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October 19, 2020 The Interim Order Respecting the Prevention and Alleviation of Shortages of kamagra for sale Drugs in Relation to erectile dysfunction treatment was signed on October 16, 2020. This interim order (IO) provides more tools for urgently addressing drug shortages related to erectile dysfunction treatment. Under certain conditions, the IO authorizes the Minister of Health to.

require anyone who sells a drug to provide information relevant to a kamagra for sale shortage or potential shortage of that drug related to erectile dysfunction treatment impose or amend terms and conditions on authorizations to sell drugs for the purpose of preventing or alleviating a drug shortage related to erectile dysfunction treatment On this page Why the interim order was introduced The erectile dysfunction treatment kamagra has. caused an unprecedented demand for some drugs contributed to drug shortages in Canada posed a significant risk to the health of Canadians How the interim order will address drug shortages in Canada Reliable and timely information is required for Health Canada to act quickly and effectively to minimize the effects of these shortages on Canadians. Tools such as this new IO will better prepare Canada to respond to the imminent threat of drug shortages from a possible future resurgence of erectile dysfunction treatment.

The IO will allow the Minister to require any person who sells a drug to provide information about a shortage or potential shortage of that drug. The IO gives the Minister this authority if kamagra for sale there are reasonable grounds to believe that. the drug is at risk of going into shortage or is in shortage the shortage is caused or made worse, directly or indirectly, by the erectile dysfunction treatment kamagra the shortage poses a risk of injury to human health the requested information is necessary to identify or assess the shortage.

why it occurred its effects on human health what measures could be taken to prevent or alleviate the shortage the person would not provide the information without a legal obligation To prevent or alleviate a shortage, the Minister may also add or amend terms and conditions to an authorization to sell a drug. The Minister may do so if there are reasonable grounds to believe that.

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Disclaimer http://www.em-hay-reichstett.site.ac-strasbourg.fr/?page_id=1663 how to get kamagra online. This document does not constitute legislation. In the event of any inconsistency or conflict between the legislation and how to get kamagra online 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 how to get kamagra online 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 how to get kamagra online 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 how to get kamagra online 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 how to get kamagra online 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 how to get kamagra online 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 how to get kamagra online 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 how to get kamagra online guidance document sets out Health Canadaâs 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 how to get kamagra online 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 how to get kamagra online. 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 how to get kamagra online 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 how to get kamagra online 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 how to get kamagra online 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 personâs 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 how to get kamagra online exact text from the FDR is provided first. This is followed by Health Canadaâs 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 how to get kamagra online 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, how to get kamagra online DEL holders must evaluate the impact that the distribution would have on Canadaâs 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 how to get kamagra online 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 organizationâs business intelligence, must how to get kamagra online 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 how to get kamagra online 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 how to get kamagra online 3 drug shortage?. Tier 3 drug shortages have the greatest potential impact on Canadaâs 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 how to get kamagra online 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 canât how to get kamagra online be addressed by other suppliers. Will the distribution of the drug for use outside Canada impact your ability to meet your Canadian customersâ requirements?. If yes, it would be difficult to show reasonable grounds to believe that distributing the drug for use outside Canada how to get kamagra online 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 how to get kamagra online 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 how to get kamagra online market share.

Is this a sole-source drug or a drug with a limited number of market authorization holders?. Drug shortages of sole-sourced how to get kamagra online 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 how to get kamagra online 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 how to get kamagra online kamagra 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 how to get kamagra online 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 how to get kamagra online 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 how to get kamagra online decisions to make. Distribution prohibited. If you have reasonable grounds to believe that the how to get kamagra online 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 âRequirements for making and retaining recordsâ) 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 how to get kamagra online (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 how to get kamagra online 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 how to get kamagra online 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 how to get kamagra online 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 how to get kamagra online Drug.shortages-Penurie.de.medicament@hc-sc.gc.ca.Definitions Actual shortage. a manufacturer's current supply cannot meet current demand in Canada (pÃ©nurie rÃ©elle) (refer to "Shortage") Anticipated shortage. a manufacturer's future supply cannot meet projected how to get kamagra online demand in Canada (pÃ©nurie anticipÃ©e) (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 how to get kamagra online Substances Act. Prescription drugs. drugs that are how to get kamagra online 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, how to get kamagra online 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 how to get kamagra online 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'Ã©tablissement 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 how to get kamagra online name, medicinal ingredient(s), strength of medicinal ingredients(s), pharmaceutical form and route of administration (numÃ©ro dâidentification dâun mÃ©dicament) 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) how to get kamagra online 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 pÃ©nuries 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 how to get kamagra online. 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 (pÃ©nurie) (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 documentsDisclaimer. This document how to get kamagra online 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 how to get kamagra online 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 how to get kamagra online on November 27, 2020.

The interim order (IO) allowed Health Canada to compel a market authorization holder (MAH) or drug establishment licence (DEL) holder to provide information on an actual or anticipated drug shortage. The provisions of how to get kamagra online that 1-year IO have been made permanent through amendments to the Food and Drug Regulations. These provisions, contained in section C.01.014.12 of the Food and Drug Regulations (FDR), come into force on November 27, 2021. This date follows the day on which how to get kamagra online the IO ceases to have effect.

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 how to get kamagra online access to the drugs they need when they need them. Health Canada works with stakeholders across the drug supply chain to. Determine the details and status of an actual or anticipated drug shortage coordinate information-sharing between parties identify mitigation strategiesMitigation strategies include exploring access to international supply and facilitating efforts by how to get kamagra online companies, whenever possible and appropriate, to make additional supply available to Canadians.

For more information on drug shortages and the roles of various parties in addressing them, refer to the drug shortages in Canada page. Purpose and scope PurposeThis guidance document is how to get kamagra online 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 help you understand how to get kamagra online section C.01.014.12 of the FDR by outlining.

The circumstances where it is mandatory for MAHs or DEL holders to provide information to Health Canada the manner in which Health Canada would require information to be providedScope InclusionsSection C.01.014.12 of the FDR applies to the following drugs for human use that have a Canadian drug identification number. Drugs that may be sold without a prescription, but are administered only under a practitionerâs supervision also known as âethicalâ drugs (for example, hemodialysis solutions, pre-filled syringes with epinephrine for severe allergic reactions, MRI contrast agents) drugs on the Prescription Drug List drugs listed in Schedules C and D of the Food and Drugs Act drugs listed in Schedules I, II, III, IV or V of the Controlled Drugs and Substances ActExclusionsNatural health products, over-the-counter drugs and drugs for veterinary use are excluded from the scope of these provisions.Responsibilities of MAHs/DEL holders and Health CanadaSection C.01.014.12 of how to get kamagra online the FDR applies to MAHs and DEL holders. For more information on when DELs are required and how to obtain one, refer to the Guidance on drug establishment licences (GUI-0002).Responsibilities of MAHs and DEL holdersMAHs and DEL holders are responsible for providing the needed information on an actual or anticipated drug shortage to Health Canada in the format and time limit indicated by Health Canada. Responsibilities of how to get kamagra online Health CanadaHealth Canada determines the drugs for which information is needed in order to prevent or mitigate a drug shortage.

Health Canada will provide MAHs and DEL holders with a reasonable amount of time to provide the information. As per laws governing the use of information, Health Canada will use the information only for the purpose how to get kamagra online for which it was collected. Health Canada may take compliance and enforcement actions for failure to meet the requirements of these regulations. Consult our compliance and enforcement policy for health products (POL-0001).The regulations In the section below, the exact text from the FDR (section how to get kamagra online C.02.014.12) is provided first, followed by an interpretation.Text on providing informationRegulatory textThe Minister may request that the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug, or any person who holds an establishment licence in respect of a drug, provide the Minister with information that is in their control if the Minister has reasonable grounds to believe that.

There is a shortage or risk of shortage of the drug. the information is necessary to establish or assess the existence of a shortage or risk of shortage of the drug, the reason for a shortage or risk of shortage of the how to get kamagra online drug, the effects or potential effects on human health of a shortage of the drug, or measures that could be taken to prevent or alleviate a shortage of the drug. And the manufacturer or licensee will not provide the information without a legal obligation to do so. (section C.01.014.12 (1)) InterpretationA person is an individual or an organization as defined in section 2 of the Criminal Code.Health Canada will act on behalf of the Minister in assuming the how to get kamagra online responsibilities mentioned above.Three conditions must be met for Health Canada to require you to provide information on an actual or anticipated drug shortage.

Health Canada must have reasonable grounds to believe that. Thereâs a shortage of the drug or the drug is at risk of going into shortage the information is necessary to establish or assess one or more of the following. the existence of a drug shortage or risk of shortage for the drug the reasons for a drug shortage or risk of shortage for the drug the effects or potential effects on human health of a shortage of the drug measures that could be how to get kamagra online taken to prevent or alleviate a shortage of the drug the MAH or DEL holder will not provide the information without a legal obligation to do soHealth Canada considers a number of factors when determining whether to collect information on a drug and when assessing the type of information to be provided. These include.

Mandatory drug shortage reports environmental scans inspection reports or reports covering other quality issues information from within the federal government or from external sources such as patients, health care professionals, provincial and territorial partners, and international regulatory agencies media reports consultations with how to get kamagra online clinicians academic literature past experience or knowledgeNote. Health Canada will continue to work with companies, provinces and territories and stakeholders from across the supply chain to address actual or anticipated shortages. Sharing information voluntarily helps mitigate how to get kamagra online shortages. This regulatory power will only be used where the criteria for requiring the information have been met and the information is not voluntarily provided by the MAH/DEL holder.

Types of information that must be providedHealth Canada can only use the authority under these regulations to how to get kamagra online obtain from an MAH or a person who holds a DEL information that is within their control. Process for providing informationHealth Canada will provide the MAH or DEL holder with a set of instructions for providing the information. The MAH how to get kamagra online or DEL holder will also receive a written reason for why this information is required. This allows for more transparent decision-making.A request for required information will include.

The name of the MAH or DEL holder the regulatory authority being how to get kamagra online relied upon the drug(s) in question a description of the information in the person's control that the Minister has reasonable grounds to believe is necessary to determine if. the product is at risk of a drug shortage and the drug shortage presents a risk to human health or the information could help prevent or alleviate the drug shortage the timeframe for providing the information the format for submitting the informationThe information must be submitted by the deadline in the format specified.Health Canada may follow up with more questions should the need arise.Contact us For 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 how to get kamagra online supply cannot meet current demand in Canada (pÃ©nurie rÃ©elle) (refer to "Shortage") Anticipated shortage. a manufacturer's future supply cannot meet projected demand in Canada (pÃ©nurie anticipÃ©e) (refer to "Shortage") Drug.

any of the following drugs for human how to get kamagra online use. drugs included in Schedule I, II, III, IV or V to the Controlled Drugs and Substances Act. Prescription drugs how to get kamagra online. Drugs that are listed in Schedule C or D to the Act.

And drugs that how to get kamagra online 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 how to get kamagra online 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 (Licence d'Ã©tablissement de produits pharmaceutiques (LEPP)) Drug identification number (DIN).

an 8-digit numerical code how to get kamagra online 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, route of administration (numÃ©ro dâidentification dâun mÃ©dicament) 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) Market authorization holder (MAH).

the legal entity that holds the notice of compliance, the drug identification number (DIN), the medical device licence, the product licence or that has received authorization to import and sell a drug for the purpose of a clinical trial (dÃ©tenteurs d'une autorisation de mise sur le marchÃ© (DAMM)) Person. an individual or an organization as defined in section 2 of the Criminal Code (personne) (FDA, section 2) 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 (pÃ©nurie) (FDR, C.01.014.8 (2))References Legislation and regulations Policies and Guides Web pages/Associated documents ContactsHealth Canada Drug Shortages Division Drug.shortages-Penurie.de.medicament@hc-sc.gc.caRelated linksLegislation and regulations Guidance on drug shortages.

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 Canadaâs 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 personâs 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 Canadaâs 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 Canadaâs 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 organizationâs 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 Canadaâs 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 canât be addressed by other suppliers. Will the distribution of the drug for use outside Canada impact your ability to meet your Canadian customersâ 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 kamagra 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 âRequirements for making and retaining recordsâ) 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 (pÃ©nurie rÃ©elle) (refer to "Shortage") Anticipated shortage. a manufacturer's future supply cannot meet projected demand in Canada (pÃ©nurie anticipÃ©e) (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'Ã©tablissement 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 (numÃ©ro dâidentification dâun mÃ©dicament) 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 pÃ©nuries 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 (pÃ©nurie) (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 documentsDisclaimer. 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) allowed Health Canada to compel a market authorization holder (MAH) or drug establishment licence (DEL) holder to provide information on an actual or anticipated 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 section C.01.014.12 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.

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 works with stakeholders across the drug supply chain to. Determine the details and status of an actual or anticipated drug shortage coordinate information-sharing between parties identify mitigation strategiesMitigation strategies include exploring access to international supply and facilitating efforts by companies, whenever possible and appropriate, to make additional supply available to Canadians.

For more information on drug shortages and the roles of various parties in addressing them, refer to the drug shortages in Canada page. Purpose and scope PurposeThis 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 help you understand section C.01.014.12 of the FDR by outlining.

