Annexes to COM(2005)567 - Advanced therapy medicinal products - Main contents

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dossier	COM(2005)567 - Advanced therapy medicinal products.
document	COM(2005)567
date	November 13, 2007

ANNEX I

Manipulations referred to in the first indent of Article 2(1)(c)

—

cutting,

—

grinding,

—

shaping,

—	centrifugation,

—	soaking in antibiotic or antimicrobial solutions,

—	sterilization,

—	irradiation,

—	cell separation, concentration or purification,

—	filtering,

—	lyophilization,

—

freezing,

—	cryopreservation,

—	vitrification.

ANNEX II

Summary of product characteristics referred to in Article 10

1. Name of the medicinal product.

Composition of the product:

2.1.   general description of the product, if necessary with explanatory drawings and pictures,

2.2.   qualitative and quantitative composition in terms of the active substances and other constituents of the product, knowledge of which is essential for proper use, administration or implantation of the product. Where the product contains cells or tissues, a detailed description of these cells or tissues and of their specific origin, including the species of animal in cases of non-human origin, shall be provided,

For a list of excipients, see point 6.1.

3. Pharmaceutical form.

Clinical particulars:

4.1.   therapeutic indications,

4.2.   posology and detailed instructions for use, application, implantation or administration for adults and, where necessary, for children or other special populations, if necessary with explanatory drawings and pictures,

4.3.   contra-indications,

4.4.   special warnings and precautions for use, including any special precautions to be taken by persons handling such products and administering them to or implanting them in patients, together with any precautions to be taken by the patient,

4.5.   interaction with other medicinal products and other forms of interactions,

4.6.   use during pregnancy and lactation,

4.7.   effects on ability to drive and to use machines,

4.8.   undesirable effects,

4.9.   overdose (symptoms, emergency procedures).

Pharmacological properties:

5.1.   pharmacodynamic properties,

5.2.   pharmacokinetic properties,

5.3.   preclinical safety data.

Quality particulars:

6.1.   list of excipients, including preservative systems,

6.2.   incompatibilities,

6.3.   shelf life, when necessary after reconstitution of the medicinal product or when the immediate packaging is opened for the first time,

6.4.   special precautions for storage,

6.5.   nature and contents of container and special equipment for use, administration or implantation, if necessary with explanatory drawings and pictures,

6.6.   special precautions and instructions for handling and disposal of a used advanced therapy medicinal product or waste materials derived from such product, if appropriate and, if necessary, with explanatory drawings and pictures.

7. Marketing authorisation holder.

8. Marketing authorisation number(s).

9. Date of the first authorisation or renewal of the authorisation.

10. Date of revision of the text.

ANNEX III

Labelling of outer/immediate packaging referred to in Article 11

(a)	The name of the medicinal product and, if appropriate, an indication of whether it is intended for babies, children or adults; the international non-proprietary name (INN) shall be included, or, if the product has no INN, the common name;

(b)

A description of the active substance(s) expressed qualitatively and quantitatively, including, where the product contains cells or tissues, the statement ‘This product contains cells of human/animal [as appropriate{] origin’ together with a short description of these cells or tissues and of their specific origin, including the species of animal in cases of non-human origin;

(c)	The pharmaceutical form and, if applicable, the contents by weight, by volume or by number of doses of the product;

(d)	A list of excipients, including preservative systems;

(e)	The method of use, application, administration or implantation and, if necessary, the route of administration. If applicable, space shall be provided for the prescribed dose to be indicated;

(f)	A special warning that the medicinal product must be stored out of the reach and sight of children;

(g)	Any special warning necessary for the particular medicinal product;

(h)	The expiry date in clear terms (month and year; and day if applicable);

(i)	Special storage precautions, if any;

(j)	Specific 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)	The name and address of the marketing authorisation holder and, where applicable, the name of the representative appointed by the holder to represent him;

(l)	Marketing authorisation number(s);

(m)	The manufacturer’s batch number and the unique donation and product codes referred to in Article 8(2) of Directive 2004/23/EC;

(n)	In the case of advanced therapy medicinal products for autologous use, the unique patient identifier and the statement ‘For autologous use only’.

ANNEX IV

Package leaflet referred to in Article 13

(a)

For the identification of the advanced therapy medicinal product:

(i)	the name of the advanced therapy medicinal product and, if appropriate, an indication of whether it is intended for babies, children or adults. The common name shall be included;

(ii)	the therapeutic group or type of activity in terms easily understandable for the patient;

(iii)

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;

(iv)	where the product contains medical devices or active implantable medical devices, a description of those devices and their specific origin;

(b)	The therapeutic indications;

(c)

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

(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;

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

(vi)	the 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 of Directive 2001/83/EC.

The list shall also take into account the particular condition of certain categories of users, such as children, pregnant or breastfeeding women, the elderly, persons with specific pathological conditions;

(d)

The necessary and usual instructions for proper use, and in particular:

(i)	the posology;

(ii)	the method of use, application, administration or implantation and, if necessary, the route of administration; and, as appropriate, depending on the nature of the product:

(iii)

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

(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)	information on what to do when one or more doses have not been taken;

(vii)

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 and quantitative composition;

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

(vi)	the name and address of the manufacturer;

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