Guidance on switching from prescription to non-prescription status: Template
Template for the PDL principles and factors assessment
Applicants should prepare their PDL principles and factors assessment using the subheadings shown in the template. Applicants should include the assessment in Module 1.0.7 of the new drug submission (NDS) or the supplement to a new drug submission (SNDS).
Applicants should ensure that in the assessment:
- each section contains the summary of evidence and the rationale to show that the indicated principle or factor does not apply to the proposed non-prescription drug (NPD) or natural health product (NHP)
- each section includes a reference to the location of the full data in the submission package, where applicable
- no section is left blank or only contains n/a, or Health Canada may issue a screening rejection letter or screening deficiency notice
Table 3: Template
PDL principles and factors assessment
Principle 1: Supervision by a practitioner is necessary
- for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in respect of which the drug is recommended for use, or
- to monitor a disease, disorder or abnormal physical state, or its symptoms, in respect of which the drug is recommended for use, or to monitor the use of the drug.
[Insert the rationale and evidence related to Principle 1]
Factor 1.1 The drug is used in the treatment of a serious disease not easily diagnosed by the public
[Insert text]
Factor 1.2 The use of the drug may mask other diseases
[Insert text]
Factor 1.3: Practitioner supervision is necessary for treatment and/or monitoring
[Insert text]
Factor 1.4: The use of the drug requires complex or individualized instructions
[Insert text]
Factors 1.5: Practitioner expertise is necessary to administer the drug or oversee the drug’s administration
[Insert text]
Factor 1.6: The drug has a narrow margin of safety
[Insert text]
Factor 1.7: At normal therapeutic dosage levels, the drug has potential or is known to cause serious adverse reactions or serious interactions with food or other drugs
[Insert text]
Factor 1.8: The drug has dependence and/or addiction potential
[Insert text]
Principle 2: The level of uncertainty respecting the drug, its use or its effects justifies supervision by a practitioner
[Insert text]
Factor 2.1: There is limited market experience with the use of the drug
[Insert text]
Principle 3: Use of the drug can cause harm to human or animal health or a risk to public health and the harm or the risk can be mitigated by a practitioner’s supervision
[Insert text]
Factor 3.1: There is potential for harm to public health
[Insert text]
Factor 3.2: There is potential for abuse or diversion leading to harmful non-medical use
[Insert text]