Consumer Affairs (Unfair Business Practices) Act, 1988 (Act No.
R 385
Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)NoticesAnnual Single Exit Price Adjustment [SEPA] of Medicines and Scheduled Substances for the year 2023Information to be provided by Manufacturers and or Importers of Medicines and Scheduled Substances when submitting for the Single Exit Price Adjustment for 20234. Annexures |
| 4.1 | Annexure A: Cover Page |
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TO BE COMPLETED BY THE APPLICANT |
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APPLICANT NAME
As it appears on the MCC license |
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CONTACT PERSON |
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Name: |
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E-mail: |
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Fax No: |
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(Person responsible for this submission) |
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NUMBER OF MEDICINES IN THE SUBMISSION (Also include medicines for which SEP adjustment is not requested, rows which contain multiple active ingredients should not be counted.) |
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NUMBER OF ROWS BEING SUBMITTED (Rows which contain only active ingredients should also be counted.) |
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FOR OFFICE USE ONLY (as per acknowledgement notice) |
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Date received: (dd/month/yyyy) |
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Received by:
(Name and Surname) |
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Signature: |
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4.2 Annexure B : Declaration
SEPA Declaration
I ..............................................., (full name and surname) in my capacity as .................................... and having the authority to sign and enter into legally binding agreements or behalf of ............................................................................ (Name of applicant) hereby certify that:
| 1. | I have read and understood the information and instructions contained in the 2023 SEPA information and instruction document. |
| 2. | I have followed the instructions contained in the 2023 information and instruction document in completing the SEPA template. |
| 3. | I have correctly calculated unit pricing for all medicines in the applicant's portfolio. |
| 4. | I have requested only the SEPA and not any other medicine details amendments for the scheduled medicines in the applicant's portfolio. |
| 5. | I have enclosed a signed covering letter on the company letterhead, stating the purpose of this submission. |
| 6. | The information supplied in this submission is true and correct. (NB please provide proof of authorization to sign on behalf of the company). |
SIGNATURE (DEPONENT)
1. ........................................................ (CFO Full Names, Surname)
........................................................ (CFO Signature)
2. ........................................................ (Responsible Pharmacist Full Names)
........................................................ (Responsible Pharmacist Signature)
The Deponent has acknowledged that he/she knows and understands the contents of this affidavit, which was signed and sworn to before me at ............... on this the ............... day of ........................ 2023 and that the regulations contained in Government Gazette Notice No. R. 1258 of 21 July 2972 (as amended) has been complied with.
COMMISSIONER OF OATHS
| 4.3 | Annexure C: Checklist |
SEPA Checklist
Tick the appropriate box (ü)
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HAVE YOU: |
YES |
NO |
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(a) |
Read and understood the entire instruction document for 2019 SEPA? |
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(b) |
Read, understood, and followed all the instructions in Section 2 and Section 3? |
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(c) |
Provided a signed covering letter on a company letterhead stating the purpose of the submission? |
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(d) |
Correctly completed the SEPA 2023 template? |
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(e) |
Completed the required fields of the covering page (Annexure A)? |
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(f) |
Signed the declaration as required, indicating that the information supplied with this application is true and correct (Annexure B)? |
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(g) |
Answered yes to all questions in this checklist (Annexure C)? |
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(h) |
There are no blanks on Tab 1 and Tab 2 |
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NOTE: If any of the answer(s) to the question(s) above is NO, the submission will be considered incomplete.
| 4.4 | Annexure D: SEPA 2023 Template |
See Excel Template Published in www.mpr.gov.za or www.doh.gov.za
and emailed to [email protected]
