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NSW will take its first steps towards reopening as the State passes the 70 per cent double vaccination target.With the first vaccination milestone being reached, the NSW Government is also easing a number of restrictions as part of the Reopening NSW roadmap, which will allow fully vaccinated adults to enjoy more freedoms from next Monday, October 11.The changes to the 70 per cent roadmap will allow up to 10 visitors (not counting children 12 and benefits of taking viagra daily under) to a home (previously five), lift the cap on outdoor gatherings to how to get viagra in the us 30 people (previously 20), and increase the cap for weddings and funerals to 100 people (previously 50). Indoor pools will also be re-opened for swimming lessons, squad training, lap swimming, and rehab activities. On the Monday after the State clears the 80 per cent double vaccination hurdle further restrictions will be relaxed, with people able to have up to 20 visitors (excluding children 12 and under) to a home (previously 10), how to get viagra in the us and up to 50 people will be allowed to gather outdoors (previously 20). Up to 3,000 people will be allowed to attend controlled and ticketed outdoor events (previously 500), nightclubs will be permitted to reopen for seated drinking only (no dancing), and masks will no longer be required in office buildings. All roadmap freedoms at 70 and 80 per cent will continue to be for fully vaccinated people only.All school students will also now return to on site learning with a range of erectile dysfunction treatment-safe measures in place by October 25, with the second and third stages of how to get viagra in the us the return to school plan now combined.

Kindergarten, Year 1 and Year 12 students will still return to face-to-face learning on October 18, with all other years now returning one week later on October 25. Premier Dominic Perrottet said the common-sense changes would help life return to how to get viagra in the us normal as soon as possible. €œVaccinations are the key to life returning to normal and the changes today will help family and friends reconnect, get kids back to school and get businesses back up and running sooner,” Mr Perrottet said.“NSW is putting in the hard yards and it’s important people continue to turn out in droves to be vaccinated.”Deputy Premier Paul Toole said workers in regional areas who have received one vaccination dose will be permitted to return to their workplace from October 11 and will be given a grace period until November 1 to receive their second dose. Regional areas are those outside Greater Sydney, the Blue Mountains, Wollongong, Shellharbour and how to get viagra in the us the Central Coast. €œThis move ensures we get businesses in the regions re-open and local economies buzzing again.

It's about ensuring we make this a roadmap that works for everyone,” Mr Toole said.Minister for Jobs, Investment, Tourism and Western Sydney Stuart Ayres said these changes would help get more people back into work, especially in Western Sydney.“We’re on the road back to normal and most importantly reaching how to get viagra in the us these vaccination targets means people can reunite with family and friends, celebrate key moments in their lives and businesses can open their doors and get back to work in a safe way,” Mr Ayres said. Health Minister Brad Hazzard said NSW residents 12-years-old and over have led the charge to get vaccinated and ensure NSW is among the safest places in the world.“Getting to 70 per cent double dose is a badge of honour for every fully vaccinated NSW citizen to wear proudly but we can do so much more and 90 per cent is within our grasp,” Mr Hazzard said.Minister for Education and Early Childhood Learning Sarah Mitchell said schools were ready to welcome students back.“The return remains safe and sensible with enough time for schools to prepare for a faster return of students over two weeks instead of three,” Ms Mitchell said.“Principals have received detailed guidance and checklists of everything required to ensure erectile dysfunction treatment-safe settings in their school. Parents and carers will also receive a detailed guide today and more specific information from their school in the coming days.”If how to get viagra in the us you are not booked in for a erectile dysfunction treatment, please book an appointment as soon possible.Note also that as the stay-at-home orders will be lifted next Monday and replaced by the roadmap settings, the list of Local Government Areas of concern will cease to exist. For the latest information visit the erectile dysfunction treatment pages on nsw.gov.au.New public health advice sets out how NSW will continue to tackle erectile dysfunction treatment as the state begins to reopen when it reaches the 70 per cent double dose vaccination target. Health Minister Brad Hazzard said while high vaccination rates were the key factor in the roadmap to recovery, erectile dysfunction treatment how to get viagra in the us will continue to circulate in the community.

€œNSW is leading the nation in so many ways with its viagra response but particularly in its vaccination efforts. I urge how to get viagra in the us those who are yet to get vaccinated to do so quickly to protect yourself, your loved ones and the community,” Mr Hazzard said. €œWe are closing-in on the 70 per cent double dose mark and when we achieve it there will be significant changes to our public health advice and the key difference will be how that advice is applied to people who are vaccinated and to those who are not. €œVaccination will provide greater freedoms as our society opens how to get viagra in the us up and it reduces the risk of you spreading the viagra to someone vulnerable, which could cost them their life. €œDespite the ongoing challenges that will continue to be posed by erectile dysfunction treatment, we have the opportunity to lead the world which is why it is vital everyone is vaccinated and follows the updated public health advice that will be in place from 11 October.”Some of the key public health advice for the general community will be.

Everyone, vaccinated how to get viagra in the us and not vaccinated, is urged to get tested if you have any symptoms of erectile dysfunction treatment and immediately self-isolate until a negative result is received.Whether you are vaccinated or not vaccinated, if you test positive for erectile dysfunction treatment you must self-isolate for 14 days. Close contacts in the community will include household members of positive cases and close social contacts of positive cases, such as partners and friends, who you spent time in close proximity with, even if fully vaccinated. Anyone may also be assessed as a how to get viagra in the us being a close contact following a risk assessment, including at workplaces, high-risk settings, such as healthcare and aged care, and other specific settings such as schools and child care centres, or where an outbreak has been identified. If you are a close contact of a positive case and vaccinated, you must get tested and self-isolate for seven days. On day how to get viagra in the us six after exposure, you must get tested again.

If a negative result is received and you are well, you can end isolation after day seven. For the following seven days you must work from home where practicable, not attend hospitality settings, and not attend a high-risk settings even if it is your place of how to get viagra in the us work. If you are a close contact of a positive case and not vaccinated you must get tested and immediately self-isolate for 14 days. On day 12, you should how to get viagra in the us get tested again. If a negative result is received, you can end isolation after day 14.The Service NSW QR code check-in system will remain in place in the general community.

