Changes from plenary report to adopted text

Added(d) special warnings and precautions for use and, in the case of immunological medicinal products, any special precautions to be taken by persons handling such medicinal products and administering them to patients, together with any precautions to be taken by the patient,

Added(e) interaction with other medicinal products and other forms of interactions,

Added(f) use during pregnancy and lactation,

Added(g) effects on ability to drive and to use machines,

Added(h) undesirable effects,

Added(i) overdose (symptoms, emergency procedures, antidotes).

Added(5) pharmacological properties:

Added(a) pharmacodynamic properties,

Added(b) pharmacokinetic properties,

Added(c) non-clinical safety data.

Added(6) pharmaceutical particulars:

Added(a) list of excipients,

Added(b) major incompatibilities,

Added(c) shelf life, when necessary after reconstitution of the medicinal product or when the immediate packaging is opened for the first time,

Added(d) special precautions for storage,

Added(e) nature and contents of container,

Added(f) special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product, if appropriate as well as any designated collection system in place. In case of antimicrobial medicinal products in addition to the precautions a warning that inappropriate disposal of the medicinal product contributes to antimicrobial resistance. [Am. 335]

Added(7) marketing authorisation holder.

Added(8) marketing authorisation numbers.

Added(9) date of the first marketing authorisation or renewal of the marketing authorisation.

Added(10) date of revision of the text.

Added(11) for radiopharmaceuticals, full details of internal radiation dosimetry.

Added(12) for radiopharmaceuticals, additional detailed instructions for extemporaneous preparation and quality control of such preparation and, where appropriate, maximum storage time during which any intermediate preparation such as an eluate or the ready-to-use pharmaceutical will conform with its specifications.

AddedFor marketing authorisations under Articles 9 to 12 and subsequent variations, those parts of the summary of product characteristics of the reference medicinal product referring to indications or dosage forms that are still covered by patent law at the time when a generic or biosimilar medicinal product is placed on the market need not be included.

AddedAnnex VI

AddedCONTENTS OF PACKAGE LEAFLET

AddedThe package leaflet shall contain, in the order indicated below, the following information:

Added(1) for the identification of the medicinal product:

Added(a) 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 medicinal product contains only one active substance and if its name is an invented name;

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

Added(2) the therapeutic indications;

Added(2a) a key information section reflecting the results of consultations with patients’ organisations to ensure that the leaflet is legible, clear and easy to use; [Am. 336]

Added(3) a list of information that is necessary before the medicinal product is taken:

Added(a) contra-indications;

Added(b) appropriate precautions for use;

Added(c) forms of interaction with other medicinal products and other forms of interaction (e.g. alcohol, tobacco, food) that may affect the action of the medicinal product;

Added(d) special warnings;

Added(4) the necessary and usual instructions for proper use, and in particular:

Added(a) the dosage,

Added(b) the method and, if necessary, route of administration, and where relevant a description of the measuring or delivery device, as well as the relevant individual steps of medicine preparation and administration; [Am. 337]

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

Added- and, as appropriate, depending on the nature of the medicinal product:

Added(d) the duration of treatment, where it should be limited;

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

Added(f) what to do when one or more doses have not been taken;

Added(g) indication, if necessary, of the risk of withdrawal effects;

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

Added(5) a description of the adverse reactions that may occur under normal use of the medicinal product and, if necessary, the action to be taken in such a case;

Added(6) references to the following:

Added(a) the expiry date indicated on the label, with a warning against using the medicinal product after that date;

Added(b) where appropriate, special storage precautions;

Added(c) if necessary, a warning concerning certain visible signs of deterioration;

Added(d) 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;

Added(e) for each presentation of the medicinal product, the pharmaceutical form and content in weight, volume or units of dosage;

Added(f) information on where the leaflet is available in formats accessible for persons with disabilities;

Added(g) the name and address of the marketing authorisation holder and, where applicable, the name of their appointed representatives in the Member States;

Added(h) the name and address of the manufacturer.

Added(7) the date on which the package leaflet was last revised;

Added(8) for antimicrobials, a warning that improper use and disposal of the medicinal product contributes to antimicrobial resistance.

AddedThe list set out in point (3) shall: