FEDERAL REG

Regulations Amending the Food and Drug Regulations (Vanessa’s Law)

PROPOSED FEDERAL REGULATION - VIA PART I OF THE GAZETTE

Proposed
April 22, 2017


REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Regulations.) Issues Vanessa’s Law provisions that require regulations to come into force Prior to the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law), the Food and Drugs Act (the Act) had not been substantially updated in over 50 years. Over time, it became apparent that changes to the Act were needed in order to ... (Click for more)


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Published on April 22, 2017

Bill Summary

Regulations Amending the Food and Drug Regulations (Vanessa’s Law)

REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Regulations.) Issues Vanessa’s Law provisions that require regulations to come into force Prior to the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law), the Food and Drugs Act (the Act) had not been substantially updated in over 50 years. Over time, it became apparent that changes to the Act were needed in order to provide Health Canada with the legislative and regulatory tools necessary to regulate more effectively and efficiently the approval and safety of drugs for Canadians based on a life cycle approach (i.e. an approach to regulating drugs where drugs are evaluated before and after they reach the market). This approach is being adopted by regulatory agencies worldwide and is based on the recognition that important information about the safety and effectiveness of a drug can only be learned after a product is marketed and as more people use the product. Vanessa’s Law received royal assent on November 6, 2014, and amended the Act to enable Health Canada to regulate a drug more efficiently and effectively throughout its life cycle, beginning with the pre-market application for an authorization to sell the drug to post-market follow-up, when the drug is made available to Canadians. The amendments provide the Minister of Health (the Minister) with a wide range of proportional regulatory tools to use and give the Governor in Council the authority to make regulations to further enhance the Minister’s ability to gain information about a drug or to mitigate risks to persons who use these drugs. For example, the Minister now has the ability to order a therapeutic authorization holder to make a label change if a safety risk has been identified once a drug is on the market, or to order the recall of a product if the Minister believes that it presents a serious risk of injury to health. Prior to these changes to the Act, the Minister had limited recourse to take timely and proportionate action when safety issues arose other than suspending or cancelling an authorization. While most of the amendments to the Act (e.g. the ability to recall unsafe drugs, impose tougher fines and penalties, order changes to a label or package, and seek an injunction) are already in force, some powers will be brought into force when regulations are in place to support them. These include the Minister’s power to order the therapeutic authorization holder to conduct an assessment of a therapeutic product and provide the Minister with the results (under section 21.31 of the Act); and order the therapeutic authorization holder to compile information, conduct tests or studies or monitor experience in respect of the therapeutic product and provide the Minister with the information or results (under section 21.32 of the Act). These statutory powers will allow Health Canada to gather information to resolve uncertainties that may arise respecting the benefits and harms associated with a therapeutic product. These uncertainties could be identified in new information that was not previously available to the Minister, such as a post-market safety signal obtained through a review of adverse drug reaction reports. Without additional information to resolve the uncertainties, the Minister could not reasonably be expected to decide whether there was a significant change to the safety profile of the product or its effectiveness that would constitute an elevated risk to patients and that could warrant further action to mitigate those risks. The orders that the Minister may issue under sections 21.31 and 21.32 can be time-consuming and financially burdensome for authorization holders to comply with; therefore, regulations are necessary to specify how and when the Minister will be authorized to exercise these powers. Notifying Health Canada of foreign risk communications Currently, authorization holders do not have to inform Health Canada of risks associated with a drug that have been identified by foreign affiliates or regulators, or may have resulted in a recall or other regulatory action, such as the suspension or revocation of a licence, in foreign jurisdictions. Many drugs may be marketed years in advance or in a higher volume in other countries (typically the United States and the European Union). As a consequence, important safety signals may be detected earlier in a foreign jurisdiction. Many Canadian drug manufacturers are often aware before Health Canada of the actions being taken by a foreign affiliate or regulator. They are well placed to assess the risks of Canadian products and inform Health Canada of this. Knowing of risks communicated or actions taken to mitigate risks in foreign jurisdictions is important, as it allows Health Canada to assess risks to Canadians and take appropriate action to mitigate those risks when warranted. There are few tools available in the Food and Drug Regulations (FDR) that Health Canada can use to compel the disclosure of this type of information, and these can only be used on a case-by-case basis and are limited in scope. For example, section C.01.013 allows the Director to request information to establish the safety and effectiveness of a drug, and sections C.01.016 to C.01.019 require authorization holders to report serious unexpected adverse drug reactions (ADRs) that occur outside of Canada and provide the Minister with the authority to require, in respect of these ADRs, annual summary reports, case reports and issue-related summary reports. In addition, Health Canada maintains a number of Memoranda of Understanding (MOUs) with certain foreign regulatory agencies. Although these MOUs allow for the exchange of certain risk information between the signatories, they do not provide coverage that is sufficiently comprehensive or timely to allow Health Canada to rapidly assess risks (if any) to Canadian patients and take necessary actions to mitigate these risks, nor do they proactively engage the Canadian authorization holder. Furthermore, Health