Q & A pertaining to the regulations requiring registration of Complementary Medicines
The Minister of Health called for the registration of complementary medicines by amending the Regulations to the Medicines and related substances Control Act on 15th November 2013.
There is a requirement that the Medicines Control Council evaluates and pronounces on the safety, quality and efficacy of complementary medicines.
What is a complementary medicine (CAM)?
Any substance or mixture of substances which
- Originates from plants, minerals or animals;
- Is used or intended to be used for, or manufactured or sold for use in assisting the innate healing power of a human being or animal to mitigate, modify, alleviate or prevent illness, or the symptoms thereof or abnormal physical or mental state, and
- In accordance with the practice of the professions regulated under the Allied Health Professions act, 1982 (Act No 63 of 1982)
What are the categories of medicines and the related disciplines?
Categories of medicines (Regulation 25)
CAMs intended for use in humans and animals which are, without further manipulation, ready for administration, including packaged preparations where only a vehicle is added to the effective medicine.
Disciplines of CAMs
- Chinese medicines
- Ayurveda medicines
- Unani Tibb medicines
- Homoeopathic medicines
- Aromatherapy medicines
- Western Herbal medicines
What are the requirements for registration of CAMs? And are there any timelines?
According to the MCC, importers, manufacturers and wholesalers should be licensed according to Good Manufacturing Practice (GMP) and Good Wholesaling Practice (GWP).
As at November 2013 all complementary medicines are to be imported by a licensed entity. And at the same date all complementary medicines are to be manufactured in a licensed GMP compliant facility. The MCC intends inspections to be done on a “Risk” basis with high risk products given preference.
The following complementary medicines, resorting in any one of the complementary medicine disciplines and falling within the following pharmacological classifications
20.2.8 (Antiviral agents),
21.2 (Oral hypoglycaemics),
6 (Cardiac medicines),
26 (Cytostatic agents) are subjected to registration from 15th November 2013.
Complementary medicines that were available for sale in the Republic before or are so available on the date on 15th November 2013 must submit for registration within six (6) months from that date. Complementary medicines that become available after the said date shall submit for registration prior to the sale thereof.
All slimming / weight reduction products and sexual stimulation medicines (so-called “Life-style” products) will be called in for assessment within 24 months after the publication of the regulations. This will also apply to all complementary or alternative medicines currently on the market as well as all new CAMs products.
All immune-boosters, medicines acting on muscular system (pharmacological classification 17) and sports supplements making any medicinal claim and in the case of sport supplements, containing supplements in excess of the identified upper limit of Vitamins or Minerals will be called in for evaluation assessment within 30 months of the publication.
The Department of Health maintains that only substances with registration as per above may be sold. The actions regarding registration should be;
- Submit new complementary medicines complying with the regulatory definition for registration prior to sale. I.e. no sale prior to registration.
- Withdraw from the market products containing banned substances.
- Withdraw from the market unregistered self-styled complementary medicines containing S1 or higher substances.
- Withdraw from the market misbranded products not fitting the regulatory definition of a complementary medicine.
What is a banned substance?
Banned substances are not recognised for medical use and have an extremely high potential for abuse or producing dependency which renders their possession harmful, unnecessary and undesirable.
“Section23 (Act 101/1965) Disposal of Undesirable Medicines.
- If the Council is of the opinion that it is not in the public interest that any medicine shall be made available to the public, it may-
(a) By notice in writing transmitted by registered post to any person direct that person; or
(b) By notice in the Gazette direct any person, to return any quantity of such medicine which he has in his possession to the manufacturer thereof or (in the case of any imported medicine) to the importer concerned or to deliver or send it to any other person designated by the Council.
- The Council may by notice in writing direct any manufacturer or importer of any such medicine who has in his possession any quantity thereof (including any quantity returned, delivered or sent to him in pursuance of a direction under sub-section (1), or any other person to whom any quantity of such medicine has been so returned, delivered or sent, to deal with or dispose of that quantity is such manner as the Council may determine.
- No person shall sell any medicine which is the subject of a notice under subsection (1) which has not been set aside on appeal.
