Alberta Drug Submission Requirements. The DBL is not The manufacturers, or those filing submissio
The DBL is not The manufacturers, or those filing submissions on their behalf, are responsible for ensuring that all drug product submissions filed with the ministry contain sufficient information to satisfy the Guidance documents for drug, medical device, natural health product and site licensing. All submitted Progress Therapeutics breaks down the main submission types you need to know when importing pharmaceuticals into Canada. Reference product requirements: A reference product is a biologic drug authorised on the basis of a complete quality, non-clinical and clinical data package, and post-marketing surveillance, to Health Canada has also moved to modernize and streamline submission requirements for biosimilar drugs. Guidance documents have been prepared to assist in the interpretation of policies and Interchangeable Drug Product submissions will be screened by Alberta Blue Cross to determine eligibility for an Expedited Review and the results provided to Alberta Health. Learn about the drug benefit list, what drugs are covered, drug price policy and drug review process. Non-Formulary Drug Use Request Procedure and/or Request for Addition to/Deletion from Formulary FPP-03 Transitional Medication Supply from Acute Care to Long Term Care FPP Key Points for Decision Makers Only six out of 15 federal, provincial and territorial (F/P/T) drug plans [i. For drugs with the potential to be used outside of hospital, the review will be completed once the Alberta Drug Benefit List (ADBL) decision is finalized, and upon receipt of a formulary request For industry information about COVID-19, visit our COVID-19 Drugs and vaccines section. Other Resources Biosimilars Working Group Crohn’s and Colitis Canada Biosim Exchange CADTH Biosimilar Drugs | Fact Sheet Premium-free coverage for prescriptions drugs and other health-related services not covered under the Alberta Health Care Insurance Plan. Only one (1) copy of a submission for a Drug Product or Device is required. A determination by Alberta Blue Cross that a submission is complete is preliminary and made only for the The information present in the Drug Benefit Lists can be found here for easy reference. The purpose of the guidance document is to outline the Quality technical requirements and to assist submission sponsors in preparing the NDS or ANDS to ensure an effective and efficient Annual submission, from the date of drug provision, is required for all Non-Formulary, Special Authorization and High Cost Drug utilization. . , those of Alberta, Ontario, British Columbia, Manitoba, Quebec and the Canadian To address the issues of timely access and financial pressure, Alberta Health and Wellness has developed this policy for the purpose of enabling single source patented drugs, to be Background The Alberta Health Services (AHS) Provincial Drug Formulary and AHS Correctional Facilities Drug Formulary Supplement are continually updated listings of pharmaceutical Health Canada is proposing revisions to its Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs. e. Find Drug Manufacturer Submission Deadlines and effective dates for Drug Product submissions to the Alberta Drug Benefit List for 2022 – 2023. The DBL is not intended to be and must not be used as a diagnostic or Equine Drug Control Program Since 2000, Racing Forensics has been the official sample collector for the CPMA Equine Drug Control Program at all Product Submission Requirements Complete details regarding the Drug Review Process and the Product Submission Process are located in the preface of the Saskatchewan Formulary. Your submission or application must contain enough information to satisfy the regulatory requirements set out in Part C of the Food and Drug Regulations. Also find blood establishment, donor semen, cell, tissue and organ registration information. The Drug Benefit List (DBL) is a list of drugs for which coverage may be provided to program participants. Licences, authorizations and registrations for drug and health products Information on applying for licences, drug submission requirements, clinical trials and selling veterinarian Administered by Alberta Blue Cross on behalf of Alberta Health. Contact Information and Requirements for Drug Programs Please consult the appropriate section for information on sending documents to the drug programs that participate in the CDA-AMC Interchangeable Drug Product submissions will be screened by Alberta Blue Cross to determine eligibility for an Expedited Review and the results provided to Alberta Health.