Canada receives safety information from authorization holders through the provision of Periodic Safety Update Reports (PSURs) or Periodic Benefit-Risk Evaluation Reports (PBRERs). This type of reporting is conducted on a voluntary basis and typically only for a small subset of new drugs (i.e. drugs that have been issued a notice of compliance [NOC] pursuant to section C.08.004 of the FDR). Furthermore, these reports do not need to be submitted to the Department of Health (the Department) on an expedited basis when emergent safety issues come to light. Clinical case reports: reducing burden Under paragraph C.08.005.1(1)(a) of the FDR, manufacturers are required to submit a copy of all clinical case reports with a new drug submission (NDS). Clinical case reports are generated when a person who is part of a study has died, or has suffered a serious adverse reaction or an unexpected adverse reaction to a drug. These reports contain details about the event, including patient history, diagnosis and treatment. However, they represent up to half of the volume of data provided with an NDS and, therefore, represent a substantial compliance burden for manufacturers. In addition, Canada is not aligned with international partners in this regard, as it is the only major regulator that requires manufacturers to routinely submit clinical case reports along with their applications for market authorizations. The elimination of this requirement would not negatively impact Health Canada’s review of an NDS for two reasons. First, under paragraph C.08.005.1(1)(c) and subsection C.08.005.1(3), manufacturers will still be required to provide Health Canada with a summary of these clinical case reports. Second, the Minister would still be able to access these clinical case reports when necessary, using existing requirements under paragraph C.08.002(3)(d), subsection C.08.002.01(4), paragraph C.08.002.1(3)(d) and subsection C.08.003(3). Objectives These proposed Regulations would support the coming into force of the new powers to require assessments, tests and studies included in Vanessa’s Law by establishing the rules needed to structure the exercise of those powers. They would further support post-market drug safety by creating new foreign incident reporting rules. Finally, the Regulations would reduce unnecessary requirements by removing an NDS reporting obligation. Together, the provisions of the Regulations would enable Health Canada to regulate drugs more efficiently and effectively, based on a life cycle approach. Description This proposal contains substantive amendments to certain provisions of Part C, Divisions 1 and 8, of the FDR that would strengthen the Department’s ability to regulate drugs based on a life cycle approach. The amendments include the following: 1. Regulations to support the coming into force of new powers under Vanessa’s Law to require assessments, tests and studies Regulatory amendments would further define the scope of sections 21.31 and 21.32 of Vanessa’s Law. These amendments would be made concurrently with an order in council that would bring these new legislative powers into force. Together, the new regulations and legislation would create and establish the scope of the Minister’s new authorities to order drug manufacturers to conduct assessments or to conduct additional tests and studies. The proposed Regulations would limit the scope of the new powers to drugs regulated under the FDR. Assessments ordered under section 21.31 of the Act The proposed Regulations would establish the following with respect to an order made under section 21.31 of the Act: The order must relate to a drug; The person to whom the order relates must be the holder of an authorization made through the assignment of a drug identification number (DIN), the issuance of an establishment licence (EL), or the issuance of a notice of compliance (NOC); The Minister must have reasonable grounds to believe that the benefits or risks of injury to health associated with the drug are significantly different than they were when the most recent authorization was issued; The Minister, after examining the results of an assessment, would be required to inform the authorization holder of the results of the examination; and A summary of the results of the examination and any actions taken as a result of the examination would be made publicly available on the Government of Canada website. As an example, information may become available through ADR reporting indicating that a drug may be causing a serious previously unknown injury to patients or that a known injury may be occurring at a rate much higher than what was established in clinical trials. In this case, the Minister could order the authorization holder to provide an assessment of whether the benefits of the drug continue to exceed the injury in light of the new information (and if not, whether actions would be required to mitigate the risks). In addition, a new regulatory provision would allow the Minister to cancel a DIN or suspend an NOC if, on the basis of an assessment, the risks of injury to health outweigh the benefits. In the case of an EL, the Minister could suspend the EL in relation to a licensable activity, if the results of an assessment led the Minister to believe that the licensee could no longer meet the requirements of the EL with respect to good manufacturing practices. Tests, studies and other activities ordered under section 21.32 of the Act The proposed Regulations would establish the following with respect to an order made under section 21.32 of the Act: The order must relate to a drug; The person to whom the order relates must be the holder of an authorization made through the assignment of a DIN, the issuance of an establishment licence (EL), or the issuance of a notice of compliance (NOC); The Minister must have reasonable grounds to believe that there are significant uncertainties relating to the benefits and harms associated with the drug; The authorization holder must be currently unable to provide the Minister with information to manage those uncertainties; Any applicable requirements of the FDR as well as any terms and conditions made on the authorization do not allow for sufficient information to be obtained to manage those uncertainties; and Before issuing an order, the Minister must consider whether the information-gathering activities proposed for the order are feasible and whether there are other less burdensome means of obtaining the information. If, during discussions with the manufacturer, the Minister decides that additional information is still needed to help him or her make a decision on the uncertainties related to the drug, then the Minister may