Non-Tariff Barriers

Non-Tariff Measure

NTM classification

A31: Labelling requirements 

Date when the measure came into force

01 January 1998 

Publication where the measure is specified

Pharmacy, Medicines and Poisons Act 

Regulation where the measure is specified

Pharmacy, Medicines and Poisons Regulations 

Country/Region applying the measure

Malawi 

The rationale of the measure

No specific objective stated 

Coded list of objectives

X: For purposes n.e.s. 

Description of the measure

14. Package inserts
Every package of a medicinal product shall, unless otherwise directed by the Board, 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 Board the following particulars which relate to medicinal product—
(a) the name and address of the owner of the medicinal product;
(b) the name and address of the manufacturer of the medicinal product;
(c) the approved name of the active ingredient of the medicinal product and the proprietary name or trade mark, if any, of the medicinal product;
(d) the logo, if any, of the owner of the medicinal product or manufacturer of the medicinal product;
(e) the name and percentage of any bacteriostatic or bactericidal agent which is added to the medicinal product as a preservative;
(f) the strength of the medicinal product, where applicable;
(g) the required storage conditions or other necessary precautions for the preservation of the medicinal product;
(h) the category of distribution of the medicinal product which may be represented by words or symbols as set out in the Third Schedule;
(i) the pharmacological classification of the medicinal product determined in accordance
with regulation 11;
(j) the dosage of the medicinal product and the directions for use;
(k) the description of the pharmacological action of the medicinal product;
(l) indications of the medicinal product;
(m) contra-indications of the medicinal product;
(n) warnings relating to the use of the medicinal product;
(o) the side-effects and special precautions of the medicinal product;
(p) known symptoms of over-dosage and particulars of its treatment;
(q) the identification of the medicinal product;
(r) the form in which the medicinal product is presented, whether tablet, capsule or liquid
and the colour thereof;
(s) the date of publication of the package insert;
(t) any necessary warning concerning the administration or use of the medicinal product by
children, old people, pregnant women or patients suffering from certain diseases, or the use of the
medicinal product in conjunction with the consumption of alcohol or any particular food or any other
medicinal product;
(u) a summary of relevant information concerning the purpose and the beneficial,
detrimental, injurious or other effects of the medicinal product, and the possible dangers that may arise
from the prolonged use of the medicinal product;
(v) relevant information, including particulars in regard to a specific medicinal product as an
antidote (if known), concerning the treatment of a patient in cases where an overdose of the medicinal
product has been administered or where a patient reacts adversely to the medicinal product; and
(w) any other particulars or warning notices as may be directed by the Board. 

Reference of the measure

Article 14 

Measure also domestic

No 

Products affected by the measure.

Description

Medicinal products 

Countries/Regions affected by the measure.

Description

Entire world