Traditional Medicines and OTC Products
The ins and outs of traditional medicines and OTC products in Zimbabwe. Prepared in association with Honey & Blanckenberg, a leading law firm in Zimbabwe, this is an extract from The Pharma Legal Handbook: Zimbabwe, available to purchase here for USD 99.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
The regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices as per the Medicines and Allied Substances Control (Complementary Medicines) Regulations, 2015 (“the Complementary Medicines Regulations”) necessitate that an application must be made for approval of the medicine by either the principal or any other person acceptable to the Medicines Control Authority of Zimbabwe “the Authority”. In addition, every complementary medicine shall, unless otherwise directed by the Authority, bear a label on the package which is printed in clear letters in the English language and any other language as directed by the Authority.
After approving a complementary medicine, the Director General of the Authority issues a certificate to the agent or principal. Furthermore, complementary medicines may only be sold on premises licensed by the Authority or authorised in terms of a general dealer’s license.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
According to Section 21(1) of the Complementary Medicines Regulations, traditional, herbal, complementary and alternative medicines can be advertised to the public, however such advertisements can only be published with the approval of the Authority in writing.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
As per Section 21 (3) of the Complementary Medicines Regulations, the only health, advertising and marketing claims permissible are those that fall within the scope of evidence submitted upon the application for approval of such medicines to the Authority. The evidence, when approved by the authority, has to be incorporated into the approved package inset of the complementary medicine. In addition, every complementary medicine approved should bear the words “NO APPROVED THERAPEUTIC CLAIMS” on the label, unless exempted by the authority.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
The Act defines “medicine” as:
“any substance or mixture of substances which is used, or is manufactured, sold or represented as suitable for use, in—
- the diagnosis, treatment, mitigation or prevention of disease or any abnormal physical or mental state or the symptoms thereof in man or in animals; or
- restoring, correcting or modifying any physical, mental or organic function in man or in animals.
As such, all the previously set out requirements relating to medicines would apply, even to over the counter medications.
Section 37 of the Regulations sets out that all medicines, including over the counter medicines ought to be labelled to show the below:
- the name and address of the principal;
- the name and address of the manufacturer;
- the approved name of the medicine which shall be of greater size and prominence than the proprietary name (trademark), if any, of the medicine;
- the housemark, if any, of the principal or manufacturer of the medicine;
- the quantity and strength of the active ingredient of the medicine;
- the name and percentage of any bacteriostatic or bactericidal agent which is added to the medicine as a preservative;
- the date of manufacture and expiry date of the medicine;
- the batch number of the medicine;
- the quantity of the medicine in the package;
- the strength of the medicine (where applicable);
- the requirements for the method of storage or other necessary precautions for the preservation of the medicine;
- the category of distribution of the medicine which may be represented by words or symbols as set out in the Sixth Schedule;
- the dosage of the medicine and the directions for use;
- any warning notices which shall be in a colour other than the colour of the particulars referred to in paragraph (a) to (m);
- any other particulars as may be directed by the Authority.
In addition, over the counter medicine must be sold in unbroken packs.
5. Are there any limitations on locations or channels through which OTC products may be sold?
Over the counter medicines may only be sold from locations or premises which are licensed by the Authority or authorized by a general dealer’s license issued in terms of the Shop Licenses Act.
6. What health, advertising, and marketing claims may be made for OTC products?
As per the National Medicines Policy of Zimbabwe, published by the Directorate of Pharmacy Services in 2011 (“the National Policy”), health, advertising and marketing claims that may be made must be based on scientific evidence which is consistent with the World Health Organisation criteria for medicine promotion and the conditions under which such products have been registered for marketing by the authority.
7. Can OTC products be marketed or advertised directly to the public?
In accordance with the National Policy, over the counter products can be marketed and advertised directly to the public provided that the product is registered with the Authority. Furthermore, advertisement and other forms of promotion directed to the general public shall be permitted only for medicines that have been licensed for sale as “over the counter” products without prescription; such advertisements and communications shall be of a technical nature and attuned to the public’s needs and level of understanding. Advertising and promotional materials and related activities will be monitored by the Authority to ensure their consistency with the conditions applicable to the products concerned and the approvals granted.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
A prescription only product can be converted to an over the counter product upon application to the Authority for a change in the registration of that product.
9. What are the requirements for the importation of either traditional medicines or OTC products?
In order to import traditional medicines or OTC products, a permit issued by the Authority is required. Furthermore, with regards to wholesale dealers, one has to be duly appointed as an authorized importer by the principal of the medicine or OTC.
Under the provisions of Section 5(2) of the Medicines and Allied Substances Control (Import & Export of Medicines) Regulations, 2008, an application for the issue of a permit should be made to the Director-General of the Authority and must include the following:
- the name and address of the importer; and
- the trade name or proprietary name of the medicine, if any; and
- the International Non-Proprietary Name (INN) or generic name of the medicine; and
- its strength; and
- the total quantity of the medicine; and
- name and address of the supplier; and
- the name and address of the manufacturer, if not the same as the supplier; and
- the Zimbabwean registration number; and
- the cost, insurance, freight (CIF) value of the consignment; and
- the port of entry.
In addition to such terms and conditions as may be fixed in a permit to import any traditional medicine or OTC, the importer shall comply with the following conditions-
- no import of any medicine shall be done through ordinary or registered post; and
- the importer of any medicine shall notify the Authority, within 30 days of the import or export of any medicine by him or her.