use this power to order an additional test or study (for example compiling information on the number of prescriptions written or filed, conducting a randomized controlled clinical trial, or monitoring misuse of the drug). An order is meant to be used when Health Canada has determined that standard product vigilance (e.g. activities related to monitoring adverse reactions or problems with reporting them) is not sufficient to obtain the additional information required for the ongoing benefit-risk assessment of the product. It is not the Minister’s intent to trigger the order powers under sections 21.31 and 21.32 without providing the authorization holder with an opportunity to address the situation, which led to the Minister considering the use of these powers. As was done for other order powers available to the Minister that are already in force (for example a label change order under section 21.2 or a recall order under section 21.3), Health Canada is developing a process to ensure that the authorization holder has an opportunity to be heard prior to the issuance of an order. 2. Notifying Health Canada of foreign actions regarding serious risk communications The proposed amendments to the FDR would require the holder of an authorization (made through the assignment of a DIN or the issuance of a notice of compliance), for a prescription drug or a drug sold without a prescription that is administered by practitioners, to provide the Minister with information in respect of any serious injury to health the holder becomes aware of and that is relevant to the safety of the drug regarding risks communicated by certain foreign regulatory authorities; changes to the labelling communicated to or requested by certain regulatory authorities; and recalls, reassessments, suspensions or revocations of authorizations within certain foreign regulatory jurisdictions. This information would be required to be provided to the Minister within 48 hours of the holder receiving it, or becoming aware of it, so as to allow the Minister to follow up without delay if similar risks exist for those drugs in Canada and action would be required to mitigate those risks. Guidance documents prepared by Health Canada would further specify the information that authorization holders would have to provide, which would include the brand name and manufacturer of the foreign product, the brand name of the relevant Canadian product, the name of the foreign regulator, a description of any action taken by them and the reasons for those actions. In addition, they would have to provide an explanation of how the issue that resulted in foreign actions may be relevant to the safety of the product sold in Canada and any actions proposed or taken by them in response. The reporting requirement would only apply with respect to prescription drugs or drugs sold without a prescription that are administered under the supervision of practitioners, as these classes of drugs are considered to have a higher risk of injury to health in comparison to non-prescription drugs. Note that this may include some but not necessarily all drugs that are subject to the Schedule II factors (see footnote 1) that the National Association of Pharmacy Regulatory Authorities (NAPRA) considers when making a scheduling decision (i.e. drugs that are recommended for sale only by a pharmacist). A list of foreign regulatory authorities would be incorporated by reference in the FDR. This list would include the United States Food and Drug Administration (FDA) as well as drug regulatory authorities in many of the nations of the European Union. The foreign authorities were chosen so as to be representative of the authorities that may have authorized the drug for sale and for use in a similar manner as Canada, and ones with which Health Canada has a working relationship through bilateral agreements or common membership in internationally recognized organizations. The list is attached as Appendix A to the Regulatory Impact Analysis Statement. 3. Clinical case reports — Reducing the burden The proposed amendments would repeal the requirement in paragraph C.08.005.1(1)(a) to provide clinical case reports when a new drug submission (NDS) is filed with the Minister. This would enhance harmonization with international regulatory requirements and reduce undue burden to businesses. This amendment is not expected to compromise the review of drug submissions since remaining provisions in section C.08.005.1 would continue to require the submission of sectional reports and comprehensive summaries in which the results of the case reports are summarized and discussed. Further to this, under subsection C.08.005.1(6), manufacturers would still be required to keep case reports, and the Minister would retain the authority to request those case reports if necessary. “One-for-One” Rule The proposal to require the holder of a drug authorization to communicate risks identified in foreign jurisdictions would be a requirement that is unique to Canada, as no other jurisdiction currently has implemented regulations that are as robust as those proposed. Authorization holders would be required to notify Health Canada of any information they receive or become aware of (that applies to a product sold in Canada and represents a possibility of serious risk) respecting risks identified in specified foreign jurisdictions within 48 hours of the moment they become aware of it. This information includes risk communications issued, changes to label requested, recalls, reassessments, suspensions, and revocations of authorization by the regulatory authorities specified. While stakeholders have indicated that this activity already occurs, by formalizing it in the regulations, they have identified an incremental cost of $1,560 to report to Health Canada. This includes 10 hours to compile a report by working level staff ($600) and 2.5 hours for functional ($600) and senior management review ($360). It has been estimated by Health Canada that industry would have to screen approximately 226 foreign-related risk issues yearly, potentially resulting in 10 unique risk signals for post-market surveillance. This creates a present value cost of $352,560 annually, or $312,912 in 2012 dollars. The costs of reporting would not be borne equally. Each authorization holder would be required to report based on the information that they become aware of, and only then, when the information is relevant to products on the Canadian market. It is therefore theoretically possible that in any given year all the reporting costs would fall on only one firm, or they could be spread evenly across the entire industry. This table shows the One-for-one Rule. One-for-One" Rule (Applies to Administrative Costs Only) One-for-One" Rule (Applies to Administrative Costs Only) Current Initiative Constitutes "IN" ("One-for-One" Rule) Total annualized average administrative costs (constant 2012 $) $312,912 Annualized average administrative costs (constant 2012 $) $3,863 Small business lens The small business lens applies to regulatory proposals that have an impact on small businesses and that have nationwide cost impacts over $1 million annually. The Treasury Board Secretariat defines small businesses as any business, including its affiliates, that has fewer than 100 employees or between $30,000 and $5 million in annual gross revenues. This definition is based on commonly used definitions for what is considered a “small” business in Canada. The prescription pharmaceutical industry in Canada does not fit the definition of small business. Further, there are no significant costs introduced by the proposed Regulations. Therefore, the small business lens does not apply. Consultation The Department has engaged stakeholders extensively since 2010 to understand their various positions on the provisions under Vanessa’s Law. For example, the Department hosted a series of technical discussions with stakeholders on regulatory modernization and regulating drugs and medical devices based on a life cycle approach. These discussions covered topics such as market authorization, amendments, terms and conditions, label changes, tests and studies, suspension, and revocation. Many of these components resulted in provisions found under Vanessa’s Law. For more information on these technical discussions, visit the Department’s website at http://www.hc-sc.gc.ca/ahc-asc/activit/strateg/mod/reg/tech-eng.php. Canadian academics, clinicians and health technology assessors have been engaged at various times and expressed support for a framework that would allow for enhanced information gathering and sharing throughout the life cycle. Health Canada conducted surveys concerning costs in 2014 regarding potential regulations stemming from the passing of the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law). The surveys provided industry with a chance to inform Health Canada of the cost impacts of various provisions and how some costs could be lowered. A notice of intent (NOI) announcing Health Canada’s intention to develop supporting regulations under Vanessa’s Law to bring into force the Minister’s power to order an assessment; to order the conduct of further tests, studies, and other activities; and to require authorization holders to report foreign risk communications was published on June 18, 2016. Only one stakeholder provided comments related to those provisions under the Act that give rise to these proposed Regulations. Notably, the stakeholder commented that the proposed Regulations should provide a clear framework for fulfilling the foreign risk communication obligations, and that orders should be issued when companies do not voluntarily comply with requests made by Health Canada. Finally, a number of information sessions were held in October 2016 with various associations representing the pharmaceutical industry in Canada. These stakeholders were provided with an overview of the Department’s policy intent with respect to this proposal. Some stakeholders expressed the need to be able to have a dialogue with Health Canada before an order is issued by the Minister. As with the order powers that have already come into force, Health Canada is developing procedures to allow an opportunity for the authorization holder to be heard prior to the issuance of an order. Some stakeholders asked which specific information each authorization holder would be required to provide the Minister under the foreign risk communication proposal. Health Canada realizes that there is the possibility of duplicative reporting in some instances and is developing guidance documents to detail what information would be required and which authorization holder would be required to submit that information in order to comply with the proposed Regulations. Rationale The proposed amendments to Division 1 are necessary to specify how and when the Minister may exercise key provisions from Vanessa’s Law. In the absence of these regulatory amendments, several safety provisions such as the Minister’s power to order an assessment of a drug or for a company to conduct further tests and studies would not be able to come into force, nor would companies be required to notify the Department of foreign risk communications of which they are aware. All of the above are important tools necessary for the Department to be able to effectively monitor a drug once it is on the market and to act upon important post-market safety information. The proposed amendment to Division 8 would bring the Department into alignment with its regulatory counterparts, and reduce unnecessary burden on industry by eliminating the requirement to produce all clinical case reports when applying for an authorization. Benefits and costs 1. Regulations to support the coming into force of new powers under Vanessa’s Law to require assessments, tests and studies The Regulations proposed in this package relating to assessments and to tests and studies are required to operationalize Vanessa’s Law. They would set, in the FDR, the thresholds and procedures to be used with these powers. Therefore, the costs set out below stem from amendments to the Act, and not the proposed Regulations. The proposed Regulations are meant to ensure the effectiveness of the new provision of the Act and provide transparency while also introducing procedural fairness for market authorization holders. These powers would only be used in instances when there is evidence that the benefit-harm-uncertainty profile of a drug may have changed. Currently, these activities are done voluntarily by industry, often as a result of pressure from other regulatory bodies, and it is expected that industry will continue to do so. While most of this information can be gained through discussions with manufacturers, the Minister needs the authority to compel a manufacturer that refuses to voluntarily act to resolve significant uncertainties associated with a product, and would typically be done once all regulatory tools available to the Minister are exhausted. It is anticipated that the new authorities created by Vanessa’s Law (assessments, tests and studies) would be utilized approximately three times per year, cumulatively. A survey of firms indicated that the annual incremental cost of these powers would be $300,000. 