Marketing, Manufacturing, Packaging & Labelling, Advertising
All legal aspects of marketing, manufacturing, packaging, labeling and advertising of drugs in South Africa. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99.
1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?
MARKETING OF MEDICINES AND MEDICAL DEVICES OR IVDS:
Marketing of medicines are regulated by Section 18 of the Medicines Act. Section 18(2) state “no person shall advertise any medicine or Scheduled substance, medical device or IVDS for sale unless such advertisement complies with the prescribed requirements” Section 18C of the Medicines Act further confirm that Marketing of medicines, medical devices or IVDs must be done in accordance with the relevant Regulations under this Act.
Regulation 42 of the General Regulations for medicines under the Act, confirm that Schedule 0 medications may be advertised to the public. Medications containing substances listed as Schedule 2, Schedule 3, Schedule 4, Schedule 5 or Schedule 6 may be advertised under specific circumstances and to specific persons only. This includes pharmacists, medical practitioners, dentists, veterinarians, practitioners and other authorised prescribers or the information should be included in a publication which is normally only available to these persons.
Advertisements of medications are also not allowed if it contains a statement which deviates from, is in conflict with or goes beyond the evidence submitted in the application for registration of such medicine with regards to its safety, quality or efficacy.
Importantly the regulation of advertising for medical devices and IVDs are controlled by the Regulations relating to Medical Devices and IN VITRO diagnostic medical devices (IVDs). Regulation 21 and 22 under the Act provides for the advertising and labelling of medical devices and IVDs.
In so far as the classification system applies to medical devices or IVDs in the South African legislative and Regulatory framework, only class A and class B medical devices and IVDs may be advertised to the public or a lay person.
Class C or class D medical devices or IVDs, when advertised for the first time to a prospective user, must include written instructions on how to use the product. After this initial advertising in writing, at subsequent occasions, the information need only be available on request.
LABELLING OF MEDICINES AND MEDICAL DEVICES OR IVDS:
Regulation 10 of the General Regulations for medicines under the Medicines Act state that the immediate container of every medicine in which a medicine intended for administration to or use by humans must have a label attached to it with specific particulars included.
Where this requirement applies to medical devices and IVDs, Regulation 22 of the Regulations relating to Medical Devices and IVDs under the Act state that the label of each medical device or IVD must contain specific information which include but is not limited to the trade name of the medical device or IVD, product description and the intended use, in cases where there is an incorporation of a medicine or biological substance with the medical device, it should be stated and either an expiry date or a date of manufacture must be present, whichever is possible and/or applicable. There are many requirements in this regard, which can be found in the regulation under discussion. One further important requirement with regards to the label of a medical device or IVD is that the label must at least be in English and must be
- On the medical device itself;
- On the packaging of each unit; and
- On the packaging of multiple medical devices or IVDs
Reprocessed medical devices must have a label which state the name of the re-processor and identify the medical device as being reprocessed.
In the case where an IVD kit includes individual reagents and articles that may be made available as separate IVD medical devices, they must comply with the requirements as set out and explained above.
2. What is the authorization process for the marketing of generic versions of these products?
There is no formal process (such as an application for example) to follow with regards to marketing the generic product, as long as the advertisement and marketing of the product adhere to the requirements as set out in the respective regulations under the Medicines Act.
The marketing of any medicine or medical device and IVD is regulated in terms of Section 18C of the Medicines Act and regulated by Regulation 42 of the General Regulations under the Act (for medicines) and Regulation 22 of the Regulations relating to medical devices and IVDs.
For example, in terms of Regulation 22, only Class A and Class B medical devices and IVDs may be advertised to the public or lay person. If advertisement of a product which falls within Class C or Class D medical device or IVD is thus made to the public, it will be in contravention of this regulation and an offense in terms of the Medicines Act, which include penalties for misconduct.
