Guide for Completing the Site Licence Application (SLA) Form
The Natural Health Products Directorate (NHPD) has changed its name to the Natural and Non-prescription Health Products Directorate (NNHPD) subsequent to its recently expanded mandate to include the oversight of non-prescription and disinfectant drugs in addition to natural health products (NHPs). Please note that we are currently modifying documents to reflect this change.
Thank you for your patience and understanding.
Version 2.0 (March 2007)
| Section # | Description |
|---|---|
| 1-3 | Health Canada Use Only |
| Part 1 - Applicant and Contact Information | |
| Block A | Applicant or Licensee |
| 4 | Applicant/Company Name: Indicate the full legal name of the applicant or company applying for a site licence. Do not abbreviate applicant/company name. |
| 5 | Company Code: A number assigned to each applicant/company by the NHPD. This number is indicated in the notice sent by the NHPD to acknowledge the receipt of an application. If unknown, please leave blank. |
| 6-10 | Provide the full mailing address of the applicant/company identified in (4). If suite address is used, provide the suite/unit number (if applicable) in addition to the street and street number (6), the city/town, the province and the postal code. If a post office number is used, include the PO Box number (6). |
| Block B | Senior Official |
| A senior official must always be designated for the applicant company. This principal contact for the applicant, at the address given, is the person to whom regulatory mail is sent. This is not the contact for site licence application-specific questions, but rather the person who represents the company. This individual should be a senior person in the company such as the Chief Executive Officer or a director. In some cases, especially small businesses, one person may be indicated as senior official and contact for the application. If the senior official of the applicant company changes, the NHPD must be notified of this change in writing or by completing the Site Licence Notification Description Form. | |
| 11-23 | Provide the name of the Senior Official (11) and the information needed to contact the individual: the full mailing address (14-23), telephone and fax numbers (21-22), position/title (12), e-mail address (23) and language of preference. The full mailing address (14-23) is not required if the Senior Official has the same address as the applicant company indicated in sections 6-10. |
| Block C | Contact for this Application |
| The contact for this application is the person to whom the NHPD will direct site licence application-specific questions. This may be an employee of the licensee/applicant, or an individual contracted from another company on behalf of the applicant (for example, a consultant). | |
| 24-37 | Provide name of contact for this application (25) and the information needed to contact that individual, i.e. company name if different from applicant company (28), full mailing address, telephone and fax numbers (35-36), position/title (26), e-mail address (37) and language of preference (27). The full mailing address is not required if the contact person has the same address as the applicant company identified in section 6-10. If the senior official is also the contact for this application, please check box 24. |
| Block D | Quality Assurance Person |
| The individual who is responsible for assuring the quality of the NHP before it is made available for sale. This person should be qualified by education, training and/or experience relating to the specific activity (i.e. manufacturing, packaging, labelling and/importing). | |
| 38-51 | Provide the name of the Quality Assurance Person (39) and the information needed to contact that individual, i.e. company name if different from applicant, full mailing address (44-48), telephone and fax numbers (49-50), position/title (40), e-mail address (51) and language of preference. The full mailing address is not required if the Quality Assurance Person has the same address as the contact. |
| Part 2 - Submission Type | |
| 52 | There are four types of site licence applications: New Site Licence Application, Site Licence Amendment, Site Licence Change Notification and Site Licence Renewal. Please indicate one type of application. |
| Part 3 - Canadian Site Information This is the building (or buildings) where authorized activities are performed. | |
| 53 | Indicate if the building will be used for warehousing/storage only, in which case indication of additional activities (55) will not be necessary. |
| 54 | Indicate if the proposed site is a place of residence. |
| 55 | Indicate the name by which the building is known, if applicable. |
| 56 | Indicate the activities to be performed at the site. |
| 57-60 | Provide the full mailing address of the site, the street address and suite number if applicable, street number (67), city/town (58), province (59) and postal code (60). |
| 61 | Provide the name of the contact for the building, if applicable. |
| 62 | Provide the name of the Quality Assurance Person responsible for quality assurance activities at this site. |
| 63 | Indicate the evidence of compliance with good manufacturing practices (GMP) as outlined in Part 3 of the Natural Health Products Regulations. Please refer to the site licensing and GMP guidance documents. |
| 65-76 77-88 89-100 | Provide the same information for additional sites as in sections 53-63. |
| Part 4 - Foreign Site Information (Information in this part must be provided by importers only.) | |
| 101 | Foreign building where authorized activities are performed. |
| 102 | Indicate if building will be used for warehousing/storage only, in which case indication of additional activities (105) will not be necessary. |
| 103 | Indicate if the proposed site is a place of residence. |
| 104 | Indicate the name by which the building is known, if applicable. |
| 105 | Indicate the activities to be performed at the site. |
| 106-109 | Provide the full mailing address of the site, the street address and suite number if applicable, street number (104), city/town (106), province/State (107), postal/Zip code (108) and country (109). |
| 111 | Provide the name of the Quality Assurance Person responsible for quality assurance activities at this site. |
| 112 | Indicate the evidence of compliance with good manufacturing practices (GMP) as outlined in Part 3 of the Natural Health Products Regulations. Please refer to the site licensing and GMP guidance documents for acceptable foreign inspection reports. |
| 113-124 125-136 137-148 | Provide the same information for additional foreign sites as in sections 101-110. |
| Part 5 - Attestation | |
| 149 | The attestation must be signed by the Quality Assurance Person for the applicant company. |
| 150 | Signature of the individual listed as the Quality Assurance Person in section 149. |
| 151 | The attestation must be signed by the senior official of the applicant company identified in sections 11-23, otherwise a Designated Party Authorization form must be completed and signed by the Senior Official. |
| 152 | Signature of the individual listed as the authorized signing official in section 151. |
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