2. Clinical case reports The removal of the requirement to automatically provide case reports should greatly reduce the compliance burden on industry. Industry provided a wide range of estimates for the annual savings of removing this requirement. Industry stated it was difficult to give a per product estimate of the savings, but numbers ranged from a low of $2,500 to a maximum of $4,000,000 per marketed product depending on certain situations that could arise. Numbers provided by industry suggest that the savings from the elimination of this requirement for a medium-sized submission would be around $5,000 per year. (see footnote 2) Health Canada’s records indicated that in the fiscal years 2012–13, 2013–14, and 2014–15, the number of filings that were made that required the inclusion of case reports were 365, 340, and 315 respectively. This represents an average of 340 filings per year that required the submission of case reports. This amounts to $1.7 million dollars per year of burden to satisfy a Canadian-specific requirement. $5,000 × 340 filings per year = $1,700,000 per year Over 10 years, the total benefit to industry would be $17 million. Adjusted for present value using a 7% discount rate, the savings would be $11.9 million over that period. Since these savings are not administrative in nature, they are also not captured in the “One-for-One” Rule. Taking into consideration the costs associated with the foreign risks reporting requirements and the savings of the clinical case reports requirements, the annualized net benefit of the proposal would be $1,347,440 per year, or a net present value benefit estimated to be $9,463,855 over 10 years. Implementation, enforcement and service standards These amendments would not alter existing compliance and enforcement mechanisms under the provisions of the Act and the FDR. Implementation activities, such as the training of staff, standard operating procedures as well as updating internal databases and the Department’s website, would be needed to support these amendments. Guidance documents (available upon request) and any corresponding templates created by the Department would be available to aid regulated parties in coming into compliance. Coming into force These proposed amendments can only come into force once subsection 6(2) of Vanessa’s Law comes into force. An order in council would bring into force this subsection and sections 4, 10 and 11 of Vanessa’s Law six months following the publication of the Regulations in the Canada Gazette, Part II. This six-month period would provide time for industry to plan for and adjust to the new regulatory requirements, and provide the Department time to update its processes and train staff. Contact Bruno Rodrigue Director Office of Legislative and Regulatory Modernization Policy, Planning and International Affairs Directorate Health Products and Food Branch Health Canada Address Locator: 3105A Holland Cross, Tower B, 5th Floor 1600 Scott Street Ottawa, Ontario K1A 0K9 Email: [email protected] Appendix A — List of Foreign Regulatory Authorities for the Purposes of Section C.01.050 of the Food and Drug Regulations Part A This table presents the list of Foreign Regulatory Authorities for the Purposes of Section C.01.050 of the Food and Drug Regulations. Regulatory Authority Country The United States Food and Drug Administration United States of America The European Medicines Agency European Commission The Australian Therapeutic Goods Administration Australia Australian Pesticides and Veterinary Medicines Authority Australia Ministry of Primary Industries New Zealand Swiss Agency for Therapeutic Products Switzerland Health Sciences Authority Singapore Bundesamt für Sicherheit im Gesundheitswesen (Federal Office for Safety in Health Care, BASG) Austria Federal Agency for Medicines and Health Products Belgium Pharmaceutical Services, Ministry of Health Cyprus Státní Ústav pro Kontrolu Léčiv (SÚKL) — State Institute for Drug Control — Institut national de contrôle des médicaments Czech Republic Laegemiddelsstyrelsen (Danish Health and Medicines Authority) Denmark State Agency of Medicines, Estonia (SAM) Estonia Lääkealan turvallisuus- ja kehittämiskeskus, Finnish Medicines Agency, Fimea Finland Agence nationale de sécurité du médicament et des produits de santé (ANSM) France Agence nationale du médicament vétérinaire France Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten Germany Bundesministerium für Gesundheit Germany Bundesamt für Verbraucherschutz und Lebensmittelsicherheit Germany National Organization for Medicines Greece Gyógyszerészeti és Egészségügyi Minőség - és Szervezetfejlesztési Intézet Országos Gyógyszerészeti Intézet Főigazgatósága (Short name: GYEMSZI-OGYI) National Institute for Quality and Organizational Development in Healthcare and Medicines (Institut national de pharmacie) [INP] Hungary State Agency of Medicines Latvia State Medicines Control Agency Lithuania Inspectie voor de Gezondheidszorg (IGZ) Health Care Inspectorate Netherlands Health Products Regulatory Authority (HPRA) Ireland Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Poland Main Pharmaceutical Inspectorate Poland Autoridade Nacional do Medicamento e Produtos de Saúde (INFARMED) — National Authority of Medicines and Health Products I.P. — Autorité nationale des médicaments et des produits de santé Portugal Italian Medicines Agency (AIFA) Italy Medicines Authority Malta National Medicines Agency Romania SIDC/State Institute For Drug Control Slovak Republic Agencija za zdravila in medicinske pripomočke — Agency for Medicinal Products and Medical Devices of the Republic of Slovenia Slovenia Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) — Spanish Agency of Medicines and Health Products — Agence Espagnole des Médicaments et des Produits de Santé Spain Medical Products Agency Sweden Medicines and Healthcare products Regulatory Agency (MHRA) United Kingdom Veterinary Medicines Directorate United Kingdom Lyfjastofnun/Icelandic Medicines Agency (IMA) Iceland Amt für Gesundheit (AG) Liechtenstein Norwegian Medicines Agency (NoMA) Norway Ministry of Agriculture, Forestry and Fisheries Japan Part B This table shows Part B of the list of Foreign Regulatory Authorities. Regulatory Authority Country The United States Food and Drug Administration United States of America The European Medicines Agency European Commission The Australian Therapeutic Goods Administration Australia Australian Pesticides and Veterinary Medicines Authority Australia Ministry of Primary Industries New Zealand Swiss Agency for Therapeutic Products Switzerland Health Sciences Authority Singapore Bundesamt für Sicherheit im Gesundheitswesen (Federal Office for Safety in Health Care, BASG) Austria Federal Agency for Medicines and Health Products Belgium Pharmaceutical Services, Ministry of Health