Streamlined Category B submissions.: H113-31/12-2023E-PDF
"The purpose of this new guidance document is to clarify the eligibility and conditions for acceptance of Streamlined Category B Submissions. With the publication of Regulatory Directive DIR2017-01, Management of Submissions Policy (8 March 2017), new terminology was introduced for submissions with a limited number of amendments, and requiring only a value assessment: Streamlined Category B Submissions. These types of submissions were formerly termed Category C Efficacy Reviews (REG2002-04). On 3 July 2020, in Regulatory Proposal PRO2020-01, the PMRA proposed to increase the number of label amendments permitted within one of these submissions to six (6). This guidance document is published pursuant to PRO2020-01 and replaces REG2002-04"--Page 1.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.955490&sl=0
| Department/Agency |
|
|---|---|
| Title | Streamlined Category B submissions. |
| Variant title |
|
| Series title |
|
| Publication type | Monograph - View Master Record |
| Language | [English] |
| Other language editions | [French] |
| Format | Digital text |
| Electronic document | |
| Note(s) |
|
| Publishing information |
|
| Description | 1 online resource (2 pages). |
| Catalogue number |
|
| Subject terms |
Request alternate formats
To request an alternate format of a publication, complete the Government of Canada Publications email form. Use the form’s “question or comment” field to specify the requested publication.Page details
- Date modified: