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This document is cialis 20mg price usa unpublished. It is scheduled to be published on 09/16/2021. Once cialis 20mg price usa it is published it will be available on this page in an official form. Until then, you can download the unpublished PDF version.

Although we make a concerted effort to reproduce the original document in full on our Public Inspection pages, in some cases graphics may not be displayed, and non-substantive markup language may appear alongside substantive text. If you are cialis 20mg price usa using public inspection listings for legal research, you should verify the contents of documents against a final, official edition of the Federal Register. Only official editions of the Federal Register provide legal notice to the public and judicial notice to the courts under 44 U.S.C. 1503 &.

1507. Learn more here.Start Preamble Centers for Medicare &. Medicaid Services (CMS), HHS. Continuation of effectiveness and extension of timeline for publication of the final rule.

This document announces the continuation of, effectiveness of, and the extension of the timeline for publication of a final rule. We are issuing this document in accordance with the Social Security Act (the Act), which allows an interim final rule to remain in effect after the expiration of the timeline specified in the Act if the Secretary publishes a notice of continuation explaining why we did not comply with the regular publication timeline. Effective September 3, 2021, the Medicare provisions adopted in the interim final rule published on September 6, 2016 (81 FR 61538) continue in effect and the regular timeline for publication of the final rule is extended for an additional year, until September 6, 2022. Start Further Info Steve Forry (410) 786-1564 or Jaqueline Cipa (410) 786-3259.

End Further Info End Preamble Start Supplemental Information Section 1871(a) of the Social Security Act (the Act) sets forth certain procedures for promulgating regulations necessary to carry out the administration of the insurance programs under Title XVIII of the Act. Section 1871(a)(3)(A) of the Act requires the Secretary, in consultation with the Director of the Office of Management and Budget (OMB), to establish a regular timeline for the publication of final regulations based on the previous publication of a proposed rule or an interim final rule. In accordance with section 1871(a)(3)(B) of the Act, such timeline may vary among different rules, based on the complexity of the rule, the number and scope of the comments received, and other relevant factors. However, the timeline for publishing the final rule, cannot exceed 3 years from the date of publication of the proposed or interim final rule, unless there are exceptional circumstances.

After consultation with the Director of OMB, the Secretary published a notice, which appeared in the December 30, 2004 Federal Register on (69 FR 78442), establishing a general 3-year timeline for publishing Medicare final rules after the publication of a proposed or interim final rule. Section 1871(a)(3)(C) of the Act states that upon expiration of the regular timeline for the publication of a final regulation after opportunity for public comment, a Medicare interim final rule shall not continue in effect unless the Secretary publishes a notice of continuation of the regulation that includes an explanation of why the regular timeline was not met. Upon publication of such notice, the regular timeline for publication of the final regulation is treated as having been extended for 1 additional year. On September 6, 2016 Federal Register (81 FR 61538), the Department of Health and Human Services (HHS) issued a department-wide interim final rule titled “Adjustment of Civil Monetary Penalties for Inflation” that established new regulations at 45 CFR part 102 to adjust for inflation the maximum civil monetary penalty amounts for the various civil monetary penalty authorities for all agencies within the Department.

HHS took this action to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990 (the Inflation Adjustment Act) (28 U.S.C. 2461 note 2(a)), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (section 701 of the Bipartisan Budget Act of 2015, (Pub. L. 114-74), enacted on November 2, 2015).

In addition, this September 2016 interim final rule included updates to certain agency-specific regulations to reflect the new provisions governing the adjustment of civil monetary penalties for inflation in 45 CFR part 102. One of the purposes of the Inflation Adjustment Act (see section 2(b)(1)) was to create a mechanism to allow for regular inflationary adjustments to federal civil monetary penalties. The 2015 amendments removed an inflation update exclusion that previously applied to the Social Security Act as well as to the Occupational Safety and Health Act. The 2015 amendments also “reset” the inflation calculations by excluding prior inflationary adjustments under the Inflation Adjustment Act and requiring agencies to identify, for each penalty, the year and corresponding amount(s) for which the maximum penalty level or range of minimum and maximum penalties was established (that is, originally enacted by Congress) or last adjusted other than pursuant to the Inflation Adjustment Act.