Cyprus Státní Ústav pro Kontrolu Léčiv (SÚKL) — State Institute for Drug Control — Institut national de contrôle des médicaments Czech Republic Laegemiddelsstyrelsen (Danish Health and Medicines Authority) Denmark State Agency of Medicines, Estonia (SAM) Estonia Lääkealan turvallisuus- ja kehittämiskeskus, Finnish Medicines Agency, Fimea Finland Agence nationale de sécurité du médicament et des produits de santé (ANSM) France Agence nationale du médicament vétérinaire France Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten Germany Bundesministerium für Gesundheit Germany Bundesamt für Verbraucherschutz und Lebensmittelsicherheit Germany National Organization for Medicines Greece Gyógyszerészeti és Egészségügyi Minőség - és Szervezetfejlesztési Intézet Országos Gyógyszerészeti Intézet Főigazgatósága (Short name: GYEMSZI-OGYI) National Institute for Quality and Organizational Development in Healthcare and Medicines (Institut national de pharmacie) [INP] Hungary State Agency of Medicines Latvia State Medicines Control Agency Lithuania Inspectie voor de Gezondheidszorg (IGZ) Health Care Inspectorate Netherlands Health Products Regulatory Authority (HPRA) Ireland Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Poland Main Pharmaceutical Inspectorate Poland Autoridade Nacional do Medicamento e Produtos de Saúde (INFARMED) — National Authority of Medicines and Health Products I.P. — Autorité nationale des médicaments et des produits de santé Portugal Italian Medicines Agency (AIFA) Italy Medicines Authority Malta National Medicines Agency Romania SIDC/State Institute For Drug Control Slovak Republic Agencija za zdravila in medicinske pripomočke — Agency for Medicinal Products and Medical Devices of the Republic of Slovenia Slovenia Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) — Spanish Agency of Medicines and Health Products — Agence Espagnole des Médicaments et des Produits de Santé Spain Medical Products Agency Sweden Medicines and Healthcare products Regulatory Agency (MHRA) United Kingdom Veterinary Medicines Directorate United Kingdom Lyfjastofnun/Icelandic Medicines Agency (IMA) Iceland Amt für Gesundheit (AG) Liechtenstein Norwegian Medicines Agency (NoMA) Norway Ministry of Agriculture, Forestry and Fisheries Japan Part C This table shows Part C of the list of Foreign Regulatory Authorities. Regulatory Authority Country The United States Food and Drug Administration United States of America The European Medicines Agency European Commission The Australian Therapeutic Goods Administration Australia Australian Pesticides and Veterinary Medicines Authority Australia Ministry of Primary Industries New Zealand Swiss Agency for Therapeutic Products Switzerland Health Sciences Authority Singapore Bundesamt für Sicherheit im Gesundheitswesen (Federal Office for Safety in Health Care, BASG) Austria Federal Agency for Medicines and Health Products Belgium Pharmaceutical Services, Ministry of Health Cyprus Státní Ústav pro Kontrolu Léčiv (SÚKL) — State Institute for Drug Control — Institut national de contrôle des médicaments Czech Republic Laegemiddelsstyrelsen (Danish Health and Medicines Authority) Denmark State Agency of Medicines, Estonia (SAM) Estonia Lääkealan turvallisuus- ja kehittämiskeskus, Finnish Medicines Agency, Fimea Finland Agence nationale de sécurité du médicament et des produits de santé (ANSM) France Agence nationale du médicament vétérinaire France Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten Germany Bundesministerium für Gesundheit Germany Bundesamt für Verbraucherschutz und Lebensmittelsicherheit Germany National Organization for Medicines Greece Gyógyszerészeti és Egészségügyi Minőség - és Szervezetfejlesztési Intézet Országos Gyógyszerészeti Intézet Főigazgatósága (Short name: GYEMSZI-OGYI) National Institute for Quality and Organizational Development in Healthcare and Medicines (Institut national de pharmacie) [INP] Hungary State Agency of Medicines Latvia State Medicines Control Agency Lithuania Inspectie voor de Gezondheidszorg (IGZ) Health Care Inspectorate Netherlands Health Products Regulatory Authority (HPRA) Ireland Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Poland Main Pharmaceutical Inspectorate Poland Autoridade Nacional do Medicamento e Produtos de Saúde (INFARMED) — National Authority of Medicines and Health Products I.P. — Autorité nationale des médicaments et des produits de santé Portugal Italian Medicines Agency (AIFA) Italy Medicines Authority Malta National Medicines Agency Romania SIDC/State Institute For Drug Control Slovak Republic Agencija za zdravila in medicinske pripomočke — Agency for Medicinal Products and Medical Devices of the Republic of Slovenia Slovenia Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) — Spanish Agency of Medicines and Health Products — Agence Espagnole des Médicaments et des Produits de Santé Spain Medical Products Agency Sweden Medicines and Healthcare products Regulatory Agency (MHRA) United Kingdom Veterinary Medicines Directorate United Kingdom Lyfjastofnun/Icelandic Medicines Agency (IMA) Iceland Amt für Gesundheit (AG) Liechtenstein Norwegian Medicines Agency (NoMA) Norway Ministry of Agriculture, Forestry and Fisheries Japan PROPOSED REGULATORY TEXT Notice is given that the Governor in Council, pursuant to section 30 (see footnote a) of the Food and Drugs Act (see footnote b), proposes to make the annexed Regulations Amending the Food and Drug Regulations (Vanessa’s Law). Interested persons may make representations concerning the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Bruno Rodrigue, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health, Address Locator: 3105A, Holland Cross, Tower B, 5th Floor, 1600 Scott Street, Ottawa, Ontario K1A 0K9 (email: [email protected]). Ottawa, April 13, 2017 Jurica Čapkun Assistant Clerk of the Privy Council Regulations Amending the Food and Drug Regulations (Vanessa’s Law) Amendments 1 (1) The portion of subsection C.01.014.6(1) of the French version of the Food and Drug Regulations (see footnote 3) before paragraph (a) is replaced by the following: C.01.014.6 (1) Le Directeur annule l’identification numérique d’une drogue dans les cas suivants : (2) Paragraphs C.01.014.6(1)(a) and (b) of the Regulations are replaced by the following: (a) the person to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number advises under section C.01.014.7 that they discontinued the sale of the drug; or (3) Paragraph C.01.014.6(1)(c) of the Regulations is replaced by the following: (c) the Director determines that the product for which the drug identification number has been assigned is not a drug (4) The portion of subsection C.01.014.6(2) of the French version