xmlns:atom="http://www.w3.org/2005/Atom" xmlns:atom="http://www.w3.org/2005/Atom"

TITLE VU.K.LABELLING AND PACKAGE LEAFLET

Article 54U.K.

The following particulars shall appear on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging:

(a)

[F1the name of the medicinal product followed by its strength and pharmaceutical form, and, if appropriate, whether it is intended for babies, children or adults; where the product contains up to three active substances, the international non-proprietary name (INN) shall be included, or, if one does not exist, the common name;]

(b)

a statement of the active substances expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names;

(c)

the pharmaceutical form and the contents by weight, by volume or by number of doses of the product;

(d)

a list of those excipients known to have a recognized action or effect and included in the [F1detailed guidance] published pursuant to Article 65. However, if the product is injectable, or a topical or eye preparation, all excipients must be stated;

(e)

[F1the method of administration and, if necessary, the route of administration. Space shall be provided for the prescribed dose to be indicated;]

(f)

[F1a special warning that the medicinal product must be stored out of the reach and sight of children;]

(g)

a special warning, if this is necessary for the medicinal product;

(h)

the expiry date in clear terms (month/year);

(i)

special storage precautions, if any;

(j)

[F1specific precautions relating to the disposal of unused medicinal products or waste derived from medicinal products, where appropriate, as well as reference to any appropriate collection system in place;]

(k)

[F1the name and address of the marketing authorisation holder and, where applicable, the name of the representative appointed by the holder to represent him;]

(l)

the number of the authorization for placing the medicinal product on the market;

(m)

the manufacturer's batch number;

(n)

[F1in the case of non-prescription medicinal products, instructions for use.]

Article 55U.K.

1.The particulars laid down [F1in Article 54] shall appear on immediate packagings other than those referred to in paragraphs 2 and 3.

2.The following particulars at least shall appear on immediate packagings which take the form of blister packs and are placed in an outer packaging that complies with the requirements laid down in Articles 54 and 62.

3.The following particulars at least shall appear on small immediate packaging units on which the particulars laid down in Articles 54 and 62 cannot be displayed:

Article 56U.K.

The particulars referred to in Articles 54, 55 and 62 shall be easily legible, clearly comprehensible and indelible.

[F2Article 56a U.K.

The name of the medicinal product, as referred to in Article 54, point (a) must also be expressed in Braille format on the packaging. The marketing authorisation holder shall ensure that the package information leaflet is made available on request from patients' organisations in formats appropriate for the blind and partially-sighted.]

Article 57U.K.

Notwithstanding Article 60, Member States may require the use of certain forms of labelling of the medicinal product making it possible to ascertain:

[F2For medicinal products authorised under Regulation (EC) No 726/2004, Member States shall, when applying this Article, observe the detailed guidance referred to in Article 65 of this Directive.]

Article 58U.K.

The inclusion in the packaging of all medicinal products of a package leaflet shall be obligatory unless all the information required by Articles 59 and 62 is directly conveyed on the outer packaging or on the immediate packaging.

[F1Article 59 U.K.

1. The package leaflet shall be drawn up in accordance with the summary of the product characteristics; it shall include, in the following order:

(a) for the identification of the medicinal product:

(i)

the name of the medicinal product followed by its strength and pharmaceutical form, and, if appropriate, whether it is intended for babies, children or adults. The common name shall be included where the product contains only one active substance and if its name is an invented name;

(ii)

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

(b) the therapeutic indications;

(c) a list of information which is necessary before the medicinal product is taken:

(i)

contra-indications;

(ii)

appropriate precautions for use;

(iii)

forms of interaction with other medicinal products and other forms of interaction (e.g. alcohol, tobacco, foodstuffs) which may affect the action of the medicinal product;

(iv)

special warnings;

(d) the necessary and usual instructions for proper use, and in particular:

(i)

the dosage,

(ii)

the method and, if necessary, route of administration;

(iii)

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

and, as appropriate, depending on the nature of the product:

(iv)

the duration of treatment, where it should be limited;

(v)

the action to be taken in case of an overdose (such as symptoms, emergency procedures);

(vi)

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

(vii)

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

(viii)

a specific recommendation to consult the doctor or the pharmacist, as appropriate, for any clarification on the use of the product;

(e) a description of the adverse reactions which may occur under normal use of the medicinal product and, if necessary, the action to be taken in such a case; the patient should be expressly asked to communicate any adverse reaction which is not mentioned in the package leaflet to his doctor or pharmacist;

(f) a reference to the expiry date indicated on the label, with:

(i)

a warning against using the product after that date;

(ii)

where appropriate, special storage precautions;

(iii)

if necessary, a warning concerning certain visible signs of deterioration;

(iv)

the full qualitative composition (in active substances and excipients) and the quantitative composition in active substances, using common names, for each presentation of the medicinal product;

(v)

for each presentation of the product, the pharmaceutical form and content in weight, volume or units of dosage;

(vi)

the name and address of the marketing authorisation holder and, where applicable, the name of his appointed representatives in the Member States;

(vii)

the name and address of the manufacturer;

(g) where the medicinal product is authorised in accordance with Articles 28 to 39 under different names in the Member States concerned, a list of the names authorised in each Member State;

(h) the date on which the package leaflet was last revised.

2. The list set out in point (c) of paragraph 1 shall:

(a) take into account the particular condition of certain categories of users (children, pregnant or breastfeeding women, the elderly, persons with specific pathological conditions);

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

(c) list those excipients knowledge of which is important for the safe and effective use of the medicinal product and which are included in the detailed guidance published pursuant to Article 65.

3. The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use.]

Article 60U.K.

Member States may not prohibit or impede the placing on the market of medicinal products within their territory on grounds connected with labelling or the package leaflet where these comply with the requirements of this Title.

Article 61U.K.

[F11. One or more mock-ups of the outer packaging and the immediate packaging of a medicinal product, together with the draft package leaflet, shall be submitted to the authorities competent for authorising marketing when the marketing authorisation is requested. The results of assessments carried out in cooperation with target patient groups shall also be provided to the competent authority.]

2.The competent authority shall refuse the marketing authorization if the labelling or the package leaflet do not comply with the provisions of this Title or if they are not in accordance with the particulars listed in the summary of product characteristics.

3.All proposed changes to an aspect of the labelling or the package leaflet covered by this Title and not connected with the summary of product characteristics shall be submitted to the authorities competent for authorizing marketing. If the competent authorities have not opposed a proposed change within 90 days following the introduction of the request, the applicant may put the change into effect.

4.The fact that the competent authority do not refuse a marketing authorization pursuant to paragraph 2 or a change to the labelling or the package leaflet pursuant to paragraph 3 does not alter the general legal liability of the manufacturer [F1and] the marketing authorization holder.

Article 62U.K.

The outer packaging and the package leaflet may include symbols or pictograms designed to clarify certain information mentioned in Articles 54 and 59(1) and other information compatible with the summary of the product characteristics which is useful [F1to the patient], to the exclusion of any element of a promotional nature.

Article 63U.K.

1.The particulars for labelling listed in Articles 54, 59 and 62 shall appear in the official language or languages of the Member State where the product is placed on the market.

The first subparagraph shall not prevent these particulars from being indicated in several languages, provided that the same particulars appear in all the languages used.

[F2In the case of certain orphan medicinal products, the particulars listed in Article 54 may, on reasoned request, appear in only one of the official languages of the Community.]

[F12. The package leaflet must be written and designed to be clear and understandable, enabling the users to act appropriately, when necessary with the help of health professionals. The package leaflet must be clearly legible in the official language or languages of the Member State in which the medicinal product is placed on the market.

The first subparagraph shall not prevent the package leaflet from being printed in several languages, provided that the same information is given in all the languages used.

3. When the product is not intended to be delivered directly to the patient, the competent authorities may grant an exemption to the obligation that certain particulars should appear on the labelling and in the package leaflet and that the leaflet must be in the official language or languages of the Member State in which the product is placed on the market.]

Article 64U.K.

Where the provisions of this Title are not complied with, and a notice served on the person concerned has remained without effect, the competent authorities of the Member States may suspend the marketing authorization, until the labelling and the package leaflet of the medicinal product in question have been made to comply with the requirements of this Title.

[F1Article 65 U.K.

In consultation with the Member States and the parties concerned, the Commission shall draw up and publish detailed guidance concerning in particular:

(a)

the wording of certain special warnings for certain categories of medicinal products;

(b)

the particular information needs relating to non-prescription medicinal products;

(c)

the legibility of particulars on the labelling and package leaflet;

(d)

the methods for the identification and authentication of medicinal products;

(e)

the list of excipients which must feature on the labelling of medicinal products and the way in which these excipients must be indicated;

(f)

harmonised provisions for the implementation of Article 57.]

Article 66U.K.

1.The outer carton and the container of medicinal products containing radionuclides shall be labelled in accordance with the regulations for the safe transport of radioactive materials laid down by the International Atomic Energy Agency. Moreover, the labelling shall comply with the provisions set out in paragraphs 2 and 3.

2.The label on the shielding shall include the particulars mentioned in Article 54. In addition, the labelling on the shielding shall explain in full, the codings used on the vial and shall indicate, where necessary, for a given time and date, the amount of radioactivity per dose or per vial and the number of capsules, or, for liquids, the number of millilitres in the container.

3.The vial shall be labelled with the following information:

Article 67U.K.

The competent authority shall ensure that a detailed instruction leaflet is enclosed with the packaging of radiopharmaceuticals, radionuclide generators, radionuclide kits or radionuclide precursors. The text of this leaflet shall be established in accordance with the provisions of Article 59. In addition, the leaflet shall include any precautions to be taken by the user and the patient during the preparation and administration of the medicinal product and special precautions for the disposal of the packaging and its unused contents.

Article 68U.K.

Without prejudice to the provisions of Article 69, homeopathic medicinal products shall be labelled in accordance with the provisions of this title and shall be identified by a reference on their labels, in clear and legible form, to their homeopathic nature.

Article 69U.K.

1.In addition to the clear mention of the words ‘homeopathic medicinal product’, the labelling and, where appropriate, the package insert for the medicinal products referred to in Article 14(1) shall bear the following, and no other, information:

2.Notwithstanding paragraph 1, Member States may require the use of certain types of labelling in order to show: