|
The following
paragraphs are taken verbatim from 2001/83/EC,
e.g. without any changes or modifications.
DIRECTIVE
2001/83/EC
OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 6 November 2001
on the Community code relating to medicinal products for human use
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,
Having regard to the Treaty establishing the
European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission;
Having regard to the opinion of the Economic and
Social Committee,
Acting in accordance with the procedure laid down
in Article 251 of the Treaty,
Whereas:
(1) Council Directive 65/65/EEC of 26
January 1965 on the approximation of provisions laid down by law,
regulation or administrative action relating to medicinal products,
Council Directive 75/318/EEC of 20 May 1975 on the approximation of the
laws of Member States relating to analytical, pharmaco-toxicological and
clinical standards and protocols in respect of the testing of proprietary
medicinal products, Council Directive 75/319/EEC of 20 May 1975 on the
approximation of provisions laid down by law, regulation or administrative
action relating to proprietary medicinal products, Council Directive
89/342/EEC of 3 May 1989 extending the scope of Directives 65/65/EEC and
75/319/EEC and laying down additional provisions for immunological
medicinal products consisting of vaccines, toxins or serums and allergens,
Council Directive 89/343/EEC of 3 May 1989 extending the scope of
Directives 65/65/EEC and 75/319/EEC and laying down additional provisions
for radiopharmaceuticals, Council Directive 89/381/EEC of 14 June 1989
extending the scope of Directives 65/65/EEC and 75/319/EEC on the
approximation of provisions laid down by law, regulation or administrative
action relating to medicinal products and laying down special provisions
for proprietary medicinal products derived from human blood or human
plasma, Council Directive 92/25/EEC of 31 March 1992 on the wholesale
distribution of medicinal products for human use, Council Directive
92/26/EEC of 31 March 1992 concerning the classification for the supply of
medicinal products for human use, Council Directive 92/27/EEC of 31 March
1992 on the labelling of medicinal products for human use and on package
leaflets, Council Directive 92/28/EEC of 31 March 1992 on the advertising
of medicinal products for human use, Council Directive 92/73/EEC of 22
September 1992 widening the scope of Directives 65/65/EEC and 75/319/EEC
on the approximation of provisions laid down by law, regulation or
administrative action relating to medicinal products and laying down
additional provisions on homeopathic medicinal products have been
frequently and substantially amended. In the interests of clarity and
rationality, the said Directives should therefore be codified by
assembling them in a single text.
(2) The essential aim of any rules
governing the production, distribution and use of medicinal products must
be to safeguard public health.
(3) However, this objective must be
attained by means which will not hinder the development of the
pharmaceutical industry or trade in medicinal products within the
Community.
(4) Trade in medicinal products within the
Community is hindered by disparities between certain national provisions,
in particular between provisions relating to medicinal products (excluding
substances or combinations of substances which are foods, animal
feeding-stuffs or toilet preparations), and such disparities directly
affect the functioning of the internal market.
(5) Such hindrances must accordingly be
removed; whereas this entails approximation of the relevant provisions.
(6) In order to reduce the disparities
which remain, rules should be laid down on the control of medicinal
products and the duties incumbent upon the Member States' competent
authorities should be specified with a view to ensuring compliance with
legal requirements.
(12) With the exception of those medicinal
products which are subject to the centralized Community authorization
procedure established by Council Regulation (EEC) No 2309/93 of 22 July
1993 laying down Community procedures for the authorization and
supervision of medicinal products for human and veterinary use and
establishing a European Agency for the Evaluation of Medicinal Products a
marketing authorization for a medicinal product granted by a competent
authority in one Member State ought to be recognized by the competent
authorities of the other Member States unless there are serious grounds
for supposing that the authorization of the medicinal product concerned
may present a risk to public health. In the event of a disagreement
between Member States about the quality, the safety or the efficacy of a
medicinal product, a scientific evaluation of the matter should be
undertaken according to a Community standard, leading to a single decision
on the area of disagreement binding on the Member States concerned.
Whereas this decision should be adopted by a rapid procedure ensuring
close cooperation between the Commission and the Member States.
(30) In this connection persons moving
around within the Community have the right to carry a reasonable quantity
of medicinal products lawfully obtained for their personal use. It must
also be possible for a person established in one Member State to receive
from another Member State a reasonable quantity of medicinal products
intended for his personal use.
