Vol. 151, No. 9 — March 4, 2017

Regulations Amending the Food and Drug Regulations and the Regulations Amending the Food and Drug Regulations (Shortages of Drugs and Discontinuation of Sale of Drugs)

Statutory authority

Food and Drugs Act

Sponsoring department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the regulations.)

Issues

This regulatory proposal would amend the Food and Drug Regulations (FDR) to address the following issues.

1. Lack of drug identification number requirements for Schedule C drugs

When Health Canada grants market authorization to a drug, a drug identification number (DIN) is issued and printed on the label of the drug. This DIN is used for a variety of regulatory purposes, including tracking of market status. Radiopharmaceuticals and drugs that are sold or represented for use in the preparation of radiopharmaceuticals (other than radionuclides) are listed in Schedule C to the Food and Drugs Act. Schedule C drugs are presently exempt from the DIN issuance requirement; thus, Health Canada does not have a mechanism to track their market authorization status and cannot easily ascertain which of them are currently available on the Canadian market. This exemption has led to difficulties finding accurate and timely information about Schedule C drugs, such as identifying alternative products on the market during drug shortage situations.

2. Discrepancies in the requirements regarding notification of 12 months of no sale for certain DIN products

Health Canada’s publicly accessible Drug Product Database (DPD) is a repository of information for all drugs authorized for sale in Canada that uses the DIN as the primary identifier. As part of the Regulations Amending the Food and Drug Regulations (Shortages of Drugs and Discontinuation of Sale of Drugs) (see footnote 1) [the Shortages and Discontinuation Regulations], a new provision was introduced that requires manufacturers to notify Health Canada within 30 days when a drug has not been sold for a period of 12 months. Once Health Canada has been notified of this fact, the status of the drug in the DPD will change from “marketed” to “dormant” to better reflect the market status. With this information, practitioners can make informed decisions on treatment options for their patients. This requirement, however, only covers certain classes of drugs and does not include all DIN products, such as non-prescription drugs and veterinary drugs. As a result, discrepancies exist between the current market statuses of all classes of DIN products in the DPD. This is problematic when practitioners and patients are relying on the DPD for accurate information.

Background

DINs for Schedule C drugs

Radiopharmaceuticals are drugs that exhibit radioactive properties and are used for diagnostic and therapeutic purposes. Radiopharmaceuticals are listed in Schedule C to the Food and Drugs Act, along with kits for the preparation of radiopharmaceuticals.

Prior to 1998, Schedule C licences were issued to manufacturers annually for Schedule C drugs. Each Schedule C licence listed all the products that were being marketed by a manufacturer at that time, and these were renewed on an annual basis. These licences were replaced by establishment licences in 1998. Since then, Schedule C drugs have been required to be labelled with the establishment licence number.

For other classes of drugs, a DIN is issued for each drug product that is authorized for sale in Canada and serves as a unique identifier that has, historically, been primarily used for reimbursement purposes by insurance companies. As most radiopharmaceuticals are administered parenterally (i.e. intravenously or via intramuscular injection) and are commonly prepared and administered by health care professionals in a clinical or hospital setting, DINs were deemed not to be required for reimbursement purposes. Therefore, Schedule C drugs were exempted from the DIN requirement.

Over time, the purpose of the DIN has evolved. Today, Health Canada uses a DIN for a variety of regulatory activities, such as the tracking of market status of a drug and displaying associated information within the public DPD. The Canada Border Services Agency (CBSA) uses a DIN to aid in compliance and enforcement activities with respect to the importation of drugs. A manufacturer’s authority to sell a product on the Canadian market is represented through the issuance of a DIN. Health Canada can similarly revoke the authority to sell a product that has been shown in the post-market context to be unsafe or for other reasons, such as non-compliance with the regulations, through the cancellation of a DIN.

Currently, once a DIN has been assigned, the manufacturer of the drug must provide Health Canada with a notification within 30 days of selling a drug in Canada. By means of an Annual Drug Notification Form, the manufacturer also confirms that all the information previously supplied with respect to that drug is correct. This information is used by Health Canada for a variety of regulatory activities, such as the tracking of market status of the drug in the DPD.

As Schedule C drugs are currently exempt from the DIN requirement, manufacturers are not required to provide market notification or an Annual Drug Notification Form. In the absence of such information on Schedule C drugs in the DPD, it has been difficult to determine which radiopharmaceutical products are available on the Canadian market. This was particularly evident during the isotope shortages that followed the shutdowns of the Chalk River National Research Universal nuclear reactor facility in 2007–2008 and 2009–2010. (see footnote 2) It was difficult for Health Canada to identify radioisotope alternatives during this shortage period due to the lack of an up-to-date list of Schedule C drugs on the market.

Notifications to Health Canada

Presently, when a drug product receives approval from Health Canada and is issued a DIN, it is listed on the DPD as “approved.” Once a manufacturer notifies Health Canada that the sale of this product has commenced, the status is changed to “marketed.” When the product is discontinued and the DIN cancelled, the status is changed to “cancelled.” If at any time the sale of the product stops, but the DIN is still active, the status of the drug remains “marketed” even though it is not available on the Canadian market.

Beginning in spring 2017, a provision in the FDR will come into force as part of the Shortages and Discontinuation Regulations that will require manufacturers (authorization holders) of certain drugs to notify Health Canada within 30 days when a period of 12 months of no sale has elapsed. Once this provision comes into force, a new “dormant” status will be introduced in the DPD. When a manufacturer notifies Health Canada that a product has not been sold for a period of 12 months, the status of the drug in the DPD will be changed from “marketed” to “dormant” to better reflect the market status and allow the public to easily distinguish drug products that are readily available on the Canadian market.

Objectives

The objectives of the proposed regulatory amendments are to amend the FDR to

  1. Remove the DIN exemption and clearly outline the labelling requirements for Schedule C drugs in order to align the DIN application process and labelling requirements for Schedule C drugs with the application process and labelling requirements of all other drug products that have DINs.
  2. Require Schedule C drug manufacturers to notify Health Canada within 30 days of a product being marketed or discontinued.
  3. Broaden the scope of the notification of 12 months with no sale to require manufacturers of all DIN products not covered under the Shortage and Discontinuation Regulations to notify Health Canada after a 12-month period of no sale as part of the annual notification process.

Description

The proposed amendments would remove the exemptions to DIN requirements with respect to Schedule C drugs, thus aligning the DIN application process and labelling requirements for Schedule C drugs with the application process and labelling requirements of all other drug products all other drug products for which a DIN has been assigned. It would also harmonize the requirement regarding the notification of 12 months with no sale for all DIN products and create a means for Health Canada to maintain a current and accurate list of marketed products.

DIN requirements

Under the proposed amendments, Part C of the FDR would be amended to remove the exemption from the requirement to be issued a DIN in order to be sold in Canada for all Schedule C drugs. In turn, manufacturers of Schedule C drugs that are currently on the market and that are sold pursuant to a notice of compliance would be required to submit an application for a DIN. When authorized, the manufacturer would be issued a Drug Notification Form, through which the DIN is assigned.

For all other Schedule C new drugs in respect of which a notice of compliance has not yet been issued, manufacturers of those drugs would be required to file a new drug submission or abbreviated new drug submission as per Part C of the FDR and, if authorized, would be assigned a DIN.

A second amendment to Part C would require that manufacturers of Schedule C drugs, like all other drugs assigned a DIN, notify Health Canada within 30 days of commencing sale once a Drug Notification Form has been issued. Additional amendments made to Part C of the FDR would require the manufacturer to either resubmit the application or notify Health Canada should any information as part of the DIN application change.

Labelling requirements

Labelling requirements for Schedule C drugs in Part C of the FDR would be consistent with the requirements of all drugs for which a DIN has been assigned. Establishment licence numbers would no longer be required on product labels and would be replaced by the DIN.

Distributors and distribution activities

The definition of distributor found in Part C would be amended to reflect the issuance of DINs for Schedule C drugs. Likewise, the list of activities for establishment licence holders would be amended to encompass the distribution of active ingredients that are used in the making of Schedule C non-biologic drugs.

Alignment of DIN provisions

Currently, several provisions in Part C of the FDR are written in such a way that drug products with a DIN, radiopharmaceuticals, and kits for the preparation of radiopharmaceuticals are listed separately. Since Schedule C drugs would be included in the category of drugs that have been assigned a DIN under the proposed amendments, these sections would be amended to reflect one single category of drugs.

