Non-Tariff Barriers

Non-Tariff Measure

NTM classification

B31: 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

13. Labelling and marking of medicinal products
(1) Subject to regulation 29, every medicinal product shall, unless otherwise directed by the
Board, bear or incorporate a label on the package in which the medicinal product is sold, 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 that medicinal product—
(a) the name and address of the person who owns the medicinal product;
(b) the name and address of the manufacturer;
(c) the approved name of the medicinal product and the proprietary name or trade mark, if any, of the medicinal product;
(d) the logo, if any, of the person who owns 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 date of manufacture and the expiry date of the medicinal product;
(g) the batch number of the medicinal product;
(h) the quantity of the medicinal product, in the package;
j) the required storage conditions or other necessary precautions for the preservation of the medicinal product;
(k) the category of distribution of the medicinal product which may be represented by
words or symbols as set out in the Third Schedule;
(l) the dosage of the medicinal product and the directions for use;
m) any warning notices which shall be in a colour or print other than the colour or print of the particulars referred to in subparagraphs (a) to (l); and
(n) any other particulars as may be directed by the Board:
Provided that in the case of a small package containing a medicinal product, it shall be adequate to record the information required by paragraphs (c), (f), (g), (h), and on the outer label.
(2) Every medicinal product shall where possible be marked with the logo of the owner of the medicinal product or manufacturer of the medicinal product, as the case may be, and such other distinguishing mark for the purpose of identifying such medicinal product. 

Reference of the measure

Article 13 

Measure also domestic

No 

Products affected by the measure.

Description

Medicinal products 

Countries/Regions affected by the measure.

Description

Entire world