Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act (S.C. 2017, c. 6)
Full Document:
Assented to 2017-05-16
PART 2Related Amendments (continued)
R.S., c. P-4Patent Act (continued)
Marginal note:1993, c. 2, s. 7
52 Subsection 85(3) of the Act is replaced by the following:
Marginal note:Research costs
(3) In determining under section 83 whether a medicine is being or has been sold in any market in Canada at an excessive price, the Board shall not take into consideration research costs other than the Canadian portion of the world costs related to the research that led to the invention pertaining to that medicine or to the development and commercialization of that invention, calculated in proportion to the ratio of sales by the rights holder in Canada of that medicine to total world sales.
Marginal note:1993, c. 2, s. 7
53 Subsections 88(1) and (2) of the Act are replaced by the following:
Marginal note:Sales and expense information, etc., to be provided
88 (1) A rights holder for an invention pertaining to a medicine shall, as required by and in accordance with the regulations, or as the Board may, by order, require, provide the Board with the information and documents that the regulations or the order may specify respecting
(a) the identity of the licensees in Canada of the rights holder;
(b) the revenue of the rights holder, and details of the source of the revenue, whether direct or indirect, from sales of medicine in Canada; and
(c) the expenditures made by the rights holder in Canada on research and development relating to medicine.
Marginal note:Additional information
(2) If the Board believes on reasonable grounds that any person has information or documents pertaining to the value of sales of medicine in Canada by a rights holder or the expenditures made by a rights holder in Canada on research and development relating to medicine, the Board may, by order, require the person to provide the Board with any of the information or documents that are specified in the order, or with copies of them.
Marginal note:1993, c. 2, s. 7
54 (1) Subsection 89(1) of the Act is replaced by the following:
Marginal note:Report
89 (1) The Board shall in each year submit to the Minister a report setting out
(a) the Board’s estimate of the proportion, as a percentage, that the expenditures of each rights holder in Canada in the preceding year on research and development relating to medicine is of the revenues of those rights holders from sales of medicine in Canada in that year; and
(b) the Board’s estimate of the proportion, as a percentage, that the total of the expenditures of rights holders in Canada in the preceding year on research and development relating to medicine is of the total of the revenues of those rights holders from sales of medicine in Canada in that year.
Marginal note:1993, c. 2, s. 7
(2) Subsection 89(3) of the Act is replaced by the following:
Marginal note:Exception
(3) The Board shall, in the report, identify the rights holders in respect of whom an estimate referred to in subsection (1) is given in the report, and may, in the report, identify any person who has failed to comply with subsection 88(1) or (2) at any time in the year in respect of which the report is made.
Marginal note:1993, c. 2, s. 7
55 Subsection 96(4) of the Act is replaced by the following:
Marginal note:Guidelines
(4) Subject to subsection (5), the Board may issue guidelines with respect to any matter within its jurisdiction but such guidelines are not binding on the Board or any rights holder or former rights holder.
Marginal note:1993, c. 2, s. 7
56 Subsections 100(2) and (3) of the Act are replaced by the following:
Marginal note:Contents
(2) The report shall contain
(a) a summary of pricing trends in the pharmaceutical industry; and
(b) the name of each rights holder and former rights holder in respect of whom an order was made under subsection 81(1) or 82(2) or section 83 during the year and a statement as to the status of the matter in respect of which the order was made.
Marginal note:Report summary
(3) The summary referred to in paragraph (2)(a) may be based on information and documents provided to the Board by any rights holder or former rights holder under section 80, 81 or 82 or in any proceeding under section 83, but shall not be set out in a manner that would make it possible to identify that rights holder or former rights holder.