Notification of 12 months with no sale

When the Shortages and Discontinuation Regulations come into force in spring 2017, the provisions regarding the requirement to notify Health Canada of 12 months with no sale will only apply to those products that meet the definition of “drug” under those Regulations (e.g. prescription drugs). In order to bring uniformity to the regulations, the proposed amendments would require notification for all products that have received a DIN (i.e. Health Canada would need to be notified of all drug products for which a DIN has been assigned).

Language consistency between English and French versions of the FDR

Several provisions were identified by the Department of Justice where the English and French texts are inconsistent. The following provisions would be amended in order to harmonize the wording between the English and French versions with no change to the original intent:

Consequential amendments — Assignment and cancellation of drug identification numbers

In order to accurately reflect how the regulations have been administered and eliminate unnecessary language, references to “the importer” and to “a person authorized by a manufacturer” would be removed from the provisions regarding the assignment and cancellation of DINs. References to “the manufacturer” would be aligned with those found in the provisions regarding drug shortages and discontinuations. These proposed amendments aim to improve the wording of the regulations without changing the original intent or the current operational process.

The provision regarding the annual notification process would be amended to specify the information to be submitted as part of the notification. This proposed amendment aims to bring more transparency to the regulations with respect to the manufacturer’s obligation without changing the original intent or current practice.

Consequential amendments — Drug shortage and discontinuation provisions

With the proposed addition of DIN requirements for Schedule C drugs, the recent amendments to the FDR concerning drug shortages and discontinuations would be updated to reflect this change. The new definition for “authorization holder” that was instituted to ensure that manufacturers of Schedule C drugs were captured under the new provisions would be removed; this change would be reflected throughout the provisions.

Consequential amendments — Fees in Respect of Drugs and Medical Devices Regulations

Amendments are also proposed to the Fees in Respect of Drugs and Medical Devices Regulations (Fee Regulations) in order to exempt manufacturers of Schedule C drugs from the fees associated with the review of a DIN application. Schedule C drug manufacturers would also be exempt from the annual right to sell fee. Current fees levied to Schedule C drug manufacturers, such as the New Drug Submission fee and the Establishment Licence fee, would continue to apply with no change to the fee level. This would be a temporary measure until a review of the Fee Regulations could be undertaken, in compliance with the User Fees Act, to expand the scope of the fees related to possession of a DIN to encompass Schedule C drugs.

Transitional provisions

Schedule C drugs that received authorizations, and that are labelled in accordance with the current Part C of the FDR, could continue to be sold on the Canadian market for a specified period of time (as outlined below) after the proposed amendments to the FDR would come into force.

Coming into force

The proposed amendments would come into force six months after the day on which they are published in the Canada Gazette, Part II.

“One-for-One” Rule

The “One-for-One” Rule applies to this proposal and would be considered an “IN.” The annual administrative cost of completing and submitting the Annual Drug Notification Form is expected to be $56 per product. Approximately 250 Schedule C drugs are estimated to be on the market, and the total administrative cost is expected to be $14,000 on an annual basis.

Additionally, manufacturers of remaining DIN products not included in previous amendments within the FDR would be required to notify Health Canada if their product has not been sold for a period of 12 months. There is an estimated backlog of 1 150 dormant DIN products, and 200 dormant products are anticipated to be reported annually. The administrative cost to notify is expected to be $75,600 the first year, and $11,200 every year thereafter, if done separately from the annual notification process. However, since industry will be able to notify Health Canada of dormant products through the annual notification process, these costs are expected to be much lower.

The net present value of these administrative costs over 10 years is $249,571, or $190,396 in 2012 dollars. The annualized cost, in 2012 dollars, is $19,225.

Small business lens

The small business lens does not apply to this proposal, as the total costs of the amendments are less than $1 million.

Consultation

In July 2007, a notice of intent outlining Health Canada’s intent to develop regulations to remove the DIN exemption for Schedule C drugs was published in the Canada Gazette, Part I. During the 30-day consultation period, two comments were received from industry stakeholders, and both were supportive of the proposal. Stakeholders did not express any concerns regarding the potential for an increased burden associated with a DIN application and confirmed that there would not be any undue financial burden with respect to changing labels, given that non-DIN labelled products could continue to be sold during the transition period.

On September 20, 2011, Health Canada sent a letter to radiopharmaceutical stakeholders to inform them and solicit their input regarding the proposed changes for the DIN requirements for Schedule C drugs. Their feedback was positive.

