| 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 2023 for all scheduled medicines appearing on the Database of Medicines Prices (DoP) published on 23 December 2022 The submission 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. |
| (iv) |
Medicines registered and allocated a Single Exit Price (SEP) with an effective date which falls after the 23rd of December 2022. These medicines must be added and listed at the bottom of tab 1 of the excel spreadsheet submitted as part of the 2023 SEPA submission. |
| (v) |
Medicines approved under a medicine details amendment Template G submission where an applicant name change or applicant transfer was approved with an effective date falling after 23 December 2022 but before 11 January 2023. |
| (vi) |
Medicines described under 2.1 (a) (v) must be submitted by the old applicant if this is the applicant appearing on the database of 23 December 2022. However if the new applicant is listed on the database of 23 December 2022, the applicant must note that this medicine may not be adjusted in terms of the 2023 SEPA notice. |
i.e. the submitting applicant must submit all the medicines that form part of their portfolio even if some of the medicines do not appear on the Database of Prices (DoP) of 23rd December 2022. For these additional items, the applicant must include all the supporting evidence (i.e. the communicated email and excel spreadsheet together with a letter of approval from National Department of Health (NDoH) where the effective date of the approved SEP is indicated) which suggests that the medicines were previously processed and allocated a SEP by NDoH. Applicants must note that medicines with an effective date prior to and including 23 December 2022 are eligible for SEPA 2023 whereas those with effective dates that fall after 23 December 2022 will not be adjusted in terms of the 2023 SEPA notice.
NB: In cases where the medicine is not available on the 23rd December 2022 database, the manufacturer must submit proof that the medicine was previously allocated an official SEP. The SEP approved for implementation on and before 23rd December 2022 shall be eligible for the 2023 SEPA. Applicants must note that medicines falling in the category of medicines described under 2.1 (a) (iv) are not eligible for 2023 SEPA but these medicines should be included under Tab 1 and Tab 2 (where applicable) when the applicant submits their SEPA 2023 documentation for processing by the NDoH.
| (b) |
The information contained in the published gazette with respect to the 2023 SEPA should be read carefully and contents thereof complied with as required. |
| (c) |
The dates and timelines contained in the published gazette with respect to the implementation period for 2023 SEPA must read carefully and complied with as required. |
| (d) |
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 2023 excel SEPA template which is available on the website www.mpr.gov.za. |
| (e) |
Provide the required information on the cover page (Annexure A).
|
| (f) |
Sign the declaration annexed to this document (Annexure B).
|
| (g) |
To ensure immediate and easy access the signed 2023 SEPA notice, guidelines and excel spreadsheet containing Tab 1 and Tab 2 will be shared via email with all representatives of applicants enlisted on the NDoH [email protected] email address. |
NB: No information appearing on the submission shall be changed post facto if the declaration form is found to be completed and signed by all the relevant officials responsible for lodging the 2023 SEPA submission.
| (h) |
Complete the checklist that is also annexed to this document (Annexure C). |
| (i) |
Complete all sections of all tabs (Tab 1 and Tab 2) of the latest 2023 SEPA template in the fields provided (Annexure D). |
| (j) |
Include a signed covering letter on a company letterhead, stating the purpose of your submission, with every submission or re-submission where applicable. NB: For re-submissions, applicants must ensure to submit only those medicines and lines which require amendments before an approval can be granted. Medicines included in the re-submission must have been part of the first submission unless the entire first submission was not approved due to not submitting the entire applicant's portfolio of medicines. |
| (k) |
A complete submission should include a fully completed latest SEPA template for 2023, Annexure A, B, C and D (A fully completed SEPA template) and a signed covering letter on the applicant's letterhead. |
| (l) |
Ensure all the SEPA template fields are completed in full and the base SEP and medicine details used as reference for the 2023 price adjustment are those which were applicable on 23rd December 2022 and that they have an effective date of 23rd December 2022 or earlier. The base SEP's for each submitted medicine must be verified as correct and that it is appropriate for the relevant medicine prior to lodging the submission. |
| (m) |
Ensure that all fields have been completed as per DoP of 23rd December 2022. |
NB: All the applicants must verify the correctness of the information which appears under the SEPA template excel spreadsheet Tab 1 column titled (Originator or Generic). This column may be corrected where applicable during the SEPA submissions processes. Should this information be declared incorrect after the 2023 SEPA implementation process, the applicant will be required to provide evidence to support their claims i.e. should the column details be changed at a later stage after 17th March 2023.
