MEDICINES CONTROL COUNCIL - mccza.com

1 Registration of MEDICINES Scheduling of MEDICINES June 2014 Page 1 of 20 Back to ToC MEDICINES CONTROL COUNCIL SCHEDULING OF MEDICINES This guideline is intended to provide guidance to applicants on the scheduling of substances submitted for registration as MEDICINES . It represents the MEDICINES CONTROL COUNCIL s current thinking on the safety, quality and efficacy of MEDICINES and takes into account the country s obligations in terms of international agreements. It is not intended as an exclusive approach. COUNCIL reserves the right to request any additional information to establish the scheduling status of a medicine in keeping with the knowledge current at the time of evaluation. Alternative approaches may be used but these should be scientifically and technically justified. It is important that applicants adhere to the administrative requirements to avoid delays in the processing and evaluation of applications.

2 Guidelines and application forms are available from the office of the Registrar of MEDICINES and the website. First publication released for Industry comment October 2013 Due Date for Comment January 2014 Final Version 1 June 2014 REGISTRAR OF MEDICINES MS M HELA Registration of MEDICINES Scheduling of MEDICINES June 2014 Page 2 of 20 Back to ToC TABLE OF CONTENTS 1 INTRODUCTION .. 4 Scope of the Guidelines .. 4 Information for Applicants .. 4 General .. 4 5 Where to send 5 Principles of Scheduling .. 5 Brief Description of the Schedules .. 6 Schedule 6 Schedule 6 Schedule 7 Schedule 3 and 4 .. 10 Schedule 5 (and specified Schedule 5) .. 10 Schedule 11 Schedule 11 Schedule 11 2 GENERAL GUIDELINES FOR CATEGORISATION IN THE SCHEDULES .. 12 3 APPLICATIONS FOR SCHEDULING OF MEDICINES OR SUBSTANCES .. 15 Applications for Registration .. 15 Products submitted for registration where a change in scheduling status is requested.

3 15 4 APPLICATIONS FOR CHANGING THE SCHEDULING CLASSIFICATION (RESCHEDULING) OF A medicine OR substance .. 15 Applications for rescheduling of selected indications, strengths, routes of administration or pack sizes .. 15 5 UPDATE HISTORY .. 16 APPENDIX: FORMAT FOR APPLICATIONS FOR 17 1 COVER/TITLE PAGE .. 17 2 DECLARATION BY APPLICANT .. 17 3 TABLE OF CONTENTS .. 17 4 SUMMARY .. 17 Registration of MEDICINES Scheduling of MEDICINES June 2014 Page 3 of 20 Back to ToC 5 BODY OF APPLICATION .. 17 Purpose of the Application .. 18 General Background .. 18 Current Regulatory Status .. 18 International Regulatory Status .. 18 Introduction of the data upon which the application is based .. 18 Technical Information .. 18 Physico-Chemical Properties of the Active Pharmaceutical Ingredient .. 18 Pharmacology .. 18 Clinical Data .. 18 Toxicology .. 18 Safety Reports .. 19 Occupational Health and Safety Information (If applicable) .. 19 Pharmaceutical Aspects.

4 19 Monitoring of the Public Health Impact .. 19 19 Proposal .. 19 Discussion .. 19 Proposed Indication for Use .. 19 Product Information and Presentation: .. 20 6 OTHER RELEVANT INFORMATION .. 20 7 BIBLIOGRAPHY .. 20 8 COPIES OF REFERENCED MATERIAL .. 20 9 APPENDICES IF REQUIRED .. 20 Registration of MEDICINES Scheduling of MEDICINES June 2014 Page 4 of 20 Back to ToC 1 INTRODUCTION Scope of the Guidelines These guidelines are intended to provide information and guidance on the criteria and procedures applied by the Names and Scheduling Committee and the secretariat of the MEDICINES CONTROL COUNCIL when evaluating the scheduling status of a medicine or substance for human or veterinary use. These guidelines should be read in conjunction with the MEDICINES and Related Substances Act, 1965 (Act 101 of 1965), as amended, and the supporting Regulations. As these guidelines are constantly evolving, due to harmonisation initiatives as well new scientific developments, applicants are advised to always consult the latest information available.

5 The MEDICINES CONTROL COUNCIL endeavours to keep abreast of such developments and to keep its requirements, procedures and policies in line with best international practice . Information for Applicants General The scheduling of MEDICINES and products containing substances already listed in the Schedules as well as those substances not yet contained in the Schedules (new chemical entities) are normally managed as part of the medicine registration process. Three broad types of applications are considered by the Names and Scheduling Committee: applications for the registration of a medicine , which may include applications for the scheduling of a new chemical entity or applications for registration of a product containing a substance already listed in the Schedules (in accordance with such listing); applications for re-scheduling a substance that has already been listed in the Schedules; applications for listing a substance in the Schedules for prescribing by an authorised prescriber other than a medical practitioner or dentist.