Marginal note:1993, c. 2, s. 7
57 (1) Paragraph 101(1)(d) of the English version of the Act is replaced by the following:
(d) specifying factors for the purposes of subsection 85(1) or (2), including factors relating to the introductory price of any medicine to which a patented invention, or invention protected by a certificate of supplementary protection, pertains;
Marginal note:1993, c. 2, s. 7
(2) Paragraph 101(1)(h) of the English version of the Act is replaced by the following:
(h) requiring or authorizing the Board to perform the duties, in addition to those provided for in this Act, that are specified in the regulations, including duties to be performed by the Board in relation to the introductory price of any medicine to which a patented invention, or invention protected by a certificate of supplementary protection, pertains; and
Marginal note:1999, c. 26, s. 50
58 Section 103 of the Act is replaced by the following:
Marginal note:Agreements with provinces
103 The Minister may enter into agreements with any province respecting the distribution of, and may pay to that province out of the Consolidated Revenue Fund, amounts received or collected by the Receiver General under section 83 or 84 or in respect of an undertaking given by a rights holder or former rights holder that is accepted by the Board in lieu of holding a hearing or making an order under section 83, less any costs incurred in relation to the collection and distribution of those amounts.
Marginal note:1999, c. 26, s. 50
59 The Act is amended by adding the following after section 103:
Supplementary Protection for Inventions — Medicinal Ingredients
Interpretation
Marginal note:Definitions
104 The following definitions apply in this section and in sections 105 to 134.
- authorization for sale
authorization for sale has the meaning assigned by regulations. (autorisation de mise en marché)
- drug
drug means a substance or a mixture of substances manufactured, sold or represented for use in
- Minister
Minister means the Minister of Health. (ministre)
Marginal note:Interpretation
105 (1) For the purposes of this section and sections 106 to 134, if a patent is reissued under section 47, it is deemed to have been granted on the day on which the original patent was granted and its application filing date is deemed to be the day on which the application for the original patent was filed.
Marginal note:Human and veterinary uses
(2) For the purposes of this section and sections 106 to 134, a medicinal ingredient or combination of medicinal ingredients contained in a drug authorized for human use and a medicinal ingredient or combination of medicinal ingredients contained in a drug authorized for veterinary use are to be treated as different medicinal ingredients or different combinations of medicinal ingredients, as the case may be.
Marginal note:Same medicinal ingredient — human use
(3) If medicinal ingredients contained in drugs authorized for human use differ from each other only with respect to a prescribed variation, they are to be treated as the same medicinal ingredient for the purposes of this section and sections 106 to 134.
Marginal note:Same medicinal ingredient — veterinary use
(4) If medicinal ingredients contained in drugs authorized for veterinary use differ from each other only with respect to a prescribed variation, they are to be treated as the same medicinal ingredient for the purposes of this section and sections 106 to 134.
Marginal note:Same combination — human use
(5) If combinations of medicinal ingredients contained in drugs authorized for human use differ from each other only with respect to a variation in the ratio between those ingredients, they are to be treated as the same combination of medicinal ingredients for the purposes of this section and sections 106 to 134.
Marginal note:Same combination — veterinary use
(6) If combinations of medicinal ingredients contained in drugs authorized for veterinary use differ from each other only with respect to a variation in the ratio between those ingredients, they are to be treated as the same combination of medicinal ingredients for the purposes of this section and sections 106 to 134.
Application for Certificate of Supplementary Protection
Marginal note:Application
106 (1) On the payment of the prescribed fee, a patentee may apply to the Minister for a certificate of supplementary protection for a patented invention if all of the following conditions are met:
(a) the patent is not void and it meets any prescribed requirements;
(b) the filing date for the application for the patent is on or after October 1, 1989;
(c) the patent pertains in the prescribed manner to a medicinal ingredient, or combination of medicinal ingredients, contained in a drug for which an authorization for sale of the prescribed kind was issued on or after the day on which this section comes into force;
(d) the authorization for sale is the first authorization for sale that has been issued with respect to the medicinal ingredient or the combination of medicinal ingredients, as the case may be;
(e) no other certificate of supplementary protection has been issued with respect to the medicinal ingredient or the combination of medicinal ingredients, as the case may be;
(f) if an application for a marketing approval, equivalent to an authorization for sale, was submitted in a prescribed country with respect to the medicinal ingredient or combination of medicinal ingredients, as the case may be, before the application for the authorization for sale was filed with the Minister, the application for the authorization for sale was filed before the end of the prescribed period that begins on the day on which the first such application for a marketing approval was submitted.