This system how to get viagra in the us will be used to notify people who were in the same venue as a positive case. People will be asked to monitor for symptoms and get tested if they become unwell. Other settings, including schools, workplaces and high-risk settings, such as healthcare and aged care, will have specific risk assessment how to get viagra in the us approaches. People aged 16 years and over will only be allowed entry into some venues or settings if fully vaccinated, along with people with exemptions. In some how to get viagra in the us venues, children under 16 will have to be accompanied by a fully vaccinated member of their household to enter.

This includes hospitality venues, non-critical retail stores, personal services, sporting, recreation and entertainment facilities and events. Critical retail such as supermarkets and pharmacies will still be accessible to those not fully vaccinated how to get viagra in the us. There are several options to show proof of erectile dysfunction treatment vaccination or exemption. Some of the key public health advice for the business how to get viagra in the us community will be. If a staff member tests positive, whether they are vaccinated or not vaccinated, they must self-isolate for 14 days and follow the advice from NSW Health.

Businesses will refer to their erectile dysfunction treatment Safety Plan and risk assessment approach for further instructions on notifying other staff.Businesses must inform NSW Health if three or more employees test positive for erectile dysfunction treatment in a seven-day period.NSW Health guidelines will enable businesses to assess workplace risk if a erectile dysfunction treatment case is identified and confirm actions to be taken.Businesses can reduce the how to get viagra in the us risk of closure or staff going into isolation by implementing rigorous erectile dysfunction treatment Safety Plans. Other proactive steps businesses can take include ensuring staff are vaccinated and implementing regular onsite testing programs for workers. With respect to how to get viagra in the us vaccination compliance and obligations:Businesses will be responsible for taking reasonable measures to stop unvaccinated people entering premises. For example, having prominent signs stating requirements, Service NSW QR codes, staff checking vaccination status upon entry and only accepting valid forms of evidence of vaccination. Authorised officers will monitor businesses re-opening, particularly those that have how to get viagra in the us vaccination requirements, for example hospitality, retail, gyms, and personal services (e.g.

Hair, beauty). Penalties may apply for individuals and businesses how to get viagra in the us who don’t comply. On the spot fines of $1,000 may apply to individuals for not complying, or for using fraudulent evidence of vaccination or check-in. On the spot fines of $5,000 may apply to businesses for not complying with the Public how to get viagra in the us Health Order vaccination requirements. Further penalties may apply for significant breaches.NSW Chief Health Officer Dr Kerry Chant said it is important to note that the new advice may be updated by NSW Health as case numbers and evidence changes.“We will continue to do what we have done throughout this viagra, which is to regularly update our advice, informed by experience, feedback, and emerging evidence.

It is only in partnership that we can reopen in a safe way.”Visit nsw.gov.au for the latest information.

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We are social epidemiologists and community advocates focused on addressing social determinants of health viagra 100mg cost inequities benefits of taking viagra daily. While we appreciate O’Neill et al’s effort to link multiple provincial-level administrative data sets to examine homicide victimisation by immigration status in Ontario, Canada, we have concerns about the framing and interpretation of findings and their potential impact on immigrants and refugees.1FRAMING AND APPROACHWhile O’Neill et al’s data and sample size are strengths, the attention to the context of being an immigrant to Canada, theoretical framework and motivation for examining immigrants in relation to homicide victimisation are not fully developed. O’Neill et al do not acknowledge having done any community engagement which is critical and ethical2 given the long history of exclusion, exploitation, racism benefits of taking viagra daily and discrimination, and the current global climate of increasing criminalisation of migrants.

Meaningful community engagement offers important context. Helps shape benefits of taking viagra daily the research purpose, questions, approach, interpretation and recommendations. And can reduce the potential for harm.Though criminalisation of migration under security pretexts is an infringement of international law,3 and contradicts evidence that immigration is related to a reduction in crime,4 many high-income countries, including Canada, are framing harmful immigration policy (eg, restricting entry, detaining immigrants) as an urgent need to protect against threats of safety and security,4 5 disproportionately targeting racialised and Muslim immigrants and refugees.

Within this policy context, along with political rhetoric to generate support for it, hate crimes are at record highs in Canada, with approximately 85% of these crimes motivated by benefits of taking viagra daily racism and ethnic or religious discrimination.6Not only does this paper fail to consider this context, the statements that immigrant communities are ‘predisposed to violence’ without evidence to support this claim. The conflation of perpetrating and dying by homicide, by alternating between the use of ‘homicide’ and ‘homicide victimisation’. And the suggestion that ‘cultural views on gender’ increase risk of violence and homicide victimisation against immigrant women, are particularly harmful.RESULTS AND INTERPRETATIONThe authors’ emphasis on the increased risk of homicide victimisation of female and male refugees compared to benefits of taking viagra daily long-term residents is misleading given that these results are not statistically significant.

The authors argue that the findings are important regardless of significance, because of large effect sizes. But for many researchers, benefits of taking viagra daily effect sizes of 1.31 and 1.23, respectively, would be considered small to medium and would lead to a much more cautious interpretation.The authors’ interpretation that non-refugee immigrants have a lower risk of homicide victimisation because Canada’s immigration policies select for highly educated and healthy immigrants reflects problems with the theory informing this research, since homicide victimisation is not within the control of an individual. Social epidemiology was founded on the need to theorise political, economic and cultural context over and above individual characteristics.7 A concerning omission is that there is no mention of the potential http://www.em-dettwiller.site.ac-strasbourg.fr/?p=619 for hate crimes6 to be at least partially responsible for homicide victimisation among refugees and immigrants.

