The Traditional and Natural Health Alliance (TNHA) is cognizant of the fact that SAHPRA inspectors are currently conducting unannounced compliance checks by visiting natural health product purveyors across South Africa. Because the regulation of the natural health products sector is new, it has come to our attention that many company owners and their management teams are not fully aware of the laws applicable to their businesses, or their rights and responsibilities when inspectors arrive unannounced. Consequently, we receive numerous frantic phone calls from both members and non-members seeking guidance on how to handle such situations. This guide is our response to these frequent queries and aims to clarify the current state of natural health product regulation by SAHPRA.
It should be noted that this guide is not a substitute for professional legal advice but is intended as a framework for our latest perspectives on these matters as they unfold. We recognize that the industry is currently navigating through a grey area after the 2017 regulations for ‘complementary medicine’ were declared unconstitutional by the Supreme Court of Appeal in April 2022. It is important to carefully navigate the current status quo to maintain compliance with the existing provision of the Medicines and Related Substances Act (Act No. 101 of 1965).
When individuals claiming to be inspectors arrive at your doorstep, it is crucial to identify who they are and understand how to conduct yourself during this potentially stressful event. Equally important is to take the time to familiarize yourself with the regulations and guidelines that are linked throughout this guide. Ignorance of the laws governing your industry is not an acceptable excuse; therefore, it is incumbent upon businesses to comprehend compliance with the Medicines Act and explore ways of operating within or outside the dense thicket of medicines regulation.
If you have any technical enquiries related to this guide, feel free to contact us.
If you are not yet a TNHA member, you can sign up here.
TABLE OF CONTENTS
- SAHPRA Appointment cards are required for inspectors.
- Request to see related ‘complaints’ prior to inspection.
- Is it considered an obstruction to ask for inspectors to provide their Appointment Certificate cards before entering your premises, or to request evidence of a genuine complaint with written support?
- Recording SAHPRA inspectors.
- What powers and duties can inspectors exercise during their inspections?
- What are the ‘Offences’ under the Medicines Act?
- What happens if my business is found to be non-compliant during an inspection?
- What types of natural health products and ingredients fall under the Medicines Act?
- What if the natural health products I sell do not fall within the definition of medicine or do not contain scheduled substances?
- Do I need to have a registered pharmacist as the ‘Responsible Person’ to run my business?
- What type of licence must I obtain for my business to be compliant?
- If my products are ‘medicines’, as defined in the Medicines Act, or contain scheduled substances, do I have to register them?
- Keep us informed
1. SAHPRA Appointment Certificate cards are required for inspectors.
To ensure the safety and security of your business, it is crucial to verify the identity of any inspectors before allowing them access to your business premises. To this end, we recommend that you follow these guidelines:
- Inspectors must properly identify themselves as SAHPRA inspectors and present their Appointment Certificate cards for your review.
- In the event that an inspector fails to provide their Appointment Certificate card, it is your right to request it before proceeding with any inspection.
The Appointment Certificate card should include the following details:
- Full Name
- ID Number
- A written declaration indicating the specific section of the Medicines and Related Substances Act under which they are appointed (Section 26)
- The signature and name of the Chief Executive Officer, who is the only authorized issuer of Appointment Certificate cards.
It is important to note that inspectors must carry their Appointment Certificate cards at all times and produce them upon request to verify their credentials in accordance with Section 26(1), (2) and (3) of the Medicines Act. By adhering to these guidelines, you can help ensure that your business remains secure and protected.
It is important to note that electronic access control cards on lanyards do not qualify as Appointment Certificate cards unless they meet the criteria outlined above.
To protect your legal interests, we recommend that you make a photocopy or photograph of the Appointment Certificate cards of each inspector before allowing them entry. You may also request additional identification, such as a South African ID or driver’s license, to confirm the identity of the inspector. It is important to remember that SAHPRA employees acting in their official capacities are not entitled to privacy in terms of the Protection of Personal Information Act (POPIA Act) and must establish their credentials before entering your premises.
If an inspector refuses to produce their Appointment Certificate card, you have the right to deny them access to your business premises. If multiple inspectors are present, each one must produce their Appointment Certificate card individually. Any individual who fails to present an Appointment Certificate card upon demand must remain outside until someone who can produce the card arrives.
In the event that SAHPRA inspectors are accompanied by members of other law enforcement agencies, you have the right to request that they also produce their appointment cards or letters of appointment. If they are unable to do so, you may refuse them entry until they can provide the necessary documentation.
Please note that any SAHPRA inspector or other law enforcement agency or authority inspector who enters your business premises or private dwelling without producing their Appointment Certificate card or letter of appointment on demand is in violation of the law and can be reported to the South African Police Services.
