Regulation 8 Insertion of Schedule 2 into the principal Regulations

After Schedule 1 there shall be inserted the following—

“SCHEDULE 2

PARTICULARS REQUIRED TO BE INCLUDED IN LEAFLETS RELATING TO RELEVANT MEDICINAL PRODUCTS

Regulation 3(2)

1

For identification of the medicinal product—

(a)

the name of the medicinal product followed where the product contains only one active ingredient and its name is an invented name, by the common name;

(b)

a full statement of the active ingredients and excipients expressed qualitatively and a statement of the active ingredients expressed quantitatively, using their common names, in the case of each presentation of the medicinal product;

(c)

the pharmaceutical form and the contents by weight, by volume or by number of doses of the product, in the case of each presentation of the product;

(d)

the pharmaco-therapeutic group, or type of activity in terms easily comprehensible for the patient;

(e)

the name and address of the holder of the product licence and of the manufacturer.

2

The therapeutic indications.

3

A list of information which is necessary before taking the medicinal product, as follows—

(a)

contra-indications;

(b)

appropriate precautions for use;

(c)

forms of interaction with other medicinal products, with alcohol, tobacco and food and any other form of interaction which may affect the action of the medicinal product;

(d)

special warnings,

which

(i)

take into account the particular condition of certain categories of users;

(ii)

mention, if appropriate, potential effects on the ability to drive vehicles or to operate machinery;

(iii)

give details of those excipients, knowledge of which is important for the safe and effective use of the medicinal product.

4

The necessary and usual instructions for proper use of the medicinal product which shall include:—

(a)

the dosage;

(b)

the method and, if necessary, route of administration;

(c)

the frequency of administration, specifying if necessary the time at which the medicinal product may or must be administered;

and, where the nature of the product makes it appropriate, shall also include—

(d)

the duration of treatment where it should be limited;

(e)

the action to be taken in the case of an overdose;

(f)

the course of action to take when one or more doses have not been taken;

(g)

indication, if necessary, of the risk of withdrawal effects.

5

A description of the undesirable effects which can occur with normal use of the medicinal product and if necessary, the action to be taken in such a case, together with an express invitation to the patient to communicate any undesirable effect which is not mentioned in the leaflet to his doctor or pharmacist.

6

A reference to the expiry date indicated on the label with:—

(a)

a warning against using the product after this date;

(b)

where appropriate, special storage precautions;

(c)

if necessary, a warning against certain visible signs of deterioration.

7

The date upon which the leaflet was last revised.”.