Additionally, in the text, it is left unclear how a refugee’s history of ‘violence, trauma and torture’ and ‘depression and psychosocial illness’ are linked to homicide benefits of taking viagra daily victimisation. Such unsupported statements omit essential consideration that Canadian neighbourhoods are heterogeneous combinations of refugees, non-refugees and long-term residents and that violence occurs within a social context which includes racism, xenophobia and Islamophobia.8With the study’s low counts of homicide victimisations among refugees (31 among females and 89 among males over 20 years), 90% of all homicide victimisations in the same time period occurring among long-term residents (table 1 of paper), and no clear data pointing to specific factors to intervene upon, we argue that this potential in excess homicide victimisation does not warrant targeted homicide prevention strategies, as the authors suggest. Broader prevention strategies targeting the entire population (eg, a national ban on handguns and assault weapons,9 10 implementing Canada’s Anti-Racism Strategy8) may be more beneficial in reducing homicide victimisation.POTENTIAL IMPACTWe are concerned that the paper’s framing, approach and interpretation could negatively impact immigrant and refugee communities targeted by significant racism, anti-immigrant sentiment and Islamophobia at policy, practice, community and individual levels.6 11 Community engagement from the start, and comprehensive multi-level, multistage social determinants of immigrant health framework,11 could have prevented misinterpretations of the findings and this benefits of taking viagra daily potential for harm.

It could have also shifted the approach from a deficit- to an asset-based one that recognises the leadership and impacts of women who founded groups such as Mothers for Peace12 and Mending a Crack in the Sky.13 These groups combat the stigmatisation of mothers and families that have lost children to violence. Support mothers and benefits of taking viagra daily families experiencing ongoing trauma due to violence. And advocate for policy and programme change to reduce poverty, violence and homicide for all people in Canada, a more inclusive public health approach.We thank Wanigaratne and Mawani et al for taking the time to write this Commentary,1 which we have read with great interest.

We agree that the framing and interpretation of findings about immigrant and refugee communities is of benefits of taking viagra daily great importance and appreciate the opportunity to provide clarification. We would first like to acknowledge the valuable expertise of the authors as well as their strong relationships and vital advocacy work within communities.The primary aim of our study was to provide descriptive epidemiology of homicide in Ontario.2 Very few population-level descriptive studies have been published characterising homicides, particularly regarding trends in homicide victimisation between and across population subgroups. Our study team includes epidemiologists, professional and academics who work at the intersection of public health and violence, experience with implementing violence prevention programmes in marginalised populations around the world and expertise in working with large linked health administrative data.The linked health and administrative databases we used help fill the data gap with respect benefits of taking viagra daily to understanding the victims of violence, including but not limited to refugee status.3 This aim is consistent with other descriptive database studies published about health and health system outcomes among immigrant and refugee populations in Ontario.4–11 The motivation for this study was to provide descriptive data that can be used by communities and researchers to better understand the distribution of health outcomes across populations.

Our study found differences in risk of homicide across several social and economic indicators, including lower socioeconomic ….

We are social epidemiologists and community advocates focused on addressing social determinants of health how much viagra cost inequities how to get viagra in the us. While we appreciate O’Neill et al’s effort to link multiple provincial-level administrative data sets to examine homicide victimisation by immigration status in Ontario, Canada, we have concerns about the framing and interpretation of findings and their potential impact on immigrants and refugees.1FRAMING AND APPROACHWhile O’Neill et al’s data and sample size are strengths, the attention to the context of being an immigrant to Canada, theoretical framework and motivation for examining immigrants in relation to homicide victimisation are not fully developed. O’Neill et how to get viagra in the us al do not acknowledge having done any community engagement which is critical and ethical2 given the long history of exclusion, exploitation, racism and discrimination, and the current global climate of increasing criminalisation of migrants. Meaningful community engagement offers important context. Helps shape the research purpose, questions, approach, interpretation and recommendations how to get viagra in the us.

And can reduce the potential for harm.Though criminalisation of migration under security pretexts is an infringement of international law,3 and contradicts evidence that immigration is related to a reduction in crime,4 many high-income countries, including Canada, are framing harmful immigration policy (eg, restricting entry, detaining immigrants) as an urgent need to protect against threats of safety and security,4 5 disproportionately targeting racialised and Muslim immigrants and refugees. Within this policy context, along with political rhetoric to generate support for it, hate crimes are at record highs in Canada, with approximately 85% of these crimes motivated by racism and ethnic or religious how to get viagra in the us discrimination.6Not only does this paper fail to consider this context, the statements that immigrant communities are ‘predisposed to violence’ without evidence to support this claim. The conflation of perpetrating and dying by homicide, by alternating between the use of ‘homicide’ and ‘homicide victimisation’. And the suggestion that ‘cultural views on gender’ increase risk of violence and homicide victimisation against immigrant women, are particularly harmful.RESULTS AND INTERPRETATIONThe authors’ emphasis on the increased risk of homicide victimisation of female and male refugees compared to long-term residents is misleading how to get viagra in the us given that these results are not statistically significant. The authors argue that the findings are important regardless of significance, because of large effect sizes.

But for many researchers, effect sizes of 1.31 and 1.23, respectively, would be considered small to how to get viagra in the us medium and would lead to a much more cautious interpretation.The authors’ interpretation that non-refugee immigrants have a lower risk of homicide victimisation because Canada’s immigration policies select for highly educated and healthy immigrants reflects problems with the theory informing this research, since homicide victimisation is not within the control of an individual. Social epidemiology was founded on the need to theorise political, economic and cultural context over and above individual characteristics.7 A concerning omission is that there is no mention of the potential for hate crimes6 to be at least partially responsible for homicide victimisation among refugees and immigrants. Additionally, in the text, it is left unclear how a refugee’s history of ‘violence, trauma and torture’ and ‘depression and psychosocial illness’ are linked to how to get viagra in the us homicide victimisation. Such unsupported statements omit essential consideration that Canadian neighbourhoods are heterogeneous combinations of refugees, non-refugees and long-term residents and that violence occurs within a social context which includes racism, xenophobia and Islamophobia.8With the study’s low counts of homicide victimisations among refugees (31 among females and 89 among males over 20 years), 90% of all homicide victimisations in the same time period occurring among long-term residents (table 1 of paper), and no clear data pointing to specific factors to intervene upon, we argue that this potential in excess homicide victimisation does not warrant targeted homicide prevention strategies, as the authors suggest. Broader prevention strategies targeting the entire population (eg, a national ban on handguns and assault weapons,9 10 implementing Canada’s Anti-Racism Strategy8) may be more beneficial in reducing homicide victimisation.POTENTIAL IMPACTWe are concerned that the paper’s framing, approach and interpretation could negatively impact immigrant and refugee communities targeted by significant racism, anti-immigrant sentiment and Islamophobia at policy, practice, community and individual levels.6 11 Community engagement from the start, how to get viagra in the us and comprehensive multi-level, multistage social determinants of immigrant health framework,11 could have prevented misinterpretations of the findings and this potential for harm.

It could have also shifted the approach from a deficit- to an asset-based one that recognises the leadership and impacts of women who founded groups such as Mothers for Peace12 and Mending a Crack in the Sky.13 These groups combat the stigmatisation of mothers and families that have lost children to violence. Support mothers and families experiencing ongoing trauma how to get viagra in the us due to violence. And advocate for policy and programme change to reduce poverty, violence and homicide for all people in Canada, a more inclusive public health approach.We thank Wanigaratne and Mawani et al for taking the time to write this Commentary,1 which we have read with great interest. We agree that the framing and interpretation of findings how to get viagra in the us about immigrant and refugee communities is of great importance and appreciate the opportunity to provide clarification. We would first like to acknowledge the valuable expertise of the authors as well as their strong relationships and vital advocacy work within communities.The primary aim of our study was to provide descriptive epidemiology of homicide in Ontario.2 Very few population-level descriptive studies have been published characterising homicides, particularly regarding trends in homicide victimisation between and across population subgroups.

Our study team includes epidemiologists, professional and academics who work at the intersection of public health and violence, experience with implementing violence prevention programmes in marginalised populations around the world and expertise in working with large linked health administrative data.The linked health and administrative databases we used help fill how to get viagra in the us the data gap with respect to understanding the victims of violence, including but not limited to refugee status.3 This aim is consistent with other descriptive database studies published about health and health system outcomes among immigrant and refugee populations in Ontario.4–11 The motivation for this study was to provide descriptive data that can be used by communities and researchers to better understand the distribution of health outcomes across populations. Our study found differences in risk of homicide across several social and economic indicators, including lower socioeconomic ….

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Disclaimer. This document does not constitute legislation. In the event of any inconsistency or conflict between the legislation and this document, the legislation takes precedence.

This document is an administrative document that is intended to facilitate compliance by the regulated party with the legislation and the applicable administrative policies.Date approved. November 8, 2021Effective date. November 27, 2021On this page IntroductionThe Interim Order respecting drug shortages (safeguarding the drug supply) took effect on November 27, 2020.

The interim order (IO) prohibited a drug establishment licence (DEL) holder from distributing drugs intended for the Canadian market for consumption or use outside Canada if they had reasonable grounds to believe the distribution would cause or exacerbate a drug shortage. The provisions of that 1-year IO have been made permanent through amendments to the Food and Drug Regulations. These provisions, contained in sections C.01.014.13 to C.01.014.14 of the Food and Drug Regulations (FDR), come into force on November 27, 2021.

This date follows the day on which the IO ceases to have effect. DEL holders who distributed drugs for consumption or use outside of Canada between November 27, 2020, and November 26, 2021, must keep records of the assessment to show that there were reasonable grounds to believe that the distribution would not cause or exacerbate a shortage. DEL holders must do so until at least 1 year after the latest expiry date of the drug distributed.

Health Canada is responsible for helping the people of Canada maintain and improve their health. This is done, in part, by our commitment and actions to help protect the Canadian drug supply, thus ensuring that people in Canada have access to the drugs they need when they need them. Health Canada expects stakeholders across the drug supply chain to make business decisions that keep in mind the stability of the Canadian drug supply.

For more information on drug shortages and the various roles and responsibilities in addressing them, refer to drug shortages in Canada. Purpose and scopePurposeThis guidance document sets out Health Canada’s interpretation of the requirements in sections C.01.014.13 to C.01.014.14 of the FDR. These sections prohibit the holder of a DEL from distributing drugs intended for the Canadian market for consumption or use outside Canada unless the licensee has reasonable grounds to believe that doing so would not cause or worsen a drug shortage.

The sections were implemented to safeguard the Canadian drug supply and help ensure that the people of Canada have continuous access to the drugs they need to maintain their health. This guidance document is meant to help regulated parties understand how to comply with the regulations. It also provides guidance to Health Canada staff, so that the rules are enforced fairly, consistently and effectively.

This guidance document will outline. When a DEL holder is allowed to distribute drugs intended for the Canadian market for consumption or use outside Canada in the context of drug shortages the type of analysis a DEL holder should perform in determining whether such distributions are allowed the types of records a DEL holder must keep when distributing drugs meant for the Canadian market for consumption or use in other countries ScopeInclusionsSections C.01.014.13 to C.01.014.14 of the FDR apply to distribution by a DEL holder of the following drugs intended for the Canadian market for human consumption or use outside Canada. ExclusionsNatural health products, over-the-counter drugs and drugs for veterinary use are excluded from the scope of these provisions.Sections C.01.014.13 to C.01.014.14 of the FDR do not apply to.

Sales made by a person who is not required to hold a DEL (for example, pharmacies selling drugs at the retail level) exports of drugs that are imported for the sole purpose of export (transhipment) exports of drugs that are manufactured in Canada for the sole purpose of export Responsibilities of DEL holders and Health CanadaSections C.01.014.13 to C.01.014.14 of the FDR apply to DEL holders. For more information on when DELs are required and how to obtain one, consult the Guidance on drug establishment licences (GUI-0002).Responsibilities of DEL holdersDEL holders are responsible for the following. Ensuring they have reasonable grounds to believe that the decision to distribute drugs intended for the Canadian market for consumption or use outside Canada does not cause or worsen a shortage maintaining a record of their decision to distribute all drugs intended for the Canadian market for consumption or use outside Canada that are subject to C.01.014.13 to C.01.014.14 of the FDR (products with a drug identification number (DIN)) for a minimum of 1 year after the latest expiry date for those drugsNote.

Any changes to the status of the DEL (for example, DEL cancelled or not renewed) would not change the person’s responsibilities for maintaining the records until 1 year after the latest expiry of the drugs.Responsibilities of Health CanadaHealth Canada is responsible for compliance monitoring and enforcement activities related to health products in order to verify that regulatory requirements are being met.Health Canada may take compliance and enforcement actions for failure to meet the requirements of these regulations. Refer to our compliance and enforcement policy for health products (POL-0001).The regulationsFor each section below, the exact text from the FDR is provided first. This is followed by Health Canada’s interpretation.The prohibition Regulatory textNo person who holds an establishment licence shall distribute a drug for consumption or use outside Canada unless the licensee has reasonable grounds to believe that the distribution will not cause or exacerbate a shortage of the drug.

(section C.01.014.13)InterpretationThese regulations apply to any distribution of in-scope drugs by DEL holders. A Canadian drug is defined above, is approved by Health Canada (assigned a DIN) and labelled with a Canadian label. Such drugs are considered to be intended for the Canadian market.

Before distributing a drug intended for the Canadian market for consumption or use outside Canada, DEL holders must evaluate the impact that the distribution would have on Canada’s drug supply. Distribution in the context of this prohibition includes the act of shipping, selling and/or delivering a drug. This includes the export of drugs meant for the Canadian market for consumption or use in other countries.DEL holder responsibilityYou must evaluate the potential impact on the Canadian drug supply if you are considering distributing a drug intended for the Canadian market for consumption or use in another country.

You should base your analysis on information available to you at the time of export/distribution. This analysis, which includes publicly available information and your organization’s business intelligence, must be documented. Examples of factors to consider in your assessment of drug shortage risks are included in Table 1 (not an exhaustive list).

Other factors may need to be considered based on the specific situation of the drug being evaluated for potential distribution. Table 1. Examples of factors to consider in an assessment of drug shortage risks Consideration Context Is the drug listed as a Tier 3 drug shortage?.

Tier 3 drug shortages have the greatest potential impact on Canada’s drug supply and health care system. It would be difficult to show reasonable grounds to believe that distributing a drug in a Tier 3 drug shortage for consumption or use outside Canada would not cause a shortage, as there are established shortage concerns for the drug. Are there any actual or anticipated drug shortages or discontinuations of the drug reported on the mandatory drug shortage reporting webpage?.

Further analysis will be required if there are actual or anticipated shortages of a drug to determine, to the best of your knowledge, if the reported drug shortages are likely to cause availability issues for people in Canada that can’t be addressed by other suppliers. Will the distribution of the drug for use outside Canada impact your ability to meet your Canadian customers’ requirements?. If yes, it would be difficult to show reasonable grounds to believe that distributing the drug for use outside Canada would not cause a shortage.

Is the quantity of drug under consideration for distribution for use outside Canada significant compared to. your historic sales your current inventory overall national sales Careful consideration will be required if the potential quantity of drugs to be exported is substantial. Companies will need to clearly demonstrate that the exports will not cause or worsen a drug shortage in Canada.

This includes an examination of their known market share. Is this a sole-source drug or a drug with a limited number of market authorization holders?. Drug shortages of sole-sourced drugs or drugs produced by companies with dominant market shares are a concern.

Sole-sourced drugs and drugs with a small number of suppliers (or a dominant supplier in terms of market share) are considered to be at a higher risk of drug shortage. Do you expect any demand changes for the drug?. Demand changes can be caused by a variety of factors, such as.

drug shortages reported by other manufacturers shortages of alternative drugs and environmental factors (for example, the erectile dysfunction treatment viagra caused major changes in drug demand) Assessments of demand projections should be included in your analysis. Is there a shortage of the drug in other markets?. Assess the global supply situation to determine if there is a risk of a shortage of this drug in Canada.

Are you aware of any other issues that may impact supply of this drug in Canada (for example, supply chain issues, shipping delays, material shortages, environmental/natural disasters such as floods or fires)?. Further assessment is required to ensure that issues which may result in a shortage of the drug in Canada are considered. There may be context specific to the drug in question that is relevant to your decision-making.

The table above is not an exhaustive list of examples of factors to consider when determining whether there are reasonable grounds to believe that drugs meant for the Canadian market can be distributed for consumption or use outside of Canada without causing or worsening a shortage. Potential decisions to make. Distribution prohibited.

If you have reasonable grounds to believe that the distribution of a drug meant for the Canadian market for consumption or use outside Canada would cause a drug shortage or exacerbate an existing drug shortage Distribution permitted. If you have no reasonable grounds to believe that the distribution would result in a drug shortage or make an existing drug shortage worse, distribution is permitted, and you maintain records of the rationale for this determination (refer to section entitled “Requirements for making and retaining records”) Requirements for making and retaining recordsRegulatory textIf a person who holds an establishment licence distributes a drug for consumption or use outside Canada, the licensee shall immediately create a detailed record of the information that they relied on to determine that the distribution of the drug is not prohibited by section C.01.014.13. (section C.01.014.14 (1))The licensee shall retain the record for at least one year after the latest expiration date of the drug that they distributed.

(section C.01.014.14 (2)).InterpretationBefore distribution, you must conduct a thorough analysis of the potential distribution of drugs intended for the Canadian market for consumption or use outside Canada. A non-exhaustive list of examples of factors to consider are described in Table 1. This is done to help determine if there are reasonable grounds to believe distributing the drug would cause or worsen a drug shortage.

You must keep documentation of this analysis, which should clearly justify your conclusions about shortage concerns, including the sources of information and the date(s) they were accessed. You must maintain these records until 1 year after the latest expiration date of the distributed drugs.As part of regulatory compliance verification activities, Health Canada may require your assessment if you distributed for consumption or use outside Canada any Canadian drugs that are subject to C.01.014.13 to C.01.014.14 of the FDR. Under section C.01.014.12 of the FDR, we may require you to provide information on a drug shortage.