2. Request to see related ‘complaints’ prior to inspection.
In the past, SAHPRA officials have conducted unannounced visits to natural health product companies and sometimes arranged appointments beforehand.
INSPECTIONS BASED ON COMPLAINTS
Historically, inspectors have often visited businesses claiming to have received a complaint about the company or its products and demanded access for inspection purposes. As per the audi alteram partem rule (“listen to the other side”), it is your right to see the specific complaint/s so that you can respond. If the inspectors cannot provide you with a copy of the complaint or refuse to show it to you, you may ask them to remove any personal identifying information and then provide you with the complaint for your own record keeping. Before allowing inspectors into your business, it is reasonable to demand proof of their appointment as inspectors and the exact nature of the inspection. If there is no specific complaint, inspectors may be looking for reasons to take action against you once inside your premises. In the case of a general inspection, inspectors would usually make an appointment in advance.
INSPECTIONS FOR LICENCE HOLDERS
If you have obtained a Section 22 licence to import, manufacture, wholesale, or distribute medicines, inspectors may conduct random inspections of your licensed facilities or facilities in the process of applying for a license. These inspections are usually scheduled in advance.
3. Is it considered an obstruction to ask for inspectors to provide their Appointment Certificate cards before entering your premises, or to request evidence of a genuine complaint with written support?
The answer is no.
According to Section 29 of the Medicines Act, obstructing or hindering any inspector while performing their duties is an offense. However, as a business owner, you have the right to ensure the legitimacy of their appointment by requesting their Appointment Certificate cards and evidence of any genuine complaint made against your product/s or business. Inspectors are obligated to provide this information prior to conducting any inspection. In the context of crime in South Africa, it is reasonable to know the identity and purpose of individuals arriving at your premises before granting them access.
It is important to maintain a professional and non-confrontational approach when dealing with inspectors. It is recommended to politely request the information that you require before allowing them access to your business premises.
It is important to note that inspectors are highly trained professionals who understand the scope of their powers and responsibilities under the Act. As with any professional, they should be treated with respect and courtesy.
Inspectors are required to produce their Appointment Certificate cards before exercising their powers or identifying themselves. Additionally, they are obligated to provide evidence of any genuine complaint related to your products or company, should one exist.
In the event that an inspector behaves unprofessionally towards you or your staff, it is recommended to report the incident to the Chief Executive Officer (Boitumelo.Semete@sahpra.org.za), along with any supporting evidence, such as recordings.
4. Recording SAHPRA inspectors.
As a business owner, you have the right to take photographs and record video or audio of any interactions with inspectors on your business premises. Inspectors are considered public servants and are therefore subject to being recorded while carrying out their official duties, provided that they are not obstructed or hindered in any way.
It is important to note that there is no provision in the Medicines Act or regulations that prohibit the taking of photographs, video clips, or audio recordings of inspectors during inspections. Furthermore, public servants in South Africa have no right to privacy while on official duty.
Recording your interactions with inspectors is recommended as it serves as a reliable reference for discussions held and can be used as evidence to support your defence if necessary. We recommend designating someone in your business to handle recording duties to ensure that the process is streamlined and efficient.
It is important to understand that SAHPRA inspectors cannot prevent you from recording nor confiscate any recording equipment to delete any recordings.
5. What powers and duties can inspectors exercise during their inspections?
Section 28 of the Medicines Act defines the powers of duly appointed inspectors, which may be summarized as follows:
Inspectors are authorized to, at a reasonable time, enter any place or premises, including private dwellings, vessels, or aircraft, with or without a warrant, where they have reasonable grounds to suspect an offence has been or is being committed under the Medicines Act. They may do so at reasonable times, and this includes premises where medicines are compounded or dispensed, scheduled substances are manufactured, kept, or sold, or at licensed facilities authorized under Section 22 of the Medicines Act.
Reasonable time means a convenient time, as soon as the circumstances permit.
In cases where entry is refused to a private dwelling, inspectors may enter with the consent of the occupier or a search warrant issued by a court. If an inspector believes on reasonable grounds that a warrant would be issued to them by a magistrate, and that a delay in obtaining such a warrant would defeat the purpose of the entry, a search warrant may not be required. Reasonable grounds mean that a reasonable person in the same circumstances would consider there to be a reasonable basis for the decision made in a fair and sensible manner.
Inspectors are also authorized to inspect any medicine, scheduled substance, book, record, or document found during the inspection. If evidence of a contravention of the Medicines Act is found, they may seize any such medicine, scheduled substance, book, record, or document. Additionally, they may take samples of any medicine or scheduled substance they consider necessary for testing, examination, or analysis under the provisions of this Act. Any samples taken will follow prescribed methods outlined in Section 31 of the Medicines Act and will be taken in the presence of the responsible pharmacist or responsible person running the business. If there is no such person, or if they are absent, any other witness employee may be present. Samples will be tested by SAHPRA, and the results will be conveyed to the business. The owner of the medicine or scheduled substance from which the sample was taken may claim an amount equal to the market value from SAHPRA.
Below is the full text of Section 28:
6. What are the ‘Offences’ under the Medicines Act?
Section 29 of the Medicines Act lays out all the offences in terms of the Act.
Below is the full text of Section 29:
7. What happens if my business is found to be non-compliant during an inspection?
In the event of non-compliance with the provisions of the Medicines Act and its regulations, inspectors have the discretion to take action against your company or issue formal warnings for compliance within specific time frames. It is important to note that being non-compliant can have serious consequences for your business. Your licenses, if any, may be suspended or revoked, and criminal charges may be filed.
We kindly draw your attention to Section 30 of the Medicines Act, which outlines penalties for offences. As a responsible business owner, it is crucial to ensure compliance with the Act and its regulations to avoid any legal consequences.
Below is the full text of Section 30:
In the event of being issued a compliance notice (warning), fine or an arrest of a TNHA member or their staff, we strongly advise immediate contact with our organization to enable us to offer assistance within our capacity. As a TNHA member, you will have access to our network of expert external lawyers who specialize in medicines law, to whom we can provide referrals.
8. What types of natural health products and ingredients fall under the Medicines Act?
SAHPRA reserves the right to conduct compliance checks or inspections on any company engaged in the import, manufacture, wholesale, or distribution of products that fall under the definition of “medicines” as stated in Section 1 of the Medicines Act, or products that contain Scheduled substances.
Until April 9th, 2023, the South African Health Products Regulatory Authority (SAHPRA) had jurisdiction over Category D products, also known as “complementary medicines,” in accordance with the 2017 General Regulations. However, in the case of the Minister of Health and Another v Alliance of Natural Health Products (South Africa) (256/2021), the Supreme Court of Appeal declared the “complementary medicine” section of the regulations ultra vires (unlawful and unconstitutional). The extended definition of “medicine” in the Medicines Act through the definition of “complementary medicine” was found to be a regulatory overreach, and thus the Minister was not empowered to legislate through regulation. The court found that it is up to the legislature (Parliament) to expand the definition of medicine in the Medicines Act to incorporate complementary medicine if it chooses to do so. At present, no legislative amendment Act has been tabled, nor have revised draft regulations been gazetted for comment that seeks to address this issue.
The Minister and SAHPRA have two options: amend the Medicines Act and its Regulations, or rely wholly on the Act itself, which defines what medicine is and the Schedules to continue regulating parts of the natural health product industry.
Your business could be subject to SAHPRA inspections (compliance checks) and all the licensing requirements to legally operate if you import, manufacture, wholesale or distribute natural health products with health claims on their labels, packaging, or associated marketing material which claim to:
diseases (by name) or symptoms thereof in humans, or
any somatic (physical biology) or psychic (psychiatric), or organ function in humans or animals. In such cases, your products are deemed ‘medicines’.
The Government (Parliament, The Minister of Health, and other organs of state) have recognized that natural health products should be regulated differently and risk-appropriately from other pharmaceutical medicines, as they are distinctly different from modern new-to-man pharmaceuticals. Most countries have either declared them food supplements under food law or created a separate 3rd category for them, between foods and drugs.
However, it is not tenable for the Minister and SAHPRA to deem all natural health products ‘medicines’ under a half a century old definition which was created for new chemical entities and patent drugs back in 1965. The Medicines Act was originally titled ‘The Drugs Act’.
We believe that a new piece of legislation needs to be passed, that ring-fences natural health products and traditional medicines, and which will be regulated by an autonomous regulatory authority staffed by experts in the various disciplines represented. This could be a stand-alone Authority like the SAHPRA, or a separate Directorate under the National Department of Health.
The Minister of Health, in consultation with the SAHPRA, has been gradually incorporating natural health ingredients into the Schedules under Section 14(2) of the Medicines Act since 2014. Many of these substances are now classified under Category D, specifically Schedule 0, with prescribed limitations on daily dosages and mandatory cautionary statements on labels.
The substances in Schedule 0 include –
- minerals & electrolytes,
- proteins & amino acids,
- probiotics & prebiotics,
- animal extracts,
- saccharides & monosaccharides,
- polyphenols (and bioflavonoids),
- and certain listed botanicals and botanical isolates (e.g Cannabidiol).
As these substances are scheduled, and therefore fall under the jurisdiction of the Act and SAHPRA inspectors. Consequently, any business that sells such substances may be subject to SAHPRA inspections (compliance checks) and may in the future be to be licenced in terms of Section 14 of the Medicines Act to operate legally.
It is our view that South Africa should not categorize dietary supplement ingredients as Schedule 0 substances. The name “health supplements” used locally was specifically selected to assign a medicinal or preventive function, thus providing a catch-all provision to include them under the Medicines Act. Other countries classify these substances as food supplement ingredients, and there is no equivalent to Schedule 0 in their scheduling tiers.
When compared to other pharmaceutical products in Schedule 0, these substances present a de minimus (trivial and to be ignored) risk. Therefore, there is a possible legal challenge being investigated, and the courts may have to determine whether it is appropriate and reasonable to retain such substances in Schedule 0 with demonstrably safe dosages.
For the time being, companies that include these substances in their products must ensure that they adhere to the maximum daily dosages listed in Schedule 0 on their labels; otherwise, they may be classified under higher schedules. To comply, companies should verify their ingredients and cross-reference them with the Schedule 0 list for natural health substances. If you are importing products, ensure that the daily dosages on your labels conform to the Schedule 0 daily dosage limits. Failure to comply may result in having products being impounded and returned to the sender, or destroyed after accruing substantial Port Health storage fees. Also, ensure that your products do not make any health claims (refer to the ‘MEDICINES’ sub-section above).
9. What if the natural health products I sell do not fall within the definition of medicine or do not contain scheduled substances?
According to the judgment of the Supreme court of Appeal in 2022, products not falling within the definition of a ‘medicines’ in terms of Section 1 of the Medicines Act, or not containing ‘scheduled substances’ in terms of Section 14(2) of the Medicines Act, fall outside of the jurisdiction of SAHPRA and its inspectorate.
However, they may fall within the definition of a foodstuff or cosmetic in terms of the Foodstuffs, Cosmetics and Disinfectants Act (Act No. 54 of 1972) and its regulations and as consumer goods, are subject to the provisions of the Consumer Protection Act (Act No. 68 of 2008) and its regulations. Responsible companies should familiarise themselves with these two pieces of legislation. The TNHA will be developing guidance documents for these in the near future.
10. Do I need to have a registered pharmacist as the ‘Responsible Person’ to run my business?
At present, the Minister of Health, SAHPRA, and Pharmacy Council are undertaking a review to determine if businesses that sell natural health products will still be required to employ a registered pharmacist on a full-time basis and appoint them as Responsible Persons. We are awaiting the decision on this matter. If you do not have a pharmacist in your employ, designated as the ‘Responsible Person’, the owner of the company or designated staff member should identify as such during an inspection.
11. What type of licence must I obtain for my business to be compliant?
In accordance with Section 22 of the Medicines Act, enterprises involved in the import, manufacture, distribution, and wholesale of scheduled substances and medicines must acquire relevant licenses to operate within South Africa. Exporters may also require local licenses, as well as additional licenses from the relevant foreign authority in the destination country.
Health practitioners must obtain a Compounding and Dispensing License from the Director-General of the Department of Health, pursuant to the regulations set forth in section 22C of the Medicines Act, along with Regulation 18 of the same Act.
Although the Minister of Health and SAHPRA currently do not enforce these licensing requirements for natural health product companies, they are currently undertaking a review to determine the applicability and implementation of such licenses.
12. If my products are ‘medicines’, as defined in the Medicines Act, or contain scheduled substances, do I have to register them?
As of the compilation of this guidance, the Minister of Health, in consultation with the South African Health Products Regulatory Authority (SAHPRA), has not yet issued a call-up for the registration of natural health products in accordance with Section 14 of the Medicines Act. A review is currently underway to determine the suitability and potential implementation of such a call-up. Currently, the sale of natural health products is legally permissible without registration, except for those containing scheduled ingredients above schedule 0.
Regarding MBR 20.8 registry letters, certain companies may possess letters acquired between February 2002 and 2011, which were issued under call-up notice R.204, titled “CALL UP NOTICE FOR MEDICINES FREQUENTLY REFERRED TO AS COMPLEMENTARY MEDICINES IN TERMS OF THE MEDICINES AND RELATED SUBSTANCES CONTROL ACT, 1965.” These registry letters constituted prima facie evidence to SAHPRA and Port Health that the company in question had lodged specific information with the Authority regarding the products they sold. The letters facilitated the reliable importation of natural health products. However, the original notice was rescinded in February 2017 through gazette notice No. 40637.
SAHPRA and the Port Health Authority no longer accept or honour MBR 20.8 registry letters.
12. Keep us informed
If your business receives an unexpected inspection from SAHPRA inspectors, please inform us promptly. We are closely monitoring the enforcement of SAHPRA’s legislation on natural health product companies and would like to stay informed.