of the Regulations before paragraph (a) is replaced by the following: (2) Le Directeur peut annuler l’identification numérique d’une drogue dans les cas suivants : (5) Paragraphs C.01.014.6(2)(a) and (b) of the Regulations are replaced by the following: (a) the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number contravenes section C.01.014.5; or (b) the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number has been notified under section C.01.013 that the evidence that they submitted in respect of the drug is not sufficient; or (c) the drug is a new drug in respect of which the notice of compliance has been suspended under section C.08.006. (6) Section C.01.014.6 of the Regulations is amended by adding the following after subsection (2): (3) The Minister may cancel the assignment of the drug identification number for a drug if, after the Minister has, under section 21.31 of the Act, ordered the holder of a therapeutic product authorization referred to in subparagraph C.01.052(1)(b)(i) or (iii) in respect of a drug to conduct an assessment of the drug in order to provide evidence establishing that the benefits associated with the drug outweigh the risks of injury to health, (a) the holder fails to comply with the order; or (b) the holder complies with the order but the Minister determines that the results of the assessment are not sufficient to establish that the benefits associated with the drug outweigh the risks of injury to health. (4) For greater certainty, the Minister’s power under subsection (3) does not affect the Director’s power under paragraph 2(b) to cancel the assignment of a drug identification number. 2 The Regulations are amended by adding the following after section C.01.049: Information — Serious Risk of Injury to Human Health C.01.050 (1) This section applies to a holder of one or more of the following therapeutic product authorizations: (a) a drug identification number that has been assigned under subsection C.01.014.2(1); and (b) a notice of compliance that has been issued under section C.08.004 or C.08.004.01. (2) The holder of a therapeutic product authorization in respect of a drug that is part of a class of drugs set out in subsection (4) shall provide the Minister with information in respect of any serious risk of injury to human health that the holder receives or becomes aware of and that is relevant to the safety of the drug, regarding (a) risks that have been communicated by any foreign regulatory authority that is set out in Part A of the List of Foreign Regulatory Authorities for the Purposes of Section C.01.050 of the Food and Drug Regulations, published by the Government of Canada on its website, as amended from time to time, or by any person who is authorized to manufacture or sell a drug within the jurisdiction of such an authority, and the manner of the communication; (b) changes that have been made to the labelling of any drug and that have been communicated to or requested by any foreign regulatory authority that is set out in Part B of the list referred to in paragraph (a); and (c) recalls, reassessments and suspensions or revocations of authorizations, including licences, in respect of any drug, that have taken place within the jurisdiction of any foreign regulatory authority that is set out in Part C of the list referred to in paragraph (a). (3) The information shall be provided to the Minister within 48 hours after the holder receives or becomes aware of it, whichever occurs first. (4) The classes of drugs are (a) prescription drugs; and (b) drugs that are permitted to be sold without a prescription but that are administered only under the supervision of a practitioner. (5) In this section, foreign regulatory authority means a government agency or other entity outside Canada that has a legal right to control the manufacturing, use or sale of drugs within its jurisdiction and that may take enforcement action to ensure that drugs marketed within its jurisdiction comply with the applicable legal requirements. 3 The Regulations are amended by adding the following after section C.01.051: Assessments Ordered under Section 21.31 of the Act C.01.052 (1) The Minister’s power to make an order under section 21.31 of the Act is subject to the following conditions: (a) the order must relate to a drug; (b) the person to whom the order is made must be the holder of one or more of the following therapeutic product authorizations in respect of the drug: (i) a drug identification number that has been assigned under subsection C.01.014.2(1), (ii) an establishment licence that has been issued under subsection C.01A.008(1), and (iii) a notice of compliance that has been issued under section C.08.004 or C.08.004.01; and (c) the Minister must have reasonable grounds to believe that (i) in the case of a holder of a therapeutic product authorization referred to in subparagraph (b)(i) or (iii), the benefits or risks of injury to health associated with the drug are significantly different than they were when the authorization was issued, (ii) in the case of a holder of an establishment licence who is an importer, the manner in which the drug is imported, or the manner in which the drug is fabricated, packaged/labelled or tested outside Canada, may present a risk of injury to health associated with the drug, or (iii) in the case of a holder of an establishment licence other than an importer, the manner in which the holder conducts an activity that is authorized under the licence may present a risk of injury to health associated with the drug. (2) The Minister shall, after examining the results of an assessment that was ordered under section 21.31 of the Act, (a) provide the holder of the therapeutic product authorization with the results of the examination; and (b) ensure that a summary of the results of the examination, together with a description of any steps that the Minister has taken or may take as a consequence of the examination, is published on the Government of Canada website. Activities Ordered under Section 21.32 of the Act C.01.053 The Minister’s power to make an order under section 21.32 of the Act is subject to the following conditions: (a) the order must relate to a drug; (b) the person to whom the order is made must be the holder of one or more of the following therapeutic product authorizations in respect of the drug: (i) a drug identification number that has been assigned under subsection C.01.014.2(1), (ii) an establishment licence that has been issued under subsection C.01A.008(1), and (iii) a notice of compliance that has been issued under section C.08.004 or C.08.004.01; (c) the Minister must have reasonable grounds to believe that (i) in the case of a holder of a