3. What are the typical fees for marketing approval?
The fees for marketing approval differ depending on the application made. An application for a New Chemical Entity (brand new medication never registered before and which is different from a vaccine) is ZAR 49 000, 00 as per the Government Gazette No 39154 published on 1 September 2015. Application for the registration of Generic Products (which include pharmaceutical, analytical and bioavailability evaluated) is ZAR 27 000, 00 per application. If the Generic Product has clinical data, the cost is ZAR 44 000, 00 per application. Many different fee allocations are available in this document depending on which type of application is made and this information is available in the public domain.
4. What is the period of authorization and the renewal process?
The process of authorisation of a new and/or generic medication is not specifically defined in the Medicines Act. The application form has a specific entry area where you indicate whether the application is for registration of a new or generic medication.
Regulation 45 of the General Regulations for medicines under the Act provides information on the time frames for considering applications by the Regulatory Authority.
No specific timeline is provided, and the wording indicates that the Authority “shall as soon as practically possible and in accordance with a timeframe as determined by the Authority, inform any applicant of the receipt of an application for the registration of a medicine, medical device and IVD.”
The acceptance of such an application will be acknowledged by the Authority “as soon as practically possible and in accordance with a timeframe as determined by the Authority after receipt of the application by the Authority”.
5. What are the requirements, if any, for post-approval pharmacovigilance?
There are two SAHPRA guidelines which apply to post-approval pharmacovigilance:
- Recall, Adverse Event and Post-Marketing Vigilance Reporting of Medical Devices and IVDs; and
- Post-Marketing Reporting of Adverse Drug Reactions to Human Medicines in South Africa.
Vigilance is also contained in Regulation 40 of the General Regulations under the Act which state that there is an onus on a person who applied for registration of a medicine in terms of Section 15 of the Act to inform the Authority of any new or existing quality, safety or effectiveness concerns related to any medicine, which includes but is not limited to adverse drug reactions. Also important is that information on the risk management activities which are present in so far it relates to the concerns raised be included.
Where it relates to a Medical Device or IVD, Adverse event reporting and vigilance for medical devices and IVDs are set out in Regulation 17 of the Regulations relating to Medical devices and IVDs under the Act.
The requirements include:
- The authorised representative or holder of a registration certificate must inform the Council of a suspected Adverse Event which was reported to him/her and which occurred as a result of usage of the medical device or IVD;
- There are specific timeframes within which such reporting has to take place, this is determined by the Council;
- The steps to be taken to address the adverse event which was reported, must be provided to the Council within the correct timeframe and conduct a concise critical analysis of the safety and performance of the medical device or IVD – the results must then be submitted to the Council.
Where reporting of Post-Marketing Adverse Drug Reactions of medicines is concerned, the SAHPRA guideline provides a list of minimum required information:
- An identifiable source (reporter) of the information;
- Suspected medicine(s); and
- Suspected reactions.
The Guideline includes a further requirement that a Holder of a Registration certificate of a medicine must have an appropriate system in place for pharmacovigilance. A specific person must also be nominated by the Responsible Pharmacist to be the pharmacovigilance officer. The role and responsibilities of the Holder of a registration certificate/applicant’s pharmacovigilance officer include:
- Establishment and maintenance of a system which ensure that information about all suspected adverse reactions which are reported (including to all medical representatives and clinical research associates), must be collect- ed and collated as it has to be accessible at a single point;
- This person must also the contact person to SAHPRA and the National Adverse Drug Event Monitoring Centre;
- Adverse drug reaction reports, summary evaluation statements of non-serious adverse drug reports occurring in South Africa and periodic safety update reports when necessary are also required;
- Ensuring that any request from SAHRA for additional information deemed necessary for the evaluation of the risk-benefit ration of a medicine, is provided to SAHPRA promptly and in accordance with all requirements.
It is important to note that on-going pharmacovigilance Evaluation is required and that the holder of a Certificate of Registration for a medicine must inform SAHPRA within 3 calendar days of first knowledge whenever new evidence becomes available (nationally and internationally) that could significantly impact on the benefit/risk assessment of a medicine or which would be sufficient to consider changes to the conditions of registration of the medicine. Any changes in the nature, severity or frequency of expected adverse drug reactions or any new risk factors identified must also be reported within three calendar days – the basis on which these assessments are made should be included.
