Principles and Practice of Pharmaceutical Medicine

4.8 Undesirable effects. The precise wording pre-
scribed for expression of frequencies of
adverse effects is given in the guideline

4.9 Overdose

5. Pharmacological properties

5.1 Pharmacodynamic properties

5.2 Pharmacokinetic properties

5.3 Preclinical safety data

6. Pharmaceutical particulars

6.1 List of excipients

6.2 Incompatibilities

6.3 Shelf-life – as packaged for sale, after recon-
stitution (if applicable), after first opening of
packaging container

6.4 Special precautions for storage

6.5 Nature and contents of container

6.6 Instructions for use and handling, and disposal

7. Marketing authorization holder


8. Marketing authorization number(s)


9. Date of first authorization/renewal of authoriza-
   tion


10. Date of revision of the text

Products authorized through the CP carry a ‘blue
box’ on the package label, containing information
specific to the MS in which the product is mar-
keted. This is the only part of the label that canvary
for those products, and is the result of retained
national authority for decisions on package size,
pricing and classification of centralized authorized
products.

Package labeling and patient

information leaflet

The PIL and the label of the drug container itself

are as precisely regulated as the SmPC. Changes in

any of these documents have to be approved by the

RA (see license variations below).

Directive2001/83,the CommunityCode sets the

standard for labeling and PIL.

IMP labeling is regulated by the GMP guide-

lines. These labels should include:

name of the sponsor;

pharmaceutical dosage form, route of adminis-

tration, quantity of dosage units (and name/iden-

tifier of the product and strength/potency in case

of an open trial);

the batch and/or code number to identify the

contents and packaging operation;

the trial subject identification number, where

applicable;

directions for use;

‘for clinical trial use only’;

the name of the investigator (if not included as a

code in the trial reference code);

a trial reference code allowing identification of

the trial site and investigator;

the storage conditions;

the period of use (use by date, expiry date or

retest date as applicable) in month/year;

‘keep out of reach of children’, except when the

product is for use only in hospital.

If the outer packaging of the IMP contains all of the

above listed items, the immediate packaging needs

to carry only the first five items; there are further

specifications on the labeling of various immediate

472 CH34 MEDICINES REGULATION IN THE EUROPEAN UNION