In accordance with section 4 of the Inflation Adjustment Act, agencies were required to. (1) Adjust the level of civil monetary penalties with an initial “catch-up” adjustment through an interim final rulemaking (IFR) to take effect by August 1, 2016. And (2) make subsequent annual adjustments for inflation. In the September 2016 interim final rule, HHS adopted new regulations at 45 CFR part 102 to govern adjustment of civil monetary penalties for inflation.

The regulation at 45 CFR 102.1 provides that part 102 applies to each statutory provision under the laws administered by HHS concerning civil monetary penalties, and that the regulations in part 102 supersede existing HHS regulations setting forth civil monetary penalty amounts. The civil money penalties and the adjusted penalty amounts administered by all HHS agencies are listed in tabular form in 45 CFR 102.3. In addition to codifying the adjusted penalty amounts identified in § 102.3, the HHS-wide interim final rule included several technical conforming updates to certain agency-specific regulations, including various CMS regulations, to identify their updated information, and incorporate a cross-reference to the location of HHS-wide regulations. Because the conforming changes to the Medicare provisions were part of a larger, omnibus departmental interim final rule, we inadvertently missed setting a target date for publication of the final rule to make permanent the conforming changes to the Medicare regulations in accordance with section 1871(a)(3)(A) of the Act and the procedures outlined in the December 2004 notice.

Therefore, in the January 2, 2020 Federal Register (85 FR 7), we published a document continuing the effectiveness of the interim final rule for an additional year, until September 6, 2020. On January 31, 2020, pursuant to section 319 of the Public Health Service Act (PHSA), the Secretary determined that a Public Health Emergency (PHE) exists for the United States to aid the Start Printed Page 50264nation's healthcare community in responding to erectile dysfunction treatment. On March 11, 2020, the World Health Organization (WHO) publicly declared erectile dysfunction treatment a cialis. On March 13, 2020, the President declared the erectile dysfunction treatment cialis a national emergency.

This declaration, along with the Secretary's January 31, 2020 declaration of a PHE, conferred on the Secretary certain waiver authorities under section 1135 of the Act. On March 13, 2020, the Secretary authorized waivers under section 1135 of the Act, effective March 1, 2020.[] Effective July 20, 2021, the Secretary renewed the January 31, 2020 determination that was previously renewed on April 21, 2020, July 23, 2020, October 2, 2020, January 7, 2021, April 15, 2021, and July 19, 2021, that a PHE exists and has existed since January 27, 2020. The unprecedented nature of this national emergency has placed enormous responsibilities upon CMS to respond appropriately, and resources have had to be re-allocated throughout the agency in order to be responsive. Due to the PHE and in accordance with section 1871(a)(3)(C) of the Act, on September 8, 2020 (85 FR 55385), we published a second document continuing the effectiveness of effect and the regular timeline for publication of the final rule for an additional year, until September 6, 2021.

Because of CMS's continued efforts to address resource challenges resulting from the PHE and consistent with section 1871(a)(3)(C) of the Act, we are publishing a third notice of continuation extending the effectiveness of the technical conforming changes to the Medicare regulations that were implemented through interim final rule and to allow time to publish a final rule. Therefore, the Medicare provisions adopted in interim final regulation continue in effect and the regular timeline for publication of the final rule is extended for an additional year, until September 6, 2022. Start Signature Karuna Seshasai, Executive Secretary to the Department, Department of Health and Human Services. End Signature End Supplemental Information [FR Doc.

2021-19382 Filed 9-3-21. 11:15 am]BILLING CODE 4120-01-P.