therapeutic product authorization referred to in subparagraph (b)(i) or (iii), there are significant uncertainties relating to the benefits or harms associated with the drug, (ii) in the case of a holder of an establishment licence, the manner in which the holder conducts an activity that is authorized under the licence has introduced significant uncertainties relating to the benefits or harms associated with the drug, (iii) the holder of the therapeutic product authorization is unable to provide the Minister with information that is sufficient to manage those uncertainties, and (iv) the applicable requirements of these Regulations, together with any terms and conditions that have been imposed on the authorization, do not allow for sufficient information to be obtained to manage those uncertainties; and (d) the Minister must take into account the following matters: (i) whether the activities that the holder of the therapeutic product authorization will be ordered to undertake are feasible, and (ii) whether there are less burdensome ways of obtaining additional information about the drug’s effects on health or safety. 4 (1) The portion of subsection C.01A.016(1) of the Regulations before paragraph (a) is replaced by the following: C.01A.016 (1) The Minister may suspend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) if the Minister has reasonable grounds to believe that (2) Paragraphs C.01A.016(1)(a) and (b) of the French version of the Regulations are replaced by the following: a) soit le titulaire de la licence a contrevenu à toute disposition de la Loi ou du présent règlement; b) soit le titulaire de la licence a fait une déclaration fausse ou trompeuse dans sa demande de licence. (3) The portion of subsection C.01A.016(3) of the Regulations before paragraph (a) is replaced by the following: (3) The Minister shall not suspend an establishment licence until 5 Subsection C.01A.017(1) of the Regulations is replaced by the following: C.01A.017 (1) The Minister may suspend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) without giving the licensee an opportunity to be heard if it is necessary to do so to prevent a risk to the health of the consumer, by giving the licensee a notice in writing that states the reason for the suspension. 6 Section C.01A.018 of the Regulations is replaced by the following: C.01A.017.1 The Minister may suspend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) if, after the Minister has, under section 21.31 of the Act, ordered the licensee to conduct an assessment in order to provide evidence establishing that the licensee’s buildings, equipment or practices and procedures, as the case may be, continue to meet the requirements referred to in paragraph C.01A.005(l), subparagraph C.01A.005(m)(ii) or (iii) or paragraph C.01A.005(o), (a) the licensee fails to comply with the order; or (b) the licensee complies with the order but the Minister determines that the results of the assessment are not sufficient to establish that those requirements continue to be met. C.01A.018 The Minister shall reinstate an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) that are the subject of the suspension if, within 12 months after the effective date of the suspension, the licensee provides the Minister with information demonstrating that (a) the situation on which the suspension was based has been corrected; or (b) the situation on which the suspension was based did not exist. 7 Section C.01A.018.1 of the Regulations is replaced by the following: C.01A.018.1 The Minister shall cancel an establishment licence if the licensee has failed to submit an application for the review of the licence in accordance with subsection C.01A.009(1). C.01A.018.2 (1) If the Minister has suspended an establishment licence in respect of all matters indicated in subsection C.01A.008(2) and the suspension is still in effect 12 months after the effective date of the suspension, the Minister shall cancel the licence. (2) If the Minister has suspended an establishment licence in respect of one or more of the matters indicated in subsection C.01A.008(2) and the suspension is still in effect 12 months after the effective date of the suspension, the Minister shall cancel the licence only in respect of the matters that are the subject of the suspension. 8 (1) Paragraph C.08.005.1(1)(a) of the Regulations is repealed. (2) Subsection C.08.005.1(5) of the Regulations is repealed. 9 (1) Subsection C.08.006(1) of the Regulations is replaced by the following: C.08.006 (1) For the purposes of subsection (2), evidence or new information obtained by the Minister includes any information or material filed by any person under Division 5 or section C.08.002, C.08.002.01, C.08.002.1, C.08.003, C.08.005 or C.08.005.1. (2) Section C.08.006 of the Regulations is amended by adding the following after subsection (2): (3) The Minister may, by notice to a manufacturer, suspend for a definite or indefinite period a notice of compliance issued to that manufacturer in respect of a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission, an abbreviated extraordinary use new drug submission or a supplement to any of those submissions, relating to a drug if, after the Minister has, under section 21.31 of the Act, ordered the holder of a therapeutic product authorization referred to in subparagraph C.01.052(1)(b)(iii) in respect of the drug to conduct an assessment of the drug in order to provide evidence establishing that the benefits associated with the drug outweigh the risks of injury to health, (a) the holder fails to comply with the order; or (b) the holder complies with the order but the Minister determines that the results of the assessment are not sufficient to establish that the benefits associated with the drug outweigh the risks of injury to health. 10 Paragraph C.08.008(c) of the Regulations is replaced by the following: (c) a summary of a record respecting any information referred to in paragraph C.08.007(1)(g) or (h), within 15 days after the day on which the manufacturer established the record. Coming into Force 11 These Regulations come into force on the day on which subsection 6(2) of the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law), chapter 24 of the Statutes of Canada, 2014, come into force, but if they are registered after that day, they come into force on the day on which they are registered. [16-1-o] Footnote 1 NAPRA Schedule II Factors are available at http://napra.ca/Content_Files/Files/NDSAC-Sched-Factors-Sched2.pdf. Footnote 2 Stakeholder input from BIOTECanada and Rx&D. Footnote a S.C. 2016, c. 9, s. 8 Footnote b R.S., c. F-27 Footnote 3 C.R.C., c. 870

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