Throughout the development of the proposed amendments, Health Canada has communicated with industry via regular stakeholder meetings and workshops. These meetings include a biannual meeting with the Nuclear Medicine Alliance, a group representing nuclear medicine companies, as well as a biannual meeting with the Canadian Association of Nuclear Medicine and the Canadian Association of Radiopharmaceutical Scientists, representing non-industry radiopharmaceutical stakeholders. Health Canada will continue to provide information and updates to stakeholders through its annual Radiopharmaceutical Regulatory Workshops.

A survey regarding the notification of no sale after 12 months for products that do not fall under the Shortages and Discontinuation Regulations was sent out to stakeholders on July 19, 2016. Respondents indicated that, while supportive of the proposal to expand the scope to capture all products assigned a DIN, the burden of notifying Health Canada would be greatly reduced if it were possible to do so as part of the annual notification process. Health Canada agrees, and the proposal has been amended so that products captured under the definition of drug by the Shortages and Discontinuation Regulations will continue to be required to be reported within 30 days after a period of 12 months of no sale has elapsed, while all other products assigned a DIN would be required to be reported as part of the annual notification process.

Rationale

DINs for Schedule C drugs

All drugs in dosage form, other than Schedule C drugs, regulated under the FDR have a DIN assigned upon authorization by Health Canada which must appear on the product label. Not requiring that a DIN be assigned to Schedule C drugs has given rise to a number of regulatory inconsistencies. Specifically, Schedule C drugs are not required to be reported to Health Canada once their sale on the Canadian market has begun, nor are notices required to be given when sales of radiopharmaceuticals are discontinued. Furthermore, since no mechanism exists to cancel a notice of compliance (the type of market authorization that Schedule C drugs receive), Health Canada does not have the authority to cancel market authorizations for these drugs. Under this proposal, Schedule C drugs would be subject to the same requirements, such as market notification and discontinuance of sales notification, as all DIN products. This would bring the regulatory oversight of these products into alignment with other products that have been assigned a DIN.

Despite the addition of Schedule C drugs to the DPD in 2015, the information within the database is still incomplete. Affected stakeholders may be unable to find adequate information relating to available alternatives when faced with a possible drug shortage. As the DPD is a publicly available database, this proposal would make market status information for Schedule C drugs available to physicians and other health care stakeholders. This is an important mitigation measure during shortages, discontinuations, and when a drug is not sold for a period of 12 months or more. Additionally, a DIN for Schedule C drugs would allow for easier identification, monitoring, and recall of these products. For example, the CBSA could access the DPD for complete and reliable information to aid in compliance activities and law enforcement in terms of drug importation. Health care institutions (hospitals and clinics) could easily identify affected drugs during product recall situations.

The proposed amendments would also bring Schedule C drugs into the scope of products more readily eligible for reimbursement through public and private insurance. Some stakeholders identified the lack of a DIN as being the primary reason why some insurers would refuse a claim.

The change in labelling requirements associated with this proposal is expected to result in costs of $1,000 per product, considering a sufficient coming-into-force period to reduce the costs associated with packaging change. Assuming that there are 250 radiopharmaceuticals currently authorized to be marketed in Canada, this requirement is expected to result in a one-time cost of $250,000. The proposal would also require manufacturers to fill out and submit a DIN application form and market notification, as well as an Annual Drug Notification Form to confirm that the information previously supplied with regard to the product is correct. This would cost industry $28,000 the first year, and $14,000 every year thereafter. The cost to Health Canada of issuing and processing DINs is conservatively estimated to be $35,360. Proposed amendments to add remission provisions to the Fee Regulations would ensure that there would not be any new or higher user fees paid by manufacturers of Schedule C products. These fees, expected to add up to $282,000 annually, would instead be absorbed by Health Canada until consultations take place and user fees can be updated in accordance with the User Fees Act.

Notifications to Health Canada

As of spring of 2017, new regulatory rules will require manufacturers to notify Health Canada within 30 days when a period of 12 months of no sale has elapsed. Once this provision comes into force, it will only apply to certain classes of drugs, but not to all DIN products. This will create discrepancies in the DPD where some products with active DINs not being sold in Canada will have a status of “marketed” while others will have a status of “dormant.”

The proposed amendment would align all DIN products in the DPD by broadening the scope of the notification to require manufacturers of all DIN products to notify Health Canada after a 12-month period of no sale within 30 days for drugs captured under the definition of drug by the Shortages and Discontinuation Regulations and as part of the annual notification process for all other products that have been assigned a DIN. It would allow Health Canada to clearly and easily distinguish between products that have been granted an authorization to be sold in Canada but are not actively being sold, and those that are presently available for sale on the Canadian market. Having this distinction on Health Canada’s website will help patients, health care practitioners, and other health care stakeholders to have a clear and current picture of which drugs are available on the Canadian market. Furthermore, it would allow DIN holders to maintain their DIN in the event that they decide to resume marketing their product.

There are approximately 1 150 DIN products which are not actively being sold, and it is expected that there will be 200 dormant products annually. Notifying Health Canada of these products is expected to cost industry $75,600 the first year, and $11,200 every year thereafter, if done separately from the annual notification process. However, since industry will be able to notify Health Canada of dormant products through the annual notification process, these costs are expected to be much lower.

Health Canada will be required to process this backlog of notifications at a cost of $34,466 the first year, as well as the notifications for 200 dormant products every year thereafter, at a cost of $6,894 per year.

The benefits of this proposal, as stated above, are expected to outweigh the costs to industry of applying for DINs, changing labels and notifying Health Canada following a period of no sale, as well as the costs to Health Canada for processing and issuing said DINs, and processing notifications for dormant DIN products.

Contact

Bruno Rodrigue
Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Address Locator: 3105A
Holland Cross, Tower B, 5th Floor
1600 Scott Street
Ottawa, Ontario
K1A 0K9
Email: LRM_MLR_consultations@hc-sc.gc.ca

New! Provide your comments on the proposed regulations online at https://regconsultation.ca/consultation/a8r-en.html. This pilot project is designed to improve ways to gather your feedback.

PROPOSED REGULATORY TEXT

Notice is given that the Governor in Council, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act (see footnote b), proposes to make the annexed Regulations Amending the Food and Drug Regulations and the Regulations Amending the Food and Drug Regulations (Shortages of Drugs and Discontinuation of Sale of Drugs).

Interested persons may make representations concerning the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice and be addressed to Bruno Rodrigue, Director, Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health, Address Locator: 3105A, Holland Cross, Tower B, 5th Floor, 1600 Scott Street, Ottawa, Ontario K1A 0K9 (email: LRM_MLR_consultations@hc-sc.gc.ca).

Ottawa, February 23, 2017

Jurica Čapkun
Assistant Clerk of the Privy Council

Regulations Amending the Food and Drug Regulations and the Regulations Amending the Food and Drug Regulations (Shortages of Drugs and Discontinuation of Sale of Drugs)

Food and Drug Regulations

1 Subsection C.01.005(1) of the Food and Drug Regulations (see footnote 3) is replaced by the following:

C.01.005 (1) The principal display panel of both the inner and outer label of a drug sold in dosage form shall show in a clear and legible manner the drug identification number assigned for that drug, preceded by the expression “Drug Identification Number” or “Drogue : identification numérique”, or both, or the abbreviation “DIN”.

2 Subsection C.01.014(2) of the Regulations is replaced by the following:

(2) Subsection (1) does not apply in respect of a study drug as defined in section C.03.301 or a medicated feed as defined in subsection 2(1) of the Feeds Regulations, 1983.

3 (1) Subsection C.01.014.1(1) of the Regulations is replaced by the following:

C.01.014.1 (1) A manufacturer of a drug may make an application for a drug identification number for that drug.

(2) Paragraph C.01.014.1(2)(o) of the Regulations is replaced by the following:

4 (1) The portion of subsection C.01.014.2(1) of the Regulations before paragraph (a) is replaced by the following:

C.01.014.2 (1) Subject to subsection (2), if a manufacturer has provided all the information and material described in subsection C.01.014.1(2) or section C.08.002, C.08.002.01 or C.08.002.1, as the case may be, in respect of a drug, the Director shall issue to the manufacturer a document that

(2) Subparagraphs C.01.014.2(1)(a)(i) and (ii) of the English version of the Regulations are re- placed by the following:

(3) The portion of subsection C.01.014.2(2) of the Regulations before paragraph (a) is replaced by the following:

(2) The Director may refuse to issue the document referred to in subsection (1) if he or she has reasonable grounds to believe that the product in respect of which an application referred to in section C.01.014.1 has been made

(4) Paragraph C.01.014.2(2)(b) of the Regulations is replaced by the following:

(5) The portion of subsection C.01.014.2(2) of the English version of the Regulations after paragraph (b) is repealed.