Marginal note:Issuance — paragraph (1)(e)
(2) Another certificate of supplementary protection is considered to have been issued for the purposes of paragraph (1)(e) even if that other certificate is subsequently held to be invalid or void or it never takes effect or ceases to have effect.
Marginal note:When application to be filed
(3) An application for a certificate of supplementary protection shall be filed with the Minister before the end of the prescribed period that begins on
Marginal note:Exception
(4) Despite subsection (3), no application shall be filed within the prescribed period preceding the expiry of the term of the patent under section 44 without taking into account section 46.
Marginal note:Contents of application
(5) An application for a certificate of supplementary protection shall
(a) set out the number, as recorded in the Patent Office, of the patent — as well as the medicinal ingredient or combination of medicinal ingredients and the number of the authorization for sale — in relation to which the certificate is sought;
(b) if paragraph (1)(f) applies with respect to the application, specify the day on which the first application for a marketing approval that is equivalent to an authorization for sale was made and the country in which that application was made; and
(c) set out any prescribed information.
Marginal note:One patent per application
(6) Each application is permitted to set out only one patent.
Marginal note:Information to be provided
107 (1) An applicant shall provide the Minister with any additional information that the Minister considers necessary.
Marginal note:Refusal
(2) Whenever the Minister is satisfied that any of the requirements set out in section 106 are not met with respect to an application for a certificate of supplementary protection, the Minister may refuse the application. The Minister shall notify the applicant of a refusal and of the grounds for it.
Marginal note:Order of priority — same authorization for sale
108 (1) Subsections (2) to (4) apply in determining the priority of applications for a certificate of supplementary protection that set out the same authorization for sale.
Marginal note:Patents granted on or before authorization for sale
(2) An application setting out a patent that was granted on or before the day on which the authorization for sale was issued has the same priority as every other such application.
Marginal note:Priority over patents granted after authorization for sale
(3) An application setting out a patent that was granted on or before the day on which the authorization for sale was issued has priority over an application setting out a patent that is granted after that date.
Marginal note:Patents granted after authorization for sale — priority
(4) Priority among applications setting out patents that were granted after the day on which the authorization for sale was issued is established according to the date on which the patent was granted, with an earlier date having priority over a later date and patents granted on the same date having the same priority.
Marginal note:Applications with same authorization for sale and priority
109 If two or more pending applications set out the same authorization for sale and have the same priority, the Minister shall provide each applicant with a written notice setting out the name and contact information of all the applicants, as well as the number, as recorded in the Patent Office, of the patent set out in each application.
Marginal note:Declaration of non-compliance
110 (1) A pending application for a certificate of supplementary protection may be declared invalid or void by the Federal Court for non-compliance with section 106 at the instance of another applicant whose application for a certificate sets out the same authorization for sale and the same priority.
Marginal note:Limitation
(2) A proceeding to obtain a declaration under subsection (1) shall be commenced before the end of the prescribed period that begins on the day that is specified by the Minister in the written notice sent under section 109.
Marginal note:Copy to Minister
(3) Anyone who commences such a proceeding, or an appeal or application for leave to appeal with respect to such a proceeding, shall provide the Minister with a copy of
Marginal note:Expiry of pending applications
111 (1) If two or more applications that set out the same authorization for sale and have the same priority are still pending at the end of the prescribed period that begins on the day specified in the written notice sent under section 109, all of those applications expire at that end of that period. However, if any proceedings are brought under section 110 with respect to any of those applications, all of those applications — if two or more are still pending — expire at the end of the prescribed period that begins on the day on which the last of any of the proceedings to be completed is finally disposed of.