TITLE II
Article 5
A Member State may, in accordance with legislation
in force and to fulfil special needs, exclude from the provisions of this
Directive medicinal products supplied in response to a bona fide
unsolicited order, formulated in accordance with the specifications of an
authorized health care professional and for use by his individual patients
on his direct personal responsibility.
TITLE III
Article 10
1. In derogation of Article 8(3)(i), and without
prejudice to the law relating to the protection of industrial and
commercial property:
(a) The applicant shall not be required to provide
the results of toxicological and pharmacological tests or the results of
clinical trials if he can demonstrate:
(i) either that the medicinal product is
essentially similar to a medicinal product authorized in the Member State
concerned by the application and that the holder of the marketing
authorization for the original medicinal product has consented to the
toxicological, pharmacological and/or clinical references contained in the
file on the original medicinal product being used for the purpose of
examining the application in question;
(ii) or that the constituent or constituents of
the medicinal product have a well established medicinal use, with
recognized efficacy and an acceptable level of safety, by means of a
detailed scientific bibliography;
(iii) or that the medicinal product is essentially
similar to a medicinal product which has been authorized within the
Community, in accordance with Community provisions in force, for not less
than six years and is marketed in the Member State for which the
application is made. This period shall be extended to 10 years in the case
of high-technology medicinal products having been authorised according to
the procedure laid down in Article 2(5) of Council Directive 87/22/EEC.
Furthermore, a Member State may also extend this period to 10 years by a
single Decision covering all the medicinal products marketed on its
territory where it considers this necessary in the interest of public
health. Member States are at liberty not to apply the six-year period
beyond the date of expiry of a patent protecting the original medicinal
product. However, where the medicinal product is intended for a different
therapeutic use from that of the other medicinal products marketed or is
to be administered by different routes or in different doses, the results
of appropriate toxicological and pharmacological tests and/or of
appropriate clinical trials must be provided.
(b) In the case of new medicinal products
containing known constituents not hitherto used in combination for
therapeutic purposes, the results of toxicological and pharmacological
tests and of clinical trials relating to that combination must be
provided, but it shall not be necessary to provide references relating to
each individual constituent.
2. Annex I shall apply by analogy where, pursuant
to point (ii) of paragraph 1, (a), bibliographic references to published
data are submitted.
TITLE VI
Article 71
1. Medicinal products shall be subject to
medicalprescription where they:
- are likely to present a danger either directly
or indirectly, even when used correctly, if utilized without medical
supervision, or
- are frequently and to a very wide extent used
incorrectly, and as a result are likely to present a direct or indirect
danger to human health, or
- contain substances or preparations thereof, the
activity and/or adverse reactions of which require further investigation,
or
- are normally prescribed by a doctor to be
administered parenterally.
2. Where Member States provide for the
sub-category of medicinal products subject to special medical
prescription, they shall take account of the following factors:
- the medicinal product contains, in a non-exempt
quantity, a substance classified as a narcotic or a psychotropic substance
within the meaning of the international conventions in force, such as the
United Nations Conventions of 1961 and 1971, or
- the medicinal product is likely, if incorrectly
used, to present a substantial risk of medicinal abuse, to lead to
addiction or be misused for illegal purposes, or
- the medicinal product contains a substance
which, by reason of its novelty or properties, could be considered as
belonging to the group envisaged in the second indent as a precautionary
measure.
3. Where Member States provide for the
sub-category of medicinal products subject to restricted prescription,
they shall take account of the following factors:
- the medicinal product, because of its
pharmaceutical characteristics or novelty or in the interests of public
health, is reserved for treatments which can only be followed in a
hospital environment,
- the medicinal product is used in the treatment
of conditions which must be diagnosed in a hospital environment or in
institutions with adequate diagnostic facilities, although administration
and follow-up may be carried out elsewhere, or
- the medicinal product is intended for
outpatients but its use may produce very serious adverse reactions
requiring a prescription drawn up as required by a specialist and special
supervision throughout the treatment.
4. A competent authority may waive application of
paragraphs 1, 2 and 3 having regard to:
(a) the maximum single dose, the maximum daily
dose, the strength, the pharmaceutical form, certain types of packaging;
and/or
(b) other circumstances of use which it has
specified.
5. If a competent authority does not designate
medicinal products into sub-categories referred to in Article 70, it shall
nevertheless take into account the criteria referred to in paragraphs 2
and 3 of this Article in determining whether any medicinal product shall
be classified as a prescription-only medicine.
Article 72
Medicinal products not subject to prescription
shall be those which do not meet the criteria listed in Article 71. |
TOP