(6) Subsections C.01.014.2(3) and (4) of the Regulations are replaced by the following:

(3) If the Director refuses to issue the document under subsection (2), the manufacturer may submit additional information or material and request the Director to reconsider his or her decision.

(4) On the basis of the additional information or material submitted under subsection (3), the Director shall reconsider the grounds on which the refusal to issue the document was made.

5 Section C.01.014.3 of the Regulations is replaced by the following:

C.01.014.3 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 shall, within 30 days after the day on which the drug is first sold following the issuance by the Director of the document, date and sign the document and return it to the Director with a statement set out on it that the information it contains is correct and with an indication of the date of that first sale.

6 Sections C.01.014.5 and C.01.014.6 of the Regulations are replaced by the following:

C.01.014.5 (1) 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 shall, annually before the first day of October and in a form established by the Director, provide the Director with a notification that is signed by them and that

(2) If any of the information that the manufacturer provided under a provision referred to in paragraph (1)(b) is not correct as of the day on which the notification is sent, the manufacturer shall update that information in the notification.

C.01.014.6 (1) The Director shall cancel the assignment of a drug identification number for a drug if

(2) The Director may cancel the assignment of a drug identification number for a drug if

7 Paragraph C.01A.003(a) of the Regulations is replaced by the following:

8 Paragraphs C.01A.004(1)(c) and (d) of the Regulations are replaced by the following:

9 (1) Item 4 of Table I to section C.01A.008 of the Regulations is replaced by the following:

Item Activities
4 Distribute as a distributor referred to in paragraph C.01A.003(a) an active ingredient that is not an active pharmaceutical ingredient or an active ingredient that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Act

(2) Item 5 of Table I to section C.01A.008 of the English version of the Regulations is replaced by the following:

Item Activities
5 Distribute as a distributor referred to in paragraph C.01A.003(b)

(3) Item 7 of Table I to section C.01A.008 of the Regulations is replaced by the following:

Item Activities
7 Wholesale a drug that is not an active pharmaceutical ingredient or an active ingredient that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Act

10 Paragraph C.02.020(1)(a) of the Regulations is replaced by the following:

11 (1) Paragraph C.03.202(1)(a) of the Regulations is amended by striking out “and” at the end of subparagraph (ii) and by adding the following after subparagraph (iii):

(2) Subparagraph C.03.202(1)(b)(v) of the Regulations is repealed.

(3) Section C.03.202 of the Regulations is amended by adding the following after subsection (1):

(2) Subparagraph (1)(a)(iv) does not apply to a radiopharmaceutical that is

12 (1) Paragraph C.03.203(1)(e) of the Regulations is replaced by the following:

(2) Section C.03.203 of the Regulations is amended by adding the following after subsection (2):

(3) Section C.01.005 does not apply to a radionuclide generator.

13 The heading before section C.03.205 of the French version of the Regulations is replaced by the following:

Drogues, autres que les radionucléides, vendues pour être employées dans la préparation de produits pharmaceutiques radioactifs ou représentées comme pouvant servir à cette fin

14 Section C.03.205 of the Regulations is replaced by the following:

C.03.205 The following definitions apply in sections C.03.206 to C.03.209.

component means

kit means a package that is intended to be used in the preparation of radiopharmaceuticals and that

15 Section C.03.207 of the Regulations is renumbered as subsection C.03.207(1) and is amended by adding the following:

(2) The component of a kit that is intended to contain the prepared radiopharmaceutical shall be labelled to display the drug identification number assigned for the kit, preceded by the expression “Drug Identification Number” or “Drogue : identification numérique”, or both, or the abbreviation “DIN”.

16 (1) Paragraph C.03.208(e) of the Regulations is replaced by the following:

(2) Section C.03.208 of the Regulations is renumbered as subsection C.03.208(1) and is amended by adding the following:

(2) Paragraph (1)(e) does not apply to a kit that is

17 Paragraph C.08.002(2)(o) of the Regulations is replaced by the following:

18 Subparagraph C.08.003(3.1)(b)(i) of the Regulations is replaced by the following:

Regulations Amending the Food and Drug Regulations (Shortages of Drugs and Discontinuation of Sale of Drugs)

19 (1) Section 1 of the Regulations Amending the Food and Drug Regulations (Shortages of Drugs and Discontinuation of Sale of Drugs) (see footnote 4) is amended by repealing the definition authorization holder that it enacts.