The circumstances where it is mandatory for MAHs or DEL holders to provide information to Health Canada the manner in which Health Canada would require information to be providedScope InclusionsSection C.01.014.12 of the FDR applies to the following drugs for human use that have a Canadian drug identification number. Drugs that may be sold without a prescription, but are administered only under a practitionerâs supervision also known as âethicalâ drugs (for example, hemodialysis solutions, pre-filled syringes with epinephrine for severe allergic reactions, MRI contrast agents) drugs on the Prescription Drug List drugs listed in Schedules C and D of the Food and Drugs Act drugs listed in Schedules I, II, III, IV or V of the Controlled Drugs and Substances ActExclusionsNatural health products, over-the-counter drugs and drugs for veterinary use are excluded from the scope of these provisions.Responsibilities of MAHs/DEL holders and Health CanadaSection C.01.014.12 of the FDR applies to MAHs and DEL holders. For more information on when DELs are required and how to obtain one, refer to the Guidance on drug establishment licences (GUI-0002).Responsibilities of MAHs and DEL holdersMAHs and DEL holders are responsible for providing the needed information on an actual or anticipated drug shortage to Health Canada in the format and time limit indicated by Health Canada. Responsibilities of Health CanadaHealth Canada determines the drugs for which information is needed in order to prevent or mitigate a drug shortage.

Health Canada will provide MAHs and DEL holders with a reasonable amount of time to provide the information. As per laws governing the use of information, Health Canada will use the information only for the purpose for which it was collected. Health Canada may take compliance and enforcement actions for failure to meet the requirements of these regulations. Consult our compliance and enforcement policy for health products (POL-0001).The regulations In the section below, the exact text from the FDR (section C.02.014.12) is provided first, followed by an interpretation.Text on providing informationRegulatory textThe Minister may request that the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug, or any person who holds an establishment licence in respect of a drug, provide the Minister with information that is in their control if the Minister has reasonable grounds to believe that.

There is a shortage or risk of shortage of the drug. the information is necessary to establish or assess the existence of a shortage or risk of shortage of the drug, the reason for a shortage or risk of shortage of the drug, the effects or potential effects on human health of a shortage of the drug, or measures that could be taken to prevent or alleviate a shortage of the drug. And the manufacturer or licensee will not provide the information without a legal obligation to do so. (section C.01.014.12 (1)) InterpretationA person is an individual or an organization as defined in section 2 of the Criminal Code.Health Canada will act on behalf of the Minister in assuming the responsibilities mentioned above.Three conditions must be met for Health Canada to require you to provide information on an actual or anticipated drug shortage.

Health Canada must have reasonable grounds to believe that. Thereâs a shortage of the drug or the drug is at risk of going into shortage the information is necessary to establish or assess one or more of the following. the existence of a drug shortage or risk of shortage for the drug the reasons for a drug shortage or risk of shortage for the drug the effects or potential effects on human health of a shortage of the drug measures that could be taken to prevent or alleviate a shortage of the drug the MAH or DEL holder will not provide the information without a legal obligation to do soHealth Canada considers a number of factors when determining whether to collect information on a drug and when assessing the type of information to be provided. These include.

Mandatory drug shortage reports environmental scans inspection reports or reports covering other quality issues information from within the federal government or from external sources such as patients, health care professionals, provincial and territorial partners, and international regulatory agencies media reports consultations with clinicians academic literature past experience or knowledgeNote. Health Canada will continue to work with companies, provinces and territories and stakeholders from across the supply chain to address actual or anticipated shortages. Sharing information voluntarily helps mitigate shortages. This regulatory power will only be used where the criteria for requiring the information have been met and the information is not voluntarily provided by the MAH/DEL holder.

Types of information that must be providedHealth Canada can only use the authority under these regulations to obtain from an MAH or a person who holds a DEL information that is within their control. Process for providing informationHealth Canada will provide the MAH or DEL holder with a set of instructions for providing the information. The MAH or DEL holder will also receive a written reason for why this information is required. This allows for more transparent decision-making.A request for required information will include.

The name of the MAH or DEL holder the regulatory authority being relied upon the drug(s) in question a description of the information in the person's control that the Minister has reasonable grounds to believe is necessary to determine if. the product is at risk of a drug shortage and the drug shortage presents a risk to human health or the information could help prevent or alleviate the drug shortage the timeframe for providing the information the format for submitting the informationThe information must be submitted by the deadline in the format specified.Health Canada may follow up with more questions should the need arise.Contact us For 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 (pÃ©nurie rÃ©elle) (refer to "Shortage") Anticipated shortage. a manufacturer's future supply cannot meet projected demand in Canada (pÃ©nurie anticipÃ©e) (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 (Licence d'Ã©tablissement 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, route of administration (numÃ©ro dâidentification dâun mÃ©dicament) 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) Market authorization holder (MAH).

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