SAHPRA variations backlog: Type II Deep-dive survey

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 survey
2. Priority therapeutic areas: HIV, TB, Vaccines, Hepatitis, Oncology, Diabetes, Malaria, Maternal and Newborn health and, Infectious/parasitic diseases
3. 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 products
6. 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 backlog@sahpra.org.za, including "[Deep-dive survey queries]" at the start of the subject line.

1. Please fill in the following questions to identify the master registered product for which a variation application(s) is pending:
Format: mm/dd/yyyy
2. Please fill in the following description of the registration:

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). 

3. For this master registered product, does the pharmacological classification contained in the registration number align correctly with the latest pharmacological classification published in the General Regulations? (For example, this question should be answered "yes" for a HIV product containing the classification code 20.2.8 in its registration number, as this is correctly aligned with "20.2.8 Antivirals" in Annexure 1 of the General Regulations)
3.1 If no, what is the updated / current pharmacological classification for this master registered product (as per Annexure 1 of the General Regulations)? Provide the code and description separated by a dash (e.g., "20.2.8 - Antivirals")
4. List all registration numbers for additional strengths with the same proprietary name of the master registered product (indicated in section 2)
5. For this master registered product, how many TYPE II variation applications has your company submitted and not received a FINALISED response? Please do not include applications for which SAHPRA has finalised the review and are pending certification. Please count each individual EU code as a separate application
6. For this master registered product, are there any other master registered products that are identically affected by a pending TYPE II variation (EXCLUDING duplicates or clones)? Please note, only indicate "Yes" for ONE master registered product (i.e., do not say yes in this survey, and yes again in the survey for the master registered product that is identically affected by this variation)

Example: A variation application for change in manufacturing site of a paracetamol 5/10/15 mg family that is identical to the variation application for an ibuprofen 5/10/15 mg family. 
6.1 If yes, list the registration numbers of master registered products that are identically affected in the text boxes below (there is NO NEED to provide individual registration numbers for each additional strength of a master registered product)
7. For this master registered product, are there any DUPLICATE OR CLONE master registered products that are identically affected by a pending TYPE II variation? Please note, only indicate "Yes" for ONE master registered product (i.e., do not say yes in this survey, and yes again in a survey for the duplicate / clone)
7.1 If yes, list the master registration numbers of any duplicates and clones in the text boxes below (there is NO NEED to provide individual registration numbers for each additional strength of a master registered clone / duplicate)
8. Please answer the following questions. There will be an opportunity to provide a written response at the end of the survey.
TopicsYesNoN/A
Is this master registered product currently inhibited from being marketed due to a pending TYPE II variation application(s)?
Is this master registered product currently stocked-out in South Africa and inhibited from being re-stocked due to a pending TYPE II variation application(s)?
Has this master registered product been awarded a tender but the Holder of Certificate of Registration is unable to fulfil their duties as prescribed by the tender due to a pending TYPE II variation application?
Will the TYPE II variations applied for change any of the information on the product's registration certificate(s)?

9. Type II variations associated with the master registered product

The 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. 

9.1 Which of the following TYPE II EU variation codes are required for the master registered product? Please only answer this for A codes (Administrative changes)
9.2 Which of the following TYPE II EU variation codes are required for the master registered product? Please only answer this for B.I codes (Active substance quality changes)
9.3 Which of the following TYPE II EU variation codes are required for the master registered  product? Please only answer this for B.II codes (Finished product quality changes)
9.4 Which of the following TYPE II EU variation codes are required for the master registered product? Please only answer this for B.III codes (CEP/TSE/monographs changes)
9.5 Which of the following TYPE II EU variation codes are required for the master registered product. Please only answer this for C.I codes (Human and Veterinary products)
10. Have these variations been approved by any of SAHPRA's recognised regulators?
10.1 If "Yes, some of the applications have been approved" please indicate the EU codes which have been approved and could make use of reliance pathways. Please use a semi-colon (;) to separate EU codes
10.2 If applicable, please select which recognised regulatory authorities have reviewed and approved either some, or all, of the TYPE II variations that will be re-submitted to SAHPRA
11. If needed, please write a text summary of the pending TYPE II variation applications.
12. If the product is inhibited from being marketed due to a TYPE II amendment, the HCR may summarise any appropriate context here

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.

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