| (n) |
Wherever the date is required, it should be stated in full (e.g. 14 March 2023). |
| (o) |
Applicants are required to submit ONLY the electronic version of the entire submission without any hard copies or compact discs (See section 2.4 (a). Each emailed submission must include the following in a zipped folder: |
| (i) |
Signed cover letter on the official letter head of the applicant; |
| (ii) |
Completed latest 2023 SEPA template; |
| (iii) |
Completed annexure A; |
| (iv) |
Completed annexure B; |
| (v) |
Completed annexure C (A fully completed latest 2023 SEPA template) and |
| (vi) |
Supporting documents where applicable |
| (p) |
Applicants must ensure that all relevant documents such as the covering letter and the declaration Form in Annexure B are signed prior to lodging the submission. |
| (q) |
The applicant officials responsible for signing the declaration Form (Annexure B) do so to verify and certify that the submission is complete and that the information contained in the submission is true, correct error-free, and every aspect of the 2023 SEPA notice, guidelines or gazette and its guidelines is complied with in totality as prescribed. |
| (r) |
The signed declaration Form (Annexure B) also confirms that the submission in its entirety has been checked by all the persons whose signatures are appended under Annexure B, in addition to the person responsible for compiling the submission. |
| 2.2 |
2023 SEPA Submission Requirements
|
| (a) |
The submissions lodged in terms of these guidelines are solely for the purpose of 2023 SEPA. For other medicine details amendments, applicants must use Template G of the SEP updates as published either on websites: www.mpr.qov.za or www.doh.qov.za emailed to applicant representatives via [email protected]
|
| (b) |
For a submission to be considered complete, ALL sections of the 2023 SEPA template, inclusive of all excel spreadsheet fields, must be fully completed. A fully completed template must have all tabs (Tab 1 and Tab 2) and all the fields of the relevant worksheets completed. Within each tab, all the required fields must be completed for every medicine in the applicant's schedule as published on DoP of 23rd December 2022 . |
| (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 the medicines (and their respective prices) that have an SEP update which was approved communicated and effected by the department in 2023, before the date of the applicant's 2023 SEPA submission, including those communicated to the applicant after the 23rd December 2022, must be included in the 2023 SEPA submission. Both the letter and excel schedule received from the directorate Pharmaceutical Economic Evaluations Directorate must be submitted for this category of items. |
| (e) |
The information requested under 2.2 (d) will serve as SEPA 2023 supporting documentation and will be used to verify the information that is included as part of the 2023 SEPA submission (on the 2023 SEPA excel templates i.e. Tab 1 and Tab 2) but which may not be appearing on the 23rd December 2022 database. Failure to provide these supporting documents will render the 2023 SEPA submission incomplete. The requirements stated under 2.2 (a) - (d) above also apply to all the re-submissions made by applicants. |
| (f) |
Only the rightful applicant as recorded on the DoP of 23rd December 2022 for the medicine as per the SAHPRA (formerly MCC) manufacturing license and MCC / SAHPRA medicines registration certificate must lodge the submission for the medicine(s) concerned. |
| (g) |
Only those applicants whose manufacturing licenses have not expired may submit 2023 SEPA submissions. |
| (h) |
In cases where an applicant name change occurred after the 23rd of December 2022 but before lodging the 2023 SEPA submission, only the applicant whose applicant name is reflected on the DoP of 23rd December 2022 shall be considered for purposes of the 2023 SEPA submissions . |
| (i) |
To eliminate any confusion regarding the applicable SEP for a particular medicine, applicants must ensure that only one type of submission is in the system for the same medicine at any one given point in time. The NDoH shall not take any responsibility for any confusion that might arise as a result of multiple or different types of submissions and or applications being submitted in parallel for the same medicine. |
| (a) |
The submission of 2023 SEPA is not obligatory. The eligible applicants are not compelled to compile and submit 2023 SEPA submissions. |
| (b) |
The 2023 SEPA is only applicable on the medicines with a Single Exit Price that was already effective on the 23rd of December 2022, regardless of how these Single Exit Prices were arrived at. This includes the SEP approvals granted after a Non-Permanent Price Reduction submission. These non-permanent SEPs shall be regarded as permanent reductions at the point of lodging the 2023 SEPA submission. |
| (c) |
Therefore, if the SEP of a medicine that appears on the 23rd December 2022 database was arrived at after the applicant submitted a Template B submission, then such an SEP shall automatically become a permanent SEP at the beginning on the first day of implementation of 2023 SEPA i.e. 11 January 2023. |
| (d) |
Applicants must note that in terms of the Medicines Pricing Regulations, there shall only be one Single Exit Price at any given point in time. |
| (e) |
Applicants are advised to compile their own list of reference medicine Single Exit Prices to enable the verification of prices during SEPA implementation. The schedule of 23rd December 2022 may be found on www.mpr gov.za under "Published Documents", click database of medicine prices. Click on the excel spreadsheet titled database of medicine prices 23rd December 2022. |
| (f) |
There can only be one SEP submission launched at any given point in time. The applicant cannot 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. |
| (g) |
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 23rd December 2022 must be maintained. Any medicines not appearing on the 23rd December 2022 list should appear at the bottom of the 2023 SEPA template in an alphabetical order. |
| (h) |
All medicines with related pack sizes that are presented on the template for 2023 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 23rd December 2022 (i.e. SEP applicable as of 23rd December 2022 + maximum allowable SEPA % as per the notice). |
| (i) |
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. |
| (j) |
Where a new pack size is introduced after 23rd December 2022, 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 23rd December 2022. (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). |
| (k) |
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. |
| (l) |
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 2023 SEPA implementation time frame prior to following up on a submission status. |
| (m) |
All processes and approved SEPs will be communicated to submitting applicants, price file managers and all the stakeholders that are registered on the department of Health emailing list. The approved prices will be published on the website (www.mpr.gov.za) at a later stage. |
| (n) |
All correspondence(s) concerning a submission will only be communicated to the applicant of the medicines applied for. |
| (o) |
The electronic version of the submitted 2023 SEPA template (Annexure D) must be in excel (not pdf format) and should be saved with a file name extension "xls". Submissions containing password-protected documents and files in a version that is not accessible when using NDoH systems; such as those with the file extensions xlsx, docx and PDF, will not be considered. |
| (p) |
2023 SEPA can only be submitted on the published latest SEPA template for 2023 including both Tab 1 and Tab 2. ANY modification to the template will result in the entire submission not being considered. This also applies to re-submissions. |
| (q) |
The final date for all 2023 SEPA submissions will be those as determined in the Minister's 2023 SEPA notice. No submission shall be reviewed outside of the dates that are stipulated in the 2023 SEPA notice. |
| (r) |
An applicant may only submit once in the 2023 SEPA cycle. This does not apply to (see point (s) below) |
| (i) |
Where no adjustment is requested, the existing SEP will be applicable for the 2023 SEPA cycle. The SEPA cycle is the period between two consecutive SEPA announcements by the Minister of Health. The applicant may not at a later stage re-submit a different SEPA request for the same medicine. The SEPA submission and the approval thereof for the 2023 cycle implies that previously approved non-permanent reductions automatically become permanent approvals at the end of the 2023 SEPA implementation cycle. |
| (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 2023 cycle. |
| (i) |
Resubmissions shall only be considered if submitted within the timelines stipulated in the 2023 SEPA notice. |
| (ii) |
Will only be reviewed for medicines that had SEPs that were previously not adjusted in terms of the 2023 SEPA quantum, as a result of discrepancies identified in the first 2023 SEPA submission. |