For more information about this provision, refer to the Guidance on requirements for providing information related to drug shortages (GUI-0146). Contact usFor questions about drug shortage and discontinuation regulations, contact us at Drug.shortages-Penurie.de.medicament@hc-sc.gc.ca.Definitions Actual shortage. a manufacturer's current supply cannot meet current demand in Canada (pénurie réelle) (refer to "Shortage") Anticipated shortage.

a manufacturer's future supply cannot meet projected demand in Canada (pénurie anticipée) (refer to "Shortage") Drug. any of the following drugs for human use. drugs included in Schedule I, II, III, IV or V to the Controlled Drugs and Substances Act.

Prescription drugs. drugs that are listed in Schedule C or D to the Act. And drugs that are permitted to be sold without a prescription but that are to be administered only under the supervision of a practitioner.

(drogue) (FDR, C.01.014.8) For clarity, prescription drugs are found on the Prescription Drug List. Drug establishment licence (DEL). a licence issued to a person in Canada pursuant to Division 1A of the FDR to conduct licensable activities in a building which has been inspected and assessed as being in compliance with the requirements of Divisions 2 to 4 of the Food and Drug Regulations conduct (Licences d'établissement de produits pharmaceutiques (LEPP)) Drug identification number (DIN).

an 8-digit numerical code assigned by Health Canada to each drug product marketed under the Food and Drugs Act and Regulations A DIN uniquely identifies the following product characteristics. Manufacturer, brand name, medicinal ingredient(s), strength of medicinal ingredients(s), pharmaceutical form and route of administration (numéro d’identification d’un médicament) Establishment licence. Refer to Drug Establishment Licence above Manufacturer.

a person, including an association or partnership, who under their own name, or under a trade, design or word mark, trade name or other name, word, or mark controlled by them sells a food or drug (fabricant) (FDR, A.01.010) Person. An individual or an organization as defined in section 2 of the Criminal Code (personne) (FDA, Section 2) Tier 3 drug shortage. drug shortages that are deemed the most critical national shortages determined by a specially convened Tier Assignment Committee on a case-by-case basis (les pénuries de niveau 3) Transhipment.

after goods have been unloaded or in any way removed from the means of transportation by which they came into Canada, their loading, placing on board or within or upon the same or any other means of transportation (transbordement) (Transhipment Regulations Part II, Section 3) Shortage. in respect of a drug, a situation in which the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for the drug is unable to meet the demand for the drug in Canada (pénurie) (FDR, C.01.014.8 (2))References Legislation and regulations Policies and Guides Web pages/Associated documents Contacts Related linksLegislation and regulations Guidance on drug shortages Web pages/Associated documents.

Disclaimer. This document does not constitute legislation. In the event of any inconsistency or conflict between the legislation and this document, the legislation takes precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the legislation and the applicable administrative policies.Date approved.

November 8, 2021Effective date. November 27, 2021On this page IntroductionThe Interim Order respecting drug shortages (safeguarding the drug supply) took effect on November 27, 2020. The interim order (IO) prohibited a drug establishment licence (DEL) holder from distributing drugs intended for the Canadian market for consumption or use outside Canada if they had reasonable grounds to believe the distribution would cause or exacerbate a drug shortage. The provisions of that 1-year IO have been made permanent through amendments to the Food and Drug Regulations.

These provisions, contained in sections C.01.014.13 to C.01.014.14 of the Food and Drug Regulations (FDR), come into force on November 27, 2021. This date follows the day on which the IO ceases to have effect. DEL holders who distributed drugs for consumption or use outside of Canada between November 27, 2020, and November 26, 2021, must keep records of the assessment to show that there were reasonable grounds to believe that the distribution would not cause or exacerbate a shortage. DEL holders must do so until at least 1 year after the latest expiry date of the drug distributed.

Health Canada is responsible for helping the people of Canada maintain and improve their health. This is done, in part, by our commitment and actions to help protect the Canadian drug supply, thus ensuring that people in Canada have access to the drugs they need when they need them. Health Canada expects stakeholders across the drug supply chain to make business decisions that keep in mind the stability of the Canadian drug supply. For more information on drug shortages and the various roles and responsibilities in addressing them, refer to drug shortages in Canada.

Purpose and scopePurposeThis guidance document sets out Health Canada’s interpretation of the requirements in sections C.01.014.13 to C.01.014.14 of the FDR. These sections prohibit the holder of a DEL from distributing drugs intended for the Canadian market for consumption or use outside Canada unless the licensee has reasonable grounds to believe that doing so would not cause or worsen a drug shortage. The sections were implemented to safeguard the Canadian drug supply and help ensure that the people of Canada have continuous access to the drugs they need to maintain their health. This guidance document is meant to help regulated parties understand how to comply with the regulations.

It also provides guidance to Health Canada staff, so that the rules are enforced fairly, consistently and effectively. This guidance document will outline. When a DEL holder is allowed to distribute drugs intended for the Canadian market for consumption or use outside Canada in the context of drug shortages the type of analysis a DEL holder should perform in determining whether such distributions are allowed the types of records a DEL holder must keep when distributing drugs meant for the Canadian market for consumption or use in other countries ScopeInclusionsSections C.01.014.13 to C.01.014.14 of the FDR apply to distribution by a DEL holder of the following drugs intended for the Canadian market for human consumption or use outside Canada. ExclusionsNatural health products, over-the-counter drugs and drugs for veterinary use are excluded from the scope of these provisions.Sections C.01.014.13 to C.01.014.14 of the FDR do not apply to.

Sales made by a person who is not required to hold a DEL (for example, pharmacies selling drugs at the retail level) exports of drugs that are imported for the sole purpose of export (transhipment) exports of drugs that are manufactured in Canada for the sole purpose of export Responsibilities of DEL holders and Health CanadaSections C.01.014.13 to C.01.014.14 of the FDR apply to DEL holders. For more information on when DELs are required and how to obtain one, consult the Guidance on drug establishment licences (GUI-0002).Responsibilities of DEL holdersDEL holders are responsible for the following. Ensuring they have reasonable grounds to believe that the decision to distribute drugs intended for the Canadian market for consumption or use outside Canada does not cause or worsen a shortage maintaining a record of their decision to distribute all drugs intended for the Canadian market for consumption or use outside Canada that are subject to C.01.014.13 to C.01.014.14 of the FDR (products with a drug identification number (DIN)) for a minimum of 1 year after the latest expiry date for those drugsNote. Any changes to the status of the DEL (for example, DEL cancelled or not renewed) would not change the person’s responsibilities for maintaining the records until 1 year after the latest expiry of the drugs.Responsibilities of Health CanadaHealth Canada is responsible for compliance monitoring and enforcement activities related to health products in order to verify that regulatory requirements are being met.Health Canada may take compliance and enforcement actions for failure to meet the requirements of these regulations.

