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

Package Inserts
11. Every package of a complementary medicine shall, unless otherwise directed by Authority, contain a package insert on which is printed in clear and indelible letters in the English language and any other language as may be directed or approved by the authority, the following particulars which relate to that complementary medicineonly-
(a) The information which is required to be included on a label in terms of Section 36 of the Act.
(b) The name and address of the manufacturer;
(c) The approved name of the active ingredient or the botanical name of the complementarymedicine, if any;
(d) the house maker, if any, of the principal or manufacturers of the complementary medicine;
(e) thequantity and strength of the active ingredient of the complementary medicine, where applicable;
(f) The name and percentage of any agent which is added to the complementary medicine as a preservative;
(g) The strength of the complementary medicine where applicable;
(h) the requirements for the method of storage or other necessary precautions for the preservation of the complementary medicine;
(I) the category for distribution of the complementary medicine which maybe represented by words or symbols as set out in the ThirdSchedule ;
(j) the dosage of the complementarymedicine and the directions for use;
(k) thedescription of the pharmacological action of the complementary medicine where applicable;
(l) approved indications of the complementary medicine ;
(m) contra-indications of the complementary medicine;
(n) warnings relating to the use of the complementary medicine and such warning shall be printed in a coulor as approved by the Authority;
(o) the side -effects and special precautions of the complementary medicine;
(p) Known symptoms of over-dosage and particulars of its treatment;
(q) theidentification of the complementary medicine;
(r) the form in which the complementary medicine is presented, whether tabulate, capsule, liquid, etc. and the colour thereof;
(s) the date of publication of the package insert;
(t) any necessary warning concerning the administration or use of the complementary medicine by children, old people, pregnant women or patients suffering from certain diseases or the use of the medicine in conjunction with the consumption of alcohol or any particular foods or any other medicines;
(u) a summary of relevant informationconcerning the purpose and the beneficial , detrimental, injurious or other effects of the complementary medicine and the possible dangers that may arise from the prolonged use of the medicine;
(v) relevant information including particulars in regard to a specific medicine as an antidote (if known) , concerning the treatment of a patient in cases where an overdose of a complementary medicine has been administered or where a patient reacts adversely to the medicine ;
(w) any other particulars or warning notices as maybe directed by the authority 

Reference of the measure

Art 11 

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