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Challengers in climate change lawsuits are failing to cheap generic cialis use the latest science on global warming to bolster their legal claims, a new study has found. The research published yesterday in the journal Nature Climate Change shows how scientific studies could support climate litigation against companies and governments in courtrooms around the world. €œWe found that the scientific evidence provided in these cases lagged substantially behind the state of the art in climate science—in particular, the evidence provided on the link between greenhouse gas cheap generic cialis emissions and specific injuries that plaintiffs allege they suffered as a result of climate change,” said Rupert Stuart-Smith, lead author of the study and a Ph.D.

Candidate at the University of Oxford. The paper focused on attribution science, a burgeoning field of research that examines whether—and how much—climate change contributes to extreme weather events. In recent years, attribution studies have found that human-caused global cheap generic cialis warming increased drought risk in California, boosted extreme rainfall during Hurricane Harvey and likely doubled the risk of a European heat wave, among other things.

These findings could help strengthen the legal claims of states and municipalities that are suing oil and gas companies over their role in causing climate change and its effects, including flooding, wildfires and sea-level rise. The evidence could also fortify the legal arguments of climate activists who are suing governments over their alleged inaction on global warming, including in the United States and Europe. But according to the paper, which assessed 73 lawsuits across 14 jurisdictions, 73% cheap generic cialis of cases failed to cite peer-reviewed scientific evidence linking the challengers’ injuries with the greenhouse gas emissions of companies or countries.

In addition, 26 lawsuits asserted that climate change had caused extreme weather events without providing any evidence to back up this claim. €œScience is not the only problem—there are substantial procedural obstacles that still need to be overcome for these cases to be successful,” Stuart-Smith cheap generic cialis said. €œBut the scientific evidence used has been insufficient to establish causation so far.” A potential ‘game changer’ The paper cites the 2008 case Kivalina v.

Exxon Mobil Corp., in which the Alaskan village of Kivalina sued 24 energy companies over their alleged contribution to loss of sea ice and coastal erosion, which forced the village to be relocated inland. The 9th cheap generic cialis U.S. Circuit Court of Appeals ultimately dismissed Kivalina, finding that the challengers had failed to demonstrate that the companies were responsible for the climate impacts.

Stuart-Smith said scientific evidence linking the companies’ emissions to the climate impacts could cheap generic cialis have been a “game changer” in the case. Such a study has not been conducted, although other attribution studies have linked fossil fuel companies’ emissions to ocean acidification and sea-level rise. Kivalina was part of the first wave of climate litigation in the United States in the mid-2000s.

Since 2017, five states and more cheap generic cialis than a dozen municipalities have launched a second wave of climate litigation against oil and gas companies. The suits are currently tied up in procedural wrangling over whether they belong in state or federal court. In addition, a group of 21 young people sued the U.S.

Government in 2015 over its promotion cheap generic cialis of fossil fuels. The challengers in Juliana v. United States are now asking a federal judge in Oregon to narrow the scope of their original complaint (Climatewire, June 28).

Fossil fuel industry attacks Groups tied to the fossil fuel industry have launched a preemptive attack on attribution science before it can cheap generic cialis be used in the courtroom against companies or countries (Climatewire, April 16). The groups have repeatedly argued that the authors of attribution studies aren’t impartial scientists—rather, they’re climate activists who are biased against the fossil fuel industry. Chief among these cheap generic cialis groups is Energy in Depth, a research and outreach campaign run by the Independent Petroleum Association of America, a trade association for independent oil and gas producers.

In an April piece about a recent E&E News article, William Allison, a spokesman for Energy in Depth and senior director at FTI Consulting, questioned the objectivity of Friederike Otto, a climate expert at the University of Oxford and a co-author of the paper released yesterday. Allison contended that Otto and her colleagues had conducted attribution studies “specifically to support lawsuits against major energy companies.” Asked for comment, Allison said in an email to E&E News yesterday that the paper authors appeared biased because they received funding from the Foundation for International Law for the Environment, which seeks to “accelerate legal action globally to address the climate and nature crises,” according to its website. €œClimate attribution science cheap generic cialis has long been called suspect even by supporters of climate litigation,” Allison said.

