Patented Medicines (Notice of Compliance) Regulations due to Comprehensive Economic and Trade Agreement (CETA)

Author: Bhavesh Patel, C. Chem. Natco Pharma (Canada) Inc.

Health Canada recently published the Notice - Patented Medicines Notice of Compliance Regulations as an update for the public regarding the recently implemented amendments to the Patented Medicines (Notice of Compliance) Regulations which came into effect on September 21, 2017 as part of Canada’s obligations under the Comprehensive Economic Trade Agreement with the European Union. 

The Notice advises the public that Heath Canada is in the process of updating the Guidance Document: Patented Medicines (Notice of Compliance) Regulations (“PM(NOC) Regulations”) and also provides guidance for industry on how to provide various information to Health Canada concerning procedures under the Regulations. 

How to provide litigation information

As the Minister of Health is no longer a party to proceedings under the amended Regulations, they will no longer be served with litigation documents. However, the Office of Patented Medicines and Liaison (“OPML”) must have access to relevant information to determine whether there are any barriers under the Regulations that would prohibit the issuance of a Notice of Compliance (“NOC”) for the second person’s submission. As such, the amended Regulations requires the first person to provide the TPD with certain documents as soon as feasible in the course of a proceeding. The TPD may also request any information or document required to assess whether NOC issuance is prohibited under section 7 of the Regulations. If an action is brought, requests for verification of any portion of a submission served with a Notice of Allegation or produced in the litigation can be made under section 6.05 of the Regulations.

All information related to litigation, including requests for verifications, must be submitted to the TPD electronically by email to: opml_bmbl@hc-sc.gc.ca. No duplicate copy should be sent in paper format. Information may be sent in other formats in certain circumstances, for more information please consult the Notice. 

How to provide other information 

Currently, non-litigation information related to the Regulations should be submitted in either the electronic Common Technical Document (“eCTD”) format or the non-eCTD electronic-only format. In accordance with Health Canada’s Frequently Asked Questions - Regulatory Activities in eCTD Format, regulatory transactions accepted in the eCTD format include:

·         Written correspondence related to the Regulations;

·         Notice of Allegation packages (e.g. including proof of service of the Notice of Allegation on the first person and certification of the date of filing of the submission) under the Regulations);

·         Form IVs, including updates, filed in accordance with the Regulations;

·         Form Vs, including updates, filed in accordance with the Regulations; and

·         Consent letters (under the Regulations).

·         For eCTD submissions, the regulatory transactions listed above should be submitted via the Common Electronic Submissions Gateway, as indicated in the Frequently Asked Questions - Common Electronic Submissions Gateway. For non-eCTD submissions, the above-noted information should be sent on an acceptable media format as indicated in the Guidance Document: Preparation of Drug Regulatory Activities in the 'Non-eCTD Electronic-Only' Format.

Form V update

Second persons are advised that Form V : Declaration re Patent List has been amended and that the amended version of the document must be filed beginning September 21, 2017. There is no need to re-submit a Form V that was filed before September 21, 2017.

Verification

Under section 6.05 of the Regulations, the Minister must verify, upon request of a party, that any portion of a submission or supplement required to be served with a Notice of Allegation, or that is produced as a result of an order, corresponds to the information in the submission or supplement.

The documents to be verified are now to be provided directly to the TPD. To facilitate the verification process, parties are encouraged to continue to provide good quality copies of documents that are indexed with respect to their location within the original submission or supplement. This format is similar to that requested for verifications under the former version of the Regulations.

If the productions are not formatted in a format acceptable to the TPD, they may be rejected for verification. To this effect, productions should be formatted as set out in the example in the Notice.

As of September 21, 2017, the TPD will no longer maintain a paper version of the Patent Register. The Patent Register continues to be available electronically for public inspection.

Addition of Certificates of Supplementary Protection to the Patent Register

All Certificates of Supplementary Protection will be assessed by the TPD for their eligibility for the Patent Register without requiring a separate form or request from the first person. It is possible that a Certificate of Supplementary Protection will be added to the Patent Register before publication on the Register of Certificates of Supplementary Protection and Applications.

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