6. Are foreign marketing authorizations recognized?
Foreign marketing authorisations are not automatically recognised in South Africa, they are however taken into consideration during the application process.
The application form for registration of a medicine includes as part of the required information under Part1D – Foreign Registration the following requirements:
- A list of countries in which an application has been lodged and the status of these applications shall be furnished, detailing approvals, deferrals, withdrawals and rejections;
- If the medicine has been registered by the regulatory authorities with which Council aligns itself, e. USA (FDA), European Union (EMEA), UK (MHRA), Sweden (MPA), Canada (Health Canada), Australia (TGA), and Japan (MWH), the following must further be included:
- a copy of the certificate of registration;
- the conditions of registration; and
- the approved package insert (data sheet) translated into English where relevant.
- Details of any negative decision by any regulatory authority reflected in the required documentation from the other regulatory authorities must also be provided as part of the
7. Are parallel imports of medicines or devices allowed?
Parallel imports of medicines and devices are allowed and the industry is guided in this regard by the SAHPRA Guideline on Parallel Importation of Medicines in South Africa.
Provisions on the Medicines Act with regards to Parallel importation in terms of Section 15C provide the means through which already patented medication which is registered in other jurisdictions can be brought into South Arica. This Section has to date not been used.
In terms of the guideline the key objective in allowing parallel importation is to address the issue surrounding escalating costs of services, facilities and medicines. Parallel importation allows for the importation and registration of medicines which are under patent, are already registered in South Africa, and which originate from any site of manufacture approved by SAHPRA, regard- less of any existing patent rights.
The Minister of Health is given the authority by the Medicines Act, to pro- cure a cost-effective or less expensive medicine than one already registered and available in the Republic. This is done by the Minister who allows the importation of the same medicine manufactured by, or on behalf of the approved manufacturer from any other country and the restrictions imposed by the Patent Act shall not apply.
Certain conditions for Parallel Importation apply and must be adhered to in order for the relevant permit to be obtained. Once of which includes that the medicine must be patented and must already be registered in South Africa. In so far the rights of the Holder of the Certificate of Registration goes, they shall not be entitled to prevent the importation of the medicine into South Africa, nor its sale on account of such registration or on account of the existence of a patent on such a medicine.
Any company or person that wishes to import a patented medicine must apply to the Minister of Health for a permit to parallel import a medicine.
The parallel importer carries the responsibility and is liable for the parallel imported medicines in the event that an adverse event occurs for example, and they must notify the SAHPRA of this. The destruction of any expired, parallel imported medicines still remaining in stock after the expiry date, is the responsibility of the Parallel importer, whether during the duration of the permit or after the parallel importation permit has expired.
8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?
The Health Professions Council of South Africa (HPCSA) is the Authority which regulates the medical professions and the practice of other specific health care practitioners such as physiotherapists and psychologists. The HPCSA acts in accordance with the Health Professions Act 56 of 1974 and the regulations under this Act.
The HPCSA also publish guidelines to ensure compliance with the legislative requirements and to provide guidance to the practitioners on specific topics. Booklet 11 of the HPCSA Guidelines on Overservicing, Perverse Incentives and Related matters confirm that healthcare practitioners (this includes clinical researchers and Primary Investigators because they are medical practitioners) are not allowed to accept commission or any financial gain or other valuable consideration from any person or body or service in return for the purchase, sale or supply of any goods, substances or materials used by the healthcare professional in his or her practice.
In terms of Rule 7 of the General Ethical and Professional Rules of the Health Professions Council of South Africa (Booklet 2), a practitioner shall also not offer or accept any payment, benefit or material consideration (monetary or otherwise) which is calculated to induce him or her to act or not to act in a particular way not scientifically, professionally or medically indicated or to under-service, over-service or over-charge patients.
9. How is the manufacturing of medicines and devices regulated and by which agencies?
The Manufacturing of medicines, medical devices and IVDs is regulated by SAHPRA. There are 2 different Guidelines which deal with the specific requirements in this regard.
The Guide to Good Manufacturing Practice (GMP) for medicines in South Africa indicate that manufacturing formulations and processing instructions should exist for each product and batch size to be manufactured. According to the latest version of this document, SAHPRA is a participating authority of the Pharmaceutical Inspection Cooperation Scheme (jointly known as PIC/S). The aim of PIC/S is to develop international standards between countries and pharmaceutical inspection authorities to provide harmonised and constructive cooperation in the field of GMP.
Section 35 of the Medicines Act and Regulation 23 of the General Regulations in accordance with it, specify that any person/company who hold a licence to manufacture, import, export, be a wholesaler and/or distributor of medicines and related substances, must have the ability to comply with good manufacturing, wholesaling or distribution practices as determined by the Authority. This allows the Authority to determine manufacturing practices and the relevant code of GMP to be applied by manufacturers.
To be noted that there are separate Regulations under the Medicines Act which deal with medicines and medical devices and IVDs, this is discussed and explained throughout this document.
The regulations regarding medical devices and IVDs define manufacture as “operations that include the design, purchasing of material, specification, development, production, fabrication, assembly, processing, reprocessing, releasing, packaging, repackaging, labelling, and refurbishing of a medical device or IVD, as the case may be, and includes putting a collection of medical devices or IVDs, and possibly other products, together for a medical purpose in accordance with quality assurance and related controls.”
Medical devices placed on the market require a Conformity Assessment as per SAHPRA’s Guideline on Conformity Assessment Procedures for Medical devices and IVDs. This Guideline confirms that the Conformity Assessment is primarily the responsibility of the manufacturer. For devices sold in South Africa – the assessment is undertaken in the context of the South African regulatory requirements and both the process and conclusions may be subject to further review by the Council and/or the Conformity Assessment Body accredited by the South African National Accreditation System (SANAS).
10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the US Food & Drug Administration (US FDA) and/or the European Medicines Agency (EMA)?
The guideline on Good Manufacturing Practice for Medicines indicate that GMP agreements with competent international regulatory authorities are deemed to support information sharing and other desirable objectives for international regulatory collaboration.
The regulatory standards in South Africa have been robust, thorough and in line with international best practices.
SAHPRA is a member of various international medicines initiatives that includes the FDA and EMA. SAHPRA also signed a memorandum of understanding with the FDA and SwissMedic (Swiss Regulator) to allow exchange of information.
SAHPRA aligns itself with regulatory authorities which are members of the International Conference on Harmonization of Technical requirements for Registration of pharmaceuticals for Human use (ICH) such as the FDA. It further aligns with ICH observers such as Swiss-medic and Health Canada and also aligns itself in cases where a regulatory authority associated with an ICH regulatory authority member through a legally binding mutual recognition agreement such as TGA in Australia, Norway, Iceland and Liechtenstein.
The aim with these alignments and associations are to ensure that local manufacturing requirements are of excellent standard and compatible with GMP requirements on and international level.
11. What is the inspection regime for manufacturing facilities?
Different quality control processes must be in place and implemented accordingly to ensure the manufacturing facilities are in line with the required standards as set out by the Regulatory Authority
Self-inspection is included in the SAHPRA guideline on Good Manufacturing Processes, whereby it is indicated that self-inspection must be conducted in order to monitor the implementation and compliance with GMP principles and to propose necessary corrective measures. All self-inspections should be conducted in an independent and detailed manner at intervals following a pre-arranged programme in order to verify their conformity with the principles of Quality Assurance.
The Medicines Act also specifies the appointment and role of Inspectors in Sections 26 and 28.
The Directorate: Inspectorate and Law Enforcement carry out regular and repeated inspection of manufacturing sites both in South Africa and in Countries with which SAHPRA does not have a Mutual Recognition Agreement. Inspection enables the Inspectorate to confirm that licence holders are complying with the conditions of their licence, with the provision of the Medicines Act and with GMP.
According to the SAHPRA Guideline on Licence to Manufacture, Import or Export, Inspectors are empowered to (amongst other things):
- enter any place or premises from which:
- The holder of a licence to manufacture, import or export conducts business;
- The holder of a certificate of registration of a medicine conducts
- inspect the premises used in the manufacture, packing, testing storage and distribution of medicinal products; and
- take samples; and
- seize any book, record, documentation or medicine or scheduled
It is required by legislation that licence holders shall make their premises available for inspection by the inspectorate at any reasonable time.
Following an inspection, the Inspector prepares a report of his/her findings. A letter is sent to the licence applicant or holder noting any deficiencies found and asking for proposals to remedy them. In the event of serious non-compliance with GMP, the report is referred to SAHPRA for formal action, which can include the refusal, suspension or revoking of a licence, or part of a licence.
Where quality control testing is contracted to a third party, the testing site should also be made available for inspection and should obtain a licence.
12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?
This is not currently specified in the guidelines or the Act, the only confirmed information relates to Inspectors with authority as provided to them by the CEO of the South African Authority – from an interpretation of the relevant Section and regulations under the act it can be inferred that this authority is extended to Inspectors from within the South African Regulatory framework only. However, there is no formal restriction on approaching the SAHPRA with a request for such allowance depending on the circumstances surrounding such request.
13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
Storage of medical devices and medicines are very important since good practice requires that wholesalers maintain storage areas within temperature limits appropriate for the product concerned and that temperatures are monitored regularly to demonstrate that specified storage conditions are met. It is also important that medical devices and IVDs are not subjected to adverse temperatures during delivery from warehouse to customer or user.
A wide variety of cold storage units are available, ranging from domestic refrigerators to large, custom-built, walk-in cold rooms. Whichever type of unit is used, it must be capable of maintaining all parts of the load within the range specified for the medicines concerned, which for products requirement cold storage is normally 2-8 degrees Celsius.
The type of temperature monitoring device used should be suitable for the type and size of the unit. As a guide, small units should be checked and recorded at least daily using a manual or electronic max./min. thermometer. Larger and walk-in units should be fitted with a continuous recording device such as a chart recorder, or a device that provides regular printouts of actual temperatures.
These records should be checked at least daily and the checks should be recorded, e.g. by annotating the chart/printout. Measuring and recording devices should be calibrated regularly. Temperature monitoring is a very important and essential part of the handling and distribution process and should be done in accordance with all the relevant regulations, rules and industry guidelines.
Packaging of medicines, medical devices and IVDs fall under the definition of “manufacturer” which means “all operations including purchasing of material, processing, production, packaging, releasing, storage and shipment of medicines and related substances in accordance with quality assurance and related controls”.
It is also the responsibility of the Responsible Pharmacist for the manufacturer or relevant licence holder, to safeguard the product users against potential hazards arising from poor distributions practices – as a result, for example of supplying suspect products and poor storage, amongst other things.
The manufacturer has obligations with regards to the licence held as provided by the Regulatory Authority. These include, but are not limited to the storage, packaging and handling of medicines, medical devices and IVDs.
14. What information must be included in medicine and device labeling?
There are several specific requirements with regards to what must be included in the labels of medicines, medical devices and IVDs.
Section 18 of the Medicines Act confirm that medication, medical devices and IVDs may only be sold if the immediate container or the package in which that medicine (or Scheduled medicine) is sold, bears a label stating the prescribed particulars and in the case of medical devices and IVDs, the medical device or IVD itself or its packaging must bear a label, where practical, stating the prescribed particulars.
The labelling of medical devices or IVDs is specifically regulated by Regulation 22 of the Regulations relating to medical devices and IVDs under the Act. According to this regulation certain information must be included on the label and include but is not limited to:
- The name or trade name of each medical device or IVD;
- Product description and intended use;
- A product catalogue code, where applicable;
- The name and business address of the manufacturer;
- The name and business address of the holder of the manufacturer;
- Where appropriate, an indication that the medical device contains or incorporates a scheduled or biological substance;
- For accessories, the serial number may be substituted with a control number and for software it may be substituted with a version number;
- The expiry date where applicable;
- Where there is no expiry date, the manufacturing date;
- Where relevant, an indication of the net quantity of content, expressed in terms of weight or volume, numerical count, or any combination of these or other terms which accurately reflect the contents of the package;
- Warnings or precautions, where applicable;
- Where appropriate an indication that the medical device is intended for single
In terms of South African law, the label of each medical device or IVD must be in at least English and must appear on the medical device or IVD itself, or on the packaging of each unit and on the packaging of multiple medical devices or IVDS.
The specific requirements for labelling of medicines are set out in Regulation 10 of the General Regulations under the Medicines Act. The information required for labelling includes but is not limited to:
- A medicine containing any Scheduled substance, must have the letter “S” followed by the number of the relevant Schedule, in a prominent typeface and size and surrounded by a square border, immediately preceding the proprietary name of such medicine;
- The proprietary name of the medicine;
- The registration number of the medicine allocated in terms of section 15(5) of the Act;
- Application number allocated by the Authority followed by the expression “Act 101/1965”;
- Dosage form of the medicine;
- The approved name of each active ingredient of the medicine and the quantity thereof contained in a dosage unit, or per suitable mass or volume or unit, ranked according to the active ingredients with the highest schedule, in lettering which has minimum legibility: provided that labelling of medicines in solutions for injections must identify the active ingredient in terms of the active component per unit volume of solution;
- The name and percentage of any bacteriostatic or bactericidal agent which has been added to the medicine as a preservative;
- The approved name of any anti-oxidant contained in the medicine;
- The content of the medicine package expressed in the appropriate unit or volume of the medicine;
- Approved indications where practical, for use of the medicine;
- The recommended dosage of the medicine, where practical;
- In the case of a medicine intended for injection by a particular route of administration only, that route of administration by means of suitable words or abbreviations.
The requirements included above for medical devices, IVDs and medicines are by no means exhaustive, but it gives an indication of how specific and detailed labelling within the South African legal contexts, is.
15. What additional information may be included in labeling and packaging?
Where medicine is concerned, the name and address of the manufacturer of the medicine, the date of manufacture of the medicine or the scheduling status and registration number allocated by another national medicines regulatory authority of a country as determined by the Authority; provided that this information is surrounded by a square border including the name of the reference country.
There are extra rules that apply where a medicine bears both an immediate container label and an outer label, which requirements are contained in Regulation 10(3) of the General Regulations under the Act.
Where Medical Devices and IVDs are concerned, if the medical device is reprocessed, the label must state the name of the re-processor and identify the medical device as a reprocessed one. If an IVD kit includes for example, individual reagents and articles that may be made available as separate IVD medical devices, they must comply with the requirements set out in sub-regulation (1) of the General Regulations under the Medicines Act.
16. What items may not be included in labeling and packaging?
Importantly labelling and packaging link directly with the marketing of a product and in terms of Regulation 21 of the Regulations for medical devices and IVDs, no advertisement for a medical device or IVD may contain a statement which deviates from, is in conflict with or goes beyond the evidence submitted in the application for registration of the medical device or IVD with regard to its safety, quality, or performance where the evidence has been accepted by Council and incorporated into the approved instructions for use. This means that the label and package of the medical device or IVD must not include any information that is in contravention of the information which was included in the original application to the Regulatory Authority when the initial request for registration of the product was made. The same principle applies in terms of Regulation 41(4) of the General Regulations under the Act which deal with Medicines.
17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?
- Only Class A and Class B (the lower risk) medical devices and IVDs may be advertised to the public
- An advertisement for a medical device or IVD may not contain a statement which deviates from, is in conflict with or goes beyond the evidence submitted in the application for registration of the medical device or IVD with regard to its safety, quality or performance where the evidence has been provided to and accepted by the council and incorporated into the approved i instructions for use of the medical device or
- A written advertisement for a medical device or IVD must contain the name of the medical device or IVD and in the case of a registered medical device or IVD, the registration number allocated to the medical device or
- Class C and Class D medical devices or IVDs, when advertised for the first time to a prospective user, written information, which must include at least the information referred to in regulation 23 or regulation 24 of the Regulations for medical devices and IVDs, must simultaneously be given to the person to whom the oral, electronic or printed advertisement is directed and;
- When the medical device or IVD is advertised on subsequent occasions, the information must be available on
Regulation 42 of the General Regulations under the Act specifically provides the requirements for advertising of medicines, this include but is not limited to the following:
- Medicines which contain Schedule 0 substances or a substance listed as Schedule 1 may be advertised to the public;
- Medicines which contain Schedule 2, Schedule 3, Schedule 4, Schedule 5 or Schedule 6 may be advertised in the following circumstances:
- Only for the information of pharmacists, medical practitioners, dentists, veterinarians, practitioners, and other authorised prescribers; or
- In a publication which is normally or only made available to person referred to in
- Despite the requirement that medicines above Schedule 2 may only be advertised in the circumstances as discussed above, it should not be construed as to prohibit informing the public of the prices, names, pack sizes and strengths of medicines which contain a substance appearing in Schedule 2, Schedule 3, Schedule 4, Schedule 5 or Schedule 6 provided that no reference inference is made to the registered indications;
- No advertisement of a medicine may contain a statement which deviates from, is in conflict with or goes beyond the evidence submitted in the application for registration of such medicine with regards to its safety, quality or efficacy where such evidence has been accepted by the Authority in respect of such medicine and incorporated into the approved professional information of such medicine;
- An advertisement for such medicine shall contain the proprietary name and where there is a written advertisement, the approved name and quantity of each active ingredient of such medicine in lettering having minimum legibility, in the case of a registered medicine, the registration number allocated to it in terms of Section 15(5) of the Act; and
- If a medicine was submitted for registration in terms of Section 14 of the Act, the reference number allocated to the application, followed by the words “Act 101/1965”; and
- If any other name than the proprietary name is used, such other name shall be in lettering one half the size of the largest type size in which the proprietary name appears in such advertisement; and
- Where the medication is veterinary medicine, it must be indicated as such; and
- In the case of complementary medicine, a statement must be included identifying the discipline of the medicine where relevant and an indication that the medicine must be used in accordance with the applicable complementary discipline and principles where If the medication has not received registration with the Authority yet, the following disclaimer must be used “This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use”; and
- Where a medicine contains more than one active ingredient, no specific reference shall be made to the specific properties of any individual active ingredient unless a reference of this nature has been approved by the Authority for inclusion in the professional information of such medicine; and
- Verbal advertisements for the first time to pharmacists, medical practitioners, dentists, veterinarians, practitioners, and other authorised prescribers, written information must be included, containing at least information which refers to professional information for medicines for human and veterinary medicines
18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?
In order to be able to sell medicines in South Africa, the relevant licence applicable to all activities must be applied for and obtained from SAHPRA. In terms of Section 22(1) (C) a person or company must be in possession of a licence to dispense or to compound medication and dispense it. It is also required that the manufacturer or person importing/exporting or distributing the medicine, must have a licence to act as a wholesaler of the product as well.
In this regard Regulation 23 of the General Regulations under the Act state that the applicant for such licence must specify the medicines or Scheduled substance to be manufactured, imported, exported or distributed and sold.
Section 22(6) of the Act clearly indicate that no one is allowed to manufacture, act as wholesaler of or distribute, as the case may be, any medicine, Scheduled substance, medical device or IVD unless he/she is the holder of a licence to manufacture, distribute or act as wholesaler of or to import or export.
It is therefore inferred that the sale and delivery of medicines via post is unlikely given the strict requirements regarding the distribution and whole- sale practices in this regard. This also link with the requirements set out in the legislation regarding dispensing of medicines.
19. What are the restrictions and requirements for electronic marketing and advertising via email, by internet, social media, and other channels?
With regards to Professional information for medicines for human use, information may be provided (and this includes advertisements) in electronic format provided that the manner in which the professional information may be accessed is stated on the patient information leaflet as contemplated in regulation 12(2) (b) of the General Regulations under the Act. The information provided may also be provided in any of the other official languages and in any other format to enable its accessibility for persons living with disabilities.
In so far electronic marketing of medical devices and IVDs are concerned, Regulation 21(e) (i) of the Regulations relating to Medical devices and IVDs confirm that it is allowed, but in such instances, with regards to a Class C and Class D medical device or IVD specifically, written information must be provided to the person to whom the product is being advertised, simultaneously with the oral, electronic or printed advertisement.
20. May medicines and devices be advertised or sold directly to consumers?
The licence to act as a distributor and wholesaler of a medical device or IVD or for a medicine is provided by the Regulatory Authority on an application and approval basis.
MEDICAL DEVICES AND IVDS
Only Class A (low risk) and Class B (low to moderate risk) medical devices and IVDs may be advertised directly to the public or a lay person. Class C (moderate to high risk) and Class D (high risk) medical devices are only allowed to be advertised to pharmacists, medical practitioners, dentists, veterinarians, practitioners, and other authorised prescribers.
A wholesaler purchases medical devices or IVDs from a manufacturer or distributor and sells them into the retail sector. All procuring, holding, supplying or exporting of medical devices and IVDs, apart from supplying medical devices and IVDS to the public, are wholesale activities.
Medicines which contain Schedule 0 or Schedule 1 substances may be advertised to the public. Medicines which contains substances listed as Schedule 2, Schedule 3, Schedule 4, Schedule 5 and Schedule 6, may be advertised only for the information of pharmacists, medical practitioners, dentists, veterinarians, practitioners, and other authorised prescribers. However, the public may be informed of the prices, names, pack sizes and strengths of medicines which contain a substance appearing in Schedule 2, Schedule 3, Schedule 4, Schedule 5 or Schedule 6 provided that no reference or inference is made to the registered indication.
The definition of “wholesaler” as contained in the SAHPRA guideline is “a dealer or trader who acquires any medicine or medical device from a manufacturer and sells or distributes it to the retail sector and includes wholesale pharmacy.”
It can thus be inferred that a wholesaler cannot sell medicine directly to consumers; they are allowed to sell to the retail sector and wholesale pharmacies, who then go on to sell the product to the consumers.
21. How is compliance monitored?
The requirements with regards to Labelling and Advertising of Medicines, Medical devices and IVDs are set out in Section 18 of the Medicines Act.
MEDICAL DEVICES AND IVDS
Regulation 21 of the Regulations relating to medical devices and IVDs under the Act, specify the requirements for advertising for these products.
Compliance to the Regulations and the requirements in this regard is contained in Regulation 20 which confirm that medical devices and IVDs must conform to the standards and specifications which were furnished to the Council on the relevant form when the initial application for registration or licencing was done and which was then accepted by Council in respect of the medical device or IVD.
There must also be compliance in the form of conforming to the Essential Principles furnished to the Council with a declaration of conformity. Any proposed deviation from accepted standards and specifications referred to in the Regulations under the Act, must be submitted to the Council for prior approval.
Regulation 42 of the General Regulations under the Act provides the specific requirements with regards to the Advertising of medicines and compliance with this Section.
Regulation 53 of the General Regulations which relate to medicines also confirm that compliance with the standards and specifications which were furnished to the authority must be ensured and adhered to.
In monitoring both the medicines and medical device and IVDs, the Regulatory Authority can send out Inspectors to investigate the premises, manufacturing, distribution, importing, exporting and wholesale activities of an applicant or licence holder, at any given time.
22. What are the potential penalties for noncompliance?
MEDICAL DEVICES AND IVDS
The Offences and Penalties should the requirement for Advertising not be adhered to include that the person/entity/company who is non-compliant, is guilty of an offence and upon conviction is liable to a fine, or to imprisonment for a period not exceeding 10 years.
Further to the above, a person who sells a medical device or IVD that has expired is guilty of an offence and upon conviction is liable to a fine, or to imprisonment for a period not exceeding 10 years.
Regulation 52 confirm that any person who fails to comply with, contravenes the provisions of or furnishes incorrect information, as the case may be in respect of amongst others, Regulation 42, shall be guilty of an offence and upon conviction be liable to a fine or to imprisonment for a period not exceeding 10 years.