| (iii) |
All the requirements for the SEP submissions as stated in this document shall be applicable to re-submissions. |
| (iv) |
A resubmission of the not-approved medicines may not be split into multiple resubmissions. |
| (v) |
MUST contain ALL the medicines listed under the Not-Approved sheet of Annexure E which is communicated to the applicant in response to the initial submission. |
| (vi) |
Resubmissions must contain only medicines listed in the Not-Approved sheet of Annexure E communicated to the applicant in response to the initial submission. |
| (vii) |
Re-submissions must only be submitted on the official and latest 2023 SEPA template. |
| (viii) |
Must only be on the 2023 SEPA template, by the close off date as specified by the Minister of Health and reflected in the 2023 SEPA notice. |
| 2.4 |
Lodging of Submissions |
| (a) |
Submissions must be lodged electronically via the department of health email [email protected] . No hard copies submissions will be considered. |
| (b) |
The cover letter must reflect the following information: |
| (ii) |
2023 SEPA Submission |
| (iii) |
Number of Medicines in TAB 1 of the submission template (e.g. Tab 1 = 50 medicines /75 line items |
| (iv) |
Number of Medicines in TAB 2 of the submission template (e.g. Tab 2 = 10 medicines /15 line items- Tab 2 is for originator medicines. |
| (c) |
Each submission MUST be lodged on the latest 2023 SEPA template and must be accompanied by annexure A, B, C and D included in this document as well as the applicant's covering letter on the official letterhead of the applicant. All these documents must be saved on a zipped folder and submitted as such. |
| (d) |
Where an applicant is uncertain about the contents of the submission being lodged, clarity must be solicited from the PEE directorate prior to lodging the submission and this must be done by no later than the closing dates for the lodging of the SEPA submissions. Queries relating to approved submissions that may contain information that was not corrected timeously will not be tolerated. |
| (e) |
Only e-mail submissions will be accepted for SEPA 2023. |
| (f) |
The 2023 SEPA email must be addressed to: |
2023 SEP Adjustment
Director: Pharmaceutical Economic Evaluations (PEE)
ATT: Ms Ntobeko Mpanza
National Department of Health
Room C6-18A Dr Xuma Building
1112 Voortrekker Road, Pretoria Townlands 351 - JR
0001
Email submissions must be lodged made between 09:00 and 12:00 Monday to Friday excluding public holidays. All submissions will be allocated a reference number and no late submissions will be considered. Where the reference number is not received within five working days from the date of lodging the submission, the applicant must resubmit since their submission will not be reflecting on the list of submissions received by the department of Health.
For any enquiries regarding 2023 SEPA implementation, you may contact Ms Mahlogonolo Ledwaba between 13:00 and 15:00 at (012) 395 8186 or by e-mail at [email protected] and [email protected] at 012 395 8210 from Monday to Friday excluding public holidays.
All queries must include the reference number provided to the applicant as an acknowledgement of receipt of the SEPA submission
Note that the Department of Health will not be held responsible for submissions that were incorrectly submitted. A reference number reflected on the acknowledgment notice should be quoted in every communication made to NDoH by the applicant.
| 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; (The cover letter should include details of the number of medicines being submitted: see point 2.4 (b) above. |
| (b) |
Completed latest 2023 SEPA template with both Tab 1 and Tab 2 |
| (e) |
Completed annexure C and |
| (f) |
No compact disc containing all of the above information will be required from the applicant. |
| 2.6 |
Acknowledgement of receipt |
Upon receipt of a submission, a reference number will be provided via email to the submitting representative of the applicant. The Pharmaceutical Economic Evaluations (PEE) Directorate official will use the email address [email protected] to communicate the reference number of the application/ submission to the email address of the application sender. This reference number must be used in all correspondences where follow ups are being made on the application. This reference number must be retained, for reference purposes.
South African Institute for Drug Free Sport Act, 1997