Refer to our compliance and enforcement policy for health products (POL-0001).The regulationsFor each section below, the exact text from the FDR is provided first. This is followed by Health Canada’s interpretation.The prohibition Regulatory textNo person who holds an establishment licence shall distribute a drug for consumption or use outside Canada unless the licensee has reasonable grounds to believe that the distribution will not cause or exacerbate a shortage of the drug. (section C.01.014.13)InterpretationThese regulations apply to any distribution of in-scope drugs by DEL holders. A Canadian drug is defined above, is approved by Health Canada (assigned a DIN) and labelled with a Canadian label.

Such drugs are considered to be intended for the Canadian market. Before distributing a drug intended for the Canadian market for consumption or use outside Canada, DEL holders must evaluate the impact that the distribution would have on Canada’s drug supply. Distribution in the context of this prohibition includes the act of shipping, selling and/or delivering a drug. This includes the export of drugs meant for the Canadian market for consumption or use in other countries.DEL holder responsibilityYou must evaluate the potential impact on the Canadian drug supply if you are considering distributing a drug intended for the Canadian market for consumption or use in another country.

You should base your analysis on information available to you at the time of export/distribution. This analysis, which includes publicly available information and your organization’s business intelligence, must be documented. Examples of factors to consider in your assessment of drug shortage risks are included in Table 1 (not an exhaustive list). Other factors may need to be considered based on the specific situation of the drug being evaluated for potential distribution.

Table 1. Examples of factors to consider in an assessment of drug shortage risks Consideration Context Is the drug listed as a Tier 3 drug shortage?. Tier 3 drug shortages have the greatest potential impact on Canada’s drug supply and health care system. It would be difficult to show reasonable grounds to believe that distributing a drug in a Tier 3 drug shortage for consumption or use outside Canada would not cause a shortage, as there are established shortage concerns for the drug.

Are there any actual or anticipated drug shortages or discontinuations of the drug reported on the mandatory drug shortage reporting webpage?. Further analysis will be required if there are actual or anticipated shortages of a drug to determine, to the best of your knowledge, if the reported drug shortages are likely to cause availability issues for people in Canada that can’t be addressed by other suppliers. Will the distribution of the drug for use outside Canada impact your ability to meet your Canadian customers’ requirements?. If yes, it would be difficult to show reasonable grounds to believe that distributing the drug for use outside Canada would not cause a shortage.

Is the quantity of drug under consideration for distribution for use outside Canada significant compared to. your historic sales your current inventory overall national sales Careful consideration will be required if the potential quantity of drugs to be exported is substantial. Companies will need to clearly demonstrate that the exports will not cause or worsen a drug shortage in Canada. This includes an examination of their known market share.

Is this a sole-source drug or a drug with a limited number of market authorization holders?. Drug shortages of sole-sourced drugs or drugs produced by companies with dominant market shares are a concern. Sole-sourced drugs and drugs with a small number of suppliers (or a dominant supplier in terms of market share) are considered to be at a higher risk of drug shortage. Do you expect any demand changes for the drug?.

Demand changes can be caused by a variety of factors, such as. drug shortages reported by other manufacturers shortages of alternative drugs and environmental factors (for example, the erectile dysfunction treatment viagra caused major changes in drug demand) Assessments of demand projections should be included in your analysis. Is there a shortage of the drug in other markets?. Assess the global supply situation to determine if there is a risk of a shortage of this drug in Canada.

Are you aware of any other issues that may impact supply of this drug in Canada (for example, supply chain issues, shipping delays, material shortages, environmental/natural disasters such as floods or fires)?. Further assessment is required to ensure that issues which may result in a shortage of the drug in Canada are considered. There may be context specific to the drug in question that is relevant to your decision-making. The table above is not an exhaustive list of examples of factors to consider when determining whether there are reasonable grounds to believe that drugs meant for the Canadian market can be distributed for consumption or use outside of Canada without causing or worsening a shortage.

Potential decisions to make. Distribution prohibited. If you have reasonable grounds to believe that the distribution of a drug meant for the Canadian market for consumption or use outside Canada would cause a drug shortage or exacerbate an existing drug shortage Distribution permitted. If you have no reasonable grounds to believe that the distribution would result in a drug shortage or make an existing drug shortage worse, distribution is permitted, and you maintain records of the rationale for this determination (refer to section entitled “Requirements for making and retaining records”) Requirements for making and retaining recordsRegulatory textIf a person who holds an establishment licence distributes a drug for consumption or use outside Canada, the licensee shall immediately create a detailed record of the information that they relied on to determine that the distribution of the drug is not prohibited by section C.01.014.13.

(section C.01.014.14 (1))The licensee shall retain the record for at least one year after the latest expiration date of the drug that they distributed. (section C.01.014.14 (2)).InterpretationBefore distribution, you must conduct a thorough analysis of the potential distribution of drugs intended for the Canadian market for consumption or use outside Canada. A non-exhaustive list of examples of factors to consider are described in Table 1. This is done to help determine if there are reasonable grounds to believe distributing the drug would cause or worsen a drug shortage.

You must keep documentation of this analysis, which should clearly justify your conclusions about shortage concerns, including the sources of information and the date(s) they were accessed. You must maintain these records until 1 year after the latest expiration date of the distributed drugs.As part of regulatory compliance verification activities, Health Canada may require your assessment if you distributed for consumption or use outside Canada any Canadian drugs that are subject to C.01.014.13 to C.01.014.14 of the FDR. Under section C.01.014.12 of the FDR, we may require you to provide information on a drug shortage. For more information about this provision, refer to the Guidance on requirements for providing information related to drug shortages (GUI-0146).