€œWhat is surprising, however, is that wealthy financers of climate litigation would bankroll a report confirming the limitations of their paid-for science that further undercuts their case in court.” In an email to E&E News, Otto strongly pushed back on these allegations. €œThere is nothing shady about [attribution science]. The methods cheap generic cialis we use are all published many times over and are freely available.

The same is true for the data,” Otto said. €œEverything we cheap generic cialis publish is open access. All the data is easily accessible.

We work really hard to make everything as transparent as possible,” she added. €œIf that’s your definition of corruption I am afraid cheap generic cialis you have to go back to the dictionary.” Reprinted from E&E News with permission from POLITICO, LLC. Copyright 2021.

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Challengers in climate change lawsuits are failing to use the latest science on cialis 20mg price usa global warming to http://cz.keimfarben.de/best-online-cipro/ bolster their legal claims, a new study has found. The research published yesterday in the journal Nature Climate Change shows how scientific studies could support climate litigation against companies and governments in courtrooms around the world. €œWe found that the scientific evidence provided in these cases lagged substantially behind the state of the art in climate science—in particular, the evidence provided on the link between greenhouse gas emissions and specific injuries that plaintiffs cialis 20mg price usa allege they suffered as a result of climate change,” said Rupert Stuart-Smith, lead author of the study and a Ph.D. Candidate at the University of Oxford.

The paper focused on attribution science, a burgeoning field of research that examines whether—and how much—climate change contributes to extreme weather events. In recent years, attribution studies have found that cialis 20mg price usa human-caused global warming increased drought risk in California, boosted extreme rainfall during Hurricane Harvey and likely doubled the risk of a European heat wave, among other things. These findings could help strengthen the legal claims of states and municipalities that are suing oil and gas companies over their role in causing climate change and its effects, including flooding, wildfires and sea-level rise. The evidence could also fortify the legal arguments of climate activists who are suing governments over their alleged inaction on global warming, including in the United States and Europe.

But according to the paper, which assessed 73 lawsuits across 14 jurisdictions, 73% of cases failed to cite peer-reviewed scientific evidence linking cialis 20mg price usa the challengers’ injuries with the greenhouse gas emissions of companies or countries. In addition, 26 lawsuits asserted that climate change had caused extreme weather events without providing any evidence to back up this claim. €œScience is not the only problem—there are cialis 20mg price usa substantial procedural obstacles that still need to be overcome for these cases to be successful,” Stuart-Smith said. €œBut the scientific evidence used has been insufficient to establish causation so far.” A potential ‘game changer’ The paper cites the 2008 case Kivalina v.

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Such a study has not been conducted, although other attribution studies have linked fossil fuel companies’ emissions to ocean acidification and sea-level rise. Kivalina was part of the first wave of climate litigation in the United States in the mid-2000s. Since 2017, five states and more than a dozen municipalities have launched cialis 20mg price usa a second wave of climate litigation against oil and gas companies. The suits are currently tied up in procedural wrangling over whether they belong in state or federal court.

In addition, a group of 21 young people sued the U.S. Government in 2015 over its promotion of fossil cialis 20mg price usa fuels. The challengers in Juliana v. United States are now asking a federal judge in Oregon to narrow the scope of their original complaint (Climatewire, June 28).

Fossil fuel industry attacks Groups tied to the fossil fuel industry cialis 20mg price usa have launched a preemptive attack on attribution science before it can be used in the courtroom against companies or countries (Climatewire, April 16). The groups have repeatedly argued that the authors of attribution studies aren’t impartial scientists—rather, they’re climate activists who are biased against the fossil fuel industry. Chief among these groups is cialis 20mg price usa Energy in Depth, a research and outreach campaign run by the Independent Petroleum Association of America, a trade association for independent oil and gas producers. In an April piece about a recent E&E News article, William Allison, a spokesman for Energy in Depth and senior director at FTI Consulting, questioned the objectivity of Friederike Otto, a climate expert at the University of Oxford and a co-author of the paper released yesterday.

