| 2.1 |
Applicant Requirements |
| (a) |
All registered applicants for medicines sold in SA, who are eligible in terms of the notice as signed by the Minister of Health, may forward submissions for the Single Exit Price Adjustment (SEPA) for 2019 for all scheduled medicines appearing on the Database of Medicines Prices (DoP) published on 21 December 2018, These submissions should also include: |
| (i) |
Scheduled medicines for which no adjustment is required; |
| (ii) |
Scheduled medicines for which no adjustment is applicable; and |
| (iii) |
Discontinued medicines. |
i.e. all medicines for the applicant as they appear on the DoP.
| (b) |
The information contained in the published gazette with respect to the SEPA for 2019 should be read carefully and contents thereof complied with as required. |
| (c) |
Read carefully the information and instructions contained in this document before completing all the fields of both tabs (Tab 1 and Tab 2) of the latest 2019 excel SEPA template which is available on the website www.mpr.gov.za. |
| (d) |
Provide the required information on the cover page (Annexure A).
|
| (e) |
Sign the declaration annexed to this document as an acknowledgement of the correctness of the contents of the submission (Annexure B).
|
| (f) |
Complete the checklist that is also annexed to this document to confirm completeness of the submission (Annexure C). |
| (g) |
Complete all sections of all tabs of the latest 2019 SEPA template in the fields provided (Annexure D). |
| (h) |
Include a signed covering letter on a company letterhead, stating the purpose of your submission, with every submission or re-submission where applicable. |
| (i) |
A complete submission should include a fully completed latest SEPA template for 2019, annexure A, B, and C and a signed covering letter on the applicant's letterhead. |
| (j) |
Ensure that all fields have been completed and Single Exit Prices used for adjustment purposes are as per DoP of 21 December 2018. |
| (k) |
Wherever the date is required, it should be stated in full (e.g. 14 March 2020). |
| (l) |
Applicants are required to submit both the hard copy and an electronic version of the entire submission for 2019 SEPA. This must include: |
| (i) |
Signed cover letter on the official letter head of the applicant; |
| (ii) |
Completed latest 2019 SEPA template; |
| (iii) |
Completed annexure A; |
| (iv) |
Completed annexure B; |
| (v) |
Completed annexure C; and |
| (vi) |
Supporting documents where applicable; |
| (m) |
Applicants are required to sign the declaration in Annexure B. The responsible officials, who are signing the declaration in Annexure B, certify that the information submitted is true, correct and error-free. The signed declaration in Annexure B, also confirms that the submission in its entirety has been checked by ail the persons who's signatures are appended under Annexure B, in addition to the person responsible for compiling the submission. |
| 2.2 |
SEPA Submission Requirements |
| (a) |
The submissions in terms of these guidelines are solely for the purpose of 2019 SEPA. For other medicine details amendments, applicants must use Template G of the SEP updates as published on the website: www.mpr.gov.za. |
| (b) |
For a submission to be considered complete, ALL sections of the 2019 SEPA template, inclusive of all excel spreadsheet fields, must be fully completed. A fully completed template must have all tabs or worksheets and all the fields completed. Within each tab, all required fields must be completed for every medicine in the applicant's schedule and Single Exit Prices reflected shall be as published on DoP of 21 December 2018. |
| (c) |
ALL scheduled medicines that make up the applicant's portfolio on the date of the submission, MUST be presented in the latest SEPA template. |
| (d) |
ALL official SEP update submissions communicated and effected in 2019 by the department, before the date of the applicant's SEPA submission, including those communicated after 21 December 2018, must be included in the submission (this includes both the letter and the excel schedule from the Directorate: PEE to the applicant). Failure to provide these supporting documents will render the 2019 SEPA submission incomplete. This requirement is also applicable to any resubmission made. |
| (e) |
Only the rightful applicant as recorded on the DoP of 21 December 2018 for the medicine as per the MCC manufacturing license and MCC medicines registration certificate must lodge the submission for the medicine(s) concerned. Submissions will not be accepted from persons other than these applicants whose manufacturing licences have not expired. In cases where an applicant name change occurred after 21 December 2018 but before lodging the 2019 SEPA submission, only the applicant name reflected on the DoP of 21 December 2018 shall be considered for purposes of this submission. |
| (a) |
The 2019 SEPA is not obligatory. Applicants must note that they are not compelled to compile and Lodge 2019 SEPA submissions. |
| (b) |
The 2019 SEPA concerns SEPs that are applicable as on 21 December 2018, regardless of how these SEPs were arrived at. This includes approved SEP's following a submission of a Non-Permanent SEP reduction. These non-permanent SEP's shall be regarded as permanent at the point of lodging the 2019 SEPA submission In terms of the medicines pricing regulations, there shall only be one SEP at any given time. The schedule of 21 December 2018 is found on www.mpr.gov.za under "Published Documents", click database of medicine prices. Click on the excel spreadsheet titled database of medicine prices 21 December 2018. |
| (c) |
There can only be one SEP submission launched at any given point in time. The applicant must not request for an update on the SEP or lodge a Regulation 9 application, whilst the submission for SEPA is still in process. Similarly, the applicant cannot submit a SEPA or Regulation 9 application whilst the submission for an SEP update is still in process. In an event where the applicant has made a SEPA submission and any other SEP submissions and/or a Regulation 9 application the SEPA will not be considered. Should the applicant wish to re-submit, a new submission may be made once the other outstanding SEP submissions and/or Regulation 9 applications have been concluded. |
| (d) |
