Contacts Select to make changes to contact person information for this licence. Exactly how the NNHPD will enforce this form a legal perspective remains unclear.
Use this form to submit post-licensing changes to the Natural and Non-prescription Health Products Directorate NNHPD for licensed natural health products and homeopathic medicines.
Nnhpd site license application form. Before you use the form Health Canada must assign a company code a number for your company. 52 Methods of Submitting an Application. For all NNHPD forms required fields are indicated by a red asterisk before the field label and the word required after the field label.
Through an active Internet connection the web PLA form searches and populates data from the Natural Health Products Ingredients Database NHPID. NNHPD will only accept applications submitted electronically. The completed application form is saved as anhtml file that must be sent to the NNHPD as part of the submission package.
The Natural Health Products Regulations require any Canadian site where natural health products are manufactured imported labelled packaged distributed andor stored to have a site license. Apply For NPN License Natural Product Number NPN After Health Canada assesses your product and decides it is safe effective and of great quality it issues a product. Natural health product licence application form The web-based natural health product licence application web PLA form is designed to be completed online and saved on the applicants workstation.
Site Licence Application SLA Form. They must also demonstrate that they meet good manufacturing practice requirements. The electronic application should include the original electronically generated application form format from the web-based NHP PLA form ie.
Released on November 12 2020 the Harmonized Site Licence and FSRN Application Form version 10 allows users to fill a site licence application or foreign site reference number FSRN application online. Site Licence Application SLA Form. Html which can be integrated into the NNHPD system.
The web-based Product Licence Application PLA form is for natural health product licence applications. Medicinal ingredient Select to change one or. Sites must have procedures in place for distribution records and product recalls and for the handling storage and delivery of their products.
Yes No Start new submission Info. The Site Licence Application Form captures all of the information outlined in section 28 a to e of the Regulations as stated above. Natural health product licence application form overview.
Since the introduction of the new policies associated with the review of Product License Applications PLAs the NNHPD has become very strict about administrative requirements the days of the courtesy call to advise you that your Designated Party Authorization form DPA was inconsistent with the NNHPDs records are over. Guidance Documents The NNHPD has provided a number of guidance documents to help the NHP industry understand and comply with the regulatory requirements of the NHPR. The site licensing system requires that all manufacturers packagers labellers and importers be licensed.
Expertise in preparing all Classes of Natural Health Product License Applications in a cost-effective and efficient manner. This June marked a milestone for the NNHPD with the release of the validated web product license application form. They govern product licensing site licensing Good Manufacturing Practices GMPs clinical trials and labelling information.
Multiple sites or an individual license for each site. It is designed to be completed online and saved to the applicants workstation where it can be retrieved at any time. This form enables the validation of class I submissions directly through the web form.
If the applicant previously conducted activities under a Site Licence that expired was refused or cancelled by the NNHPD then a Summary of Net Changes SNC form is required in place of a QAR form even though the application is considered new. The Site Licence Application Form captures all of the information outlined in the GMP Regulations. To apply for a site licence applicants must provide to the NNHPD a site licence application which includes the following forms and documents.
The web-based harmonized site licence and foreign site reference number FSRN application form web SLA is designed to be completed online and saved on the applicants workstation. Businesses can choose to have a single site license for all their operations ie. The site licence holder and foreign site reference number extracts are updated on a periodic basis.
When submitting multiple product licence applications to the NNHPD it is worth saving templates prior to completing and finalizing the form. Response to a notice required Is this amendment or notification in response to a notice issued by the NNHPD Risk Management Division. Natural Product Number NPN License Registration Registered over 5000 NPNs.
For example if a company is submitting a renewal application that falls under Class II they must submit the renewal 65 business days prior to the site licence expiration date. The majority of submissions 75 submitted using the new web form are for hand sanitizers. The site licence holder extracts indicate sites that have been authorized to manufacture package label andor import natural health products by Health Canada.
Note that this form applies only to amendments and notifications as described in Part 1 Section 11 and 12 of the Natural Health Products Regulations NHPR.