Allison contended that Otto and her colleagues had conducted attribution studies “specifically to support lawsuits against major energy companies.” Asked for comment, Allison said in an email to E&E News yesterday that the paper authors appeared biased because they received funding from the Foundation for International Law for the Environment, which seeks to “accelerate legal action globally to address the climate and nature crises,” according to its website. €œClimate attribution science has long been called suspect even by supporters of climate cialis 20mg price usa litigation,” Allison said. €œWhat is surprising, however, is that wealthy financers of climate litigation would bankroll a report confirming the limitations of their paid-for science that further undercuts their case in court.” In an email to E&E News, Otto strongly pushed back on these allegations. €œThere is nothing shady about [attribution science].

The methods we use are all published many times cialis 20mg price usa over and are freely available. The same is true for the data,” Otto said. €œEverything we publish is open access cialis 20mg price usa. All the data is easily accessible.

We work really hard to make everything as transparent as possible,” she added. €œIf that’s your definition of corruption I am afraid you have to go back to the cialis 20mg price usa dictionary.” Reprinted from E&E News with permission from POLITICO, LLC. Copyright 2021. E&E News provides essential news for energy and environment professionals..

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€œOur efforts for improvement results in better outcomes for our patients which shows by our improving Leapfrog performance.”Developed under the guidance of a national Expert Panel, the Leapfrog Hospital Safety Grade uses up to 27 measures of publicly available hospital safety data to assign grades to more than 2,700 U.S. Acute-care hospitals twice per year. The Hospital Safety Grade’s methodology is peer-reviewed and fully transparent, and the results are free to the public.Those interested in viewing the full grades may visit www.hospitalsafetygrade.org.

About The Leapfrog GroupFounded in 2000 by large employers and other purchasers, The Leapfrog Group is a national nonprofit organization driving a movement for giant leaps forward in the quality and safety of American health care. The flagship Leapfrog Hospital Survey and new Leapfrog Ambulatory Surgery Center (ASC) Survey collect and transparently report hospital and ASC performance, empowering purchasers to find the highest-value care and giving consumers the lifesaving information they need to make informed decisions. The Leapfrog Hospital Safety Grade, Leapfrog’s other main initiative, assigns letter grades to hospitals based on their record of patient safety, helping consumers protect themselves and their families from errors, injuries, accidents, and s..

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However, it whats cialis has now been published.Coming into forceThe post-market surveillance regulations amending the Medical Devices Regulations were published in the Canada Gazette, Part II (CGII) on December 23, 2020. The various provisions under the regulations are coming into force as follows. Amending whats cialis Regulations Coming into Force Date Note Summary Reports (Medical Device Regulations) First anniversary after publication in CGII December 23, 2021 Relates to Summary Report provisions under sections 61.4, 61.5 and 61.6 Other amendments to the Medical Devices Regulations Six months after publication in CGII June 23, 2021 Excludes sections related to Summary Report provisions under sections 61.4, 61.5 and 61.6 Guidance documentsWe have prepared and updated 4 guidance documents.

We’ll be releasing and publishing these guidance documents in the weeks following publication of the amending regulations in Canada Gazette, Part II. The guidance documents whats cialis are for. Incident reporting for medical devices foreign risk notification for medical devices summary reports and issue-related analyses of safety and effectiveness for medical devices guide to new authorities on the amendments to include power to require assessments and power to require tests and studiesNote.