Each submission should include all the applicant's scheduled medicines, including discontinued medicines. Discontinued medicines should be indicated as such, as per the DoP under the status column. SEPA will not be allowed on officially declared discontinued medicines. The row order of all the applicant's medicines, as they appear on the DoP of 21 December 2018 must be maintained. Any medicines not appearing on the 21 December 2018 list should appear at the bottom of the 2019 SEPA template in an alphabetical order. |
| (e) |
All medicines presented on the template for SEPA must be unit priced. When computing the unit prices, the resulting SEPs should not exceed the maximum allowable SEP after the adjustment on the SEP that existed on 21 December 2018 (i.e. SEP applicable as of 21 December 2018 + maximum allowable SEPA % as per the notice). |
| (f) |
All medicines including those with multiple pack sizes are required by law to be unit priced i.e. all same ingredient and dosage form medicines with related pack sizes must have the same unit price. Non-compliance with unit pricing will result in the entire submission not being considered. |
| (g) |
Where a new pack size is introduced after 21 December 2018, it is expected that this will result in a unit price that is no greater than the unit price that existed on pack sizes on 21 December 2018. (Note that the newly launched medicines and/or pack sizes should be included in the portfolio of medicines in the submission for SEPA and should also be unit priced with their related pack sizes). |
| (h) |
All submissions for SEPA will be processed within 32 working days (excluding weekends and holidays) upon receipt of the submission by the PEE Directorate of the Department. |
| (i) |
The outcome of each processed submission will be communicated to the applicant within 32 working days of the date of your submission. Applicants are required to take note of this time frame prior to following up on a submission status. |
| (j) |
All approved SEPs will be communicated to price file managers and published on the website (www.mpr.gov.za) by the PEE Directorate. |
| (k) |
At correspondence(s) concerning a submission will only be communicated to the applicant of the medicines applied for. |
| (I) |
The electronic version of the submitted 2019 SEPA template should be saved with a file name extension "xls". Submissions containing password-protected documents and files in a version that the PEE Directorate is unable to access such as those with the file extensions xlsx, docx and PDF will not be considered. |
| (m) |
SEPA can only be submitted on the published latest SEPA template for 2019 including both Tab 1 and 2. ANY modification to the template will result in the entire submission not being considered. This also applies to resubmissions. |
| (n) |
The final date for all 2019 SEPA submissions will be the date determined as per the Minister's notice. |
| (o) |
An applicant may only submit once in the 2016 SEPA cycle. This does not apply to resubmissions (see point (p) below) |
| (i) |
Where no adjustment is requested, the existing SEP will be applicable for the 2019 SEPA cycle. The SEPA cycle s the period between two consecutive SEPA announcements by the Minister of Health. The applicant may not at a later stage resubmit a different SEPA request for the same medicine. The submission of a SEPA and the approval thereof for the 2019 cycle implies any non permanent reduction is concluded. |
| (ii) |
An applicant's portfolio may not be divided into multiple submissions. |
| (iii) |
The maximum allowable adjustment may not be divided into multiple submissions. Should an applicant request less than the maximum published adjustment, the balance will be forfeited for the 2018 cycle; |
| (i) |
Will only be reviewed for medicines who's SEPs were previously not adjusted in terms of the 2019 SEPA quantum, as a result of discrepancies identified in the first submission; |
| (ii) |
All the requirements for the SEP submissions as stated in this document shall be applicable to resubmissions. |
| (iii) |
Resubmissions must contain only medicines listed in the Not-Approved sheet of Annexure E communicated to the applicant in response to the initial submission. |
| (iv) |
The resubmissions process shall not be used to accommodate errors made by the applicants in their first 2019 SEPA submission. |
| (v) |
Must only be or the 2019 SEPA template, by the close off date as specified by the Minister of Health and reflected in the SEPA notice. |
| 2.4 |
Lodging of Submissions |
| (a) |
Submissions must be lodged electronically on a compact disc and hard copy. |
| (b) |
Each submission MUST be lodged on the latest 2019 SEPA template and must be accompanied by annexure A, B and C included in this document as well as the applicant's covering letter on the official letterhead of the applicant. |
| (c) |
Where an applicant is uncertain on a submission being made clarity must be sought from PEE. |
| (d) |
No e-mail submissions will be accepted. |
| (e) |
Spreadsheets must be submitted in excel format and not pdf. |
| (f) |
Electronic copies and hardcopies of the submissions MUST be addressed to: |
2019 SEP Adjustment
The Director: Pharmaceutical Economic Evaluations (PEE)
ATT: Ms Ntobeko Mpanza
The National Department of Health
Room S0419 Civitas Building
Corner of Thabo Sehume Street and Struben Street
0001
And hand-delivered between 09:00 and 11:59 Monday to Friday excluding public holidays. For any enquiries regarding SEPA for 2019, you may contact Ms Mahlogonolo Ledwaba between 10:00 and 15:00 at (012) 395 8186 or by e-mail at Mahlogonolo.[email protected] from Monday to Friday excluding weekends and public holidays.
All queries must include the acknowledgement of receipt provided when the submission was made as well as any/all responses received by the applicant from DoH.
Note that the Department of Health will not be held responsible for submissions that were not received signed for by official of the PEE Directorate. A reference reflected on the acknowledgement notice should be quoted in every communication.
| 2.5 |
Documents to be submitted |
Applicants are required to submit all the following documents to ensure completeness of the submissions:
| (a) |
Signed cover letter on the official letter head of the applicant; |
| (b) |
Completed latest 2019 SEPA template |
| (e) |
Completed annexure C and |
| (f) |
Compact disc containing all of the above in the prescribed format |
| 2.6 |
Acknowledgement of receipt |
| 2.6.1 |
Upon receipt of a submission, an acknowledgement notice will be provided to the representative of the applicant by the PEE Directorate official. All applicants should retain their acknowledgement notice, for reference purposes. |
Statistics Act, 1999
