Principles and Practice of Pharmaceutical Medicine

of administration and any information necessary
for the safe use of the traditional herbal medicinal
product. Where an application will refer to a pro-
duct included in that list, it will not be necessary to
provide proof of long-term use, or evaluation of
safety data.
The new Directive became effective on March
31, 2004 and implemention was mandatory in MS
by October 30, 2005. For traditional herbal medic-
inal products already in the market, these new
provisions become effective by March 31, 2011,
thus providing a seven-year transitional period for
manufacturers to comply with the minimal regula-
tory requirements of the Directive.

34.12 Labeling

Summary of product characteristics

The SmPC is amongst the most crucial documents
in the marketing authorization application, as it
forms the basis of the MA and consequently is
the basis for the labeling of the product. Any state-
ment in the SmPC must be supported by experi-
mental data in the dossier. It is defined during the
development of the drug and finalized through a
scientific discussion with the RA, and therefore
constitutes a reference that cannot be changed,
unless new experimental data are made available,
approved and authorized. The SmPC represents the
basic element of communication for the company;
in fact any information on the drug, including
labeling and advertising, is bound to this document
that also plays a fundamental role in the MRP.
Directive 2001/83/EC as amended by Directive
2004/27, specifies the required information for the
SmPC and the PIL.
In the guideline on SmPC the exact layout and
the contents are defined. Additional guidelines
issued by central bodies as well as national regu-
latory authorities provide recommended wording
for specific text in various different classes of
medical products in the jurisdiction of the RA
(e.g. the MHRA document ‘generic’ overdose sec-
tions for selected SmPCs, Feb 2004).
Separate SmPCs for each pharmaceutical form
and strength of a medicinal product are required.

Reasonable merging of multiple SmPCs into one

for advertising of a single product is permitted.

The headings in the SmPC are as follows:

1. Name of the medicinal product (Trade) name of
   product, strength and pharmaceutical form


2. Qualitative and quantitative composition for the
   active substances


3. Pharmaceutical form (standard terminology per
   the European Pharmacopoeia and Section 1 of
   the SmPC)


4. Clinical particulars

4.1 Therapeutic indications

4.2 Posology and method of administration,

including advice on pediatric experience, or

lack thereof with reference to section 5.3; dose

adjustments (e.g. in renal insufficiency)

4.3 Contraindications (pregnancy only to be men-

tioned if actually contraindicated)

4.4 Special warnings and precautions for use (in

the order: relative contraindications, warnings

and precautions) including special popula-

tions at risk. Warnings about excipients and

hypersensitivity are mandatory in this section.

However, interactions, pregnancy, lactation

and ability to operate machines do not belong

in this section

4.5 Interaction with other medicinal products and

other forms of interactions, with recommen-

dations for contraindication of concomitant

use, mechanism of interaction (if known)

4.6 Pregnancy and lactation. It must be made clear

what extent of experience in pregnancy or lac-

tation, or the lack of experience, exists. Rele-

vant preclinical details should be given in

Section 5.3. Further recommendations about

women of childbearing potential and lactation

4.7 Effects on ability to drive and use machines

34.12 LABELING 471