Marginal note:Expiry of application with lower priority
(2) A pending application that sets out the same authorization for sale as another application of higher priority expires on the day on which the Minister issues a certificate of supplementary protection in respect of that other application.
Marginal note:Withdrawal
112 An applicant for a certificate of supplementary protection may withdraw their application in accordance with the regulations.
Certificate of Supplementary Protection
Marginal note:Issue of certificate
113 The Minister shall issue, to the patentee, a certificate of supplementary protection for the patented invention set out in the patentee’s application if, on the day of issuance,
(a) the Minister is satisfied that all requirements set out in section 106 are met;
(b) the applicable period referred to in subsection 106(3) for filing the application has ended;
(c) there is no other pending application that sets out the same authorization for sale and that has priority over, or the same priority as, the application; and
(d) any court proceedings, brought under section 110 with respect to the application or to another pending application that sets out the same authorization for sale and that has priority over, or the same priority as, the application, have been finally disposed of.
Marginal note:Contents of certificate
114 A certificate of supplementary protection shall set out
(a) the number, as recorded in the Patent Office, of the patent set out in the application;
(b) the medicinal ingredient or combination of medicinal ingredients set out in the application;
(c) a statement as to whether the certificate relates to use in humans or to veterinary use;
(d) the number of the authorization for sale set out in the application; and
(e) the day on which the certificate’s term begins and the day on which the term ends, as determined under section 116.
Marginal note:Scope of supplementary protection
115 (1) The issuance of a certificate of supplementary protection grants the certificate’s holder and their legal representatives, during the certificate’s term, the same rights, privileges and liberties that are granted by the patent set out in the certificate, but only with respect to the making, constructing, using and selling of any drug that contains the medicinal ingredient, or combination of medicinal ingredients, set out in the certificate, by itself or in addition to any other medicinal ingredient.
Marginal note:No infringement — export
(2) Despite subsection (1), it is not an infringement of the certificate of supplementary protection for any person to make, construct, use or sell the medicinal ingredient or combination of medicinal ingredients for the purpose of export from Canada.
Marginal note:Validity
116 (1) After the certificate is issued, it shall, in the absence of any evidence to the contrary, be valid and avail the holder and the holder’s legal representatives for its term.
Marginal note:Taking effect
(2) A certificate of supplementary protection takes effect on the expiry of the term under section 44, without taking into account section 46, of the patent set out in the certificate, but the certificate takes effect only if the patent remains valid until, and not void before, the expiry of that term.
Marginal note:Calculation of term
(3) The certificate’s term is calculated by subtracting five years from the period beginning on the filing date of the application for the patent and ending on the day on which the authorization for sale set out in the certificate is issued, but in any event is for a maximum of two years.
Marginal note:Reduction in period
(4) Despite subsection (3), if the person to whom the authorization for sale set out in the certificate is issued is also the patentee, the Minister may, if he or she is of the opinion that that person’s failure to act resulted in a period of unjustified delay in the process of obtaining the authorization for sale, reduce the term of the certificate when issuing it by the amount of that period.
Marginal note:Never takes effect
(5) A certificate of supplementary protection that has been issued never takes effect if the calculation of its term, including any reduction under subsection (3), produces a result of zero or a negative value.
Marginal note:Revocation of certificate
117 The Minister shall revoke a certificate of supplementary protection in the prescribed circumstances.
Transfer
Marginal note:Transfer of patent
118 (1) A certificate of supplementary protection, or an application for one, is not transferable other than by the transfer of the patent, or part of the patent, that is set out in the certificate or application.
Marginal note:Whole of patent
(2) If the whole of the patent is transferred, the certificate or application is transferred accordingly.
Marginal note:Part of patent
(3) If part of the patent is transferred, any part of the certificate or application — including, as the case may be, the whole of it — that corresponds to the transferred part of the patent is transferred accordingly.
Marginal note:For greater certainty
(4) For greater certainty, the transfer of part of an application for a certificate of supplementary protection does not result in its division into more than one application.
