicinal foods.

In the case of a permit referred to in any of paragraphs 2 to 4 of section 2, the applicant must, in addition, have equipment that complies with the provisions of section 5.

O.C. 1633-92, s. 2; 1443-2022O.C. 1443-2022, s. 21.

4.1.1. The Minister shall issue a permit to an applicant who meets the conditions set out in the first paragraph and, where applicable, the second paragraph of section 4.1. The permit application must be submitted using the form prescribed by the Minister, on which the applicant must enter

(1) his name, address, telephone number and, where applicable, email address or fax number; that information is also required from the applicant’s representative, if any;

(2) the applicant’s Québec business number assigned under the Act respecting the legal publicity of enterprises (chapter P-44.1), where applicable;

(3) the name under which the establishment is operated;

(4) the address of the place of operation;

(5) the nature of the permit applied for; and

(6) in the case of a permit referred to in paragraphs 2 to 4 of section 2, a description of

(a) the equipment that will come into contact with a medicine, a medicinal premix or a medicinal food; and

(b) the mixing equipment and, where applicable, of the scales, specifying the serial number, make and model.

The applicant must declare in the application that the premises and containers and, where applicable, equipment comply with the provisions of section 4.1.

1443-2022O.C. 1443-2022, s. 21.

4.2. (Revoked).

O.C. 1633-92, s. 2; O.C. 248-96, s. 4; 1443-2022O.C. 1443-2022, s. 31.

4.3. The Minister shall renew the permit of a holder who applies for renewal using the form prescribed by the Minister, on which the holder must

(1) indicate, where applicable, any change in the information provided pursuant to section 4.1.1 for the last application;

(2) declare having kept and sent, for the preceding calendar year, the registers provided for in section 14 or 15, as the case may be, and in the case of the register provided for in section 23.1, declare having kept the register; and

(3) in the case of a permit referred to in any of paragraphs 2 to 4 of section 2, provide the information listed in subparagraphs 1 to 7 of the first paragraph of section 9 establishing that the mixing equipment provides homogeneous distribution of medicines in accordance with the provisions of section 8.

The fees specified in section 2 must be included with the application.

O.C. 1633-92, s. 2; O.C. 248-96, s. 5; 1443-2022O.C. 1443-2022, s. 41.

4.4. A permit issued or renewed by the Minister shall state the name and address of the holder, the permit number, the activity authorized under the permit, the dates of issue and expiry of the permit and, where applicable, the place of operation covered by the permit, as well as the conditions, restrictions and prohibitions imposed by the Minister under section 55.28 of the Act.

O.C. 1633-92, s. 2.

4.5. (Revoked).

O.C. 248-96, s. 6; 1443-2022O.C. 1443-2022, s. 51.

DIVISION II

STANDARDS OF OPERATION

O.C. 1633-92, s. 3; 1443-2022O.C. 1443-2022, s. 61.

§ 1. — Permit for sale, supply and preparation of medicinal premixes or medicinal foods

O.C. 728-87, Div. I, Sd. 2; O.C. 1633-92, s. 3; O.C. 728-94, s. 1.

5. The equipment used by a permit holder for the preparation of a medicinal premix or medicinal food must

(1) be made of non-rotting, waterproof, non-toxic materials; and

(2) be so designed that no residue is left after use.

The equipment must also allow any parts coming into contact with a medicine, a medicinal premix or a medicinal food to be inspected from the interior.

O.C. 728-87, s. 5; 1443-2022O.C. 1443-2022, s. 71.

6. The holder of a permit shall clean any part of the equipment that came into contact with medicines, medicinal premixes or medicinal foods before reusing the equipment to prepare foods without medicine, or medicinal premixes or medicinal foods containing different medicines from those used in the preceding preparation.

O.C. 728-87, s. 6.

7. The holder of a permit must keep in good operating condition the equipment used by him in the preparation of a medicinal premix or a medicinal food on the premises where he operates under such permit.

O.C. 728-87, s. 7.

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; 1443-2022O.C. 1443-2022, s. 81.

8.1. The holder of a permit may not prepare a medicinal food using equipment with continuous batch feeding, except where a medicinal premix is being used in quantities greater than 20 kg per tonne of prepared medicinal food.

O.C. 728-94, s. 2.

