23

Feb2018

Québec Gazette Announces Draft Regulations for Implementation of Fees for INESSS Submissions

On February 21, 2018, the Gazette officielle du Québec announced that draft regulations, relating to the implementation of fees for manufacturers submitting a scientific evaluation to the Institut national d’excellence en santé et en services sociaux (INESSS), have been submitted to the government of Québec for approval. The fees will vary ... Read More

30

Jan2018

INESSS Releases Additional Information – Requests for Changes of an Administrative Nature

On January 29, 2018, Québec’s Institut national d’excellence en santé et en services sociaux (INESSS) released a notice to manufacturers. This notice is a supplement to the information published on August 18, 2017 regarding changes of an administrative nature. Requests for withdrawals from the Liste des médicaments and the Liste des ... Read More

14

Dec2017

TODAY at 1 pm: Government of Canada Officials to Speak on Proposed Regulatory Amendments

Government of Canada officials will hold a bilingual web-based information session about the proposed regulatory amendments. See the Government of Canada announcement for details on today’s webinar.

04

Dec2017

Manitoba Health Amends Submission Requirements

On December 1, 2017, Manitoba Health, Seniors and Active Living released a notice announcing a number of updates to their product submission criteria (last updated in 2007) to consider requirements introduced since 2007 including: requirement to complete pan-Canadian Pharmaceutical Alliance (pCPA) negotiations for brand products; the pCPA Centralized Price Confirmation ... Read More

01

Dec2017

Proposed Amendments to Patented Medicines Regulations Announced

Proposed regulatory text of amendments to the Patented Medicines Regulations is published by the Governor-in-Council in Canada Gazette Part I (CG1) on December 2, 2017.  Interested persons may submit comments on the proposed regulations within 75 days of publication in CG1 (by ... Read More

29

Nov2017

INESSS Releases Additional Information on the Continuous Evaluation Process

On November 28, 2017, Québec’s Institut national d’excellence en santé et en services sociaux (INESSS) released a notice to manufacturers announcing further details on the continuous evaluation process. Effective today, INESSS is initiating the consultation period for drug products for which a listing request was filed between October 2, 2017 and ... Read More

27

Nov2017

2017 Québec City Healthcare Industry Forum

Join PDCI Market Access Inc.’s Nancy Paul Roc and Carla Freige at Québec’s International 11th edition of the Québec City Healthcare Industry Forum held on December 5 and 6, 2017 at the Hilton Québec. As in previous editions, the 2017 Québec City Healthcare Industry Forum will spark discussions between stakeholders in ... Read More

16

Nov2017

INESSS Releases Additional Information on the Continuous Evaluation Process

On November 13, 2017, Québec’s Institut national d’excellence en santé et en services sociaux (INESSS) released a Notice to Manufacturers announcing further details on the continuous evaluation process. As of December 1, 2017, manufacturers can submit an application for registration to INESSS for a new innovative drug product or a ... Read More

08

Nov2017

INESSS Releases Additional Information on the Continuous Evaluation Process

On November 7, 2017, Québec’s Institut national d’excellence en santé et en services sociaux (INESSS) released a notice to manufacturers announcing further details on the continuous evaluation process. INESSS would like to inform manufacturers that as of November 1, 2017, new terms and conditions apply for manufacturers who wish to request ... Read More

03

Nov2017

INESSS Releases List of Drug Products Currently Being Reviewed Under the Continuous Evaluation Process

On November 2, 2017, Québec’s Institut national d’excellence en santé et en services sociaux (INESSS) announced they have now published the list of drug products currently undergoing review under their new continuous evaluation process on their website. Citizens, health professionals, patients and their caregivers, as well as their associations or ... Read More