Administrative Matters
Marginal note:Applications, fees and documents
119 Applications, fees and documents relating to certificates of supplementary protection shall be submitted to the Minister.
Marginal note:Inspection by public
120 (1) The Minister shall ensure that the prescribed contents of all certificates of supplementary protection and applications for a certificate are made available for public inspection under the conditions that may be prescribed.
Marginal note:Non-application
(2) Subsection (1) does not apply with respect to the contents of applications for a certificate that are refused, declared invalid or void, expired or withdrawn.
Marginal note:Copy in case of loss or destruction
121 The Minister may issue a certified copy of a certificate of supplementary protection to replace one that is lost or destroyed.
Marginal note:Issuance of patent under section 47
122 (1) If a patent set out in a certificate of supplementary protection or in a pending application for such a certificate is surrendered, and a new patent is issued, under section 47, the holder of the certificate or the applicant shall, before the end of the prescribed period that begins on the day on which the new patent is issued, provide the Minister with written notice of the number, as recorded in the Patent Office, of the new patent to which the certificate or application relates.
Marginal note:One patent
(2) If more than one new patent is issued under section 47, the holder of the certificate or the applicant shall provide the number for only one of the new patents.
Marginal note:New certificate
(3) If notice is provided under subsection (1) by a holder of a certificate, the Minister shall issue a new certificate of supplementary protection, setting out the new patent number, to replace the original certificate. The new certificate’s term is the then unexpired term of the original certificate.
Marginal note:Effect of new certificate
(4) The new certificate is deemed to have been issued on the day on which the new patent is issued. The original certificate and the new certificate have the same effect in law, in any action commenced after the issuance of the new certificate for any cause accruing after that issuance, as if the new patent had been set out in the original certificate; however, insofar as the claims of the new patent and the original patent are identical, the issuance of the new certificate does not affect any action pending at the time of the issuance of the new certificate or abate any cause of action that existed at that time and the new certificate constitutes a continuation of the original certificate and has effect accordingly.
Marginal note:Application
(5) If notice is provided under subsection (1) by an applicant for a pending application, the Minister shall
Marginal note:Effect of amendment to application
(6) The amended application has the same effect, for the purposes of sections 106 to 113, as if the pending application had been originally filed in its amended form.
Use of Certificates of Supplementary Protection by Government
Marginal note:Application
123 Sections 19 to 19.2 apply with respect to certificates of supplementary protection, with
(a) any reference to “patented invention” to be read, with any grammatical adaptations, as a reference to “invention protected by a certificate of supplementary protection”; and
(b) any reference to “patentee” to be read as a reference to “holder of the certificate of supplementary protection”.
Infringement and Impeachment
Marginal note:Action for infringement
124 (1) An action for the infringement of a certificate of supplementary protection may be brought in the same manner as an action for the infringement of a patent, and the following provisions apply to the action:
(a) sections 54, 57 and 59, with any reference to “patent” to be read as a reference to “certificate of supplementary protection”;
(b) subsection 55(1), and subsection 55(3) as it applies to that subsection (1), with any reference to “patent” to be read as a reference to “certificate of supplementary protection”, any reference to “patentee” to be read as a reference to “holder of the certificate of supplementary protection” and any reference to “grant” to be read as a reference to “taking of effect”;
(c) section 55.01;
(d) section 55.1, with any reference to “patent” to be read as a reference to “certificate of supplementary protection” and any reference to “patented process” to be read as a reference to “process protected by the certificate of supplementary protection”;
(e) subsections 55.2(1) and (6), with any reference to “patent” to be read as a reference to “certificate of supplementary protection” and any reference to “patented invention” to be read as a reference to “invention protected by the certificate of supplementary protection”;
(f) subsection 56(1), with any reference to “patentee” to be read as a reference to “holder of a certificate of supplementary protection that sets out that patent”;
(g) section 58, with the reference to “a patent that contains two or more claims” to be read as a reference to a “two or more claims in a patent that is set out in a certificate of supplementary protection” and with the reference to “the patent as if it” to be read as a reference to “the certificate as if the patent set out in it”.