9. The holder of a permit must submit to the Minister, with the holder’s application for renewal, the following information on the verification of his mixing equipment:

(1) the identification of the mixing equipment including its serial number, make and model;

(2) the type of mix prepared;

(3) the trade name of the medicine and its concentration;

(4) the place of sampling and sampling method used for the 9 samples provided for in any of sections 28, 29 and 30;

(5) the mixing time in minutes and seconds and the duration of the mixing time from the addition of the last ingredient and the beginning of emptying;

(6) the name of the laboratory where the samples were sent and the analytic method used;

(7) the coefficient of variation as a percentage.

The permit holder must also, within 3 months of the date of issue of his permit, forward to the Minister the information provided for in subparagraphs 1 to 7 of the first paragraph.

The permit holder must keep the information in the place of operation covered by the permit for a period of 2 years.

O.C. 728-87, s. 9; O.C. 1633-92, s. 4; 1443-2022O.C. 1443-2022, s. 91.

10. The holder of a permit may not prepare, supply or sell a medicinal premix having a medicinal strength in each of its parts that is more than 10% lower or higher than the strength prescribed by prescription of a veterinary surgeon or, failing such prescription, by the Compendium of Medicating Ingredient Brochures published by the Canadian Food Inspection Agency.

O.C. 728-87, s. 10; O.C. 1633-92, s. 5; O.C. 248-96, s. 7; 1443-2022O.C. 1443-2022, s. 91.

11. Furthermore, the holder of a permit may not prepare, supply or sell a medicinal food

(1) having a strength in antibiotics of each of its parts that is more than 25% lower or higher than the strength prescribed by prescription of a veterinary surgeon or, failing such prescription, by the Compendium of Medicating Ingredient Brochures; or

(2) having a strength in any other medicine of each of its parts that is more than 20% lower or higher than the strength prescribed by prescription of a veterinary surgeon or, failing such prescription, by the Compendium of Medicating Ingredient Brochures.

O.C. 728-87, s. 11; O.C. 1633-92, s. 6; O.C. 248-96, s. 8; 1443-2022O.C. 1443-2022, s. 91.

12. The holder of a permit shall obtain the vouchers for all purchases of medicines, medicinal premixes or medicinal foods and keep them at the place of operation covered by the permit for a period of 2 years from the date of purchase.

O.C. 728-87, s. 12; O.C. 1633-92, s. 7; 1443-2022O.C. 1443-2022, s. 91.

13. The holder of a permit shall keep, in the place of operation covered by the permit, the original or a copy of any prescription issued by a veterinary surgeon relating to the sale, supply or preparation of medicinal premixes or medicinal foods, as the case may be, containing a medication appearing on the list provided for in section 9 of the Veterinary Surgeons Act (chapter M-8); such original or a copy shall be kept from the date on which the prescription is issued for a period of 2 years following the date on which it is filled, including renewals.

O.C. 728-87, s. 13; O.C. 1633-92, s. 8; O.C. 728-94, s. 3; 1443-2022O.C. 1443-2022, s. 1011.

14. The holder of a permit shall keep a register of retail sales and supplies of medicinal foods showing, for each sale or supply,

(1) the name and address of the purchaser or person receiving the medicinal food, along with his permit number, if any;

(2) the address of the sites where the medicinal foods were sold or supplied, if different from the address referred to in subparagraph 1.

The register must contain the following information for each site:

(1) the date of the sale or supply;

(2) the trade name and concentration, in kilograms per tonne, of the medicinal products contained in the medicinal food;

(3) the name of the veterinary surgeon who prescribed the medicinal food, the number of his operating permit and the date of the prescription in the case of a medicinal food containing a medication appearing on the list provided for in section 9 of the Veterinary Surgeons Act (chapter M-8);

(4) the quantity, in kilograms, of the medicinal food sold or supplied;

(5) the animal species, number and age of the animals for which the medicinal food is intended and the types of agricultural production involved.

A permit holder who administers a medicinal food to his own animals or to animals in his custody must also keep a register of the medicinal foods administered. The second paragraph applies, with the necessary modifications, to the keeping of the register.

The registers must be kept for the period between 1 January and 31 December and be forwarded to the Minister not later than 31 March each year. They must be kept at the place of operation covered by the permit for a period of 2 years as of 31 December of the year concerned.

O.C. 728-87, s. 14; O.C. 728-94, s. 4; 1443-2022O.C. 1443-2022, s. 111.

15. The permit holder shall also keep a register of sales and supplies showing each sale and supply of medicinal premixes made to the holder of a permit referred to in any of subdivisions 3 and 4 of this Division and containing

(1) the name and address of the purchaser or person receiving the medicinal premix along with his permit number; and

(2) the address of the sites where the medicinal foods prepared using medicinal premixes will be administered, if different from the address referred to in subparagraph 1 of this paragraph.