6 Applications for the registration of a medicine may only be made by manufacturers or importers of MEDICINES . However, applications for re-scheduling of a substance may be made by any person or organisation. Applications for listing a substance for prescribing by an authorised prescriber other than a medical practitioner or dentist would usually be made by a statutory health COUNCIL , but could also be made by an individual or organisation. In addition, requests to reconsider the scheduling status of a substance may be submitted by individuals, private sector firms, organisations, law enforcement agencies or specific departments of directorates within the public sector. The processing of all applications may only proceed once all requirements, outlined in this document, are complied with. The application will be considered complete only if the submission is in the proper format, with the required data, the correct number of copies and the prescribed application fee, if applicable.

7 Once an application has been received, it will be logged in, acknowledged, and processed for evaluation. From this point on, time lines will be followed as determined by the MEDICINES CONTROL COUNCIL for the evaluation and these will be communicated to the applicant. At no stage will the applicant be permitted to communicate directly with an evaluator. All queries and concerns must be communicated through the regulatory authority to allow for these to be logged in and processed. Registration of MEDICINES Scheduling of MEDICINES June 2014 Page 5 of 20 Back to ToC Language In terms of Regulation 22 of Act 101 of 1965, all applications and supporting data submitted to the MEDICINES CONTROL COUNCIL must be presented in English. Any documents in languages other than English must be accompanied by a translation. Where to send Applications Applications may be posted to Private Bag X 828, Pretoria, 0001 or delivered at the MCC reception; NDoH, CIVITAS, corner Thabo Sehume (Andries) and Struben streets, PRETORIA, 0001 where these will be logged in and acknowledged.

8 All correspondence should be addressed to the Registrar of MEDICINES . Applications received in any manner other than as stated above will not be considered for processing. Principles of Scheduling In terms of the MEDICINES and Related Substances Act (Act 101 of 1965), a 'Scheduled substance ' is defined as follows: means any medicine or other substance prescribed by the Minister under section 22A . Section 22A(2) empowers the Minister of Health on the recommendation of the COUNCIL , to make the Schedules referred to in that section, Section 37A also empowers the Minister, again on the recommendation of the COUNCIL , to amend the Schedules by notice in the Government Gazette. The official Schedules shall therefore always be those that have been published in the Government Gazette or amended by subsequent notice in the Gazette. All MEDICINES are subject to a scheduling process on the basis of the substances (active pharmaceutical ingredients) they contain.

9 The sale and supply of MEDICINES in South Africa is governed by section 22A of the MEDICINES and Related Substances Act, 1965 (Act 101 of 1965), read together with the supporting Regulations. CONTROL over access to MEDICINES and substances are therefore regulated by the process of scheduling, and the CONTROL measures provided for in the Act and Regulations. Scheduling allows for different levels of regulatory CONTROL over pharmacologically active substances, whether in the form of active pharmaceutical ingredients, naturally-occurring products or extracts thereof, or finished pharmaceutical products ( MEDICINES ). In addition, these legal provisions enable South Africa to comply with its obligations in terms of the Single Convention on Narcotic Drugs (1961), the Convention on Psychotropic Substances (1971) and the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (1988), to which it is a THIS, IT IS NOT POSSIBLE TO LABEL ANY SINGLE PRODUCT (AS DISTINCT FROM substance ) WITH MORE THAN ONE SCHEDULE STATUS.

10 WHERE APPLICANTS WISH TO MARKET PRODUCTS WITH DIFFERENT SCHEDULES, THIS WILL REQUIRE DIFFERENT PRODUCT REGISTRATIONS AND ALSO DIFFERENT PROPRIETARY NAMES. The primary consideration in scheduling a substance is its safety profile, in relation to the therapeutic indications for its use. Substances may be listed in one or more of eight Schedules. However, substances may also be listed in more than one Schedule, based on dosage form, route of administration, strength, indication, dose, duration of treatment or a combination of these factors. Where a substance or medicine has been listed in more than one Schedule, the other Schedule(s) in which it is listed is/are indicated in parentheses after the inscription in a particular Schedule. Where exceptions are included in an entry, these have been emphasised by printing the word except in bold type. 1 Details of the conventions can be obtained from the website of the International Narcotics CONTROL Board at Registration of MEDICINES Scheduling of MEDICINES June 2014 Page 6 of 20 Back to ToC Brief Description of the Schedules Section 22A of the MEDICINES and Related Substances Act, 1965 (Act 101 of 1965) provides for a graduated system of CONTROL over sale and supply of substances, ranging from access via any retail outlet, at one extreme, to outright prohibition, at the other.