Second Person'S Medicine

Medicinal Ingredient(S):

Brand Name:

Dosage Form:

Route(S) of Administration:

Human: OR Veterinary:

Strength Per Unit:

Use(S) of Medicinal Ingredient(S)

First Person'S Reference Product:  Under subsection 5(1) and 5(2) of the Regulations, address each patent listed in respect of the drug to which you directly or indirectly compare, or make reference.

Medicinal Ingredient(S):

Brand Name:

Dosage Form:

DIN:

Human: Or Veterinary:

Route(S) of Administration:

STRENGTH PER UNIT:

Use(S) of Medicinal Ingredient(S)

Name of Manufacturer:

Patent Number

Expiration Date (yyyy-mm-dd)

The Second Person has obtained consent from the patent owner to the making, constructing, using or selling of the drug in Canada.

The Second Person accepts that the Notice of Compliance will not be issued until the declared expiration date for the above patent number.

The Second Person alleges that:

the statement made by the First Person pursuant to paragraph 4(4)(d)) is false;

the patent has expired;

the patent is not valid;

no claim for the medicinal ingredient, no claim for the formulation., no claim for the dosage form and no claim for the use of the medicinal ingredient would be infringed by the second person making, constructing, using or selling the drug for which the submission is filed.

NoTE: IF YOU HAVE CHECKED ANY OF THE ALLEGATIONS ABOVE, YOU ARE REQUIRED TO COMPLY WITH SUBSECTION 5(3) OF THE REGULATIONS.

Certification: I certify that the information included in this Declaration is accurate and relevant to the Patented Medicines (Notice of Compliance) Regulations.

Name:

Title:

Address:

Name of Manufacturer:

Signature:

Date:

Contact:

Phone #:

Fax#:

For Office Use Only: 

Submission No.:

Filing Date:

Notes