Establishment Licence and Product Licence
123. No person shall prepare, manufacture, preserve, pack, label or test a veterinary biologic unless he does so under and in accordance with an establishment licence issued by the Minister.
- SOR/2002-438, s. 18(F).
124. No person shall manufacture a veterinary biologic unless he does so under and in accordance with a product licence issued by the Minister.
- SOR/2002-438, s. 18(F).
125. [Repealed, SOR/97-85, s. 72]
126. Subject to section 127, every applicant for a product licence shall include with his application the material and information referred to in subsection 122(1).
127. Where the Minister has issued a product licence to a person, he may issue a product licence to such person in any subsequent year and that person is exempt from any of the requirements of subsection 122(1) as the Minister may specify.
Requirements of Operation in a Licensed Establishment
128. (1) No person shall prepare, manufacture, preserve, pack, label, store or test a veterinary biologic in a licensed establishment unless
(a) the establishment and the equipment therein is sound in construction, clean, in good repair and equipped with means to maintain it in a sanitary condition;
(b) the area immediately adjacent to the establishment is clean and protected against the incursion of animals;
(c) animal wastes, effluents from processing or testing, contaminated matter and dead animals are decontaminated before being removed or discharged from the establishment;
(d) the floors and walls of every room and area in which a veterinary biologic is prepared, manufactured, preserved or tested are of a hard finish suitable for cleaning;
(e) the establishment has drainage, plumbing and sewerage that are
(i) adequate to handle all wastes, and
(ii) equipped with suitable traps and vents;
(f) the establishment has dressing rooms, lavatories and showers that are
(i) adequate in size and equipment for the number of persons using them, and
(ii) well lighted and ventilated to the outside;
(g) eating rooms, if provided, are separate from, and do not lead directly into, any room used for preparing, manufacturing, preserving, storing, testing, packing or labelling a veterinary biologic;
(h) rooms or areas are provided, where required, that are capable of being maintained at a uniform and constant temperature within any desired range and are equipped with thermometers that provide a continuous permanent record of temperature;
(i) means are provided for warning of any failure of power or equipment or any change in the required temperature;
(j) rooms, areas and equipment are provided, where required, that are capable of being maintained free of air-borne contaminants to any desired degree and preventing the escape of micro-organisms therefrom;
(k) animals being used in a testing program or for any special purpose are segregated from all animals not being used in such program or for such purpose;
(l) a separate room is provided for animals being examined or tested
(i) ante mortem, and
(ii) post mortem; and
(m) every person employed therein is qualified to perform the task assigned to him.
(2) Every holder of a licence issued under these Regulations shall without delay inform the Minister of any change or addition to the material or information furnished to the Minister for the purpose of obtaining the licence.
(3) Every person employed in a licensed establishment shall
(a) [Repealed, SOR/97-85, s. 73]
(b) be immunized against diseases likely to be encountered therein; and
(c) wear clothing and use equipment adequate to protect him against all hazards likely to be encountered therein.
(4) Unless otherwise permitted by a veterinary inspector, no veterinary biologic shall be tested in a licensed establishment except in a separate room or building that is used exclusively for testing veterinary biologics.
(5) No diagnostic examination or procedure involving the use of
(a) a dead or diseased animal,
(b) diseased animal matter, or
(c) an unidentified culture of micro-organisms, fungi or moulds
shall be conducted in a licensed establishment except in a room or area separate from and not leading into any room or area used for preparing, manufacturing, preserving, storing or testing a veterinary biologic.
(6) Unless otherwise permitted by a veterinary inspector, no research or experimentation shall be conducted in a licensed establishment except in a room or area separate from and not leading into any room or area used for preparing, manufacturing, preserving, storing or testing a veterinary biologic.
- SOR/97-85, s. 73;
- SOR/2002-438, ss. 13(F), 18(F);
- SOR/2012-286, s. 59.
- Date modified: