Non-Tariff Barriers

Non-Tariff Measure

NTM classification

B31: Labelling requirements 

Date when the measure came into force

11 September 2015 

Publication where the measure is specified

Statutory Instrument 97 of 2015 

Regulation where the measure is specified

Medicines and Allied Substances Control (Complementary Medicines) Regulations, 2015 

Country/Region applying the measure

Zimbabwe 

The rationale of the measure

Not stated in the regulations 

Coded list of objectives

X: For purposes n.e.s. 

Description of the measure

10.(1) Every complementary medicine shall, unless otherwise directed by the Authority , bear or incorporate a label on the package in which such complementary medicine is sold on which is printed in clear and indelible letters in the Englishlanguage and any other languages as may be directed or approved by the Authority , in addition to the approval number , the following particulars which relate to that complementary medicine only-
(a) the name and address of principal;
(b) the name and address of manufacturers;
(c) theapproved name of the complementary medicine , if any
(d) thehouse maker, if any, of the principal manufacturer of the complementary medicines;
(e) the quantity and strength of the active ingredient of the complimentary medicine where applicable
(f ) the name and the percentage of any agent which is added to the complementary medicine as a preservative;
(g) the date of the manufacture and the expiry date of the complementary medicine;
(h) the batch number of the complementary medicine;
(i) the quantity of the complementary medicine the package;
(j) thestrength of the complementary , where applicable;
(k) therequirements for the method of storage or other necessary precautions for the preservation of a complementary medicine.
(l) The category for the distribution of the complementary medicine which may be represented by words or symbols as setoutinthe Third Schedule.
(m) The dosage of the complementary medicine and the directions for use;
(n) Any warning notices which shall be in a colour other than the colours of the particulars referred to in paragraphs (a) to (m);
(o) any other particulars as may be directed by the Authority. Provided that in the case of a package containing a complementary package containing a complementary package of a quantity of five millilitres or less, it shall beadequate torecord the information required by the paragraphs (a), (b), (c) , (d), (e), (f), (g), (h), (l) and (o) on the outer label.
(2) Notwithstandingsubsection (l), the Authority may, if it deems it expedient, direct that the name and address of the manufacturer of a particular complementary medicine shall not appear on the package. 

Reference of the measure

Art 10 (1) ad (2) 

Measure also domestic

No 

Products affected by the measure.

Description

Aromatherapeutic substances, Ayurvedic Medicines, Energy Substances or Medicines, Homeopathic Remedies, Nutritional Substance in pharmaceutical form, Traditional Chinese Medicines, Traditional Dutch Remedies, Unanni Tibb Medicines, Western Herbal Medicines and such other medicines or remedies as may be approved by the Authority 

Countries/Regions affected by the measure.

Description

All countries