Regulation 32 (1) Seizure of Medicines,
A medicine may be seized if it-
(a) Is unregistered and sold in contravention of the Act…….
(g) Has been declared undesirable in terms of the Act………
Products that contain “banned” substances – such as yohimbine, damiana, kava kava and apiol – should be withdrawn from the market with immediate effect. In addition, those that contain Scheduled substances that are currently listed in the schedules to the Act should be withdrawn from the market with immediate effect. These include glucosamine when used for arthrititis (S3), silymarin (as contained in “milk thistle” (S3), Vitamin D in amounts greater than 500 I.U. a day (S3), phenylephrine (m-synephrine, contained in Citrus aurantium or Bitter Orange (S1)), dehydroepiandrosterone (DHEA, prasterone (S5)), dimethylaminoethanol (DMAE) and deanol (S5) to mention a few.
What is a scheduled substance?
Scheduled substance means any medicine or other substance prescribed by the Minister under Section 22A (Medicines and Related Substances Act 101 of 1965).
What options does a manufacturer have in terms of the new regulations?
In respect of a product that satisfies the definition of a medicine and has been called up for registration in terms of section 14(2) of the Medicines Act, importers, manufacturers, wholesalers and/or retailers may exercise one of two options at the point the rescission notice comes into effect:
– They may choose to remove such a medicine from the market until such time as the medicine has been registered by the MCC; or
– They may choose to keep such a product on the market on condition that they refrain from making any medicinal claim in any form that is reasonably capable of being understood as referring to the product in question – this applies to any form of published information, including but not limited to product labels, package inserts and advertisements.
It is the intention of the Medicines Control Council to apply the provisions of the registration of complementary medicines to all such medicines by November 2019.
What is a category A medicine as opposed to a category D medicine?
Generally, all medicines are Category A medicines unless there are specific characteristic that indicate otherwise.
A category D medicine refers to a CAM intended for use in humans and animals which are, without further manipulation, ready for administration, including packaged preparations where only a vehicle is added to the effective medicine.
What category is relevant if combination ingredients fall under different disciplines?
Combination products are intended to be handled as follows:
- Applicants will need to demonstrate explicit, cogent philosophies of use amongst all ingredients or will be referred for category A registrations.
- The registration-sub-category will be “combination Product” and the discipline(s) it relates to:
- Where vitamins. Minerals or other substances of food origin are included in a combination product and where such items fall below prescribed maximum food levels and provided that no medicinal claim is made, complementary registration will be permitted, and
- Where classified foods further purport to make medicinal claims or are above prescribed maximum food levels, these products will be referred for category A registration.
What are the labelling requirements for CAMs?
Labelling of Complementary medicines In terms of the provisions of Regulations 8, 9 and 10 of the Medicines and Related Substances Act, 1965 all medicines falling in Category D must comply with the labelling requirements in so far as the product label, the Package Insert and the Patient Information Leaflet are concerned. (iii) All other requirements in terms of the Medicines and Related Substances Act, 1965.
A CAM should state on the label the category of medicine, the pharmacological classification, a statement identifying the discipline where the medicine is used and if not registered should have the disclaimer “This medicine has not been evaluated by the Medicines Control Council. The medicine is not intended to diagnose, treat, cure or prevent any disease”.
These amendments came into effect three months after the publication of notice R870 or 15th February 2014.
Are exemptions likely to be allowed in terms of Section 36 of the Medicines and Related substances Act from packaging requirements- Regulations 8,9, and 10?
Products will only qualify for exemption if;
- They are CAMS in terms of the current definition of CAMS (regulation in notice R870 of 15 Nov 2013
- They were submitted in terms of the 2002 Notice, i.e. have received MBR 20.8 registry numbers.
- Full details were provided per product:
i. Product name
iv. Allied Health practitioner relationship needs to be defined. E.g. Homeopathic product.
2. “Blanket approvals” will not receive positive outcomes.
3. Commitment in terms of compliance plan must be included with request.
In what format should applications for complementary medicines be made?
Applications to the MCC should be made in the ZA_CTD format.