(2) Section 1 of the Regulations is amended by replacing the definition discontinue that it enacts with the following:

discontinue means, in respect of the sale of a drug by 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, to permanently cease the sale of the drug. (cesser)

20 Section 3 of the Regulations is repealed.

21 (1) Section 5 of the Regulations is amended by replacing the sections C.01.014.7 and C.01.014.8 that it enacts with the following:

C.01.014.7 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 shall, within 30 days after the day on which they discontinue the sale of the drug, submit the following information to the Minister:

C.01.014.71 If a period of 12 months has elapsed since 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 as defined in section C.01.014.8 last sold the drug, the manufacturer shall notify the Minister in writing of the 12-month period within 30 days after the day on which that period ends.

C.01.014.72 If 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 resumes the sale of the drug after a period of 12 months during which they did not sell the drug, the manufacturer shall notify the Minister in writing of the resumption within 30 days after the day on which they resume the sale of the drug.

C.01.014.8 The following definitions apply in this section and in sections C.01.014.9 to C.01.014.11.

drug means any of the following drugs for human use for which a drug identification number has been assigned:

shortage means, 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. (pénurie)

(2) Section 5 of the Regulations is amended by replacing the portion of the subsection C.01.014.9(1) before paragraph (c) that it enacts with the following:

C.01.014.9 (1) If a shortage of a drug exists or is likely to occur, 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 shall post the following information in English and French on a website that is operated by a party for that purpose with whom Her Majesty in right of Canada has entered into a contract to make that information available to the public:

(3) Section 5 of the Regulations is amended by replacing the paragraph C.01.014.9(1)(k) that it enacts with the following:

(4) Section 5 of the Regulations is amended by replacing the portion of the subsection C.01.014.9(2) before paragraph (a) that it enacts with the following:

(2) The manufacturer shall post the information

(5) Section 5 of the Regulations is amended by replacing the subsections C.01.014.9(3) and (4) that it enacts with the following:

(3) If any of the information that was posted by the manufacturer changes, they shall update that information on the website within two days after the day on which they make or become aware of the change.

(4) Within two days after the day on which the manufacturer is able to meet the demand for the drug, they shall post information on the website to that effect.

(6) Section 5 of the Regulations is amended by replacing the portion of the subsection C.01.014.10(1) before paragraph (c) that it enacts with the following:

C.01.014.10 (1) If 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 decides to discontinue the sale of the drug, they shall post the following information in English and French on the website referred to in subsection C.01.014.9(1):

(7) Section 5 of the Regulations is amended by replacing the paragraph C.01.014.10(1)(j) that it enacts with the following:

(8) Section 5 of the Regulations is amended by replacing the portion of the subsection C.01.014.10(2) before paragraph (a) that it enacts with the following:

(2) The manufacturer shall post the information

(9) Section 5 of the Regulations is amended by replacing the subsection C.01.014.10(3) that it enacts with the following:

(3) If any of the information that was posted by the manufacturer changes, they shall update that information on the website within two days after the day on which they make or become aware of the change.

(10) Section 5 of the Regulations is amended by replacing the sections C.01.014.11 and C.01.014.12 that it enacts with the following:

C.01.014.11 The Minister shall ensure that a hyperlink to the website referred to in subsection C.01.014.9(1) is maintained on the Government of Canada website.

Transitional Provisions

22 In sections 23 and 24, drug means a drug that is listed in Schedule C to the Food and Drugs Act, that is in dosage form and that was sold in Canada before the day on which section 2 comes into force.

23 (1) Despite these Regulations, if the labels of a drug display information in accordance with one of the following provisions of the Food and Drug Regulations, as they read immediately before the day on which section 2 comes into force, that provision continues to apply in respect of the drug:

(2) Subsection (1) ceases to apply in respect of a drug

24 (1) Despite these Regulations, subsection C.01.014(2) of the Food and Drug Regulations, as it read immediately before the day on which section 2 comes into force, continues to apply in respect of a drug.

(2) Subsection (1) ceases to apply in respect of a drug

Coming into Force

25 (1) These Regulations, except sections 19 to 21, come into force on the day that, in the sixth month after the month in which they are published in the Canada Gazette, Part II, has the same calendar number as the day on which they are published, or, if that sixth month has no day with that number, the last day of that sixth month.

(2) Sections 19 to 21 come into force on the day on which these Regulations are registered.

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