SAHPRA has a backlog of variation applications that has accumulated over the past 5 years. To appropriately clear the variations backlog, SAHPRA needs to have a detailed understanding of which registered products are affected and the types of variation applications per registered product. Two surveys have been developed to assist in understanding the variations backlog. An Overview survey, which provides a summary of the total number of variation applications pending per company, has already been completed. SAHPRA now requires applicants to fill out the Deep-dive survey, which provides a detailed view of all pending TYPE II variation applications by individual master registered products. The deadline for completion is 13 September 2019.Only master registered products (human category A medicines) with variation applications submitted prior to 1 February 2018 are eligible for this survey. For only these eligible master registered products, applicants must include all TYPE II variations (submitted before or after 1 February) in a single survey. Applicants must complete one survey for each master registered product in the backlog that has one or more pending variation application(s). SAHPRA will use the survey to identify all products in the variations backlog, and verify all subsequent resubmissions against this list. Thus, only products correctly submitted in this survey will have their associated variation applications evaluated as part of the Backlog Clearance Program. Terminology: 1. Variation application: Each individual EU code represents a single variation application. It is important for applicants to count each code as a new application when filling out this survey2. Priority therapeutic areas: HIV, TB, Vaccines, Hepatitis, Oncology, Diabetes, Malaria, Maternal and Newborn health and, Infectious/parasitic diseases3. Master registered product: A product associated with a master registration number and the related strengths, excluding clones / duplicates. The typical example is a product with multiple strengths, but otherwise identical (including trading name)4. Clone: An application submitted by the HCR of the innovator or generic product as a copy of its own product under a different proprietary name at any stage during the product life cycle (of the initially registered product)5. Duplicate: An application submitted simultaneously by the same applicant, which is identical to the master registered product in every aspect except for the proposed proprietary name(s). This includes duplicate or multiple applications of innovator and generic products6. Registration number: The unique number provided for a product upon registration (including the pharmacological classification code)Please note that a revised certificate of registration is required when - There is a change in the proprietary name of a product (A.2.a & A.2.b in the EU Variation Classification Guideline)- There is a transfer of the Holder of Certificate of Registration (A.0.1)If you have any queries regarding this survey please email firstname.lastname@example.org, including "[Deep-dive survey queries]" at the start of the subject line.
SAHPRA is busy exploring structuring TYPE II resubmission windows according to the pharmacological classifications contained in Annexure 1 of the General Regulations. To operationalise this effectively, SAHPRA needs to identify which older product registration numbers contain outdated / irrelevant pharmacological classification codes (as a result of amendments to the pharmacological classifications following the issuance of a product registration number).
9. Type II variations associated with the master registered productThe following sections require the HCR to select the TYPE II EU variations codes which are yet to be finalised by SAHPRA for this master registered product. This includes TYPE II variations submitted both before and after 01 February 2018 for products which qualify for the survey (i.e., products which will be evaluated by the Backlog Clearance Program - see introductory note of this survey). These TYPE II variations will need to be consolidated and resubmitted during a product's associated resubmission window. Note that the HCR should also include TYPE II variations which have not yet been submitted to SAHPRA, but will be included as part of the consolidated resubmission. For products with no new TYPE II variations (i.e., those not yet submitted to SAHPRA), the total number of variations codes selected in this section (9) should add up to the number listed in question 5 previously.
Thank you for completing this survey. Please click the "Submit" button and you will be redirected to complete a new survey. Please complete one survey for each master registered product in the backlog that has a pending variation application.