To inform us of notifiable actions under foreign risk notification requirements for medical devices, industry will be using an whats cialis electronic form. We will make this form available on Canada.ca in the coming months. You can whats cialis find information on what’s required in the form in the Guidance Document for Foreign Risk Notification for Medical Devices.Contact usIf you have questions about this notice, please contact:Medical Devices DirectorateHealth Products and Food Branch11 Holland Avenue, Tower AAddress Locator 3002AE-mail.

Hc.meddevices-instrumentsmed.sc@canada.caTelephone. 613-957-4786Facsimile. 613-957-6345Teletypewriter.

1-800-465-7735 (Service Canada)Therapeutic Goods Administration (TGA) Australia Austrian Agency for Health and Food Safety (AGES) Austria Federal Agency for Medicines and Health Products (FAMHP) Belgium National Health Surveillance Agency (ANVISA) Brazil Bulgarian Drug Agency Bulgaria National Medical Products Administration China Agency for Medicinal Products and Medical Devices of Croatia (HALMED) Croatia Cyprus Medical Devices Competent Authority Cyprus State Institute for Drug Control Czechia Danish Medicines Agency Denmark Health Board, Medical Devices Department Estonia Finnish Medicines Agency (FIMEA) Finland National Agency for the Safety of Medicine and Health Products (ANSM) France Federal Institute for Drugs and Medical Devices (BfArM) Germany National Organization for Medicines (EOF) Greece National Institute of Pharmacy and Nutrition (OGYEI) Hungary Health Products Regulatory Authority (HPRA) Ireland Medical Devices and Active Implantable Medical Devices, Ministry of Health Italy Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW) Japan Ministry of Health of the Republic of Latvia- Health Inspectorate Latvia State Health Care Accreditation Agency (VASPVT) Lithuania State Health Care Agency, Ministry of Health Luxembourg Malta Competition and Consumer Affairs Authority (MCCAA) Malta Federal Commission for Protection Against Sanitary Risk (COFEPRIS) Mexico Healthcare and Youth Care Inspectorate (IGZ) Netherlands Medicines and Medical Devices Safety Authority (MEDSAFE) New Zealand Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Poland National Authority of Medicines and Health Products (INFARMED) Portugal National Agency for Medicines and Medical Devices (NAMMDR) Romania Russian Ministry of Health Russia Health Sciences Authority (HSA) Singapore State Institute for Drug Control (SIDC) Slovak Republic Agency for Medicinal Products and Medical Devices of the Republic (JAZMP) Slovenia Ministry of Food and Drug Safety South Korea Spanish Agency for Medicines and Health Products (AEMPS) Spain Medical Products Agency (MPA) Sweden Swiss Agency for Therapeutic Products (Swissmedic) Switzerland Medicines and Healthcare Products Regulatory Agency (MHRA) United Kingdom United States Food and Drug Administration (US FDA) United States of America.

On this page Changes to cialis 20mg price usa the regulationsHealth Canada is making regulatory changes to the Medical Devices Regulations to strengthen the lifecycle approach to the regulation try this out of medical devices by increasing post-market surveillance authorities. With these amendments, we have implemented certain powers included in Vanessa’s Law and additional measures to improve post-market surveillance of medical devices. Together these will help to reduce the risk of medical devices and improve their safety, quality and effectiveness.The post-market surveillance regulations amending the Medical Devices Regulations will improve our ability to identify, assess and manage new risks for medical devices used in Canada.Consultations and publicationIn the spring of 2018, Health Canada published a cialis 20mg price usa notice on our intent to strengthen the post-market surveillance and risk management of medical devices in Canada. We consulted with manufacturers and importers of medical devices on the proposed regulatory changes and related guidance documents.The proposed regulations were published in Canada Gazette, Part I, on June 15, 2019. Stakeholders had 70 days cialis 20mg price usa within which to comment.