Contact usFor questions about drug shortage and discontinuation regulations, contact us at Drug.shortages-Penurie.de.medicament@hc-sc.gc.ca.Definitions Actual shortage. a manufacturer's current supply cannot meet current demand in Canada (pénurie réelle) (refer to "Shortage") Anticipated shortage. a manufacturer's future supply cannot meet projected demand in Canada (pénurie anticipée) (refer to "Shortage") Drug. any of the following drugs for human use.

drugs included in Schedule I, II, III, IV or V to the Controlled Drugs and Substances Act. Prescription drugs. drugs that are listed in Schedule C or D to the Act. And drugs that are permitted to be sold without a prescription but that are to be administered only under the supervision of a practitioner.

(drogue) (FDR, C.01.014.8) For clarity, prescription drugs are found on the Prescription Drug List. Drug establishment licence (DEL). a licence issued to a person in Canada pursuant to Division 1A of the FDR to conduct licensable activities in a building which has been inspected and assessed as being in compliance with the requirements of Divisions 2 to 4 of the Food and Drug Regulations conduct (Licences d'établissement de produits pharmaceutiques (LEPP)) Drug identification number (DIN). an 8-digit numerical code assigned by Health Canada to each drug product marketed under the Food and Drugs Act and Regulations A DIN uniquely identifies the following product characteristics.

Manufacturer, brand name, medicinal ingredient(s), strength of medicinal ingredients(s), pharmaceutical form and route of administration (numéro d’identification d’un médicament) Establishment licence. Refer to Drug Establishment Licence above Manufacturer. a person, including an association or partnership, who under their own name, or under a trade, design or word mark, trade name or other name, word, or mark controlled by them sells a food or drug (fabricant) (FDR, A.01.010) Person. An individual or an organization as defined in section 2 of the Criminal Code (personne) (FDA, Section 2) Tier 3 drug shortage.

drug shortages that are deemed the most critical national shortages determined by a specially convened Tier Assignment Committee on a case-by-case basis (les pénuries de niveau 3) Transhipment. after goods have been unloaded or in any way removed from the means of transportation by which they came into Canada, their loading, placing on board or within or upon the same or any other means of transportation (transbordement) (Transhipment Regulations Part II, Section 3) Shortage. in respect of a drug, a situation in which the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for the drug is unable to meet the demand for the drug in Canada (pénurie) (FDR, C.01.014.8 (2))References Legislation and regulations Policies and Guides Web pages/Associated documents Contacts Related linksLegislation and regulations Guidance on drug shortages Web pages/Associated documents.

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"We now have the consensus and the commitment of every country to work in an integrated, cross-cutting manner in tackling all the neglected tropical diseases", said Dr Ren Minghui, WHO Assistant Director-General for Universal Health Coverage, Communicable and Noncommunicable Diseases.2030 targetsThe freshly-inked roadmap sets global Viagra 100mg online targets and milestones to prevent, control, eliminate and eradicate 20 neglected tropical diseases and disease groups, which affect hundreds of millions of people.It replaces the first blueprint published in 2012, whose targets will not be achieved, despite significant progress, WHO explained.In addition to a focus on improved coordination and collaboration among health partners in the next decade in all countries, another distinct feature how to get viagra in the us is a drive for greater ownership by governments and communities.The 2030 targets include a 90 per cent reduction in the number of people requiring treatment for neglected tropical diseases and a call to eradicate dracunculiasis – also known as Guinea-worm disease - and the chronic skin disease yaws, that affects mainly children below 15 years of age.“The new road map addresses critical gaps across multiple diseases, integrates and mainstreams approaches within national health systems and coordinates action across sectors," said Dr Mwelecele Ntuli Malecela, Director, WHO Department of Control of Neglected Tropical Diseases. "It also provides us with opportunities to evaluate, assess and adjust programmatic actions as needed over the next decade."Vertical v horizontalThe emphasis of the new approach is on sustainability and follows a decades-old discussion about the relative merits of so-called “vertically” funded programmes that target specific illnesses, compared with the longer-term “horizontal” approach that involves comprehensive primary health care services offering greater overall protection."To do so effectively…countries must change their operating models and culture to facilitate greater ownership of (disease eradication) programmes”, Dr Minghui added, in a call for “smarter investments and high-level political commitment” to reduce the social and economic consequences of neglected tropical diseases.Drugs arsenal neededWhile most neglected tropical disease-control programmes rely on medicines to treat sufferers, WHO has also warned that emerging drug resistance threatens decades of advances.It remains crucial to monitor drug efficacy closely and develop “an appropriate arsenal of second-line drugs” to ensure that populations continue to be protected against neglected tropical diseases, it how to get viagra in the us said.In a related development, erectile dysfunction treatment had played its part in making communities more vulnerable, the UN agency noted, as some people have taken antibiotics in the mistaken belief that they would protect them from the viagra.Antibiotics alarmWhile some countries have seen their antibiotic use dramatically decline during viagra lockdowns, physical distancing and improved hand and respiratory hygiene, “in other situations, antibiotic use has risen alarmingly”, WHO said.These challenges are on the agenda at the annual World Antimicrobial Awareness Week (WAAW) from 18-24 November.Its aims are to increase awareness and understanding of global antimicrobial resistance and encourage best practices among members of the public, health workers and policy-makers, to avoid the further emergence and spread of drug-resistant s.Meningitis and epilepsy resolutionsMember States recommended the adoption of two resolutions on meningitis control and epilepsy at the World Health Assembly on Thursday.Committee A, which focuses on programme and budget matters, decided to recommend the adoption of the first-ever resolution on meningitis, which would approve a global roadmap to defeat meningitis by 2030 – a disease that kills 300,000 people annually and leaves one in five of those affected with devastating long-term consequences.The Committee also recommended the adoption of a resolution calling for scaled-up and integrated action on epilepsy and other neurological disorders such as stroke, migraine and dementia. Neurological disorders are the leading cause of disability and the second leading cause of death how to get viagra in the us worldwide..

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