The register must contain the following information for each site:

(1) the date of the sale or supply;

(2) the trade name and concentration, in kilograms per tonne, of the medicinal products contained in the medicinal premix;

(3) the name of the veterinary surgeon who prescribed the medicinal premix, the number of his operating permit and the date of the prescription in the case of a medicinal premix containing a medication appearing on the list provided for in section 9 of the Veterinary Surgeons Act (chapter M‐8);

(4) the quantity, in kilograms, of the medicinal premixes sold or supplied;

(5) the animal species, number and age of the animals for which the medicinal food that will be prepared later using the premix is intended, and the types of agricultural production involved.

The register must be kept for the period between 1 January and 31 December and be forwarded to the Minister not later than 31 March each year. It must be kept at the place of operation covered by the permit for a period of 2 years as of 31 December of the year concerned.

O.C. 728-87, s. 15; 1443-2022O.C. 1443-2022, s. 111.

16. The holder of a permit shall identify each lot of medicines, medicinal premixes and medicinal foods held by him and shall preserve them in a manner that avoids any chemical, biological or physical contamination of the products by keeping them away from direct sunlight and vermin in a dry, clean place.

He shall clean the containers and the premises used for storage or medicines, medicinal premixes or medicinal foods before storing different products there.

O.C. 728-87, s. 16.

§ 2. — Permit for sale or supply of medicinal premixes or medicinal foods

O.C. 728-87, Div. II; O.C. 1633-92, s. 10.

16.1. (Revoked).

O.C. 1633-92, s. 10; O.C. 728-94, s. 5; 1443-2022O.C. 1443-2022, s. 121.

16.2. Sections 12 to 16 apply, with the necessary modifications, to the holder of a permit to whom this Subdivision applies.

O.C. 1633-92, s. 10; O.C. 728-94, s. 6; 1443-2022O.C. 1443-2022, s. 131.

§ 3. — Permit for preparation of medicinal foods intended for the permit holder’s own animals or animals in his custody

O.C. 1633-92, s. 10; 1443-2022O.C. 1443-2022, s. 141.

17. (Revoked).

O.C. 728-87, s. 17; O.C. 1633-92, s. 11.

18. (Revoked).

O.C. 728-87, s. 18; O.C. 1633-92, s. 11.

19. (Revoked).

O.C. 728-87, s. 19; O.C. 1633-92, s. 11.

20. (Revoked).

O.C. 728-87, s. 20; 1443-2022O.C. 1443-2022, s. 151.

21. (Revoked).

O.C. 728-87, s. 21; 1443-2022O.C. 1443-2022, s. 151.

22. (Revoked).

O.C. 728-87, s. 22; O.C. 1633-92, s. 12; O.C. 248-96, s. 9; 1443-2022O.C. 1443-2022, s. 151.

23. The holder of a permit shall keep a copy of any prescription issued by a veterinary surgeon relating to the purchase of medicinal premixes or medicinal foods containing a medication appearing on the list provided for in section 9 of the Veterinary Surgeons Act (chapter M-8); such copy shall be kept for a period of 1 year following the date on which the prescription is filled, including renewals.

He shall also obtain vouchers for each purchase of medicinal premixes and medicinal foods made by him.

The documents referred to in the first and second paragraphs must be kept at the place of operation covered by the permit for a period of 2 years from the date of the prescription or purchase, as the case may be.

O.C. 728-87, s. 23; O.C. 1633-92, s. 13; 1443-2022O.C. 1443-2022, s. 1611.

23.1. The holder of a permit shall keep a register of the medicinal foods administered to the holder’s own animals or to animals in his custody, indicating the address of the sites where the animals receiving the foods are located. The register must contain the following information for each site:

(1) the date of administration;

(2) the trade name and concentration, in kilograms per tonne, of the medicinal products contained in the medicinal food administered;

(3) the name of the veterinary surgeon who prescribed the medicinal foods, the number of his operating permit and the date of the prescription in the case of a medicinal food containing a medication appearing on the list provided for in section 9 of the Veterinary Surgeons Act (chapter M-8);

(4) the quantity of the medicinal food administered;

(5) the animal species, number and age of the animals for which the medicinal food is intended, and the types of agricultural production involved.

The register must be kept at the place of operation covered by the permit for a period of 2 years following the date of administration.