We also made available guidance documents for comment.In June 2020, Health Canada advised that this regulatory initiative had been delayed due to the erectile dysfunction treatment cialis. However, it has now been published.Coming into forceThe post-market surveillance regulations amending the Medical Devices Regulations were published in the Canada Gazette, Part II cialis 20mg price usa (CGII) on December 23, 2020. The various provisions under the regulations are coming into force as follows. Amending Regulations Coming into Force Date Note Summary Reports (Medical Device Regulations) First anniversary after publication in CGII December 23, 2021 Relates to Summary Report provisions under sections 61.4, 61.5 and 61.6 Other amendments to the Medical Devices Regulations Six cialis 20mg price usa months after publication in CGII June 23, 2021 Excludes sections related to Summary Report provisions under sections 61.4, 61.5 and 61.6 Guidance documentsWe have prepared and updated 4 guidance documents. We’ll be releasing and publishing these guidance documents in the weeks following publication of the amending regulations in Canada Gazette, Part II.

The guidance documents are cialis 20mg price usa for. Incident reporting for medical devices foreign risk notification for medical devices summary reports and issue-related analyses of safety and effectiveness for medical devices guide to new authorities on the amendments to include power to require assessments and power to require tests and studiesNote. To inform us of notifiable actions under foreign cialis 20mg price usa risk notification requirements for medical devices, industry will be using an electronic form. We will make this form available on Canada.ca in the coming months. You can find information on what’s required in cialis 20mg price usa the form in the Guidance Document for Foreign Risk Notification for Medical Devices.Contact usIf you have questions about this notice, please contact:Medical Devices DirectorateHealth Products and Food Branch11 Holland Avenue, Tower AAddress Locator 3002AE-mail.

Hc.meddevices-instrumentsmed.sc@canada.caTelephone. 613-957-4786Facsimile. 613-957-6345Teletypewriter. 1-800-465-7735 (Service Canada)Therapeutic Goods Administration (TGA) Australia Austrian Agency for Health and Food Safety (AGES) Austria Federal Agency for Medicines and Health Products (FAMHP) Belgium National Health Surveillance Agency (ANVISA) Brazil Bulgarian Drug Agency Bulgaria National Medical Products Administration China Agency for Medicinal Products and Medical Devices of Croatia (HALMED) Croatia Cyprus Medical Devices Competent Authority Cyprus State Institute for Drug Control Czechia Danish Medicines Agency Denmark Health Board, Medical Devices Department Estonia Finnish Medicines Agency (FIMEA) Finland National Agency for the Safety of Medicine and Health Products (ANSM) France Federal Institute for Drugs and Medical Devices (BfArM) Germany National Organization for Medicines (EOF) Greece National Institute of Pharmacy and Nutrition (OGYEI) Hungary Health Products Regulatory Authority (HPRA) Ireland Medical Devices and Active Implantable Medical Devices, Ministry of Health Italy Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW) Japan Ministry of Health of the Republic of Latvia- Health Inspectorate Latvia State Health Care Accreditation Agency (VASPVT) Lithuania State Health Care Agency, Ministry of Health Luxembourg Malta Competition and Consumer Affairs Authority (MCCAA) Malta Federal Commission for Protection Against Sanitary Risk (COFEPRIS) Mexico Healthcare and Youth Care Inspectorate (IGZ) Netherlands Medicines and Medical Devices Safety Authority (MEDSAFE) New Zealand Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Poland National Authority of Medicines and Health Products (INFARMED) Portugal National Agency for Medicines and Medical Devices (NAMMDR) Romania Russian Ministry of Health Russia Health Sciences Authority (HSA) Singapore State Institute for Drug Control (SIDC) Slovak Republic Agency for Medicinal Products and Medical Devices of the Republic (JAZMP) Slovenia Ministry of Food and Drug Safety South Korea Spanish Agency for Medicines and Health Products (AEMPS) Spain Medical Products Agency (MPA) Sweden Swiss Agency for Therapeutic Products (Swissmedic) Switzerland Medicines and Healthcare Products Regulatory Agency (MHRA) United Kingdom United States Food and Drug Administration (US FDA) United States of America.

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