Marginal note:Regulations — subsection 55.2(4)
(2) The Governor in Council may make regulations respecting the infringement of any certificate of supplementary protection that, directly or indirectly, could result or results from the making, construction, use or sale of a patented invention or invention protected by a certificate of supplementary protection in accordance with subsection 55.2(1), including regulations described in paragraphs 55.2(4)(a) to (k), with
Marginal note:Inconsistency or conflict
(3) In the event of an inconsistency or conflict between regulations made under subsection (2) and any Act of Parliament or regulations made under such an Act, the regulations made under subsection (2) prevail to the extent of the inconsistency or conflict.
Marginal note:Impeachment
125 (1) A certificate of supplementary protection, or any claim in the patent set out in such a certificate, may be declared invalid or void — including on the basis that the certificate was issued despite non-compliance with any of the requirements, as they existed at the time that the certificate was issued, of subsection 106(1) or that the patent set out in the certificate no longer complies with the requirements, as they existed at that time, set out in paragraph 106(1)(c) — by the Federal Court at the instance of the Attorney General of Canada or any interested person.
Marginal note:Application
(2) Subsections 60(2) and (3) apply with respect to a certificate of supplementary protection, with any reference to “patentee” to be read as a reference to “holder of a certificate of supplementary protection” and any reference to “patent” to be read as a reference to “certificate of supplementary protection”.
Marginal note:Judgment voiding certificate or claim
126 (1) A certificate of supplementary protection, or a claim in the patent set out in such a certificate, that is voided by a judgment shall be and be held to have been void and of no effect, unless the judgment is reversed on appeal as provided in subsection (2).
Marginal note:Appeal
(2) Every judgment voiding a certificate of supplementary protection or any claim in the patent set out in such a certificate, and every judgment refusing to do so, is subject to appeal to any court having appellate jurisdiction in other cases decided by the court by which the judgment was rendered.
Abuse of Rights
Marginal note:Abuse of patent rights
127 (1) The Commissioner may, in respect of application under section 65, exercise any of the powers under any of paragraphs 66(1)(a), (d) and (e) with respect to an issued certificate of supplementary protection if he or she is satisfied that a case of abuse of the exclusive rights under the patent that is set out in the certificate has been established.
Marginal note:Abuse — application to Commissioner
(2) The Attorney General of Canada or an interested person may, at any time after a certificate of supplementary protection takes effect and after the expiry of three years from the date of the grant of the patent set out in the certificate, apply to the Commissioner alleging that there has been an abuse of the exclusive rights granted under a certificate of supplementary protection issued with respect to that patent and asking for relief under this Act.
Marginal note:What amounts to abuse
(3) The exclusive rights under a certificate of supplementary protection are abused in any of the following circumstances:
(a) the demand in Canada for a drug that contains the medicinal ingredient or a combination of the medicinal ingredients set out in the certificate is not being met to an adequate extent and on reasonable terms;
(b) by reason of the refusal of the certificate’s holder to grant a licence or licences on reasonable terms, the trade or industry of Canada or the trade of any person or class of persons trading in Canada, or the establishment of any new trade or industry in Canada, is prejudiced, and it is in the public interest that a licence or licences should be granted;
(c) any trade or industry in Canada, or any person or class of persons engaged in such a trade or industry, is unfairly prejudiced by the conditions attached by the certificate’s holder to the purchase, hire, licence, use or working of the invention protected by the certificate.
Marginal note:Provisions that apply
128 Sections 66 to 71, other than paragraph 66(1)(c), apply for the purposes of section 127, with
(a) any reference to “patent”, other than with respect to the Patent Office, to be read as a reference to “certificate of supplementary protection”;
(b) any reference to “patentee” to be read as a reference to “holder of the certificate of supplementary protection”;
(c) any reference in paragraphs 66(1)(d) and (e) and subsection 68(1) to “section 65” to be read as a reference to “section 127”;
(d) any reference in subsection 69(1) or section 71 to “sections 65 to 70” to be read as a reference to “sections 66 to 70 and 127”; and
(e) the reference in subsection 69(3) to “the Minister” to be read as a reference to “the Minister of Industry”.
