Regulation 204 Amendment of Schedule 27 (package leaflets)I1

Schedule 27 M1 is amended as follows.

In paragraph 8(c)(ii), for “Article 65 of the 2001 Directive”, substitute “ published under regulation 257D F1in the case of products for sale or supply in Great Britain, or in the case of products for sale or supply in Northern Ireland, any guidance published pursuant to Article 65 of the 2001 Directive or under regulation 257D that is applicable to such products. ”.

In paragraph 11(f), F2for “marketing authorisation,” substitute “UK marketing authorisation, EU marketing authorisation”.

F3In paragraph 12 F4 after “ Where the product ” insert "is authorised for sale or supply in Northern Ireland and”. .

In paragraph 13—

At the end insert—

“Part 3

Advanced therapy medicinal products F7for sale or supply in Great Britain only

18

The name of the advanced therapy medicinal product.

19

Where appropriate, whether the product is intended for babies, children or adults.

20

The common name of the advanced therapy medicinal product.

21

The therapeutic group, or type of activity, of the product, in terms easily comprehensible for the patient.

22

Where the product contains cells or tissues, a description of those cells or tissues and of their specific origin, including the species of animal in cases of non-human origin.

23

Where the product contains medical devices or active implantable medical devices, a description of those devices and their specific origin.

24

The product's therapeutic indications.

25

A list of information which is necessary before the medicinal product is taken or used, including—

(a)

contra-indications;

(b)

appropriate precautions for use;

(c)

interactions with other medicinal products which may affect the action of the product;

(d)

interactions with other substances, including alcohol, tobacco and foodstuffs which may affect the action of the product;

(e)

special warnings; if any, relating to the product.

26

The list mentioned in paragraph 25 must—

(a)

take into account the special requirements of particular categories of users (including, in particular, children, pregnant or breastfeeding women, the elderly and persons with specific pathological conditions);

(b)

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

(c)

list any excipients—

(i)

if knowledge of the excipients is important for the safe and effective use of the product; and

(ii)

the excipients are included in the guidance published under regulation 257D.

27

Instructions for proper use of the product including in particular—

(a)

the dosage;

(b)

the method of use, application, administration or implantation and, if necessary, the route of administration;

(c)

the frequency of administration (including, if necessary, specifying the times at which the product may or must be administered);

(d)

the duration of treatment if this is to be time limited;

(e)

symptoms of an overdose and the action, if any, to be taken in the case of an overdose;

(f)

what to do if one or more doses have not been taken;

(g)

a specific recommendation to consult a doctor or pharmacist, as appropriate, for further explanation of the use of the product.

28

A description of the adverse reactions which may occur in normal use of the medicinal product and, if necessary, the action to be taken in such a case.

29

A reference to the expiry date printed on the packaging of the product with—

(a)

a warning against using the product after that date;

(b)

if appropriate, details of special storage precautions to be taken;

(c)

if necessary, a warning concerning visible signs of deterioration;

(d)

the full qualitative and quantitative composition;

(e)

the name and address of the UK marketing authorisation holder and, if applicable, the name of the holder's appointed representative; and

(f)

the name and address of the manufacturer.

30

The date on which the package leaflet was last revised.”.