Drug Manufacturer InformationSubmission Deadlines
Drug Manufacturer Forms
These forms are available in a pdf format or excel format (listed below). To request the Budget Impact Assessment Form, Resubmission Form or APC Resubmission Form in a Word format, click here.
(Note: This contains the amended Price Policy as of February 10, 2020)
The Budget Impact Assessment form was introduced in April 2001. It is intended to assist manufacturers with the preparation of budget impact assessments that are a requirement for all submissions of new chemical entity drug products, changes to special authorization or restricted benefit status of listing single source drug products due to a new indication, line extension drug products and resubmitted drug products (if applicable)
Alberta Price Policy Resubmission Form (Excel) (March 25,2011)
This form applies to Drug Products that have not been listed on the ADBL, or that have been removed from the ADBL, by the Minister where the requirements of an Alberta Price Confirmation (APC) or Interim APC were not satisfied or for Price Policy considerations. This form may also be used for Drug Products that have been removed from the ADBL at the request of the Manufacturer.
The Resubmission form was introduced in April 2002. It is intended to ensure consistency in the type of information reviewed and to assist manufacturers with the preparation of resubmissions for previously reviewed Drug Products. This form applies to all drug products that have been reviewed by the Expert Committee and a decision made by the Minister of Health to not add the Drug Product to the ADBL, to add the Drug Product as a special authorization or restricted benefit, or to maintain the criteria for coverage of a special authorization or restricted benefit Drug Product despite the manufacturer's request for a change. In order to have the recommendation/decision reconsidered, the manufacturer must make a resubmission of the Drug Product using this form.
Please note: Resubmissions will not be accepted for products prior to a decision being rendered on the product in question.
The Biosimilar Summary form was introduced in March 2020. It is intended to assist manufacturers with the preparation of submissions for Biosimilar Products, and to ensure consistency in the type of information received.
Announced in March 2011, Alberta Health has developed the Product Listing Agreement (PLA) policy for the purpose of enabling single source patented drugs, to be considered for listing through a PLA agreement.
The PLA policy forms part of the Alberta Drug Benefit List (ADBL) and combined with a Request for Product Listing Agreement (RFPLA) sets out the requirements that must be met for a PLA Submission to be considered for listing on the ADBL through a PLA. The application of the PLA policy is subject at all times to the sole discretion of the Minister of Health.
This form applies to applicants responding to a Request For Product Listing Agreement (RFPLA). It is intended to assist manufacturers with the preparation of a PLA Submission. Please refer to the PLA Policy and individual RFPLA for the complete PLA Submission requirements.
Request For Product Listing Agreement (RFPLA)
The Minister may, in the Minister’s sole discretion, issue an RFPLA to invite certain or all Manufacturers to make a PLA submission for the consideration of the Minister. Manufacturers are invited to submit a response according to the specifications, terms and conditions set out in the RFPLA(s) below.
|RFPLA||Issue Date||Updates||Closing Date|
|12-016 Drug Products Indicated for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)||Dec. 11, 2012||Jan. 17, 2013||Jan. 23, 2013|
An RFPLA is not a tender; it is not a competitive bidding process. No representation or commitment is made that any or all PLA submissions made in response to an RFPLA will be screened, evaluated, negotiated or result in a PLA. Failure to satisfy any term, condition or mandatory requirement of the RFPLA submission requirements may result in rejection of the PLA Submission.
The DBL, DBS and related publications require knowledgeable interpretation and are intended primarily for professional health care practitioners, pharmacies, hospitals and organizations associated with the manufacture, distribution and use of pharmaceutical preparations.
Electronic versions of all DBL and DBS related publications are unofficial versions and are provided for convenience and private use only. Official paper versions can be obtained from Alberta Blue Cross who publishes them on behalf of Alberta Health and Alberta Human Services.
Alberta Health reserves the right to make changes, without notice, to the List through the Interactive DBL (iDBL), and any such changes to the Interactive DBL (iDBL) are effective the date of the change (unless otherwise stated) and regardless of the date of publication in the paper version or updates.