O.C. 1633-92, s. 14; O.C. 728-94, s. 7; 1443-2022O.C. 1443-2022, s. 171.

24. (Revoked).

O.C. 728-87, s. 24; 1443-2022O.C. 1443-2022, s. 181.

25. Sections 5 to 11 and 16 apply, with the necessary modifications, to the holder of a permit to whom this Subdivision applies.

O.C. 728-87, s. 25; O.C. 1633-92, s. 15; O.C. 728-94, s. 15; 1443-2022O.C. 1443-2022, s. 191.

§ 4. — Permit for preparation of medicinal foods or medicinal premixes intended for the permit holder’s own animals or animals in his custody

O.C. 1633-92, s. 16; 1443-2022O.C. 1443-2022, s. 201.

25.1. Sections 5 to 13, 16 and 23.1 apply, with the necessary modifications, to the holder of a permit to whom this Subdivision applies.

O.C. 1633-92, s. 16; O.C. 728-94, s. 9; 1443-2022O.C. 1443-2022, s. 211.

25.2. (Revoked).

O.C. 1633-92, s. 16; 1443-2022O.C. 1443-2022, s. 221.

25.3. (Revoked).

O.C. 1633-92, s. 16; 1443-2022O.C. 1443-2022, s. 221.

DIVISION III

TAKING AND ANALYSIS OF SAMPLES

26. (Revoked).

O.C. 728-87, s. 26; 1443-2022O.C. 1443-2022, s. 221.

27. (Revoked).

O.C. 728-87, s. 27; 1443-2022O.C. 1443-2022, s. 221.

28. In the case of a medicinal premix, the 9 samples of not less than 100 g per sample shall be taken from a volume of medicinal premix corresponding to the maximum capacity of the mixer, at the level of the first opening available after mixing in the following manner:

Percentage of duration of emptying
Samples of medicinal premix

1st 5
2nd 15
3rd 25
4th 40
5th 50
6th 60
7th 75
8th 85
9th 95

O.C. 728-87, s. 28.

29. In the case of a medicinal food, where the equipment used includes a mixer, the 9 samples of not less than 100 g per sample shall be taken from a volume of medicinal foods corresponding to the maximum capacity of the mixer, at the level of the first opening available after mixing in the following manner:

Percentage of duration of emptying
Samples of medicinal food

1st 5
2nd 15
3rd 25
4th 40
5th 50
6th 60
7th 75
8th 85
9th 95

O.C. 728-87, s. 29.

30. In the case of a medicinal food, where the equipment used does not include a mixer, the 9 samples of not less than 100 g per sample shall be taken from a volume of 1,000 kg of medicinal food, at the level of the first opening available after the last operation of preparation and in the manner prescribed by section 29.

O.C. 728-87, s. 30.

30.1. The 9 samples taken must be sealed and labelled to identify the permit holder and equipment concerned, and the number of each sample.

The samples must be sent to a laboratory to determine the coefficient of variation in accordance with section 8.

O.C. 1633-92, s. 18; O.C. 1829-93, s. 1; 1443-2022O.C. 1443-2022, s. 231.

30.2. The holder of a permit is required to keep the laboratory analysis results at the place of operation covered by the permit for a period of 2 years.

O.C. 1633-92, s. 18; O.C. 1829-93, s. 2; 1443-2022O.C. 1443-2022, s. 231.

DIVISION III.1

(Revoked)

O.C. 1633-92, s. 18; 1443-2022O.C. 1443-2022, s. 241.

30.3. (Revoked).

O.C. 1633-92, s. 18; O.C. 1829-93, s. 3; 1443-2022O.C. 1443-2022, s. 241.

30.4. (Revoked).

O.C. 1633-92, s. 18; O.C. 1829-93, s. 3; 1443-2022O.C. 1443-2022, s. 241.

30.5. (Revoked).

O.C. 1633-92, s. 18; O.C. 1829-93, s. 3; 1443-2022O.C. 1443-2022, s. 241.

30.6. (Revoked).

O.C. 1829-93, s. 3; 1443-2022O.C. 1443-2022, s. 241.

DIVISION IV

OFFENCES

O.C. 728-87, Div. IV; O.C. 1633-92, s. 19; 1443-2022O.C. 1443-2022, s. 251.

31. Any person contravening any of sections 5 to 16.2 and sections 23 to 30.2 shall be subject to the penalties prescribed by section 55.43 of the Animal Health Protection Act (chapter P-42).