General
Marginal note:Electronic form and means
129 (1) Subject to the regulations, any document, information or fee that is submitted to the Minister under this Act may be submitted in any electronic form, and by any electronic means, that is specified by the Minister.
Marginal note:Collection, storage, etc.
(2) Subject to the regulations, the Minister may use electronic means to create, collect, receive, store, transfer, distribute, publish, certify or otherwise deal with documents or information under sections 106 to 134.
Marginal note:Definition
(3) In this section, electronic, in reference to a form or means, includes optical, magnetic and other similar forms or means.
Marginal note:Certified copies as evidence
130 In any action or proceeding respecting a certificate of supplementary protection authorized to be had or taken in Canada under this Act, a copy purporting to be certified by the Minister of any such certificate, or of any other document that is made by or filed with the Minister and is connected to such a certificate, may be produced before the court or other tribunal, or a judge or member of the court or tribunal, and the copy purporting to be so certified may be admitted in evidence without production of the original and without proof of the Minister’s certification.
Marginal note:Costs of proceedings
131 In all proceedings before any court under this Act, including, for greater certainty, an application for judicial review of a decision of the Minister under this Act, the costs of the Minister are in the discretion of the court, but the Minister shall not be ordered to pay the costs of any other of the parties.
Marginal note:Time limit deemed extended
132 (1) If any time period fixed under any of sections 106 to 134 in respect of dealings with the Minister ends on a prescribed day or a day that is designated by the Minister, that time period is extended to the next day that is not a prescribed day or a designated day.
Marginal note:Power to designate day
(2) The Minister may, on account of unforeseen circumstances and if the Minister is satisfied that it is in the public interest to do so, designate any day for the purposes of subsection (1). If a day is designated, the Minister shall inform the public of that fact on the Department of Health’s website.
Marginal note:User Fees Act
133 The User Fees Act does not apply in respect of the fees referred to in section 106 or 134.
Marginal note:Regulations
134 (1) The Governor in Council may make rules or regulations
(a) defining the term authorization for sale;
(b) respecting the form and contents of applications for certificates of supplementary protection;
(c) respecting the processing of such applications;
(d) respecting the determination of when, for the purpose of paragraph 106(1)(f), an application for an authorization for sale was filed and, for the purpose of subsection 106(3), an application for a certificate of supplementary protection is filed;
(e) prescribing the fees or the manner of determining the fees that may be charged in respect of the filing of applications for certificates of supplementary protection, the issuance of such certificates or the taking of other proceedings under sections 106 to 133 or under any rule or regulation made under this section, or in respect of any services or the use of any facilities provided by the Minister under those sections or such a rule or regulation;
(f) respecting the payment of any prescribed fees including the time when and the manner in which such fees shall be paid, the additional fees that may be charged for the late payment of such fees and the circumstances in which any fees previously paid may be refunded in whole or in part;
(g) respecting the submission, including in electronic form and by electronic means, of documents and information to the Minister, including the time at which they are deemed to be received by the Minister;
(h) respecting the use of electronic means for the purposes of subsection 129(2), including requiring the use of those electronic means;
(i) respecting the withdrawal of an application for a certificate of supplementary protection;
(j) respecting communications between the Minister and any other person;
(k) respecting the correction of obvious errors in documents submitted to the Minister, in certificates of supplementary protection or in other documents issued under sections 106 to 133, including
(l) generally, for carrying into effect the objects and purposes of sections 104 to 133 or for ensuring their due administration by the Minister.
Marginal note:For greater certainty
(2) For greater certainty, the Governor in Council may make rules or regulations under paragraphs 12(1)(d), (g), (h) and (k) for the purposes of this section and sections 104 to 133.
- Date modified: