The details must be copied from the 23rd December 2022 DoP for all the medicines for the applicant. All details and formatting must remain as it appears on DoP of 23rd December 2022.
Failure to comply with the prescribed requirements under this section 3 below will result in the entire submission not being considered as it will be deemed incomplete and non compliant with the requirements set for 2023 SEPA submissions.
| 3.1 |
SEPA 2023 TEMPLATE TAB 1 |
| 3.1.1 |
For the information required under the following listed columns labels (headings) in the Template, applicants are required to copy such information from the DoP published on 23rd December 2022 for all medicines that sought SEPA for 2023. All the information and formats and the order of medicines must remain as they appear on the DoP of 23rd December 2022. |
| • |
APPLICANT MCC LICENCE NUMBER |
| • |
APPLICANT NAME AS REGISTERED WITH MCC |
| • |
MCC MEDICINE REGISTRATION NUMBER |
| • |
MEDICINE PROPRIETARY NAME |
| • |
MANUFACTURER PRICE AS AT 23 DECEMBER 2022 |
| • |
LOGISTICS FEES AS AT 23 DECEMBER 2022 |
| • |
SEP AS AT 23 DECEMBER 2022 |
| • |
UNIT PRICE AS AT 23 DECEMBER 2022 |
This must be the total quantity of sales of each medicine for the period 01 January 2022 to 31 December 2022. Where the medicine is not being sold this should be indicated in the column. A blank will result in submission not being considered.
| 3.1.3 |
Requested Manufacturer Price |
This is the requested VAT exclusive manufacturer price of the medicine in South African Rands. This is a numerical field displayed at 2 decimal places, with no currency symbols. This column should be indented to the right.
| 3.1.4 |
Requested Logistics Fee |
This is the requested VAT exclusive logistics fee for the medicine in South African Rands. This is a numerical field displayed at 2 decimal places, with no currency symbols. This column should be indented to the right.
| 3.1.5 |
VAT on requested Components |
This column is the VAT component of the SEP, calculated at 15% to the sum of the requested manufacturer price and the requested logistics fee. This is a numerical field displayed at 2 decimal places with no currency symbols This column should be indented to the right.
This is the requested Single Exit Price for the medicine in South African Rands. It is the sum of the requested ex-manufacturer price, the requested logistics fee and VAT. This is a numerical field displayed at 2 decimal places with no currency symbols. This column should be indented to the right.
| 3.1.7 |
Requested Unit Price |
This is the resulting unit SEP of the medicine, considering its pack size and quantity of presentation as per the MCC approved package insert (P1). The unit price should be obtained by; dividing the requested SEP by the pack size and then further divided by the quantity.
| (a) |
This is the price of a unit of the medicine, e.g. one tablet, capsule, millilitre, gram, etc. The unit price as described in the Regulations Relating to a Transparent Pricing System for Medicines and Scheduled substances (section 22G of the Medicines and Related Substances Act) is the SEP divided by the number of units of the product. Note that unit pricing applies to all medicines with the same proprietary name, strength and dosage form. |
| (b) |
For injections the unit price shall be calculated per ml of reconstituted volume, even where the total volume of the medicine administered to a single patent is less than 1 ml. |
| (c) |
For inhalers, where the pack size is described in the MCC approved PI as doses or puffs the unit price will be for 1 dose or puff. |
| (d) |
The unit price is the SEP divided by the pack size and then further divided by the quantity [the "quantity" represents the multiples in which the medicine is packed/the number of pack sizes e.g. for injections, the "quantity" for 50 vials containing 500mg powder for injection packed in 20ml vial to be reconstituted with 10ml of diluents is 50]. |
This is a numerical field displayed at decimal places with no currency symbols. This column should be indented to the right.
Any blanks on Tab 2 will result in the submission not being considered. where the medicine is a generic the applicant must comment. Where there is no price available the applicant must indicate this as well as measures taken to obtain the price. Proof of this communication must be supplied. Only those exchange rats provided under section 3.2.3 4 of these guidelines may be used during completion of details required under Tab 2 of the 2023 SEPA application. All the information required under Tab 2 of the 2023 SEPA excel template must be submitted on the same date of the first submission but where this information is not readily available, applicants must note that the last date for sending international benchmarking information is 17 March 2023.
| 3.2.1 |
For the following columns: |
| • |
APPLICANT SAHPRA/MCC LICENCE NUMBER |
| • |
APPLICANT NAME AS REGISTERED WITH SAHPRA/MCC |
| • |
SAHPRA/MCC MEDICINE REGISTRATION NUMBER |
| • |
MEDICINE PROPRIETARY NAME |
| • |
MANUFACTURER PRICE AS AT 23 DECEMBER 2022 |
| • |
LOGISTICS FEES AS AT 23DECEMBER 2022 |
| • |
SEP AS AT 23 DECEMBER 2022 |
| • |
UNIT PRICE AS AT 23 DECEMBER 2022 |
| • |
IS / WAS THERE A PATIENT ACCESS PROGRAMME FOR THIS MEDICINE (YES/NO) |
| • |
HOW MANY PATIENTS ARE I WERE ON A PATIENT ACCESS PROGRAMME FOR THIS MEDICINE |
The details must be copied from the 23 December 2022 DoP for all the medicines for the applicant. All details and formatting must remain as it appears on DoP of 23 December 2022.
| 3.2.2 |
For all medicines that are labelled originator, the following columns must be completed: Closest Australian Pack Size, Related Australia Quantity. Australian Manufacturer Price in AUS Dollars, AUSDollar Exchange Rates, Australian Price in Rands, Australian matching pack size in Rands, Comment on Australian Price Provided, Closest Canada Pack Size, Related Canada Quantity, Canada Manufacturer Price in CANDollars, CANDollar Exchange Rates, CAN Price in Rands, Canadian matching pack size in Rands, Comment on Canadian Price Provided, Closest New-Zealand Pack Size, Related NZ Quantity, New-Zealand Manufacturer Price in NZDollars, NZDollar Exchange Rates, New-Zealand Price in Rands, New Zealand matching pack size in Rands, Comment on New Zealand Price Provided, Closest Spain Pack Size, Related Spain Quantity, Spain Manufacturer Price in EURO, EURO Exchange Rates, Spain Price in Rands, Spanish matching pack size in Rands, Comment on Spanish Price Provided, Closest Alternate Country Pack Size, Related Alternate Country Quantity, Manufacturer Price alternate currency, Alternate Currency Exchange Rates, Alternate Country Price in Rand, Alternate Country matching pack size in Rands, Comment on Alternate Country Price Provided. Where a medicine does not have a comparator product from Australia, Canada, New Zealand & Spain all other countries where the medicine is being sold must be listed and provided as alternate countries. |
| 3.2.3 |
Where the exact pack size does not exist in the international market, the closest pack size will be used e.g. if there is 30 pack size in South Africa and only 28's and 100's in Spain the 28 pack size will be used as the closest pack to 30's. The related quantity refers to the quantity in which the pack size of the medicine is being sold in that country and allows for a like comparison of the South African medicine. |
| 3.2.4 |
The exchange rate will be the average over the 12 month period (i.e. 01 November 2021 to 30 November 2022). These values will be published in the template for consistency. The following are the for the conversion to Rands: |
AUS$: 11,31298348
CAN$: 12,51866382
NZD$: 10,39435235
EUR€: 17,21627759
NOTE: The template with Tab 1 and 2 must always be maintained in the font and format as it appears on DoP. Applicants should only make use of space, dashes or any other characters if these are represented as such in official documentation.
Statistics Act, 1999
