http://ec.europa.eu/enterprise/pharmaceuti..._2001_83_en.pdfDIRECTIVE 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
Homeopathic medicinal product:
Any medicinal product prepared from products,
substances or compositions called homeopathic stocks in
accordance with a homeopathic manufacturing procedure
described by the European Pharmacopoeia or, in absence
thereof, by the pharmacopoeias currently used officially in
the Member States.
A homeopathic medicinal product may also contain a
number of principles.
CHAPTER 2
Specific provisions applicable to homeopathic medicinal
products
Article 13
1. Member States shall ensure that homeopathic medicinal
products manufactured and placed on the market within the
L 311/76 EN Official Journal of the European Communities 28.11.2001
Community are registered or authorized in accordance with
Articles 14, 15 and 16, except where the products are covered
by a registration or authorization which was granted under
national law on or before 31 December 1993 (and whether or
not that registration or authorization has been renewed after
that date). Each Member State shall take due account of
registrations and authorizations previously granted by another
Member State.
2. A Member State may refrain from establishing a special,
simplified registration procedure for the homeopathic
medicinal products referred to in Article 14. A Member State
shall inform the Commission accordingly. The Member State
concerned shall allow the use in its territory of homeopathic
medicinal products registered by other Member States in
accordance with Articles 14 and 15.
Article 14
1. Only homeopathic medicinal products which satisfy all
of the following conditions may be subject to a special,
simplified registration procedure:
they are administered orally or externally,
no specific therapeutic indication appears on the labelling
of the medicinal product or in any information relating
thereto,
there is a sufficient degree of dilution to guarantee the
safety of the medicinal product; in particular, the medicinal
product may not contain either more than one part per
10 000 of the mother tincture or more than 1/100th of
the smallest dose used in allopathy with regard to active
substances whose presence in an allopathic medicinal
product results in the obligation to submit a doctor's
prescription.
At the time of registration, Member States shall determine the
classification for the dispensing of the medicinal product.
2. The criteria and rules of procedure provided for in
Article 4(4), Article 17(1) and Articles 22 to 26, 112, 116 and
125 shall apply by analogy to the special, simplified
registration procedure for homeopathic medicinal products,
with the exception of the proof of therapeutic efficacy.
3. The proof of therapeutic efficacy shall not be required
for homeopathic medicinal products registered in accordance
with paragraph 1 of this Article, or, where appropriate,
admitted in accordance with Article 13(2).
Article 15
An application for special, simplified registration may cover a
series of medicinal products derived from the same
homeopathic stock or stocks. The following documents shall
be included with the application in order to demonstrate, in
particular, the pharmaceutical quality and the batch-to-batch
homogeneity of the products concerned:
scientific name or other name given in a pharmacopoeia of
the homeopathic stock or stocks, together with a statement
of the various routes of administration, pharmaceutical
forms and degree of dilution to be registered,
dossier describing how the homeopathic stock or stocks
is/are obtained and controlled, and justifying its/their
homeopathic nature, on the basis of an adequate
bibliography,
manufacturing and control file for each pharmaceutical
form and a description of the method of dilution and
potentization,
manufacturing authorization for the medicinal product
concerned,
copies of any registrations or authorizations obtained for
the same medicinal product in other Member States,
one or more specimens or mock-ups of the outer
packaging and the immediate packaging of the medicinal
products to be registered,
data concerning the stability of the medicinal product.
Article 16
1. Homeopathic medicinal products other than those
referred to in Article 14(1) shall be authorized and labelled in
accordance with Articles 8, 10 and 11.
2. A Member State may introduce or retain in its territory
specific rules for the toxicological and pharmacological tests
and clinical trials of homeopathic medicinal products other
than those referred to in Article 14(1) in accordance with the
principles and characteristics of homeopathy as practised in
that Member State.
In this case, the Member State concerned shall notify the
Commission of the specific rules in force.
3. Title IX shall apply to homeopathic medicinal products,
with the exception of those referred to in Article 14(1
karaokeწადი ახლა და უჩივლე ევროკავშირს.
შარლატანები ხართ თქო
This post has been edited by basa-ttt on 5 Jul 2009, 16:50
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უნდა იყოს თუ არა ჰომეოპათია აკრძალული?, უნდა იყოს თუ არა ჰომეოპათია აკრძალული?
