SOR/2010-171 天然保健品营业执照申请条例(Natural Health Products Regulation)

　　Natural Health Products （Unprocessed Product Licence Applications） Regulations

　　SOR/2010-171

　　FOOD AND DRUGS ACT

　　Registration 2010-08-04

　　Natural Health Products （Unprocessed Product Licence Applications） Regulations

　　P.C. 2010-958 2010-08-04

　　Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30（1）a of the Food and Drugs Actb, hereby makes the annexed Natural Health Products （Unprocessed Product Licence Applications） Regulations.

　　aS.C. 2005, c. 42, s. 2

　　bR.S., c. F-27

　　Application

　　1. These Regulations apply to a natural health product in respect of which

　　（a） a product licence application has been submitted to the Minister in accordance with section 5 of the Natural Health Products Regulations and has not been withdrawn; and

　　（b） the Minister has not issued a product licence under section 7 of those Regulations nor sent a notice under subsection 9（1） of those Regulations.

　　Exemption number — assignment

　　2. （1） The Minister must assign an exemption number to a natural health product to which these Regulations apply before the later of

　　（a） 15 days after the day on which these Regulations come into force; and

　　（b） 180 days after the day on which the product licence application for the product was submitted in accordance with section 5 of the Natural Health Products Regulations.

　　Exemption number — notice

　　（2） The Minister must, before the deadline imposed under subsection （1）, send to the person who submitted the product licence application for the product a notice that sets out

　　（a） the exemption number; and

　　（b） the fact that the person has 60 days after the date indicated on the notice to submit to the Minister, in the form established by him or her, the following documents, failing which the person will not be deemed to have been issued a product licence for the product under subsection 3（1）:

　　（i） a consent to the posting of their name, the exemption number and the brand name of the product on the Health Canada website, and

　　（ii） a statement by the person confirming that the product is not described in any of subparagraphs （3）（a）（i） to （v） nor, to the best of the person’s knowledge, in paragraph （3）（b）.

　　Information — posting on website

　　（3） The Minister must post on the Health Canada website and keep up-to-date the information referred to in subparagraph 2（b）（i） for each natural health product for which a consent and statement are submitted in accordance with paragraph （2）（b）, unless

　　（a） the product is

　　（i） a sterile product for ophthalmic use,

　　（ii） a drug referred to in any of sections C.01.036, C.01.036.1, C.01.040 or C.01.040.1 of the Food and Drug Regulations or a drug that is adulterated within the meaning of section C.01.038 of those Regulations,

　　（iii） recommended for use as a treatment, preventative or cure in respect of a disease, disorder or abnormal physical state referred to in Schedule A to the Food and Drugs Act,

　　（iv） recommended for use in children under 12 years old, or

　　（v） recommended for use in pregnant or breast-feeding women; or

　　（b） the Minister has reasonable grounds to believe that the product contains an ingredient that is likely to result in injury to the health of a purchaser or consumer and whose presence in a natural health product or other drug has led to

　　（i） a recall of that product or other drug, or

　　（ii） the sale of that product or other drug being stopped under section 17 of the Natural Health Products Regulations or section C.01.013 of the Food and Drug Regulations, respectively.

　　Information — non-posting

　　（4） The information referred to in subparagraph （2）（b）（i） in respect of a natural health product may be posted on the Health Canada website only if

　　（a） the documents referred to in paragraph （2）（b） were submitted to the Minister in accordance with that paragraph;

　　（b） the product is not described in any of subparagraphs （3）（a）（i） to （v）; and

　　（c） the Minister has no reasonable grounds to believe that the product is described in paragraph （3）（b）.

　　Application for product licence

　　（5） A statement referred to in subparagraph （2）（b）（ii） that is submitted to the Minister in respect of a natural health product is, for the purposes of the Natural Health Products Regulations, deemed to be part of the product licence application for the product.

　　NHPR — licence deemed issued

　　3. （1） As of the time the information referred to in subparagraph 2（2）（b）（i） is posted on the Health Canada website in respect of a natural health product, the person who submitted the product licence application for the product is deemed, for the purposes of the Natural Health Products Regulations, to have been issued a product licence for the product.

　　No longer deemed

　　（2） The person is no longer deemed to have been issued a product licence for the natural health product as of the time

　　（a） the person withdraws the product licence application;

　　（b） the Minister issues a product licence for the product under section 7 of those Regulations or sends a notice in respect of the product under subsection 9（1） of those Regulations; or

　　（c） these Regulations are repealed.

　　NHPR — greater certainty

　　（3） For greater certainty, in respect of a natural health product for which a product licence is deemed to have been issued,

　　（a） the prohibition on sale set out in subsection 4（1） of the Natural Health Products Regulations does not apply; and

　　（b） subsections 4（2） and （3） of those Regulations apply.

　　NHPR — non-application

　　（4） The following provisions of the Natural Health Products Regulations do not apply in respect of a natural health product for which a product licence is deemed to have been issued:

　　（a） section 11;

　　（b） paragraph 12（2）（b）;

　　（c） section 13;

　　（d） paragraph 18（1）（b）;

　　（e） section 22;

　　（f） paragraph 62（c）;

　　（g） subparagraph 93（1）（a）（ii）; and

　　（h） subparagraph 94（1）（a）（vii）.

　　Suspension — additional power

　　4. （1） In addition to the power set out in paragraph 18（1）（a） of the Natural Health Products Regulations, the Minister may also, subject to subsection 18（2） of those Regulations, suspend a product licence that is deemed to have been issued if the Minister has reasonable grounds to believe that

　　（a） the person to whom the licence is deemed to have been issued has contravened these Regulations; or

　　（b） the natural health product to which the licence relates is described in any of subparagraphs 2（3）（a）（i） to （v） or in paragraph 2（3）（b）.

　　Suspension under subsection （1）

　　（2） A suspension under subsection （1） is deemed to be a suspension under section 18 of the Natural Health Products Regulations.

　　Site information — sale not yet commenced

　　5. （1） A person who is deemed to have been issued a product licence for a natural health product must provide the Minister with the information referred to in subsection 22（1） of the Natural Health Products Regulations before commencing the sale of the product under the deemed product licence.

　　Change of information

　　（2） If the person makes a change to any of the information provided under subsection （1） in respect of the product, the person must notify the Minister of the change within 60 days after the day on which the change is made.

　　Recall

　　6. In addition to the information set out in section 62 of the Natural Health Products Regulations, every manufacturer, importer or distributor referred to in that section who commences a recall of a natural health product for which an exemption number is posted on the Health Canada website must provide the Minister with the exemption number for the product within three days after the day on which the recall is commenced. The same rule applies to a person who is deemed to have been issued a product licence for a natural health product and who commences a recall of the product.

　　Labelling — exemption number

　　7. （1） A person who is deemed to have been issued a product licence for a natural health product must ensure that the product’s exemption number, preceded by the designation “EN”， is shown within a reasonable time on the label for the product in accordance with

　　（a） section 88 and, if applicable, section 89 of the Natural Health Products Regulations; and

　　（b） the requirements that apply to product numbers in section 93 and, if applicable, section 94 of those Regulations.

　　Prohibition — label

　　（2） A person must not display an exemption number on the label of a natural health product unless the number is posted on the Health Canada website in accordance with subsection 2（3）.

　　Repeal

　　8. These Regulations are repealed on the day that is 30 months after the day on which they come into force.

　　Coming into force

　　9. These Regulations come into force on the day on which they are registered.