Non-Tariff Barriers

Non-Tariff Measure

NTM classification

B33: Packaging requirements 

Date when the measure came into force

01 July 1991 

Publication where the measure is specified

Statutory Instrument 150 of 1991 

Regulation where the measure is specified

Medicines and Allied Substances Control (General) Regulations, 1991 

Country/Region applying the measure

Zimbabwe 

The rationale of the measure

Not specified in the regulations 

Coded list of objectives

X: For purposes n.e.s. 

Description of the measure

Package inserts
38. Every package of a medicine shall, unless otherwise directed by the 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 medicine only –
(a) the information, which is required to be included on a label in terms of section 36 of the Act;
[amended by S. I. 257 of 2002, with effect from the 27th September 2002.]
(b) the name and address of the principal;
(c) the name and address of the manufacturer;
(d) the approved name of the active ingredient of the medicine which shall be of greater size and prominence than the proprietary name (trade mark), if any, of the medicine;
(e) the housemark, if any, of the principal or manufacturer of the medicine;
(f) the quantity and strength of the active ingredient of the medicine;
(g) the name and percentage of any bacteriostatic or bactericidal agent which is added to the medicine as a preservative;
(h) the strength of the medicine where applicable;
(i) the requirements for the method of storage or other necessary precautions for the preservation of the medicine;
(j) the category of distribution of the medicine which may be represented by words or symbols as set out in the Sixth Schedule;
(k) the pharmacological classification of the medicine determined in terms of section 34;
(l) the dosage of the medicine and the directions for use;
(m) the description of the pharmacological action of the medicine;
(n) indications of the medicine;
(o) contra – indications of the medicine;
(p) warnings relating to the use of the medicine and such warning shall be printed in a colour as approved by the Authority;
(q) the side-effects and special precautions of the medicine;
(r) known symptoms of overdosage and particulars of its treatment;
(s) the identification of the medicine;
(t) the form in which the medicine is presented, whether tablet, capsule, liquid, etc., and the colour thereof;
(u) the date of publication of the package insert;
(v) any necessary warning concerning the administration or use of the 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 food or any other medicine;
(w) a summary of relevant information concerning the purpose and the beneficial, detrimental, injurious or other effects of the medicine, and the possible dangers that may arise from the prolonged use of the medicine;
(x) relevant information, including particulars in regard to a specific medicine as an antidote (of known), concerning the treatment of a patient in cases where an overdose of the medicine has been administered or where a patient reacts adversely to the medicine;
(y) any other particulars or warning notices as may be directed by the Authority. 

Reference of the measure

Art 38 

Measure also domestic

Yes 

Products affected by the measure.

Description

All medicines except for substances controlled by the Hazardous Substances and Articles Act [Chapter 15:05] 

Countries/Regions affected by the measure.

Description

All countries